On November 1, 2021 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200301 (Press release, HiFiBiO Therapeutics, NOV 1, 2021, View Source [SID1234594087]). HFB200301 is a first-in-class monoclonal agonist antibody designed to promote an antitumor response by stimulating both innate and adaptive immune systems through TNFR2 in solid tumors identified through HiFiBiO’s Drug Intelligent Science (DISTM) platform.

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"The FDA’s clearance of our IND for HFB200301 is an important milestone for HiFiBiO as it further demonstrates the power of our single cell-powered DIS platform to identify and develop novel therapeutics. This milestone also signifies our transition to a clinical stage company," said co-founder and CEO of HiFiBiO Therapeutics, Liang Schweizer, Ph.D. "The FDA’s clearance brings us one step closer toward achieving our mission of delivering novel therapeutics that improve treatment options for cancer patients"

"We were excited to discover that our TNFR2 clinical candidate not only stimulated effector CD4 and CD8 T cells, but also activated NK cells to drive anti-tumor activity" shared Francisco Adrián, Ph.D., CSO of HiFiBiO Therapeutics. "HFB200301 has shown strong in vivo efficacy alone and combined with anti-PD-1 at doses well tolerated in mice and NHPs."

"The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts in selected solid tumors identified through HiFiBiO DISTM platform. The company is also exploring a potential combination with checkpoint inhibitor therapy", said Luigi Manenti, M.D., CMO of HiFiBiO Therapeutics. "We remain committed to further developing novel immune therapies for patients with cancer and autoimmune diseases."

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select patients who may benefit the most from HFB200301 treatment.

On November 1, 2021 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported that the company will provide an update on its ACTengine IMA203 trial in a late-breaking oral presentation as well as an update on Immatics’ next-generation CD8ab TCR-T approach at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) (Press release, Immatics, NOV 1, 2021, View Source [SID1234594068]). The conference will take place, both in person and virtually, from November 10 – 14, 2021.

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Today, SITC (Free SITC Whitepaper) announced presentation titles and timings as follows:

IMA203 Phase 1a Clinical Data Update:

Presentation Title: Safety and anti-tumor activity of TCR-engineered autologous, PRAME-directed T cells across multiple advanced solid cancers at low doses – clinical update on the ACTengine IMA203 trial
Speaker: Martin Wermke, MD, Coordinating Investigator of Immatics ACTengine trials in Germany and Head of the Early Clinical Trial Unit of the National Center for Tumor Diseases Dresden (NCT/UCC) at the University Hospital Carl Gustav Carus in Dresden, Germany
Abstract Number: 959
Category: Late-breaking oral abstract presentation
Date & Time: Saturday, November 13, 2021; 12:00 – 12:15 pm EDT

Next-generation CD8ab TCR-T approach – Preclinical Data Update:

Presentation Title: Improved anti-tumor activity of next-generation TCR-engineered T cells through CD8 co-expression
Speaker: Mamta Kalra, PhD, Director CMC (Process Development) at Immatics
Abstract Number: 163
Category: Poster abstract presentation
Date & Time: Friday, November 12, 2021; Poster Hall Hours: 7 am–8:30 pm EDT

All posters presented at the poster hall will be made available as virtual ePosters throughout the SITC (Free SITC Whitepaper) 36th Annual Meeting.

About ACTengine IMA200 programs
Each of the product candidates of the IMA200 programs is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. IMA204 is currently in pre-clinical development. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine IMA200 Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

On November 1, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, reported that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company’s novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation (Press release, BioNTech, NOV 1, 2021, View Source [SID1234594067]). The presentation is scheduled for the late-breaking abstract poster session at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held both in person and virtually from November 10 – 14, 2021.

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"Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology."

BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company’s clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial (NCT04503278) to evaluate safety and preliminary efficacy in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Poster Details:

Program: BNT211
Poster Title: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors
Abstract Number: 958
Presenter: Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany
Date & Time: Friday, November 12, 2021; 12.25 – 12.40 pm ET

On November 1, 2021 Lab Genomics, a personalized medicine company providing state of the art molecular genetic testing in Southern California and other US locations, reported in partnership with Canexia Health that MolDX has finalized coverage determination under the policy "Plasma-Based Genomic Profiling in Solid Tumors” for Follow It, a circulating tumor DNA (ctDNA) assay (Press release, Lab Genomics, NOV 1, 2021, View Source [SID1234594058]). The coverage decision provides Medicare reimbursement for Follow It for use in breast, lung, and colorectal cancers.

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Follow It, which requires only a simple blood draw from patients, analyzes ctDNA in plasma to evaluate somatic mutations in 337 hotspots and 26 exons in 38 cancer associated genes. This information can be used to guide targeted treatment selection, which has been shown to improve patient outcomes up to threefold.

"Medicare coverage for liquid biopsy is a critical step in helping cancer patients gain access to targeted therapies," said Leena Dalal, Founder of Lab Genomics. "We commend MolDX for this decision that supports our focus on delivering individualized medical care."

"Reimbursement for Follow It greatly expands access to a minimally-invasive test for cancer treatment selection for some of the most prevalent forms of solid tumor cancer," said Michael Ball, CEO of Canexia Health. "This MolDX decision marks a significant milestone in our mission to transform cancer care."

On November 1, 2021 CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies, reported that it has entered into a two-year sponsored research agreement with the University of Washington School of Medicine, in Seattle, Washington, for gene therapy research in Duchenne muscular dystrophy (DMD), a rare neuromuscular disease (Press release, CANbridge Life Sciences, NOV 1, 2021, View Source [SID1234594057]). The program will be under the direction of Jeffrey Chamberlain, Ph.D., professor in the Departments of Neurology, Medicine and Biochemistry, the McCaw Endowed Chair in Muscular Dystrophy at the University of Washington School of Medicine, and Director of the Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Center of Seattle. Guy Odom, Ph.D., Research Assistant Professor in the Department of Neurology at the University of Washington, will serve as the co-principal investigator.

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Dr. Chamberlain is internationally renowned as a pioneer and one of the top researchers in the field of gene therapies for muscle diseases. His lab has been studying muscular dystrophy mechanisms, particularly dystrophin structure, and gene therapy approaches. They were the first to show that adeno-associated virus (AAV) vectors could be used for systemic gene delivery to muscle.

"We are thrilled to enter into this research agreement with Dr. Chamberlain, who has been leading the world in DMD research for decades, as we advance our gene therapy research program in neuromuscular disorders," said James Xue, Ph.D., Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc. "Duchenne muscular dystrophy is the most common of the hereditary neuromuscular diseases and, despite recent approvals for exon-skipping therapies, remains severely underserved medically. We believe that the best gene therapy for this devastating disease has not yet been discovered, and we look forward to working with Dr. Chamberlain and his team on their innovative research, as well as the new treatments that may arise from it."

About Dystrophinopathies

Duchenne muscular dystrophy (DMD) is a rare muscle disorder, but it is one of the most frequent genetic conditions that primarily affects males. DMD usually presents in early childhood and is characterized by rapidly progressive muscle degeneration and weakness, leading to loss of ambulation by about 12 years of age. Cardiomyopathy is a common cause of morbidity and death in DMD patients. The incidence of DMD is estimated to be 1/3,500 – 1/5,000 male births worldwide and 1/4,560 in China, according to the National Organization for Rare Disease and published peer review.