On May 20, 2024 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported upcoming presentations at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, Illinois from May 31st to June 4th (Press release, GeneCentric Therapeutics, MAY 20, 2024, View Source [SID1234643475]). Presentations include new clinical validation results for a novel signature identifying patients with head and neck squamous cell carcinoma (HNSCC) that may benefit from treatment beyond typical surgical resection. The results are from GeneCentric’s ongoing collaboration with Neil Hayes, MD, MPH, at the University of Tennessee Health Science Center’s Center for Cancer Research, and Jose P. Zevallos, MD, MPH, at the University of Pittsburgh School of Medicine, to discover and develop new prognostic and/or predictive signatures to aid in the treatment selection for patients with HNSCC. In addition, GeneCentric will present updated findings from its development of a novel RNA-based immune checkpoint inhibition predictive response signature (ICI-PRS) that optimizes the selection of patients with a primary diagnosis of urothelial cancer who are potential candidates for anti-PD-(L)1 inhibition treatment.

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Details of the ASCO (Free ASCO Whitepaper) presentations are as follows:

Title: Clinical validation of a mesenchymal gene expression signature for prognosis and treatment decision making in early-stage oral cavity squamous cell carcinoma.
Session: Head and Neck Cancer
Date: June 2, 2024, 9:00am – 12:00pm CDT
Abstract/Poster Number: 6091/407

Title: Prediction of immune checkpoint inhibitor (ICI) response in patients with urothelial cancer (UC) by a novel RNA-based ICI response signature (ICI-PRS).
Session: Publication Only: Genitourinary Cancer — Kidney and Bladder
Abstract: e16502

The poster and abstracts will be accessible under the News & Events section of the Company’s website following the conference.

On May 20, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the completion of its purchase of antibodies and related assets from Atreca, Inc (Press release, Immunome, MAY 20, 2024, View Source [SID1234643474]). Under the terms of the agreement, Immunome paid Atreca $5.5 million upfront, and Atreca will be eligible for up to $7.0 million in clinical development milestones. Immunome received the rights to 28 antibodies as well as certain materials.

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"Novel and underexplored targets are central to Immunome’s pipeline strategy," said Jack Higgins, PhD, Chief Scientific Officer. "The antibodies acquired from Atreca add to our ADC toolbox, complementing our existing discovery programs pursuing undisclosed targets."

Added Clay Siegall, PhD, President and Chief Executive Officer, "Immunome intends to further expand its ADC portfolio through cost-effective business development, rigorous discovery efforts, and disciplined development. We believe this purchase accelerates our efforts to bring innovative therapies to cancer patients."

On May 20, 2024 Xcell Biosciences Inc. (Xcellbio), an innovative technology company focused on cell and gene therapy manufacturing applications, and AmplifyBio, a rapidly growing contract development and manufacturing organization, reported the launch of a partnership designed to streamline and improve the manufacturing process for engineered T-cell receptor (TCR) therapies targeting solid tumors (Press release, AmplifyBio, MAY 20, 2024, View Source [SID1234643473]). Preliminary results of this work will be presented at the annual meeting of the International Society for Cell & Gene Therapy (ISCT 2024), taking place May 29 – June 1 in Vancouver, British Columbia.

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"We are focused on enabling the development of a broad range of advanced therapies and believe there are significant opportunities for improving upon therapies that work effectively for solid tumors, from concept to commercialization," said J. Kelly Ganjei, President and CEO of AmplifyBio. "There is a pressing need for more effective and potent therapies, and we believe that working with the Xcellbio team and their unique AVATAR Foundry platform will allow us to make significant progress in that journey, and the results from this work will help create a better sandbox for our clients."

