Innovent to Present Clinical Data of Multiple Novel Molecules at the 2024 ASCO Annual Meeting

On April 24, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that about 20 accepted abstracts of clinical data from multiple trials in relation to multiple novel mono-/bi-specific antibodies and antibody-drug-conjugates (ADCs) as well as innovative drugs including TYVYT (sintilimab injection), olverembatinib, taletrectinib (ROS1 TKI) from its oncology pipeline will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 from May 31 to June 4, 2024, in Chicago, IL, U.S (Press release, Innovent Biologics, APR 24, 2024, View Source [SID1234642306]).

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Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules for the first time at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. As one of the few biopharmaceutical companies with both the technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing doctors and patients with more innovative, effective and safe treatment options."

Details on the abstracts are listed below:

Abstract Title

Abstract No.

Session Type and Title

Presentation Time (CDT)

Presenter

IBI363 (PD-1/IL-2 bispecific antibody)

First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with advanced colorectal cancer: Safety and efficacy results from a phase I study.

3593

Poster Session

-Gastrointestinal Cancer

-Colorectal and Anal

6/1/2024

1:30 PM

-4:30 PM

Dr. Yiwen Chen

First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with advanced melanoma: Safety and efficacy results from a phase I study.

9562

Poster Session

-Melanoma/Skin Cancers

6/1/2024

1:30 PM

-4:30 PM

Dr. Yu Chen

First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with other solid tumors: Safety and efficacy results from a phase I study.

e14593

Online publication

5/23/2024

5:00 PM

Dr. Xueli Bai

IBI389 (anti-CLDN18.2/CD3 bispecific antibody)

Safety and preliminary efficacy results of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: A phase 1 dose escalation and expansion study.

2519

Rapid Oral Abstract

-Developmental Therapeutics

-Immunotherapy

6/2/2024

11:30AM

-1:00 PM

Dr. Li Zheng

Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a phase 1 study.

4011

Clinical Science Symposium(Oral)-Building Novel Antibody-Based Approaches in Gastrointestinal Cancers

6/2/2024

4:30 PM

-6:00 PM

Dr. Jihui Hao

IBI343(anti-CLDN18.2 ADC)

Safety and efficacy of IBI343 (anti-claudin18.2 antibody-drug conjugate) in patients with advanced pancreatic ductal adenocarcinoma or biliary tract cancer: Preliminary results from a phase 1 study.

3037

Poster Session

-Developmental Therapeutics

-Molecularly Targeted Agents and Tumor Biology

6/1/2024

9:00 AM

-12:00 PM

Dr. Xianjun Yu

IBI310 (anti-CTLA-4 antibody)

Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study.

3505

Oral Abstract Session

-Gastrointestinal Cancer

-Colorectal and Anal

6/2/2024

8:00 AM

-11:00 AM

Dr. Rui-Hua Xu

Taletrectinib (ROS1 TKI)

Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study.

8520

Rapid Oral Abstract

-Lung Cancer

-Non-Small Cell Metastatic

6/1/2024

4:30PM

-6:00 PM

Dr. Wei Li

IBI110 (anti-LAG-3 antibody)

Efficacy and safety of IBI110 (anti-LAG-3 antibody) plus sintilimab (anti-PD-1 antibody) in patients with advanced alveolar soft part sarcoma: Results from a phase II study.

11559

Poster Session

-Sarcoma

6/1/2024

1:30 PM

-4:30 PM

Dr. Jiayong Liu

TYVYT(sintilimab)[1]

Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial.

5512

Rapid Oral Abstract

-Gynecologic Cancer

6/1/2024

8:00 AM

-9:30 AM

Dr. Jihong Liu

Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: single-arm, phase II trial.

6011

Clinical Science Symposium (Oral) -making the Cut: Decision Support Tools in Surgically Treated HPV+ Oropharyngeal Cancer

6/3/2024

3:00 PM

-4:00 PM

Dr. Ming Song and Dr. Shida Yan

Sintilimab, doxorubicin and ifosfamide (AI) as first-line treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS), synovial sarcoma (SS), myxoid liposarcoma (MLPS) and dedifferentiated liposarcoma (DDLPS): A single-arm phase 2 trial.

