On May 11, 2023 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, and the International Conference on Malignant Lymphoma (ICML), underscoring the company’s momentum towards delivering treatment options with the hope to transform clinical outcomes for patients (Press release, Bristol-Myers Squibb, MAY 11, 2023, View Source [SID1234631491]). Data from more than 160 company-sponsored studies, investigator-sponsored studies and collaborations evaluating compounds spanning 20 cancer types and serious blood disorders will be featured across the three meetings, including the COMMANDS study, which has been selected for the official ASCO (Free ASCO Whitepaper) press program (Abstract #7003) and EHA (Free EHA Whitepaper) plenary session (Abstract #S102).

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"We look forward to sharing our research during ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ICML, demonstrating the diversity of our assets, cutting-edge pipeline, and science-driven strategy focused on shaping the next generation of cancer care," said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. "The breadth of data and results illustrate how we are leveraging novel technologies to develop therapies that disrupt the course of disease for patients with solid tumors, blood cancers, and blood disorders. Positive study outcomes are critical, and so is ensuring those results represent and can benefit a diverse population of patients. Our health equity commitments are enabling inclusive innovation, better science and greater reach of our medicines to the patients who need them most."

Key data being presented by Bristol Myers Squibb at ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ICML 2023 include:

Hematology

First disclosure of data from the Phase 3 COMMANDS study of Reblozyl (luspatercept-aamt)versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), demonstrated highly statistically significant and clinically meaningful improvement in patients with anemia associated with very low- to intermediate-risk myelodysplastic syndromes, who require red blood cell (RBC) transfusions and are ESA-naïve. (ASCO/EHA)

Preliminary results from the dose-escalation and expansion components of the Phase 1 CC-93269-MM-001 study demonstrate subcutaneous administration of bispecific T-cell engager alnuctamab exhibited promising dose-dependent anti-tumor activity in heavily pretreated multiple myeloma, with a high proportion of responders achieving minimal residual disease negativity. (EHA) (Free EHA Whitepaper)

Results from the dose-escalation components of a Phase 1/2 study evaluating BET inhibitor BMS-986158 as monotherapy and in combination with ruxolitinib or Inrebic (fedratinib), show generally manageable safety and robust spleen volume reduction in patients with intermediate- or high-risk myelofibrosis. (EHA) (Free EHA Whitepaper)

First disclosure of clinical data from a Phase 1b study evaluating golcadomide (CC-99282), a novel CELMoDTM agent, in combination with R-CHOP in patients with previously untreated aggressive B-cell lymphoma will be presented. (ICML)

Results from a dose-expansion cohort of the Phase 1/2 CC-92480-MM-001 study, evaluating novel CELMoD agent, mezigdomide, with dexamethasone in patients with relapsed/refractory multiple myeloma, showed the combination’s safety profile and promising efficacy in patients with triple-class refractory multiple myeloma. (EHA) (Free EHA Whitepaper)
Cell Therapy

First disclosure of data from the primary analysis of the TRANSCEND CLL 004 study of Breyanzi (lisocabtagene maraleucel) demonstrated deep and durable responses and a manageable safety profile, with no new safety signals, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. (ASCO) (Free ASCO Whitepaper)
Multiple analyses from the KarMMa-3 study showed improved health-related quality of life (HRQOL) and patient-reported outcomes, in addition to lower risk of disease progression, with Abecma (idecabtagene vicleucel), regardless of baseline high-risk disease or number of prior lines of therapy, in patients with triple-class exposed relapsed and refractory multiple myeloma. (ASCO/EHA)
Interim results from Phase 1 study of GPRC5D CAR T (BMS-986393/CC-95266) demonstrated durable responses with an overall generally manageable safety profile, including in patients with prior BCMA-directed therapy. (EHA) (Free EHA Whitepaper)
Solid Tumor

Results from the registrational TRIDENT-1 trial showed durable clinical activity with repotrectinib in ROS1 tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with locally advanced or metastatic ROS1-positive NSCLC with or without baseline central nervous system metastases, including robust intracranial responses. (ASCO) (Free ASCO Whitepaper)
Four-year data from the Phase 3 CheckMate -9LA trial reinforce durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for patients with metastatic NSCLC, including subgroups with higher unmet needs. (ASCO) (Free ASCO Whitepaper)
Three-year results demonstrated long-term clinical benefit of neoadjuvant Opdivo with chemotherapy in patients with resectable NSCLC who received definitive surgery in the Phase 3 CheckMate -816 trial. (ASCO) (Free ASCO Whitepaper)
Biomarker analyses from the Phase 3 CheckMate -76K trial support a potential clinical benefit of Opdivo for the adjuvant treatment of patients with stage IIB/C melanoma, across all biomarker sub-groups. (ASCO) (Free ASCO Whitepaper)
Three-year data from the Phase 3 CheckMate -649 trial evaluating Opdivo plus chemotherapy continue to demonstrate durable long-term survival and HRQOL benefits in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (ASCO) (Free ASCO Whitepaper)
Two-year data from the Phase 2/3 RELATIVITY-047 trial showed consistent benefit with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in patients with previously untreated metastatic or unresectable melanoma. (ASCO) (Free ASCO Whitepaper)
Please see below for Important Safety Information and full Prescribing Information for Reblozyl, Opdualag, Opdivo, and Opdivo+Yervoy.

