On May 21, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as "subcutaneous nivolumab") across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib (Press release, Bristol-Myers Squibb, MAY 21, 2024, View Source [SID1234643483]). The updated goal date is December 29, 2024.

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The application is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.

About CheckMate -67T

CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.

On May 21, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will present clinical trial data for selected programs from the Company’s diversified immuno-oncology pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, Illinois, from May 31 to June 4, 2024 (Press release, BioNTech, MAY 21, 2024, View Source [SID1234643482]). Moreover, in support of the Company’s ongoing CAR-T cell and individualized mRNA programs, BioNTech will also present epidemiological and real-world data from two observational studies in patient populations for which product candidates are being developed in the Company’s respective clinical programs.

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"Our aim is to develop innovative treatment options across the continuum of cancer disease and establish new treatment paradigms that have the potential to address the fundamental challenges of treating cancer to drive meaningful improvements in the long-term survival rates for patients," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The data from the interventional and observational studies that we will present at this year’s ASCO (Free ASCO Whitepaper) are of relevance for progress towards our goal as they will contribute to informing the direction of further development of several of our priority product candidates as well as the design of planned pivotal and later-stage clinical trials across all three key pillars of our diversified oncology pipeline, including novel immunomodulators, targeted therapies such as cell therapies and ADCs, and mRNA-based therapeutic cancer vaccines."

Highlights of BioNTech’s updates to be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024:

•Updates on several Phase 1b/2a trials investigating BNT327/PM8002 as a monotherapy in patients with solid tumors will be presented. BNT327/PM8002 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization to create a cycle of vascular normalization and immunostimulation in the microenvironment of the tumor. Two posters will provide clinical data updates for cohorts with advanced cervical cancer, platinum-resistant recurrent ovarian cancer and advanced non-small cell lung cancer ("NSCLC"). The product candidate is being developed in collaboration with Biotheus Inc. ("Biotheus").
•Initial results from the randomized, open-label, Phase 2 trial (NCT05117242) with the bispecific antibody candidate BNT311/GEN1046 (acasunlimab) alone or in combination with pembrolizumab in patients with previously treated metastatic NSCLC ("mNSCLC") will be presented. BNT311/GEN1046 combines PD-L1 checkpoint inhibition with 4-1BB costimulatory activation. The product candidate is being developed in collaboration with Genmab S/A ("Genmab").
•BioNTech will present preliminary data of an epidemiological study (NCT04813627) that correlates post-operative circulating tumor DNA ("ctDNA"), a cancer biomarker for minimal residual disease, with disease-free survival in patients with colorectal cancer ("CRC"). This observational study provides supportive epidemiological and prognostic data for the ongoing interventional Phase 2 trial (NCT04486378) with the individualized neoantigen-specific immunotherapy ("iNeST") candidate autogene cevumeran (BNT122, RO7198457) in ctDNA-positive, high-risk stage II/stage III adjuvant CRC. Autogene cevumeran is jointly being developed by BioNTech and Genentech Inc. ("Genentech"), a member of the Roche Group.
•BioNTech will present an analysis of real-world data that investigated the overall survival, treatment patterns and prognostic variables of patients with testicular germ cell tumors receiving palliative chemotherapy. This analysis will inform the design of BioNTech’s planned pivotal trial with the Company’s CAR-T cell therapy candidate BNT211 in patients with germ cell tumors. BNT211 combines an autologous CAR-T cell therapy candidate targeting the oncofetal antigen Claudin-6 ("CLDN6") and an investigational CLDN6-encoding CAR-T cell amplifying RNA vaccine ("CARVac").

