On October 1, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance broadening protection of Anixa’s novel Chimeric Antigen Receptor-T cell (CAR-T) cancer treatment technology, known as its Chimeric Endocrine Receptor T-cell, or CER-T approach, or more specifically, "Follicle Stimulating Hormone Receptor-Mediated CAR-T technology," which has been licensed from The Wistar Institute and is being developed in partnership with Moffitt Cancer Center (Press release, Anixa Biosciences, OCT 1, 2021, View Source [SID1234590645]).

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The patent is titled, "Methods and Compositions for Treating Cancer," and the inventors are Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt, both formerly of The Wistar Institute. Dr. Conejo-Garcia is Chair of the Department of Immunology at Moffitt Cancer Center and Dr. Perales-Puchalt is Vice President of R&D at Geneos Therapeutics. The patent is assigned to The Wistar Institute and Anixa Biosciences’ majority-owned subsidiary, Certainty Therapeutics, Inc. is the exclusive, world-wide licensee. This patent is in the family of the originally granted patent, and it covers additional intellectual property related to Anixa’s CAR-T technology.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are pleased to receive this notice from the USPTO, confirming additional protection of our novel CAR-T cancer treatment technology. This technology takes advantage of specific hormone-to-hormone receptor biology to address malignancies and holds promise to be the first successful CAR-T therapy against solid tumors. While our initial focus is the treatment of ovarian cancer—with clinical trials expected to begin before year-end—the technology covered by the patent is broad and may have applicability in treating other solid tumors by exploiting an anti-angiogenesis mechanism of action."

About Anixa’s CER-T approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s Chimeric Antigen Receptor-T cell (CAR-T) Technology approach, known as "Follicle Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology," is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.
The therapy based on this technology was recently authorized by the U.S. Food and Drug Administration (FDA) for Phase 1 clinical testing.

On October 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 and preclinical data will be presented in six posters and one presentation 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 (Press release, BioNTech, OCT 1, 2021, View Source [SID1234590644]). The presentations will include new data from multiple programs across various drug classes along with first-in-human data for three programs. This is the largest data collection the company will present at a scientific meeting, showcasing BioNTech’s diversified oncology pipeline.

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"The data we will be presenting at SITC (Free SITC Whitepaper) 2021 is indicative of our continued pursuit of pathbreaking science and the development of our platform technologies that tailor anti-cancer therapies to individual patient needs," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We are encouraged by the considerable progress within our oncology portfolio seeing multiple programs now coming to fruition. They represent critical steps for us towards bringing cancer immunotherapy into the next generation and we are looking forward to sharing the data with the scientific community at a key conference."

Presentation Details:

Antibodies, Next-Generation Checkpoint Immunomodulators

Program: BNT312
Presentation Title: First-in-human phase 1/2 trial to evaluate the safety and initial clinical activity of DuoBody-CD40×4-1BB (GEN1042) in patients with advanced solid tumors
Session Title: Concurrent Rapid Oral Abstract Presentation Session 206: Clinical
Speaker: Melissa L. Johnson, M.D., Lead Investigator, Associate Director, Lung Cancer Research, Sarah Cannon Cancer Institute, TriStar Centennial Medical Center
Abstract Number: 493
Date & Time: Saturday, November 13, 2021, 12:45 pm – 1:45 pm ET

This product candidate GEN1042 (BNT312) is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future profits on a 50:50 basis.

Poster Details:

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

mRNA Therapeutics, FixVac

Program: BNT111
Poster Title: An RNA lipoplex (RNA-LPX) vaccine demonstrates strong immunogenicity and promising clinical activity in a Phase I trial in cutaneous melanoma patients with no evidence of disease at trial inclusion
Abstract Number: 15965
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET

Program: BNT112
Poster Title: A first-in-human (FIH) Phase I/IIa clinical trial assessing a ribonucleic acid lipoplex (RNA-LPX) encoding shared tumor antigens for immunotherapy of prostate cancer; preliminary analysis of PRO-MERIT
Abstract Number: 15941
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET

Engineered Cell Therapies, NEO-STIM

Program: BNT221
Poster Title: BNT221, an autologous neoantigen-specific T-cell product for adoptive cell therapy of metastatic ovarian cancer
Abstract Number: 201
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET

Antibodies, Next-Generation Checkpoint Immunomodulators

Program: BNT311
Short Presentation Title: Peripheral and tumoral immune activity in the expansion part of the first-in-
human DuoBody-PD-L1×4-1BB (GEN1046) trial
Abstract Number: 516
Date & Time: Saturday, November 13, 2021, 7:00 am – 8:30 pm ET

The product candidate GEN1046 (BNT311) is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future profits on a 50:50 basis.