Please see below for Important Safety Information and full Prescribing Information, including Boxed Warnings, for Abecma, Breyanzi and Inrebic.

Investor Event

Bristol Myers Squibb will host a virtual Investor Event on Tuesday, June 6, 2023, from 7:00-8:00 a.m. CT/8:00-9:00 a.m. ET to discuss data presented at ASCO (Free ASCO Whitepaper). Company executives will provide an overview of data presented and address questions from investors and analysts.

Investors and the general public are invited to listen to a live webcast of the event at View Source An archived edition of the session will be available later that day.

Summary of Presentations

Select Bristol Myers Squibb studies at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Abstract Title

Author

Presentation
Type/#

Session Title

Session
Date/Time
(EDT)

Acute Myeloid Leukemia

Implications for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic: A Connect Myeloid Registry study.

Bart L. Scott

Poster

Abstract #7021

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Gastrointestinal

First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): 64-month (mo) follow-up from CheckMate 142.

Heinz-Josef Lenz

Poster

Abstract #3550

Gastrointestinal Cancer—Colorectal and Anal

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Predictive value of tumor-infiltrating lymphocyte (TIL) dynamics in the tumor microenvironment (TME) during preoperative chemoradiotherapy (CRT) on pathologic complete response (pCR) in microsatellite-stable (MSS) locally advanced rectal cancer (LARC).

Mitsuho Imai

Poster

Abstract #3608

Gastrointestinal Cancer—Colorectal and Anal

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Nivolumab (NIVO) plus chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 3-year follow-up from CheckMate 649.

Yelena Y. Janjigian

Poster

Abstract #4025

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): 36-month results of nivolumab plus chemotherapy (N+C) versus (C) from CheckMate 649.

Elena Elimova

Poster

Abstract #4038

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Genitourinary

Health-related quality of life (HRQoL) of risk-based patient subgroups with advanced renal cell cancer (aRCC) treated with nivolumab plus cabozantinib (NIVO+CABO) vs sunitinib (SUN) in the CheckMate 9ER trial.

David Cella

Poster

Abstract #4527

Genitourinary Cancer—Kidney and Bladder

Saturday,
June 3, 2023

9:00 AM –
12:00 PM

Adjuvant nivolumab plus ipilimumab vs placebo for patients with localized renal cell carcinoma at high risk of relapse after nephrectomy: Subgroup analyses from the phase 3 CheckMate 914 (part A) trial.

Robert J. Motzer

Oral

Abstract #4506

Genitourinary Cancer—Kidney and Bladder

Monday,
June 5, 2023

12:30 PM –
3:30PM

Gynecologic

Preliminary antitumor activity of the combination of COM701 + BMS-986207 + nivolumab in patients with recurrent, metastatic MSS endometrial cancer.

Drew W. Rasco

Poster

Abstract #5595

Gynecologic Cancer

Monday,
June 5, 2023

2:15 PM –
5:15 PM

Efficacy and final safety analysis of pre- and co-administration of nivolumab (Nivo) with concurrent chemoradiation (CCRT) followed by Nivo maintenance therapy in patients (pts) with locally advanced cervical carcinoma (LACvCa): Results from the phase I trial, GOTIC-018.

Kazuto Nakamura

Poster

Abstract #5519

Gynecologic Cancer

Monday,
June 5, 2023

5:30 PM –
7:00 PM

Preclinical testing of farletuzumab ecteribulin (FZEC [MORAb-202]) and MORAb-109, folate receptor α and mesothelin targeting antibody-drug conjugates (ADCs), in rare gynecologic cancers.

Cassandra Vandenberg

Publication Only

Abstract #e17634

Gynecologic Cancer

N/A

Head & Neck

A phase 2, open-label, multicenter study investigating efficacy and safety of RP3 oncolytic immunotherapy combined with other therapies in patients with locoregionally advanced or recurrent squamous cell carcinoma of the head and neck.

Kevin Joseph Harrington

Poster

Abstract #TPS6106

Head and Neck Cancer

Monday,
June 5, 2023

2:15 PM –
5:15 PM

Lymphoma

Longitudinal, prospective cardiovascular and metabolic risk in treatment-naive patients with chronic myeloid leukemia in chronic phase (CML-CP) starting tyrosine kinase inhibitor (TKI) therapy in a real-world setting.

Javid J. Moslehi

Poster

Abstract #7053

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Subgroup analyses of primary refractory (refr) vs early relapsed (rel) large B-cell lymphoma (LBCL) from the TRANSFORM study of lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line (2L) therapy.

Loretta J. Nastoupil

Poster

Abstract #7526

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Response-adapted therapy (tx) with nivolumab plus brentuximab vedotin (nivo + BV) without autologous hematopoietic cell transplantation (auto-HCT) in children, adolescents, and young adults (CAYA) with low-risk relapsed/refractory (R/R) classic Hodgkin lymphoma (cHL): CheckMate 744.

Paul David Harker-Murray

Poster

Abstract #7515

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,
June 5, 2023

2:15 PM –
3:45 PM

Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004.

Tanya Siddiqi

Oral

Abstract #7501

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Tuesday,
June 6, 2023

10:45 AM –
1:45 PM

Melanoma

The validity of a machine learning algorithm in predicting response to immune checkpoint inhibitors in melanoma.

Faisal Fa’ak

Poster

Abstract #9523

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of RP2 as a single agent and in combination with nivolumab in a cohort of patients with uveal melanoma.