BioNTech has established a diversified clinical oncology pipeline based on its modular multi-platform approach. The Company is advancing more than 20 clinical programs in unmet medical need solid tumor indications, including mRNA-based immunotherapies, targeted therapies entailing cell therapies and antibody-drug conjugates (ADCs), and novel immunomodulators. These candidates are currently being evaluated in more than 30 clinical studies, including nine programs in advanced Phase 2 trials and two candidates in pivotal Phase 3 trials. BioNTech is advancing key programs into late-stage development with the aim to have ten or more potentially registrational trials in its oncology pipeline by the end of 2024. The Company aims to launch its first cancer immunotherapy in 2026. By 2030, BioNTech plans to obtain approvals for a total of ten cancer indications across various drug classes.
The full abstracts will be available on the ASCO (Free ASCO Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline candidates.

Full poster details:

Candidate: BNT327/PM8002
Session title: Lung Cancer—Non-Small Cell Metastatic
Abstract Title: A Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients with advanced NSCLC
Location: Hall A, Poster Board 397
Abstract Number: 8533
Date: Monday, June 3, 2024
Time: 1.30 PM-4.30 PM CDT

Candidate: BNT327/PM8002
Session title: Gynecologic Cancer
Abstract Title: Efficacy and Safety of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients with Solid Tumors: Clinical Data from Advanced Cervical Cancer and Platinum-resistant Recurrent Ovarian Cancer Cohorts
Location: Hall A, Poster Board 395
Abstract Number: 5524
Date: Monday, June 3, 2024
Time: 9.00 AM-12.00 PM CDT

Candidate: BNT326/YL202
Session title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract Title: YL202/BNT326, a HER3-targeted ADC, in patients with locally advanced or metastatic non-small cell lung cancer and breast cancer: Preliminary results from a first-in human phase I trial
Location: Hall A, Poster Board 179
Abstract Number: 3034
Date: Saturday, June 1, 2024
Time: 09:00 AM – 12:00 PM CDT

Candidate: BNT311/GEN1046 (acasunlimab)
Session Title: Developmental Therapeutics—Immunotherapy
Abstract Title: Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in combination with pembrolizumab (pembro) in patients (pts) with previously treated metastatic non-small cell lung cancer (mNSCLC): initial results of a randomized, open-label, phase 2 trial
Location: Hall A, Poster Board 12
Abstract Number: 2533
Date: Saturday, June 1, 2024
Time: 9.00 AM-12.00 PM CDT

Candidate: Autogene cevumeran (BNT122, RO7198457)
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Abstract Title: Preliminary results correlating post-operative ctDNA status with disease-free survival in Stage II (high risk) / III Colorectal Cancer Patients in the BNT000-001 epidemiology study
Location: Hall A, Poster board 189
Abstract Number: 3526
Date: Saturday, June 1, 2024
Time: 1.30 PM-4.30 PM CDT

Candidate: BNT211
Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: Real-world evidence of overall survival (OS) and treatment patterns of patients (pts) with testicular germ cell tumors (DCT) receiving palliative chemotherapy in the United States
Location: Poster board 356
Abstract Number: 5038
Date: Sunday, June 2, 2024
Time: 9.00 AM – 12.00 PM CDT

On May 21, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that treatment has commenced for the fifth patient in its ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, MAY 21, 2024, View Source [SID1234643481]). The study is being conducted through a research partnership with Moffitt Cancer Center.

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Anixa’s first-in-human trial (NCT05316129) is enrolling female adult patients with recurrent/progressing ovarian cancer who were unresponsive to at least two prior therapies. Safety was confirmed in the first three-patient cohort. The patients in the second cohort, including patient #5, receive triple the dose of engineered T-cells compared with the first cohort of three patients. The study will identify the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR), found only on ovarian cells

"With our fifth patient treated, our trial is progressing, and we continue to see that our therapy appears to be safe and well-tolerated," said Dr. Amit Kumar, Chairman and CEO of Anixa. "The technology behind our novel CAR-T therapy differs from traditional CAR-T therapies by targeting the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. We developed this approach to tackle preexisting difficulties with CAR-T cell therapies in solid ovarian tumors. In our trial, we will also explore several parameters for applying our CAR-T therapy to solid tumors in general."

Anixa’s FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

On May 21, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate a Phase 3 study to evaluate HLX22 (AC101) in combination with trastuzumab (Herceptin) and chemotherapy in 1st line HER2-positive advanced gastric cancer patients (Press release, Alligator Bioscience, MAY 21, 2024, View Source [SID1234643480]).

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Gastric/gastroesophageal junction (G/GEJ) cancer is one of the most common cancers and approximately 20% of these patients show HER2 amplification or overexpression. Despite the approval of Herceptin (trastuzumab) in the US in 2010, the median overall survival of patients suffering from HER2+ gastric cancer remains limited.

HLX22 (AC101) is an innovative monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China. Alligator retains an ownership interest entitling the company to 35% of AbClon’s income from the agreement with Henlius Biotech.

In January 2024, Henlius Biotech presented promising Phase 2 results at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), which were also published in the Journal of Clinical Oncology. The data demonstrated that the addition of HLX22 (AC101) to HLX02 (a biosimilar of trastuzumab) and XELOX (Oxaliplatin and capecitabin) in 1st line treatment of HER2-positive locally advanced or metastatic G/GEJ cancer led to a dose-dependent increase in Progression Free Survival, meeting the study’s main efficacy endpoint.

"We are very pleased to see the highly encouraging progress Henlius Biotech are making with the development of HLX22 in gastric cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "The Phase 2 results presented at ASCO (Free ASCO Whitepaper) earlier this year followed by this Phase 3 IND clearance demonstrate our ability to deliver an asset like HLX22 with a highly differentiated profile and a great deal of potential to improve treatment outcomes for patients suffering from a devastating disease like gastric cancer."

On May 21, 2024 Glenmark Specialty S.A. (Glenmark), a subsidiary of Glenmark Pharmaceuticals Ltd., a research-led, global pharmaceutical company, reported an exclusive marketing and distribution agreement with BeiGene, a global oncology company (Press release, Glenmark, MAY 21, 2024, View Source [SID1234643468]). Under this agreement, Glenmark will register and commercialize BeiGene’s oncology medicines, Tislelizumab and Zanubrutinib in India.

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Speaking on this partnership, Alok Malik, President and Business Head – India Formulations, Glenmark Pharmaceuticals Ltd. said, "We are excited about our partnership with BeiGene, signifying our commitment to advancing healthcare in India. The addition of Tislelizumab and Zanubrutinib to our oncology portfolio underscores our dedication to the cancer patients’ community and our commitment to provide access to novel therapies across India"

"This collaboration is a testament to our shared vision of enhancing healthcare access across Asia," said Adam Roach, Vice President, and Head of Asia-Pacific at BeiGene. "We take great pride in advancing mission-driven access, especially given the significant disease burden in India, where rising cancer rates require comprehensive healthcare solutions – a commitment we share with our partners at Glenmark," Mr. Roach said.

With a population exceeding 1.43 billion, India stands as the world’s most populous country and the largest lower-middle-income nation.1,2 This partnership is timely, as many low-and middle-income countries, including India, are experiencing an increasing cancer burden. Recent statistics indicate that India has the third highest number of cancer cases worldwide, with predictions suggesting this could reach 2.08 million cases by 2040 – a 57.5 per cent increase from 2020.3 Currently, cancer claims approximately 900,000 lives annually in India.4

While solid tumors remain the majority of cancers diagnosed, of particular concern is the burgeoning prevalence of blood cancer, ranking third highest globally, following only the US and China.5 In India, a blood cancer diagnosis strikes every five minutes, claiming an estimated 70,000 lives each year.5 Amidst this grim reality, Glenmark envisions a future where affordable and effective therapies serve as a beacon of hope for those in need.

About Tislelizumab

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.

About Zanubrutinib

Zanubrutinib 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, zanubrutinib has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.