11505

Oral Abstract Session

-Sarcoma

6/3/2024

3:00 PM

-6:00 PM

Dr. Zhiguo Luo

Updated survival results of BBCAPX-II: sintilimab combined with bevacizumab and CapeOx as first-line treatment in patients with RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer.

3563

Poster Session

-Colorectal and Anal

6/1/2024

1:30 PM

-4:30 PM

Dr. Ying Yuan

Updated results and biomarker analyses from the phase 2 trial of nab-paclitaxel plus sintilimab as second-line therapy for advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (G/GEJA).

4037

Poster Session

-Gastrointestinal Cancer

-Gastroesophageal, Pancreatic, and Hepatobiliary

6/1/2024

1:30 PM

-4:30 PM

Dr. Zhichao Jiang

Sintilimab plus axitinib for advanced fumarate hydratase-deficient renal cell carcinoma: A multi-center, open-label, single-arm, phase II study (SAFH).

4523

Poster Session

-Genitourinary Cancer

-Kidney and Bladder

6/2/2024

9:00 AM

-12:00 AM

Dr. Hao Zeng

Anlotinib combined with sintilimab as first-line treatment in patients with advanced non-clear cell renal cell carcinoma (nccRR): Preliminary results from an exploratory prospective multicentre clinical study.

4544

Poster Session

-Genitourinary Cancer

-Kidney and Bladder

6/2/2024

9:00 AM

-12:00 AM

Dr. Pei Dong

Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with PMMR status: Results from a multicenter, single-arm phase 2 study.

5619

Poster Session

-Gynecologic Cancer

6/3/2024

9:00 AM

-12:00 AM

Dr. Xiaohua Wu

Final survival outcomes and exploratory biomarker analysis from the randomized, phase 2 neoSCORE trial: Two versus three cycles of neoadjuvant sintilimab plus chemotherapy for resectable non-small cell lung cancer

.

8048

Poster Session

-Lung Cancer

-Non-Small Cell Local

-Regional/Small Cell/Other Thoracic Cancers

6/3/2024

1:30 PM

-4:30 PM

Dr.Fuming Qiu

Olverembatinib

Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) and paraganglioma

11502

Oral Abstract Session

-Sarcoma

6/3/2024

3:00 PM

-6:00 PM

Dr. Haibo Qiu

AFFIMED ANNOUNCES ACCEPTANCE OF AFM24 CLINICAL ABSTRACT AT THE 2024 ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY

On April 24, 2024 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that an abstract presenting preliminary data from the phase 2 combination study of AFM24, its innate cell engager (ICE), in combination with atezolizumab, Roche’s checkpoint inhibitor, in patients with EGFR-wildtype (EGFRwt) non-small cell lung cancer (NSCLC) has been accepted for poster presentation at 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Affimed, APR 24, 2024, View Source [SID1234642305]).

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Details of the poster presentation are as follows:

Title: Preliminary results from the phase 2 study of AFM24 in combination with atezolizumab in patients with EGFR wild-type (EGFR-WT) non-small cell lung cancer (NSCLC)

Presenting Author: Hye Ryun Kim

Poster Session: Developmental Therapeutics—Immunotherapy

Abstract Number: 2522

Poster Presentation Time: Saturday, June 1, 2024, 9:00 a.m. – 12:00 p.m. CDT

The full abstract will become available on ASCO (Free ASCO Whitepaper)’s website on May 23, 2024 at 5:00 p.m. (EDT). More details about the ASCO (Free ASCO Whitepaper) conference are available online at Attend | ASCO (Free ASCO Whitepaper) Annual Meeting.

About AFM24
AFM24 is a tetravalent, bispecific ICE that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO

On April 24, 2024 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was selected for an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, (May 31 – June 4, 2024, Chicago) (Press release, Autolus, APR 24, 2024, View Source [SID1234642304]).