Joseph J. Sacco

Poster

Abstract #9527

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Durable clinical outcomes in patients (pts) with advanced melanoma and progression-free survival (PFS) ≥3y on nivolumab (NIVO) ± ipilimumab (IPI) or IPI in CheckMate 067.

F. Hodi

Poster

Abstract #9542

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Efficacy and safety of first-line (1L) nivolumab plus relatlimab (NIVO + RELA) versus NIVO plus ipilimumab (NIVO + IPI) in advanced melanoma: An indirect treatment comparison (ITC) using patient-level data (PLD).

Dirk Schadendorf

Poster

Abstract #9552

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Association of circulating tumor DNA kinetics with disease recurrence in patients with stage IIB/C/IV melanoma treated with adjuvant immunotherapy in CheckMate 238.

Mahrukh M. Syeda

Poster

Abstract #9577

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year results from RELATIVITY-047.

Hussein A. Tawbi

Oral

Abstract #9502

Melanoma/Skin Cancers

Monday,
June 5, 2023

4:00 PM –
7:00 PM

Association of biomarkers (BMs) with efficacy of adjuvant nivolumab (NIVO) vs placebo (PBO) in patients with resected stage IIB/C melanoma (CA209 -76K).

Georgina V. Long

Oral

Abstract #9504

Melanoma/Skin Cancers

Monday,
June 5, 2023

4:00 PM –
7:00 PM

Merkel Cell Carcinoma

Non-comparative, open-label, international, multicenter phase I/II study of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic Merkel cell carcinoma (MCC) (CheckMate 358).

Shailender Bhatia

Oral

Abstract #9506

Melanoma/Skin Cancers

Monday,
June 5, 2023

4:00 PM –
7:00 PM

Multiple Myeloma

Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM).

Julia Piasecki

Poster

Abstract #8031

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Health related quality of life (HRQoL) in patients with triple-class-exposed relapsed/refractory multiple myeloma (TCE RRMM) treated with idecabtagene vicleucel (ide-cel) versus standard regimens: Patient-reported outcomes (PROs) from KarMMa-3 phase 3 randomized controlled trial (RCT).

Michel Delforge

Poster

Abstract #8032

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Tumor-intrinsic features associated with progression-free survival (PFS) in patients (pts) with relapsed and refractory multiple myeloma (RRMM) treated with idecabtagene vicleucel (ide-cel).

Nicholas Strong

Poster

Abstract #8035

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

EXCALIBER-RRMM: A phase 3, two-stage study of iberdomide, daratumumab, and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM).

Sagar Lonial

Poster

Abstract #TPS8069

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

A phase 3, two-stage, randomized study of mezigdomide, carfilzomib, and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM): SUCCESSOR-2.

Paul G. Richardson

Poster

Abstract #TPS8070

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Myelodysplastic Syndrome

Efficacy and safety results from the COMMANDS trial: A phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (ESA)-‑naive transfusion-dependent (TD) patients (pts) with lower-‑risk myelodysplastic syndromes (LR-MDS).

Guillermo Garcia-Manero

Oral

Abstract #7003

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Friday,
June 2, 2023

2:00 PM –
5:00 PM

Hematologic and transfusion outcomes in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) receiving luspatercept: Real-world assessment in the community practice setting.

Sudipto Mukherjee

Poster

Abstract #7057

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Clinical outcomes by SF3B1 mutation status in patients (pts) with lower-risk myelodysplastic syndrome (LR-MDS) retreated with erythropoiesis-stimulating agents (ESAs).

Adeola Y. Makinde

Poster

Abstract #7071

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

A phase 2/3 trial of oral azacitidine (Oral-AZA) in patients (pts) with low- or intermediate-risk myelodysplastic syndromes (MDS).

Guillermo Garcia-Manero

Poster

Abstract #TPS7083

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Myelofibrosis

Safety and efficacy of luspatercept for the treatment of anemia in patients with myelofibrosis: Results from the ACE-536-MF-001 study.

Aaron Thomas Gerds

Poster

Abstract #7016

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

12:30 PM –
2:00 PM

Thoracic

Phase 2 small cell lung cancer (SCLC) cohort of a phase 1b/2 trial of a liposomal formulation of eribulin in combination with nivolumab.

Koichi Azuma

Poster

Abstract #8593

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday,
June 4, 2023

9:00 AM –
12:00 PM

Clinical outcomes with neoadjuvant nivolumab (N) + chemotherapy (C) vs C by definitive surgery in patients (pts) with resectable NSCLC: 3-y results from the phase 3 CheckMate 816 trial.

Jonathan Spicer

Poster

Abstract #8521

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday,
June 4, 2023

12:30 PM –
2:00 PM

Intracranial and systemic efficacy of repotrectinib in advanced ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) and central nervous system metastases (CNS mets) in the phase 1/2 TRIDENT-1.

Jessica Jiyeong Lin

Poster

Abstract #9017

Lung Cancer—Non-Small Cell Metastatic

Sunday,
June 4, 2023

5:30 PM –
7:00 PM

First-line (1L) nivolumab (N) + ipilimumab (I) + chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4‑y clinical update and outcomes by tumor histologic subtype (THS).

