2seventy bio and JW Therapeutics Announce Strategic Partnership to Accelerate the Research and Development of T Cell-based Immunotherapies

On October 27, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, and JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported a strategic alliance to establish a translational and clinical cell therapy development platform designed to more rapidly explore T cell-based immunotherapy therapy products in the Chinese mainland, Hong Kong (China), and Macao (China) (Press release, 2seventy bio, OCT 27, 2022, View Source [SID1234622447]).

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"The true patient benefit of this collaboration lies in the ability to establish additional capabilities to rapidly test, learn and progress our innovative cell therapy programs," said Steve Bernstein, chief medical officer, 2seventy bio. "JW Therapeutics possesses extensive understanding of the unmet medical needs of the population and the regulatory affairs process in China as well as the clinical development pathways. The opportunity to bring together our distinctive areas of experience to create a differentiated platform supports our goal of bringing new therapies to patients as quickly as possible."

The initial focus of the collaboration is 2seventy bio’s MAGE-A4 TCR program in solid tumors which is being developed as part of a collaboration with Regeneron. MAGE-A4 is a member of the MAGE family of cancer-testis antigens expressed in a number of solid tumor types. The program is designed to develop T cell receptor (TCR) therapies for the treatment of MAGE-A4 positive solid tumors.

"We are delighted to work with 2seventy bio to jointly develop the MAGE-A4 TCR program and potentially other assets in China," said Dr. Mark J. Gilbert, Chief Medical Officer of JW Therapeutics. "2seventy is a top-tier cell therapy company with advanced technologies and a highly experienced team. This alliance will further leverage our world-class integrated capabilities, including translational research and clinical development, and we look forward to accelerating the development of more cell immunotherapy products with breakthrough therapeutic value to serve more patients with cancer in China and potentially worldwide."

Under the terms of the agreement, 2seventy bio will grant JW Therapeutics a license for the MAGE-A4 cell therapy in the Chinese mainland, Hong Kong (China), and Macao (China). JW Therapeutics will be responsible for development, manufacturing, and commercialization within China. 2seventy bio is eligible to receive milestones and royalties on product revenues in China. Additionally, 2seventy bio may leverage the early clinical data generated under the collaboration to support development in other geographies. The detailed arrangements are not disclosed. The closing of the transaction will be subject to the approval of the JW Therapeutics shareholders and other customary closing conditions.

About the MAGE-A4 Program
MAGE-A4 is a member of the MAGE family of cancer-testis antigens expressed in a number of solid tumor types. Our program employs a highly potent TCR discovered in our MediGene collaboration that recognizes HLA-presented MAGE-A4 peptides and further enhances the potency of these re-directed T cells using our CTBR12 TGF-beta "flip" receptor technology — which converts the immunosuppressive effects of TGF-beta into an activation signal for the T cells. Regeneron and 2seventy bio are co-developing the program under their collaboration entered into in 2018.

Oncternal Therapeutics to Provide Business Update and Report Third Quarter 2022 Financial Results

On October 27, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will report third quarter 2022 financial results after the U.S. financial markets close on Thursday, November 3, 2022 (Press release, Oncternal Therapeutics, OCT 27, 2022, View Source [SID1234622496]). Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a comprehensive business update and discuss the Company’s financial results.

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The live webcast of the call will be available online at investor.oncternal.com and the call will be archived there for at least 30 days.

Veracyte to Participate in the Credit Suisse 31st Annual Healthcare Conference

On October 27, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in a fireside chat at the Credit Suisse 31st Annual Healthcare Conference on Tuesday, November 8, at 1:25 p.m. Eastern Time (Press release, Veracyte, OCT 27, 2022, View Source [SID1234622495]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

Veracyte to Participate in the Credit Suisse 31st Annual Healthcare Conference

On October 27, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in a fireside chat at the Credit Suisse 31st Annual Healthcare Conference on Tuesday, November 8, at 1:25 p.m. Eastern Time (Press release, Veracyte, OCT 27, 2022, View Source [SID1234622495]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

PDS Biotech Provides Highlights from Head and Neck Cancer KOL Roundtable

On October 27, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that highlights from its Head and Neck Cancer Key Opinion Leader (KOL) Roundtable (Press release, PDS Biotechnology, OCT 27, 2022, View Source [SID1234622494]). The virtual event was held from 8:30 to 9:30 AM, ET on Wednesday, October 26, 2022.