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ASCO Oral Presentation, abstract #6504:
Title: Obecabtagene autoleucel (obe-cel, AUTO1) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL): Overall survival (OS), event-free survival (EFS) and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and consolidative stem cell transplantation (SCT) in the open-label, single-arm FELIX Phase Ib/II study
Session Title: Oral Abstract Session – Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session date and time: Friday, May 31, 2024, 14:45 – 17:45 EDT, 19:45 – 22:45 BST
Presenting Author: Dr Elias Jabbour, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX

A conference call and webcast to discuss the presented data will be held at 9:30 am EDT/2:30 pm BST on Saturday June 1, 2024. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

Merus Announces Abstracts Accepted for Presentation at the 2024 ASCO Annual Meeting

On April 24, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the acceptance of three abstracts for presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, Illinois on May 31- June 4, 2024 (Press release, Merus, APR 24, 2024, View Source [SID1234642303]).

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Rapid oral presentation:

Title: Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 study
Abstract #: 6014
Session Title: Head and Neck Cancer
Session Date and Time: June 3, 2024, 8:00-9:30 a.m. CT

The presentation concerns petosemtamab evaluated in combination with pembrolizumab in patients with untreated advanced PD-L1+ HNSCC.

Rapid oral presentation:

Title: Phase I study of MCLA-145, a bispecific antibody targeting CD137 and PD-L1, in solid tumors, as monotherapy or in combination with pembrolizumab
Abstract #: 2520
Session Title: Developmental Therapeutics—Immunotherapy
Session Date and Time: June 2, 2024, 11:30 a.m.-1:00 p.m. CT

The presentation concerns MCLA-145 evaluated as monotherapy or in combination with pembrolizumab in patients with solid tumors.

Poster presentation:

Title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in non-small-cell lung cancer (NSCLC) with c-MET exon 14 skipping mutations (METex14)
Abstract #: 8583
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: June 3, 2024, 1:30-4:30 p.m. CT

The presentation concerns MCLA-129 evaluated as monotherapy in patients with locally advanced/metastatic METex14 NSCLC.

The abstracts will be available on the ASCO (Free ASCO Whitepaper) website on May 23, 2024 at 5:00 p.m. ET. The full presentations will be available on the Merus website at the start of each session.

About Petosemtamab
Petosemtamab, or MCLA-158, is a bispecific Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

About MCLA-145
MCLA-145 is a Biclonics T-cell agonist that binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the potential to potently activate immune effector cells in the context of the tumor microenvironment while blocking inhibitory signals among T-cells within the same immune cell population.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant NSCLC in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

Cue Biopharma to Present at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 24, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, reported that it will present an oral abstract and poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL (Press release, Cue Biopharma, APR 24, 2024, View Source [SID1234642302]).

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The presentations will highlight the Company’s Phase 1 trials of its lead interleukin 2 (IL-2)-based biologics, CUE-101 in recurrent/metastatic head and neck cancer and CUE-102 in Wilms’ Tumor 1 positive recurrent/metastatic cancers.

The Company will host a Business Update call and webcast in June 2024 that will include a discussion on the clinical progress and associated data presented at ASCO (Free ASCO Whitepaper) on June 1 and June 4. Call details will be issued prior to the event.

Oral Abstract and Poster Details

Abstract Number: 6004
Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).
Presenter: Douglas R. Atkins, M.D., Professor of Medicine, Washington University School of Medicine
Session Type and Title: Oral Abstract Session; Head and Neck Cancer
Session Date and Time: June 4, 2024, 9:45 AM-12:45 PM CDT

Abstract Number: 3553
Title: A phase 1 open-label, dose escalation and expansion study of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein, in patients with HLA-A*0201 positive disease and WT1-positive recurrent/metastatic cancers.
Presenter: Nataliya Uboha, M.D., Ph.D. University of Wisconsin Carbone Cancer Center
Session Type and Title: Poster Session; Gastrointestinal Cancer, Colorectal and Anal
Session Date and Time: June 1, 2024, 1:30 PM-4:30 PM CDT

The oral abstract and poster presentations will be available in the Investor & Media section of the Company’s website at www.cuebiopharma.com under Scientific Publications and Presentations, following ASCO (Free ASCO Whitepaper).