David Paul Carbone

Poster

Abstract #LBA9023

Lung Cancer—Non-Small Cell Metastatic

Sunday,
June 4, 2023

5:30 PM –
7:00 PM

All abstracts except late-breaking abstracts will be available on the ASCO (Free ASCO Whitepaper) website at 5:00 PM EDT on Thursday, May 25. All late-breaking abstracts will be available on the ASCO (Free ASCO Whitepaper) website at 8:00 AM EDT on the day of the scientific session for the abstract presentation.

Select Bristol Myers Squibb studies at the 2023 EHA (Free EHA Whitepaper) Congress include:

Abstract Title

Author

Presentation
Type/#

Session
Date/ Time
(EDT)

Acute Myeloid Leukemia

Longitudinal characterization of molecular variants at remission and relapse: subanalyisis of the QUAZAR AML-001 trial.

Andrew Wei

Poster

Abstract #P411

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Disease monitoring of NPM1-mutant (mut) acute myeloid leukemia (AML) using measurable residual disease (MRD) assessments during oral azacitidine (oral-AZA) treatment (tx): a QUAZAR AML-001 subanalysis.

Gail Roboz

Poster

Abstract #P459

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

A real-world evaluation of treatment patterns and outcomes of acute myeloid leukemia induction therapies in the community setting.

Keri Maher

Poster

Abstract #P515

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Phase 1b OMNIVERSE trial: Safety and tolerability of oral azacitidine in combination with venetoclax for treatment of acute myeloid leukemia.

Shaun Fleming

Poster

Abstract #P567

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Real-world characteristics and use of antiemetic therapies among patients with acute myeloid leukemia treated with oral azacitidine maintenance therapy.

Ying Qui

Poster

Abstract #P587

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Implications of registry data for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic.

John Kelly

Poster

Abstract #P589

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Beta Thalassemia

Effect of luspatercept on bone mineral density in patients with beta-thalassemia enrolled in the phase 3 BELIEVE trial.

Thomas D. Coates

Poster

Abstract #P1466

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Long-term erythroid response data from patients (pts) with non-transfusion-dependent beta-thalassemia (NTDT) receiving luspatercept in the BEYOND trial.

Ali T. Taher

Oral

Abstract #S273

Sunday, June 11, 2023

5:30 – 6:45 AM (11:30 AM

– 12:45 PM CEST)

Alpha Thalassemia

Trial in Progress: A phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of luspatercept to treat anemia in adults with alpha-thalassemia.

Vip Viprakasit

Abstract only publication

Abstract #PB2535

N/A

Lymphoma

Economic burden in chronic lymphocytic leukemia (CLL) for patients with ≥2 prior lines of therapy including a bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i).

Farrukh Awan

Poster

Abstract #P1696

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Qualitative interviews to describe burden in patients (pt) with third-line or later CLL/SLL with prior exposure to bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i).

Mona L Martin

Abstract only publication

Abstract #PB2696

N/A

Multiple Myeloma

Synergistic antitumor activity of the BCMA 2+1 T cell engager (TCE) alnuctamab (ALNUC; BMS-986349; CC-93269) and CELMoD agents in multiple myeloma (MM) preclinical models.

Bruno Paiva

Poster

Abstract #P799

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class-exposed relapsed and refractory multiple myeloma.

Marc S. Raab

Poster

Abstract #P801

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Baseline characteristics identifying patients with multiple myeloma treated with idecabtagene vicleucel (ide-cel; BB2121) who are at risk for severe/refractory inflammatory adverse events.

Yi Lin

Poster

Abstract #P809

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Soluble factors correlated with cytokine release syndrome (CRS) with IV vs subcutaneous (SC) alnuctamab (ALNUC; BMS-986349; CC-93269) in patients with relapsed/refractory multiple myeloma (RRMM).

Luciano Costa

Poster

Abstract #P825

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class-exposed (TCE) relapsed and refractory multiple myeloma (RRMM): KarMMa-3 subgroup analysis by prior lines of therapy.
Saloman Manier

Poster

Abstract #P866

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Mezigdomide (MEZI) plus dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): results from the dose-expansion phase of the CC-92480-MM-001 trial.

Nizar J. Bahlis

Poster

Abstract #P868

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Idecabtagene vicleucel (ide-cel) in patients with an inadequate response to frontline autologous stem cell transplantation (ASCT): results from KarMMa-2 cohort 2c.

Melissa Alsina

Poster

Abstract #P871

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Pomalidomide, daratumumab, and dexamethasone after lenalidomide treatment in patients with relapsed or refractory multiple myeloma (RRMM): final overall survival analysis of the phase 2 MM-014 study.

Nizar J. Bahlis

Poster

Abstract #P882

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Alnuctamab (ALNUC; BMS-986349; CC-93269), a BCMA × CD3 T-cell engager, in patients (pts) with relapsed/refractory multiple myeloma (RRMM): latest results from a phase 1 first-in-human clinical study.

Sandy W. Wong

Poster

Abstract #P883

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Patient reported outcomes in triple class exposed, relapsed/refractory multiple myeloma (TCE RRMM) patients in KarMMa-3 trial (phase 3 RCT): idecabtagene vicleucel (ide-cel) versus standard regimens.

Michel Delforge

Poster

Abstract #P905

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Treatment patterns and clinical outcomes of patients with multiple myeloma previously treated with lenalidomide and an anti-CD38 monoclonal antibody: findings from the Connect MM disease registry.

