On April 24, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the acceptance of two abstracts for poster presentation at the 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4 in Chicago (Press release, Bicycle Therapeutics, APR 24, 2024, View Source [SID1234642273]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

Poster Presentation Details:

Title: Breaking from the paradigm of antibody-drug conjugates: Evaluation of clinical pharmacokinetics and safety of Bicycle Toxin Conjugates (BTCs)
Poster Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Saturday, June 1, at 9 a.m. CT
Abstract Number: 3088
Speaker/Lead Author: Justin Bader, Pharm.D., MBA, Bicycle Therapeutics

Title: A phase 2/3 study of Bicycle Toxin Conjugate BT8009 targeting Nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2
Poster Session Title: Genitourinary Cancer – Kidney and Bladder
Date and Time: Sunday, June 2, at 9 a.m. CT
Abstract Number: TPS4619
Speaker/Lead Author: Yohann Loriot, M.D., Ph.D., Institut de Cancérologie Gustave Roussy, Université Paris-Saclay

The posters will be made available in the Publications section of bicycletherapeutics.com following the presentations.

On April 24, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, May 31 – June 4, 2024 (Press release, BeiGene, APR 24, 2024, View Source [SID1234642272]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

"Our presentations at this year’s ASCO (Free ASCO Whitepaper) highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors," Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "The exciting data we will share during ASCO (Free ASCO Whitepaper) showcase BRUKINSA’s uniquely differentiated clinical profile and add to the growing body of evidence supporting its role across the blood cancer treatment paradigm."

BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include:

A network meta-analysis comparing the efficacy of BRUKINSA vs acalabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL); and
A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA vs ibrutinib evaluating the risk of developing hypertension based on the initiation and adjustment of antihypertensive medications.
Reflecting BeiGene’s growing solid tumor development program, TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple presentations – as a monotherapy, in combination with chemotherapy agents, and as part of immunotherapy regimens across a range of tumor types. Key highlights include:

New data from the Phase 3 RATIONALE-306 study evaluating TEVIMBRA plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC); and
Initial data from a first-in-human study evaluating HPK1 inhibitor BGB-15025 alone and in combination with TEVIMBRA.
"Our data at ASCO (Free ASCO Whitepaper) are a testament to the potential versatility of TEVIMBRA across a range of tumor types, and we are excited by the momentum of this critical pillar of our solid tumor development program," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "During the meeting, we look forward to sharing a new analysis from our RATIONALE-306 study, which will provide insights into the three-year efficacy and safety of TEVIMBRA as a first-line treatment for ESCC."

BeiGene Presentations During ASCO (Free ASCO Whitepaper) 2024

Abstract Title

Abstract #

Presentation Details

Lead Author

Hematology

Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis (NMA)

7048

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Shadman

Real-world treatment patterns and outcomes of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL)

11158

Session Type and Title: Poster Session – Quality Care/Health Services Research

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Krackeler

Risk of hypertension in patients with CLL/SLL who participated in ALPINE: a post hoc analysis

N/A

Online

D. Ramirez

Risk of new-onset hypertension in newly diagnosed chronic lymphocytic leukemia (CLL) patients (pts) treated with Bruton tyrosine kinase inhibitors (BTKi): A real-world data study using the Symphony Health Solution database

N/A

Online

T. Kou

Real-world treatment switching and sequencing to next line of therapy of zanubrutinib, acalabrutinib, and ibrutinib in CLL/SLL

N/A

Online

J. Pinilla-Ibarz

Real-world adherence and healthcare resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in mantle cell lymphoma

N/A

Online

B. Shah

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

N/A

Online

T. Munir

Clinical and financial burden of mental health (MH) conditions in patients (pts) with low-grade non-Hodgkin lymphoma (LG-NHL)

7072

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

K. Yang

Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)

N/A

Online

S. Gaballa

Real-world Bruton tyrosine kinase inhibitor (BTKi) treatment patterns and outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in US community oncology practices

N/A

Online

J. Hou

BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia

TPS7090

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

H. Lee

CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL

TPS7087

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Shadman

Solid Tumor/IO

Global, randomized, phase III study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma (RATIONALE-306 update): minimum 3-year survival follow-up

4032

Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Session Date and Time: June 1 at 1:30-4:30 PM CDT

H. Yoon

BGB-A317-212: A multicenter, open-label, phase II study to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors

2610

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

L. Yufei

Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study

3599

Session Type and Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal

Session Date and Time: June 1 at 1:30-4:30 PM CDT

K. Ding

Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305

2605

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

D. Serrano

A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors

2585

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

S. Deva

Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

N/A

Online

C. Zhou

About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

Please see full U.S. Prescribing Information for BRUKINSA (zanubrutinib), including U.S. Patient Information or visit www.brukinsa.com.

About TEVIMBRA (tislelizumab-jsgr)
Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Please see full U.S. Prescribing Information for TEVIMBRA (tislelizumab-jsgr), including Medication Guide.

About Sonrotoclax (BGB11417)
Sonrotoclax is an investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations.