Program: BNT311
Short Presentation Title: Dose selection for DuoBody-PD-L1×4-1BB (GEN1046) using a semimechanistic
pharmacokinetics/pharmacodynamics model that leverages preclinical and clinical data
Abstract Number: 786
Date & Time: Saturday, November 13, 2021, 7:00 am – 8:30 pm ET

The product candidate GEN1046 (BNT311) is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future profits on a 50:50 basis.

Small Molecule Immunomodulators, Toll-like Receptor (TLR) Binding platform

Program: BNT411
Short Presentation Title: Preliminary safety, PK/PD and efficacy results from a first-in-human phase I/IIa clinical trial of BNT411, a systemic Toll-like receptor 7 agonist in patients with solid tumors
Abstract Number: 525
Date & Time: Friday, November 12, 2021, 7:00 am – 8:30 pm ET

On October 1, 2021 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported it will present preclinical data for its anti-VISTA (V-domain Ig suppressor of T cell activation) product candidate, SNS-101, during the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held in Washington, D.C. from November 10 – 14, 2021 (Press release, Sensei Biotherapeutics, OCT 1, 2021, View Source [SID1234590642]). These data are the first preclinical data to be presented by Sensei Bio in a scientific forum from the company’s TMAb (Tumor Microenvironment Activated biologics) platform.

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"Our TMAb technology has the potential to address the challenges of current immune checkpoint therapies by identifying antibodies that preferentially bind in the tumor microenvironment, providing the potential for an improved safety and clinical activity profile," said Robert Pierce, M.D., chief scientific officer at Sensei Bio. "We believe SNS-101 has the potential to unleash potent anti-cancer immune responses through selective inhibition of VISTA, an important immune checkpoint regulator. The key to unlocking the power of the VISTA immune checkpoint is to select an antibody that binds VISTA at low pH in order to avoid target mediated drug disposition and on target/off-tissue side effects."

Poster Presentation Details

Abstract #228: Antagonistic pH-selective VISTA antibody SNS-101 potentiates anti-PD-1/PD-L1-induced anti-tumor immunity

Poster Session Date & Time: Saturday, November 13, 2021, from 7:00 a.m. – 8:30 p.m. ET

Presenter: Edward van der Horst, Ph.D., Vice President, Preclinical Development at Sensei Biotherapeutics

About SNS-101
SNS-101 is a potent, pH-dependent fully human monoclonal antibody designed to block the interaction of VISTA, a novel immune checkpoint that is expressed primarily on myeloid cells, with its receptor, PSGL-1. Selectivity is achieved because SNS-101 targets VISTA only at the acidic pH of the tumor (pH~6), which is lower than the blood (pH 7.4) and may result in a favorable pharmacokinetic (PK) profile. Blocking the interaction of VISTA with its receptor PSGL-1 activates T-cells and may result in tumor microenvironment selective activity of SNS-101. VISTA has been shown to play an important role in multiple tumor types, including non-small cell lung cancer (NSCLC).

On October 1, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported it will present initial data from its ongoing Phase 1 clinical trial of ONCR-177 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 12–14, 2021 in Washington, D.C. and virtually (Press release, Oncorus, OCT 1, 2021, View Source [SID1234590640]).

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ONCR-177, Oncorus’ lead oncolytic Herpes Simplex Virus (oHSV) product candidate, is an intratumorally (iTu) administered viral immunotherapy being developed for multiple solid tumor indications. The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors.