Rafat Abonour

Poster

Abstract #P915

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Real-world clinical outcomes among triple-class exposed relapsed refractory multiple myeloma patients in US and Europe: PREAMBLE registry study.

Hartmut Goldschmidt

Poster

Abstract #P945

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

BMS-986393 (CC-95266), a G protein–coupled receptor class C group five member D (GPRC5D)–targeted CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM): Results from a phase 1 study.

Susan Bal

Oral

Abstract #S193

Saturday, June 10, 2023

5:30

– 6:45 AM (11:30 AM

– 12:45 PM CEST)

Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class–exposed (tce) relapsed and refractory multiple myeloma (rrmm): a KarMMa-3 analysis in high-risk subgroups.

Krina Patel

Oral

Abstract #S195

Saturday, June 10, 2023

10:30

– 11:45 AM (4:30

– 5:45 PM CEST)

Elotuzumab or daratumumab in combination with pomalidomide and dexamethasone (EPd and DPd) in relapsed refractory multiple myeloma (RRMM): a network meta-analysis.

Adriana Cury

Abstract only publication

Abstract #PB2095

N/A

Myelodysplastic Syndromes

Luspatercept versus epoetin alfa for treatment (TX) of anemia in ESA-naïve patients with lower-risk myelodysplastic syndromes(LR-MDS) patients (PTS) requiring RBC transfusions: data from the COMMANDS study.

Matteo Giovanni Della Porta

Oral plenary and special session

Abstract #S102

Saturday, June 10, 2023

8:45

– 10:15 AM (2:45

– 4:15 PM CEST)

Luspatercept restores effective erythropoiesis and provides superior and sustained benefit vs epoetin alfa: biomarker analysis from the phase 3 COMMANDS study.

Uwe Platzbecker

Poster

Abstract #P693

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Distinct splicing alternations associated with clinical response to luspatercept in patients with lower-risk myelodysplastic syndromes from the MEDALIST study.

Amit Verma

Poster

Abstract #P697

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Treatment patterns and outcomes among patients with lower-risk myelodysplastic syndromes receiving luspatercept in routine clinical practice in the United States.

Sudipto Mukherjee

Poster

Abstract #P733

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

First-line treatment patterns and outcomes among patients with the newly diagnosed myelodysplastic syndromes: a global, retrospective observational cohort study.

Amer M. Zeidan

Abstract only publication

Abstract #PB2010

N/A

Myelofibrosis

Efficacy and safety of luspatercept for the treatment of anemia in patients with myelofibrosis: results from the ACE-536-MF-001 Study.

Francesco Passamonti

Oral

Abstract #S167

Friday, June 9, 2023

8:45

– 10:00 AM (2:45

– 4:00 PM CEST)

Fedratinib is effective in ruxolitinib-resistant cells: clinical and preclinical correlations.

Vikas Gupta

Poster

Abstract #P997

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Real-world treatment patterns and healthcare resource utilization in myelofibrosis patients with anemia.

John Mascarenhas

Poster

Abstract #P1059

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

BMS-986158, a potent BET inhibitor, as monotherapy and in combination with ruxolitinib or fedratinib in intermediate- or high-risk myelofibrosis (MF): results from a phase 1/2 study.

Haifa Kathrin Al-Ali

Oral

Abstract #S213

Saturday, June 10, 2023

5:30 – 6:45 AM (11:30 AM – 12:45 PM CEST)
All EHA (Free EHA Whitepaper) abstracts except late-breaking abstracts will be available on May 11. All late-breaking abstracts will be available on June 1.

Select Bristol Myers Squibb studies at the 2023 ICML Annual Meeting include:

Abstract Title

Author

Presentation
Type/#

Session Title

Session
Date/ Time
(EDT)

Non-Hodgkin Lymphoma

CC-99282 plus R-CHOP in patients (pts) with previously untreated aggressive B-cell lymphoma (aBCL): early safety and efficacy results from a phase 1b study.

Javier Munoz

Poster

Abstract #438

Phase I-II

Wednesday, June 14, 2023

6:00AM

– 12:00 PM (12:00

– 6:00 PM CEST)

Thursday, June 15 – Friday, June 16, 2023

4:00 AM

– 12:00 PM

(10:00 AM

– 6:00 PM CEST)

Open-label phase 1/2 study of CC-99282, a cereblon E3 ligase modulator (CELMoD) agent ± rituximab,

in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).

Jean-Marie Michot

Oral

Abstract #90

Session 14 Novel Agents

Saturday, June 17, 2023

2:45

– 4:15 AM (9:45

– 10:15 AM CEST)

Chronic Lymphocytic Leukemia

Health-related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with liso-cel in TRANSCEND CLL 004.

S.S. Kenderian

Poster

Abstract #400

CAR-T (Cellular Therapies)

Wednesday, June 14, 2023

6:00AM

– 12:00 PM (12:00

– 6:00 PM CEST)

Thursday, June 15

– Friday, June 16, 2023

4:00 AM – 12:00 PM

(10:00 AM ‒ 6:00 PM CEST)

Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): primary analysis of TRANSCEND CLL 004.

Tanya Siddiqi

Oral

Abstract #26

Session 4 CLL and Richter Syndrome

Thursday, June 15, 2023

7:45

– 9:15 AM (1:45

– 3:15 PM CEST)

Large B Cell Lymphoma

Comparison of overall survival of lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) adjusting for crossover in second-line (2L) R/R large B-cell lymphoma.

Franck Morschhauser

Poster

Abstract #332

DLBCL

Wednesday, June 14, 2023

6:00AM

– 12:00 PM (12:00

– 6:00 PM CEST)

Thursday, June 15

– Friday, June 16, 2023

4:00 AM

– 12:00 PM

(10:00 AM

– 6:00 PM CEST)

Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line therapy in large B-cell lymphoma (TRANSFORM study): Subgroup analyses by prior therapy response.

Loretta J. Nastoupil

Oral

Abstract #138

Session 8

"Focus on…"

Large B-Cell and Double Hit Lymphomas

Thursday, June 15

11:00 AM – 12:00 PM (5:00 ‒ 6:00 PM CEST)

All ICML accepted abstracts (except encore abstracts) will be available on June 9.

On May 11, 2023 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2023 and provided a business update (Press release, Bolt Biotherapeutics, MAY 11, 2023, View Source [SID1234631490]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are pleased to be advancing our lead Boltbody ISAC, BDC-1001, into a broader Phase 2 program in four different HER2-positive solid tumor types, following the recent positive topline results from our Phase 1 dose-escalation trial. We are looking forward to presenting a comprehensive dataset at ASCO (Free ASCO Whitepaper) from this first-in-human study, in which BDC-1001 achieved target drug exposure levels, was well tolerated from a safety perspective and demonstrated objective clinical responses and long-term durability both as a single agent and in combination with nivolumab," said Randall Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "As we prepare for Phase 2 studies in the U.S. and internationally, we look forward to investigating the benefits of BDC-1001 and our novel ISAC mechanism to aid HER2-positive cancer patients who are not benefitting from current therapeutic options. Additionally, the Bolt team is excited to be advancing our next program, BDC-3042, a proprietary Dectin-2 agonist antibody, into the clinic later this year."

Recent Highlights and Anticipated Milestones

•
Topline BDC-1001 Phase 1 dose-escalation clinical data unveiled from a multi-center, multi-dose clinical trial in more than 100 patients. The data demonstrated BDC-1001 was well-tolerated at all dose levels and schedules. BDC-1001 achieved objective clinical responses as a monotherapy and in combination with the PD-1 inhibitor nivolumab across a diverse range of solid tumor types. Target drug exposure levels were achieved at or near the recommended Phase 2 dose (RP2D) by more frequent administration including every other week (q2w) and weekly (q1w) administration schedules.
Comprehensive first-in-human safety and efficacy data will be presented by Bob Li, M.D., Ph.D., MPH, medical oncologist, and principal investigator at Memorial Sloan Kettering Cancer Center (MSK) in a poster presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2023) on Saturday, June 3 in Chicago, Illinois.

•
Phase 2 BDC-1001 studies in four HER2+ solid tumor types are planned to initiate in 2023 with trials conducted at clinical sites in the U.S., Europe, and South Korea. Phase 2 dose expansions will investigate BDC-1001 as a monotherapy in three separate cohorts of patients with colorectal, endometrial, and gastroesophageal cancer. A separate combination arm with nivolumab is expected to initiate following demonstration of monotherapy anti-tumor activity in each of the three tumor types. An additional study, a randomized two-arm Phase 2 clinical trial, will investigate BDC-1001 as monotherapy and in combination with pertuzumab in patients with HER2-positive metastatic breast cancer whose disease has progressed following treatment with Enhertu.
Under a new supply agreement with Roche announced in the first quarter of 2023, Roche will provide pertuzumab for the Phase 2 breast cancer study. Under a previously announced agreement, BMS will provide nivolumab for the Phase 2 expansion studies.

•
New BDC-3042 data presented at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023 in Orlando, Florida. BDC-3042 is an agonist antibody targeting Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs) in solid tumors. These preclinical data highlight recent findings on key characteristics of BDC-3042 in reprogramming Dectin-2-expressing TAMs, leading to the production of an array of pro-inflammatory cytokines and chemokines associated with anti-tumor immunity, and tumor growth inhibition in humanized mouse models of cancer, alone and in combination with a PD-1 checkpoint inhibitor.
BDC-3042 to enter the clinic in 2023 following completion of Investigational New Drug (IND)-enabling activities, and clearance of a U.S. IND to initiate first-in-human studies later in 2023.

•
Boltbody ISAC collaborations with Genmab and Innovent to develop next-generation Boltbody ISACs continue to make progress. These collaborations are exploring proprietary linker-payloads from the Boltbody ISAC platform in combination with Genmab’s proprietary bispecific antibodies and with Innovent’s proprietary antibodies, respectively.
•
Cash, cash equivalents, and marketable securities were $171.0 million as of March 31, 2023. Cash on hand, coupled with collaboration revenues, is expected to fund clinical milestones and operations through 2025.

Upcoming Events

•
BDC-1001 poster presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Ill.
Title: A phase 1/2 study of a first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors

Abstract ID: 2538

Abstract Category: Developmental Therapeutics—Immunotherapy

Presenter: Dr. Bob Li, medical oncologist, and principal investigator at MSK

Poster Session: Developmental Therapeutics—Immunotherapy

Details: Saturday, June 3, 2023, 8:00 – 11:00 a.m. CDT

Location: McCormick Place Convention Center, Chicago, Illinois

First Quarter 2023 Financial Results

•
Collaboration Revenue – Collaboration revenue was $1.8 million and $0.8 million for the quarter ended March 31, 2023, and 2022, respectively. The increase in revenue for the comparative periods was due to increased activity in our collaborations with Genmab and Innovent as we fulfill our performance obligations.

