On April 5, 2023 Certis Oncology Solutions ("Certis"), a precision oncology and translational science company focused on combining functional assays and artificial intelligence to advance personalized medicine, reported that three abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in Orlando, Fla. from April 14-19, 2023 (Press release, Certis Oncology Solutions, APR 5, 2023, View Source [SID1234629849]).

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"Immunotherapy development to date has largely focused on hematological cancers. As cancer researchers turn their attention to applying immuno-oncology to solid tumors, the need for preclinical models that recapitulate tumor microenvironment is becoming critical," said Peter Ellman, Certis President and Chief Executive Officer. "Our science shows that immune response to cancer therapies is dramatically different in humanized subcutaneous and orthotopic PDX models—a likely cause of false positives in preclinical immuno-oncology studies. We’re excited to showcase this and other important areas of cancer research at Certis."

Certis scientists will highlight research in humanized cancer models for immunotherapy, artificial intelligence and circulating DNA as a clinically relevant biomarker. Session titles and information for the three abstracts are listed below and are now available on the AACR (Free AACR Whitepaper) online itinerary planner.

Abstract 4299/30-Section 32: Gene Expression-Based Machine Learning Classifier to Predict and Validate Cancer Type in Patient-Derived Xenograft (PDX) Models
Poster session: April 18, 2023, 9:00 a.m.-12:30 p.m. EDT
Abstract: Patient-derived xenograft (PDX) models are increasingly utilized in translational research and drug development. Characterizing the genomic features of PDX is essential to establishing reliable models for cancer research. Despite great interest, problems remain in PDX tumor data banks, including improper cancer type diagnosis and sample mix-ups. To improve annotation and quality of PDX models, Certis developed a machine learning model trained on gene expression data from the Cancer Genome Atlas (TCGA). Certis then applied the model to corresponding data collected from nearly 300 Certis PDX models as well as the National Cancer Institute’s (NCI) Patient-Derived Models Repository (PDMR). The model shows high precision and variable recall and provides a fast and accurate method for cancer type diagnosis.

Abstract 4762/10-Section 6: In Vivo Tumor Implantation Site Exhibits Differential Immune Response in Solid Tumors
Poster session: April 18, 2023, 1:30 – 5:00 p.m. EDT
Summary: Successful discovery and development of cancer therapeutics depend on testing agents in the most clinically relevant translational models. Emerging evidence highlights the importance of the local tumor microenvironment in evaluating the efficacy of new therapeutics, especially for immunotherapies. Historically, PDX modeling involves subcutaneous implantation which minimally represents the actual human tumor site. Here, Certis uses peripheral blood mononuclear cell (PBMC) humanized PDX models to demonstrate differences in the tumor microenvironment, overall immune response, and the pharmacological outcome, between subcutaneous and orthotopic PDX models. These findings highlight the importance of testing new therapies in the most clinically relevant setting for greater translation into clinical success.

Abstract 6690/10 – Section 40: Monitoring Drug Response with Circulating Tumor DNA in a Non-Small Cell Lung Cancer (NSCLC) Patient-Derived Xenograft Model
Poster session: April 19, 2023, 9:00 a.m.-12:30 p.m. EDT
Abstract: Circulating tumor DNA (ctDNA) has been shown as a clinically relevant biomarker for non-invasive monitoring of therapy response, disease burden and disease progression in cancer patients. Patient-derived xenograft (PDX) mice are essential preclinical models to evaluate therapeutic response. Patients with a KRAS G12 mutation in Non-Small Cell Lung Cancer (NSCLC) have been shown to be resistant to EGFR inhibitors. Here, Certis reports Whole Genome Sequencing (WGS) of ctDNA from PDX for the monitoring of therapeutic response and demonstrates measurable ctDNA changes concordant with therapeutic response. Altogether, the isolation of ctDNA from PDX models is a robust methodology for interrogating therapeutic efficacy, response and resistance in a preclinical setting that can be translated as a viable biomarker for non-invasive monitoring in patients.

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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.