On April 24, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that updated Phase 1/2 data for AU-007 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting (Press release, Aulos Bioscience, APR 24, 2024, View Source [SID1234642271]). AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers. It is the first AI-designed human monoclonal antibody to be tested in a clinical trial. The ASCO (Free ASCO Whitepaper) meeting is being held online and at McCormick Place in Chicago, Illinois, from May 31–June 4, 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

Details of the poster presentation are as follows:

Poster Title: Updated results of a phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors.
Abstract: 2527
Session Type/Title: Poster Session/Developmental Therapeutics—Immunotherapy
Session Date and Time: Saturday, June 1, 2024, 9:00 a.m.-12:00 p.m. CDT

The poster will be presented in the Exhibit Hall at McCormick Place. An electronic version will also be available on the ASCO (Free ASCO Whitepaper) 2024 online meeting platform.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On April 24, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported the acceptance of two abstracts for poster presentation at the American Society of Cancer Oncology ("ASCO"), which will be held in Chicago from May 31-June 4, 2024 (Press release, ALX Oncology, APR 24, 2024, View Source [SID1234642270]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

Session titles and information for the two abstracts are listed below and are now available on the ASCO (Free ASCO Whitepaper) online program planner.

Evorpacept plus enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma: Phase 1a dose escalation results
Session Type and Title: Poster Presentation – Genitourinary Cancer – Kidney and Bladder
Session Date and Time: Sunday, June 2, 2024, 9:00 AM – 12:00 PM CDT
Location: Hall A
Abstract Number: 4575
ALX Oncology Sponsored Clinical Trial

Results of a Phase 2 study of evorpacept (ALX148), and cetuximab, and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer
Session Type and Title: Poster Presentation – Gastrointestinal Cancer – Colorectal and Anal
Session Date and Time: Saturday, June 1, 2024, 1:30 PM – 4:30 PM CDT
Location: Hall A
Abstract Number: 3530
Investigator-Sponsored Trial at the University of Colorado Cancer Center

Copies of the presentations will be available on the Publications section of ALX Oncology’s website following presentation at the meeting.

On April 24, 2024 Flindr Therapeutics B.V. ("Flindr" or "the Company"), a precision oncology therapeutics company, reported a €20 million Series A financing to advance its pipeline of first-in-class, small molecule inhibitors for treatment of cancer (Press release, Flindr Therapeutics, APR 24, 2024, View Source [SID1234642263]). V-Bio Ventures led the financing alongside other new investors Johnson & Johnson Innovation – JJDC, Inc. (JJDC), QBIC Fund, Flanders Future Tech Fund and Curie Capital, as well as existing investors Oncode Oncology Bridge Fund, Swanbridge and Brabantse Ontwikkelings Maatschappij (BOM).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

Flindr combines world class science and expertise in translational biology, cancer target identification, immuno-oncology and small molecule oncology drug development. The expert team has a successful track record in the identification and development of covalent small molecules inhibitors from discovery to market approval.

The Company utilizes the "ImmunoGram Drug Discovery Engine", which has evolved from seminal work in the laboratories of the Netherlands Cancer Institute (NKI) and the Oncode Institute. This approach involves reverse-translating the heterogeneity in tumor-specific and host-specific factors, as commonly seen in patients in the clinic, into lab-based biological models to screen for and select the most important drug targets involved in patient clinical response.

Flindr’s lead program is a first-in-class small molecule inhibitor of RNF31 (also known as HOIP), a protein-stabilizing E3 ubiquitin ligase which is aberrantly activated in solid and hematological malignancies. The Company has already obtained highly promising activity for the drug candidate in preclinical ovarian cancer and B-cell lymphoma models, and identified biomarkers which will help select patients most likely to respond to treatment with RNF31 inhibitors. Flindr will use the funds to progress its lead program to IND, develop an exciting second program, and broaden its pipeline using the ImmunoGram Drug Discovery Engine.

Flindr Therapeutics was created in 2020, with Maarten Ligtenberg as the founding CEO, and initial seed financing from BOM, Oncode Oncology Bridge Fund, Swanbridge Capital and Innovatiefonds Noord Holland. In 2023, Flindr joined forces with VIB, Flanders’ leading life sciences research institute, and the lab of Professor Rudi Beyaert (of the VIB-UGent Center for Inflammation Research), to leverage their deep expertise of immunology – including RNF31 biology – and development of animal cancer models. Their work with Flindr in these areas will provide further validation of RNF31 as a target and will enable the Company to make safety predictions.

Maarten Ligtenberg, PhD, Chief Executive Officer and Founder at Flindr, said: "This €20 million Series A financing will help us translate our precision targets into precision therapies, with the ultimate goal of potentially transforming the lives of patients with cancer. The backing of this highly regarded investor syndicate is a strong validation of our unique approach and the potential of our pipeline."

Christina Takke, Managing Partner at V-Bio Ventures, commented: "We strongly believe that a complementary team is crucial for any success. The Flindr team combines well-established identification expertise from the NKI with world class biological insights from VIB, and its deep experience and successful track record in the identification and development of covalent small molecules inhibitors."

Following financing, the Flindr Supervisory Board of Directors will include Christina Takke, V-Bio Ventures, Chris De Jonghe, Oncode Institute, Tine Bekaert, Flanders Future Tech Fund, Cedric van Nevel, QBIC Fund and Allard Kaptein, CEO of Genase Therapeutics and Chief Strategy Officer of IMMIOS, as well as a representative of JJDC.