•
Research and Development (R&D) Expenses – R&D expenses were $14.6 million for the quarter ended March 31, 2023, compared to $18.4 million for the same quarter in 2022. The decrease in R&D expenses was due to lower manufacturing expenses related to the timing of batch production of our product candidates and lower contract service expenses as well as our pipeline reprioritization in June of 2022, offset by higher clinical expenses related to the ongoing BDC-1001 clinical trial.

•
General and Administrative (G&A) Expenses – G&A expenses were $5.6 million for the quarter ended March 31, 2023, compared to $6.3 million for the same quarter in 2022. The decrease in G&A expenses was due to lower consulting and professional services expenses.

•
Loss from Operations – Loss from operations was $18.4 million for the quarter ended March 31, 2023, compared to $23.9 million for the same quarter in 2022.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines that attract other immune cells and lower the activation threshold for an immune response. This process increases the number of activated immune cells in the tumor microenvironment and promotes a robust immune response, with the goal of generating durable therapeutic responses for patients with cancer.

On May 11, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Biodesix, MAY 11, 2023, View Source [SID1234631489]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Throughout the quarter we continued to make excellent progress and I am pleased with the start to the year. Looking at our financial performance, we reported total revenue of $9.1 million for the first quarter 2023, which represents growth of 38% compared to the first quarter of 2022, while core lung diagnostic revenue of $8.6 million grew by 86% over the comparable period," said Scott Hutton, President and Chief Executive Officer. "Importantly, the momentum seen in the first quarter and the continued growth in our core lung diagnostic testing business clearly indicates the clinical need and growing acceptance of our on-market tests."

First Quarter 2023 Financial Results

For the three-month period ended March 31, 2023, as compared to the same period of 2022 (where applicable):

•
Total revenue of $9.1 million, an increase of 38%, driven primarily by strong year-over-year growth in core lung diagnostics:
o
Core lung diagnostic revenue of $8.6 million reflected a year-over-year increase of 86% driven primarily by the continued adoption of Nodify Lung nodule management tests;
o
BioPharma Services revenue of $0.4 million decreased 55% year-over-year. Timelines for existing and new agreements continue to be impacted by delayed enrollment in clinical trials; entered the second quarter of 2023 with continued strong dollars under contract;
o
COVID-19 testing revenue decreased by 99% year-over-year, and consistent with our revenue guidance. In connection with the expected expiration of the Public Health Emergency declaration, the Company will no longer provide COVID-19 diagnostic testing services commercially;
•
First quarter 2023 gross profit of $5.9 million, or 65% gross margin as compared to 51% gross margin in the comparable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;
•
Operating expenses (excluding direct costs and expenses) of $22.3 million, an increase of approximately $4.5 million, or 25% as compared to the first quarter 2022 (includes non-cash stock compensation expense of $2.3 million as compared to $1.3 million);
o
Approximately $3.0 million of the increase was attributable to increased sales and marketing costs to support core lung diagnostic sales growth including growth in the sales force, increased travel-related costs, and marketing programs to enhance product awareness;
o
Approximately $1.6 million was associated with increased general and administrative expenses primarily associated with non-cash stock compensation costs;

•
Net loss of $18.7 million and basic and diluted net loss per share of $0.24;
•
Cash and cash equivalents of $25.3 million as of March 31, 2023;
o
Scheduled milestone payment of $2.2 million paid in January 2023 to Integrated Diagnostics.
2023 Financial Outlook

The Company reaffirms our 2023 financial outlook and expects to generate between $52 million and $55 million in total revenue in 2023.

Conference call and webcast information

Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

For a full list of Biodesix’s press releases and webinars, please visit biodesix.com.

On May 11, 2023 Bicycle Therapeutics plc (NASDAQ: BCYC) and Orano Med, two biotechnology companies respectively, reported pre-clinical results (Press release, Bicycle Therapeutics, MAY 11, 2023, View Source [SID1234631488]). Bicycle is pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology and Orano Med is developing innovative radioligand therapies with lead-212 in oncology. The companies reported co-authored preclinical results of Pb-BCY20603, a Bicycle radio-conjugate (BRC) that binds with high affinity to the tumor antigen MT1-MMP and carries a chelate of lead-212, a potent alpha particle emitting radioisotope. The results were presented at TIDES 2023 in San Diego, CA and can be accessed here.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are encouraged by the preclinical results that were presented at TIDES 2023 and are excited by the potent anti-tumor activity observed with this molecule," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We estimate that on a dose per dose basis this prototype is over 1,000 times more potent than a comparator Bicycle toxin conjugate, demonstrating just how powerful targeted alpha therapy with lead-212 may be and providing further evidence that the unique properties of Bicycles make them a potentially powerful modality for precision guided delivery of radionuclide payloads."

Pb-BCY20603 showed tumor targeting in rodent tumor xenograft studies, with radioactivity levels of >45% Injected Dose (ID/g) 24 hours post injection. No body weight loss was seen in mice treated up to 30 μCi, and no significant changes were observed in hematology readout compared to vehicle treated mice. Pb-BCY20603 showed potent anti-tumor activity after a single dose of 5 μCi. Complete tumor regressions were seen after 3 dosing cycles of 10 μCi, given two weeks apart. Median survival was increased for each dosing group with 90% survival observed for the 3 cycles of 10 μCi, treatment at the end of the 100-day study. Importantly, the Bicycle displayed differentiated tumor penetration compared to a comparator antibody, highlighting an advantage of smaller molecules over larger biologics.

