On April 5, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will participate in a fireside chat at the 22nd Annual Needham Virtual Healthcare Conference on Wednesday, April 19 at 3:00 p.m. Eastern Time (Press release, Personalis, APR 5, 2023, View Source [SID1234629848]).

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On April 5, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that management will present at the 22nd Annual Needham Virtual Healthcare Conference being held April 17-20, 2023 (Press release, Sapience Therapeutics, APR 5, 2023, View Source [SID1234629847]).

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Sapience CEO and President, Dr. Barry Kappel, will present a company overview on Monday, April 17, 2023, at 11:00 am ET. Company management will also participate in virtual one-on-one meetings with investors during the conference.

On April 5, 2023 Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory disease, reported it has entered into a Research Collaboration and License agreement with Incyte to discover and develop targeted protein degraders for novel oncology targets (Press release, BioTheryX, APR 5, 2023, View Source [SID1234629846]).

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"We are pleased to embark on this collaboration with Incyte to identify targeted protein degraders for novel oncology targets. Biotheryx and Incyte share a commitment to finding new, transformative treatment options for people living with cancer," said Philippe Drouet, President and Chief Executive Officer of Biotheryx. "Our PRODEGY platform is designed to increase efficiency in degrader discovery and design, enabling the development of therapies for previously undruggable targets. We look forward to leveraging this differentiated approach in our collaboration with Incyte and in the continued advancement of our pipeline of first-in-class, next generation bifunctional degraders and molecular glues for the treatment of cancers and inflammatory disease."

Under the terms of the agreement, Biotheryx will utilize its distinctive PRODEGY platform to identify and initially develop molecular glue degraders for multiple historically undruggable oncology targets. For the initial target, Biotheryx will receive a technology access fee of $7 million plus up to an additional $6 million in potential research and development funding from Incyte for costs associated with the collaboration. Biotheryx is also eligible to receive potential future regulatory and commercial milestones of up to $347 million plus tiered single-digit royalties on global net product sales for the initial target. Incyte will be solely responsible for further development and commercialization of any molecular glue degraders discovered by Biotheryx’s PRODEGY platform. Additionally, under the terms of the agreement, the collaboration can be expanded under the same financial terms. Further financial terms of the deal were not disclosed.

"As we work to transform the oncology treatment landscape, Incyte is harnessing breakthrough science that may offer patients with unmet needs new treatment options," said Dashyant Dhanak, Ph.D., Executive Vice President and Chief Scientific Officer of Incyte. "The Biotheryx team has significant expertise in targeted protein degradation, one of the most promising modalities in oncology, and we look forward to collaborating to develop therapies that can help improve patient lives."

On April 5, 2023 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (Press release, Intas Pharmaceuticals, APR 5, 2023, View Source [SID1234629845]).

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"The promise of HLX02’s reference product—Herceptin1—is well documented, and we’re thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology, and critical care," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "Biosimilars are key to making healthcare more affordable and accessible. We’re working to develop the deepest portfolio of biosimilars to enhance the patient experience and improve the cost of care across the continuum."

HLX02 was originally developed by Accord’s business partner Shanghai Henlius Biotech, Inc. headquartered in Shanghai, China. In 2021, Henlius granted Accord BioPharma the exclusive rights to develop and commercialize HLX02 in the U.S. and Canada.

Approved in more than 30 countries, HLX02 was approved for commercialization by the European Commission (EC) and China’s National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively, for the same indications as the innovator product.

The BLA submission is based on robust structural and functional analytical comparison data using multiple orthogonal techniques and head-to-head clinical studies between HLX02 and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a phase 1 PK similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations, which compared HLX02 to the reference trastuzumab. The clinical results demonstrated that HLX02 and reference trastuzumab are highly similar in terms of quality, safety, and efficacy.

Accord BioPharma has already received BLA approval on two other biosimilars, and the company plans to introduce several additional biosimilars to the U.S. market in the next five years.

On April 5, 2023 Deka Biosciences ("Deka"), a clinical-stage biotechnology company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, reported that the first subject has been dosed in a Phase 1 clinical trial of DK210 (EGFR) at NEXT Oncology in Fairfax, Virginia (Press release, Deka Biosciences, APR 5, 2023, View Source [SID1234629844]). The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK210 (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR) (NCT05704985).

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"We are beyond thrilled to begin the clinical trial of DK210 (EGFR), marking our first program to enter clinical development," said John Mumm, Ph.D., President and CEO of Deka. "Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first DiakineTM, establishing a solid foundation for the expanded use of this treatment in cancer patients."

"This novel agent holds significant potential for patients and we are excited to be at the forefront of this groundbreaking platform that places great emphasis on patient comfort and convenience via a self-administered treatment," shared Dr. Spira, CEO and Clinical Director at NEXT Oncology in Virginia.

DK210 (EGFR) is the first of several experimental therapeutics developed as part of Deka’s platform of molecules, which combines the cytokines full strength IL-2 and a high affinity IL-10. While IL-2 is known to be toxic, when coupled with IL-10, toxicity is not only reduced but its potency is increased, thereby creating a more tolerable and effective treatment for patients. It is the first of several experimental therapeutics in Deka’s platform of molecules which are being developed to treat both cancer and inflammatory diseases. These therapeutics, known as DiakinesTM, involve coupling two cytokines together onto a single chain variable fragment (scFv) targeting system to enhance their precision in targeting specific tissues. Furthermore, the scFv scaffold used in the DiakineTM platform also improves efficacy, safety and manufacturability of each treatment.