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This PDS Biotech-sponsored event was organized to provide analysts, investors, and the scientific community with a comprehensive overview of the head and neck cancer treatment landscape, including current challenges and unmet medical needs, and how PDS0101, the company’s lead product candidate, might fit into the treatment paradigm. PDS0101, which combines the utility of the Versamune platform with targeted antigens in HPV-positive cancers, is currently being studied in multiple Phase 2 clinical trials, including a Phase 2 clinical trial (VERSATILE-002) investigating PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent and/or metastatic head and neck cancer.

The Head and Neck Cancer KOL Roundtable was moderated by PDS Biotech’s Chief Medical Officer, Lauren V. Wood, MD, and featured presentations from Neil D. Gross, MD, Director of Clinical Research and Head of the Oropharynx Section in the Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center; Katharine A. R. Price, MD, Co-chair, Head, and Neck Disease Group, Mayo Clinic; and Jared Weiss, MD, Section Chief, Thoracic and Head/Neck Oncology, Lineberger Comprehensive Cancer Center, UNC School of Medicine.

"We are very honored to have had the opportunity to conduct a KOL Roundtable featuring such an accomplished panel of experts in head and neck cancer research and treatment," said Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "As we advance the development of PDS0101 in multiple Phase 2 clinical trials targeting HPV-positive cancers, including recurrent and/or metastatic head and neck cancer, we are continually reminded of the need for improved treatment options for this devastating disease. On behalf of PDS Biotech, I would like to personally thank Drs. Gross, Price, and Weiss for discussing these important opportunities and where HPV-targeted immunotherapies, such as PDS0101, may help to improve the lives of head and neck cancer patients."

The webcast replay and presentation slides from PDS Biotech’s KOL Roundtable Investor Event can be accessed via the Investor Relations section of the company’s website at View Source The replay will be available for 90 days.

The following is a recap of key topics from the event:

Current Treatment of Head and Neck Cancer
Led by Dr. Neil Gross, the first presentation provided a review of the head and neck cancer environment, including a historical review of the disease, the increasing incidence of HPV-positive head and neck cancer, current treatment regimens, recurrence of disease, and physical as well as emotional treatment-related issues impacting patients and caregivers. Additionally, Dr. Gross discussed opportunities for improved interventions and strategies for de-escalating side effects inherent to current treatment approaches.

Unmet Medical Needs in Head and Neck Cancer
In the next presentation, Dr. Katharine Price discussed the challenges and opportunities facing patients with recurrent/metastatic HPV-positive head and neck cancer, including current treatment options, the potential of new immunotherapy-based treatments to improve outcomes while delaying the need for cytotoxic chemotherapy, and the need to improve quality of life for patients while on treatment.

PDS0101 for the Potential Treatment of HPV16-Positive Head and Neck Cancer
In the final KOL presentation, Dr. Jared Weiss provided a review of the ongoing Phase 2 clinical trial (VERSATILE-002) investigating PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent and/or metastatic head and neck cancer. Dr. Weiss discussed the design of the study and data observed from 17 patients, including an objective response rate of 41.5%, clinical benefit rate of 76.5%, and an overall survival rate of 87.2% at nine months. Published results indicate the overall response rate of KEYTRUDA alone as 19%, as noted in published reports. Dr. Jared Weiss also discussed the lack of differences in poor clinical outcomes for HPV-positive and negative patients with recurrent or metastatic disease.