The details for Oncorus’ SITC (Free SITC Whitepaper) poster are as follows:

Title: Initial results of a Phase 1 study of intratumoral ONCR-177, an oncolytic herpes-simplex virus-1 expressing five immunomodulatory transgenes, in subjects with advanced injectable tumors
Abstract #: 511
Primary Author/Presenter: Jong Chul Park, M.D., Instructor, Medicine, Harvard Medical School and Assistant, Medicine, Massachusetts General Hospital
Date/Time: November 12–14, 2021, 7:00 a.m.– 8:30 p.m. ET
Location: Poster Hall, Walter E. Washington Convention Center, Washington, D.C.

On October 1, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that one oral and four poster presentations for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 10-14, 2021 (Press release, Fate Therapeutics, OCT 1, 2021, View Source [SID1234590638]).

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The oral presentation will highlight preclinical data for FT536, the Company’s off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) NK cell product candidate that uniquely targets the α3 domain of the MHC class I related proteins A (MICA) and B (MICB). In a recent publication in Cancer Immunology Research (DOI: 10.1158/2326-6066.CIR-19-0483), Kai W. Wucherpfennig, M.D., Ph.D., Chair of the Department of Cancer Immunology and Virology at the Dana-Farber Cancer Institute and co-leader of the Cancer Immunology Program at Dana-Farber / Harvard Cancer Center, demonstrated that cancers with loss of MHC Class I expression can be effectively targeted with MICA/B α3 domain-specific antibodies to restore NK cell-mediated immunity against solid tumors. The FT536 program is supported by an exclusive license from the Dana-Farber Cancer Institute to intellectual property covering novel antibody fragments binding MICA/B for iPSC-derived cellular therapeutics. The Company expects to submit an Investigational New Drug (IND) application for FT536 in the fourth quarter of 2021 for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.

Poster presentations at SITC (Free SITC Whitepaper) will include preclinical data on new functional elements that the Company is evaluating for incorporation into its iPSC-derived cell product candidates for solid tumors. These synthetic features include engineered chemokine receptors, which the Company has demonstrated can enhance the trafficking and homing of iPSC-derived CAR T cells to tumors, and synthetic TGFβ re-direct receptors, which the Company has shown can exploit immuno-suppressive cytokines found in the tumor microenvironment to potentiate iPSC-derived CAR T cells and improve anti-tumor activity.

Oral Presentation

FT536 Path to IND: Ubiquitous targeting of solid tumors with an off-the-shelf, first-of-kind MICA/B-specific CAR-iNK cellular immunotherapy
Abstract #: 117
Session 212: Cellular Therapies; November 13, 3:40 pm – 4:55 pm EST
Poster Presentation

Synthetic re-direction of TGFβ receptors as a novel strategy to enhance the anti-tumor activity of iPSC-derived CAR-T cells in solid tumors
Abstract #: 138
Chemokine receptor engineering enhances trafficking and homing of primary and iPSC-derived CAR-T cells to solid tumors
Abstract #: 120
Off-the-shelf, engineered iPSC-derived NK cells mediate potent cytotoxic activity against primary glioblastoma cells and promote durable long-term survival in vivo
Abstract #: 169
Novel FcyR recombinant fusion facilitates antibody arming of engineered iPSC-derived NK cells to enhance targeting and killing of ovarian cancer cells
Abstract #: 197
About MICA and MICB Proteins
The major histocompatibility complex (MHC) class I related proteins A (MICA) and B (MICB) are induced by cellular stress, damage or transformation, and the expression of MICA and MICB proteins has been reported for many tumor types. Cytotoxic lymphocytes, such as NK cells and CD8+ T cells, can detect and bind the membrane-distal α1 and α2 domains of MICA/B, activating a potent cytotoxic response. However, cancer cells frequently evade immune cell recognition by proteolytic shedding of the α1 and α2 domains of MICA/B. The clinical importance of proteolytic shedding is reflected in the association of high serum concentrations of shed MICA/B with disease progression in many solid tumors. Several recent publications have shown that therapeutic antibodies targeting the membrane-proximal α3 domain strongly inhibited MICA/B shedding, resulting in a substantial increase in the cell surface density of MICA/B and restoration of NK cell-mediated tumor immunity (DOI:10.1126/science.aao0505). Therapeutic approaches aimed at targeting the α3 domain of MICA/B therefore represent a potentially promising novel strategy to overcome this prominent evasion mechanism as a means of restoring anti-tumor immunity.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.