"The promising preclinical results of Pb-BCY20603 confirm the potential of targeted alpha therapies to open new perspectives for patients with difficult to treat cancers," said Julien Dodet, Chief Executive Officer of Orano Med. "We are convinced that alpha therapies, combined with innovative vectors such as Bicycle peptides, are the future of radiopharmaceutical therapies, providing an increased cytotoxic potential against cancer cells with limited toxicity to surrounding healthy cells. This reinforces Orano Med’s commitment to make lead-212 based therapies available to the medical community and patients worldwide."

These data build on previously published studies demonstrating the precision-guided potential of Bicycles. Imaging data were also reported from two separate independent research groups. At the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, an independent team from Johns Hopkins published data from an EphA2 binding Bicycle in an orthotopic pancreatic cancer model (Sharma, et. al., Non-invasive detection of pancreatic adenocarcinoma using Ga-88 labelled EphA2 targeting peptide). In addition, a separate independent research team (Duan, et al., Clinical Cancer Research, 2023) demonstrated specific and sensitive imaging of a Nectin-4 targeted Bicycle observed in Nectin-4 positive metastases in human patients, despite the molecule not being optimized for this purpose. These data provide further evidence to support the ability of Bicycles to fully penetrate and bind to their targets deep into tumors providing additional confidence in the platform’s potential clinical utility.

On May 11, 2023 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported its financial results for the first quarter ended March 31, 2023, and provided clinical development and operational highlights (Press release, Aura Biosciences, MAY 11, 2023, View Source [SID1234631487]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are encouraged by our recent interactions with the FDA in support of our global Phase 3 trial designed to enable us to develop the first vision preserving targeted therapy for the treatment of patients with early-stage choroidal melanoma, a disease with a high unmet medical need and no approved therapies," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "With a strong balance sheet, we are well-positioned to execute and advance our pipeline to meaningful clinical milestones."

Recent Pipeline Developments

•
Aura is planning to initiate a potentially registration-enabling Phase 3 clinical trial in 1H 2023 to evaluate the safety and efficacy of Belzupacap Sarotalocan (bel-sar) for the first-line treatment of adult patients with early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved therapies.
o
The Phase 3 clinical trial design incorporates guidance and feedback from the FDA following a recent Type C meeting.

•
The FDA recommended that the Phase 3 trial follow a standard three-arm randomized, controlled and masked design. The trial is intended to enroll approximately 100 patients and it will be randomized 2:1:2 to receive investigational therapeutic regimen bel-sar, low dose regimen bel-sar or a sham control. The primary efficacy analysis is planned to be a time to event composite endpoint that will compare the tumor control and visual acuity of the therapeutic regimen group to sham when the last patient meets 12 months of follow up.

o
Enrollment is complete in the Phase 2 trial evaluating suprachoroidal (SC) administration of bel-sar for the first-line treatment of adult patients with early-stage CM. Updated interim data of patients treated with the therapeutic regimen intended to be used in the Phase 3 trial is on track to be presented in 2H 2023.

•
Enrollment is ongoing for the Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC). This represents an area of high unmet need with approximately 80,000 patients diagnosed in the United States every year. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in June 2022.

o
The Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 23 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The primary endpoint of the Phase 1 trial is the incidence and severity of treatment-related adverse events, serious adverse events and/or the incidence of dose-limiting toxicities. The trial will provide histopathological evaluation after the local treatment to support bel-sar’s biological activity. Aura expects to report initial Phase 1 data in 2H 2023.

•
Beyond early-stage CM, Aura continues to build its ocular oncology franchise. Aura’s goal is to initiate clinical development in choroidal metastasis, an indication with a high unmet medical need and no approved therapies, as the second ocular oncology indication. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in February 2023, and the Investigational New Drug application was opened in January 2023. Aura is on track to initiate start-up activities for the Phase 2 trial in 2H 2023.

Recent Corporate Events

•
Enhanced Senior Leadership Team. In March 2023, Aura appointed Patrick Nealon as SVP, Clinical Development Operations. Mr. Nealon brings over 20 years of biopharmaceutical industry experience, leading the clinical development of therapeutics across multiple disease areas. Mr. Nealon will be responsible for overseeing all aspects of clinical operations as Aura transitions into late-stage clinical development.

First Quarter 2023 Financial Results

•
As of March 31, 2023, Aura had cash and cash equivalents and marketable securities totaling $173.5 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 2025.

•
Research and development expenses increased to $14.4 million for the three months ended March 31, 2023 from $8.3 million for the three months ended March 31, 2022, primarily due to ongoing clinical costs associated with the progression of our Phase 2 study and CRO costs associated with the start of our global Phase 3 trial, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

•
General and administrative expenses increased to $5.0 million for the three months ended March 31, 2023 from $4.5 million for the three months ended March 31, 2022. General and administrative expenses include $1.1 million and $1.0 million of stock-based compensation for the three months ended March 31, 2023 and 2022, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to growth of the Company.

Net loss for the three months ended March 31, 2023 was $17.5 million compared to $12.8 million for the three months ended March 31, 2022.