On August 24, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a poster presentation featuring Neo-STAT, the Company’s next generation Immuno-STAT (Selective Targeting and Alteration of T cells) scaffold, at the 16th Annual PEGS Boston Essential Protein Engineering & Cell Therapy Summit (Press release, Cue Biopharma, AUG 24, 2020, View Source [SID1234608298]). Neo-STAT biologics are designed for targeted modulation of tumor-specific T cells with enhanced antigen modularity.

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Presentation Details
Title: Neo-STAT: A new biologics platform for selective targeting of tumor-specific T cells with enhanced antigen modularity
Presenter: Ahmet S. Vakkasoglu, Ph.D., senior scientist
Date: August 31-September 4, 2020

The poster highlights the engineering of the Neo-STAT platform, a scaffold with pocket-stabilized, peptide-free HLA molecules that enables enhanced antigen modularity through exogenous peptide loading. Compared to first generation scaffolds, the design of Neo-STAT improves the productivity and efficiency of scaffold production. Additionally, Neo-STAT biologics can incorporate diverse T cell epitopes, including peptides bearing post-translational modifications, peptide mixtures and peptides derived from tumor neo-antigens, thereby broadening the flexibility and therapeutic impact of the Immuno-STAT platform to target a wider spectrum of disease-associated epitopes.

"We are pleased to be presenting the Neo-STAT platform, which was developed to allow for the generation of therapeutic molecules incorporating diverse T cell epitopes," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "The Neo-STAT platform enables us to access a wider range of therapeutically relevant epitopes, including near-term applications in cancer immunotherapy with shared as well as personalized tumor antigens. In addition to cancer immunotherapy, we are also assessing the potential applications of Neo-STAT in infectious diseases, particularly against novel pathogens where immediate T cell responses could provide protective immunity before other prophylactic vaccination approaches are developed."

About Immuno-STAT
Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On August 24, 2020 Tentarix reported that it was launched with a $50 Million Series A Financing and will leverage the ITS HuTARG core protein engineering platform to create multispecific binding molecules based on fully human antibody variable domains (Vds) (Press release, Tentarix Biotherapeutics, AUG 24, 2020, View Source [SID1234570452]). Tentarix’s mission is to develop first-in-class multispecific therapies. The Company is focused on modalities that have tissue specific function and is building a team that aims to transform biologics.

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On August 24, 2020 Enlivex Therapeutics Ltd., a clinical-stage immunotherapy company, reported that the U.S. Patent and Trademark Office issued a notice of allowance for a new patent application covering ALLOCETRATM, the company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, AUG 24, 2020, View Source [SID1234569021]). Upon issuance, the new patent will provide added intellectual property protection, including methods, uses and pharmaceutical compositions. The company expects that this new patent will be issued in the United States during the fourth quarter of 2020.

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ALLOCETRATM has been designed to provide a novel immunotherapy mechanism of action that targets life-threatening clinical indications that are defined as "unmet medical needs", including organ dysfunction and acute multiple organ failure associated with Sepsis and COVID-19, as well as treating solid tumors by modulating such tumors’ microenvironment.

On August 24, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the Food and Drug Administration (FDA) granted a third Fast-Track designation to its lead drug candidate, repotrectinib (Press release, Turning Point Therapeutics, AUG 24, 2020, View Source [SID1234564367]).

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The designation was granted for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK tyrosine kinase inhibitors (TKIs) and have no satisfactory alternative treatments. Repotrectinib was previously granted two Fast Track designations for the treatment of ROS1-positive advanced non-small cell lung cancer patients, first for patients with one prior line of platinum-based chemotherapy and one prior ROS1 TKI, and second for patients without prior ROS1 TKI treatment. There are no approved targeted therapies for patients previously treated with another ROS1 or TRK TKI.

"We believe repotrectinib has the potential to make a meaningful difference in the lives of cancer patients with ROS1- or NTRK-driven tumors and are pleased to receive our third Fast-Track designation that may help expedite its development," said Athena Countouriotis, M.D., president and chief executive officer. "NTRK-driven cancers are estimated to occur in up to 50,000 patients annually, however there are currently no approved therapies for those patients previously treated with another TRK TKI."

Turning Point recently reported early interim data from its registrational Phase 2 TRIDENT-1 study of repotrectinib, showing a confirmed objective response rate of 50 percent (3/6) in the cohort of NTRK-positive TKI-pretreated advanced solid tumor patients. A total of 40 patients are planned for enrollment in this cohort, and the FDA recently provided guidance that 6 months of follow up from the last response in this cohort may be sufficient to support potential approval. Previous guidance was 12 months. This recent guidance and Fast-Track designation may provide a faster path to potential approval.

About Fast Track Designation
Fast Track is an FDA program intended to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.

A drug candidate that receives Fast Track designation may be eligible for:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication with FDA;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met;
Rolling submission of a New Drug Application (NDA) for review by FDA.

On August 24, 2020 ImmunoGenesis reported that it has been awarded a $15.5 M grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to advance development of IMGS-001, the company’s dual specific Checkpoint Inhibitor and Tumor Microenvironment (TME) remodeling agent. IMGS-001, through its mechanism of action, has the potential to provide superior blockade of the PD-1 pathway and clear out immunosuppressive elements in the TME (Press release, ImmunoGenesis, AUG 24, 2020, View Source [SID1234564032]). This ability to remodel the TME to a more immune supportive environment is believed to be a critical factor in facilitating efficacy in immunologically "cold" cancers such as prostate, colorectal and pancreatic cancer.

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"We are extremely excited that CPRIT recognized the therapeutic potential of our novel dual specific checkpoint inhibitor antibody, IMGS-001, with the awarding of a Product Development Grant," commented ImmunoGenesis Founder, Dr. Michael A. Curran. "Compared to existing immunotherapy drugs, we believe this antibody will both provide more consistent benefit for patients with immune-infiltrated tumors, and, for the first time, will also benefit patients with immune ‘cold’ cancers."

"IMGS-001 is the keystone asset of our therapeutic platform – it has been rationally designed to improve cancer treatment outcomes through modification of the tumor microenvironment," said ImmunoGenesis CEO and President, James Barlow. "Dr. Curran created this next generation checkpoint inhibitor with multi-tasking ability to both provide superior PD-1 pathway blockade and also eliminate immunosuppressive cells. As a result, we believe IMGS-001 will represent a superior foundation of efficacy, particularly in tumors that have not been responsive to current immunotherapies – this efficacy can then be further enhanced through rational combinations."

The award underscores CPRIT’s mission of supporting novel research. IMGS-001 is based on discoveries made by the laboratory of Dr. Curran at The University of Texas MD Anderson Cancer Center and the Oncology Research for Biologics & Immunotherapy Translation (ORBIT) platform, part of MD Anderson’s Therapeutics Discovery division. The technology was licensed to ImmunoGenesis in 2019. Dr. Curran’s financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee.

Dr. Cindy WalkerPeach, Chief Product Development Officer of CPRIT, said "Dr. Curran is a previous recipient of CPRIT funding for research in his lab and CPRIT is thrilled to now fund this exciting company which was founded by Dr. Curran and has the potential to have a significant clinical impact across a wide range of cancers."

ImmunoGenesis is headquartered in Houston and the CPRIT award allows the company to further build-out its management team and corporate infrastructure in the medical community. James Barlow commented "ImmunoGenesis is excited to be a part of an increasingly vibrant biotech community in Houston and Texas, in general."