Across the cell and gene therapy field, scientists are looking for ways to boost the fitness and potency of T cells to turn them into more effective therapies for solid cancers, enabling therapeutic options to patients that are not available today. "Current cell therapies have been highly effective for liquid tumors, but little progress has been made for the vast majority of patients with solid tumors. With low oxygen levels, low pH, and other hostile factors, the microenvironment within solid tumors makes it very difficult for T cells to kill cancer cells," said James Lim, co-founder and Chief Scientific Officer of Xcellbio. "Our joint development work with AmplifyBio will demonstrate how the AVATAR Foundry will improve the manufacturability and potency of engineered TCRs by significantly reducing manufacturing times and utilizing non-viral workflows to produce scalable and cost-effective therapies."

Xcellbio previously developed the AVATAR incubator system for cell and gene therapy research and development. Its AVATAR Foundry platform is a cGMP cell therapy manufacturing platform that delivers novel capabilities for improving the potency of cell and gene therapies. In this partnership, scientists from AmplifyBio will work with the Xcellbio team to develop novel cell therapy manufacturing methods based on the AVATAR Foundry platform. The efforts will focus on identifying key elements for successful manufacture of TCR therapies, such as product characterization matrix, correlation to metabolic profile, and potency. An IND filing is expected next year to target human papillomavirus-positive (HPV+) tumors using an engineered TCR therapy.

Brian Feth, co-founder and CEO at Xcellbio, commented: "We are pleased to team up with AmplifyBio, which has a strong track record in supporting the discovery, development, and manufacture of candidate therapies. We’re excited to work together to demonstrate that T cells grown in the AVATAR system can achieve higher potency and greater tumor-killing activity compared to T cells grown in traditional incubators. This has tremendous potential to one day make a difference for patient care."

Scientists from AmplifyBio and Xcellbio will present their joint poster, "Adapting T Cells for the Tumor Microenvironment (TME) During Manufacturing for Improved Anti-Tumor Potency," at ISCT 2024 (poster #933). It will include data about how T cells were metabolically conditioned in the AVATAR system to improve their fitness and potency.

To learn more about the beta access program for the AVATAR Foundry platform, please visit View Source

On May 20, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that in an abstract published on 14 May 2024 for the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Congress on SAR443579/IPH6101, submitted by Sanofi, it was mentioned that the molecule received breakthrough designation (Press release, Innate Pharma, MAY 20, 2024, View Source [SID1234643472]). This is an error. The molecule has US FDA Fast Track Designation, as communicated before in June 2023.

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About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About the Innate-Sanofi research collaboration and licensing agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn in development and commercial milestone payments as well as royalties on net sales.

On May 20, 2024 Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Cantex’ azeliragon, a well-tolerated once-a-day pill, for the treatment of pancreatic cancer (Press release, Cantex, MAY 20, 2024, View Source [SID1234643471]). This new azeliragon orphan drug designation adds to azeliragon’s previous orphan drug designation for the treatment of glioblastoma, received in early 2023.

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Pancreatic cancer, unless controlled at its earliest stages, often spreads to local tissues and to distant organs. Although surgery can be curative if pancreatic cancer is diagnosed at its very earliest stages, once the cancer has spread to distant organs, the current treatment has some, although limited, efficacy. New treatments are clearly needed.

Cantex has an ongoing clinical trial studying the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer. This clinical trial is enrolling metastatic pancreatic cancer patients in several world-class cancer treatment centers in the U.S.

"Receiving FDA orphan drug status for azeliragon for the treatment of pancreatic cancer underscores the significant unmet need for novel treatment options for patients with pancreatic cancer, particularly for those patients with locally advanced, unresectable, or metastatic disease," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "This designation strengthens our continued commitment to developing new azeliragon treatment options for patients with pancreatic cancer, as well as for other cancers and their complications, including glioblastoma, brain metastasis and breast cancer."

FDA Orphan Drug Designation provides Cantex with seven years of azeliragon marketing exclusivity from the time of product launch for the orphan indication, and several other important benefits, including assistance in the drug development process, tax credits for clinical costs, and exemptions from certain FDA fees.

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.

Cantex has ongoing Phase 2 clinical trials in pancreatic cancer, glioblastoma, brain metastasis, breast cancer, and a Phase 3 trial in hospitalized patients with pneumonia. These trials are based on azeliragon’s robust preclinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials.