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Tarveda Therapeutics Announces Data from Phase 2 Trial of PEN-221 to Be Presented at NANETS 2021 Multidisciplinary NET Virtual Symposium

On November 1, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that data from the Phase 2 clinical trial of PEN-221 will be presented at the North American Neuroendocrine Tumor Society (NANETS) 2021 Multidisciplinary NET Medical Virtual Symposium occurring November 3-6, 2021 (Press release, Tarveda Therapeutics, NOV 1, 2021, View Source [SID1234594041]).

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The presentation details are as follows:

Date: Saturday, November 6, 2021
Time: 1:25pm Eastern Time
Title: The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 Results
Location: Virtual – Register to attend

Synthekine Establishes Collaboration with Merck to Develop Therapeutic Candidates Using its Proprietary Surrogate Cytokine Agonist Platform

On November 1, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported it has entered into a worldwide research collaboration and license agreement with Merck, known as MSD outside the United States and Canada (Press release, Synthekine, NOV 1, 2021, View Source [SID1234594040]). The collaboration will leverage Synthekine’s proprietary surrogate cytokine agonist platform to discover, develop, and commercialize novel cytokine therapeutics.

"At Synthekine, we are focused on advancing cytokine science through three protein engineering platforms to create optimized therapeutics in this important space. Our surrogate cytokine agonist platform produces a new class of cytokine therapeutics that are designed to deliver selective immunotherapies for the treatment of autoimmune diseases and cancer," said Debanjan Ray, chief executive officer of Synthekine. "We are thrilled to announce our first collaboration using this platform with an unequivocal leader in the field."

Under the terms of the agreement, Synthekine is responsible for initial research efforts in collaboration with Merck, and Merck will have exclusive rights to develop, manufacture and commercialize surrogate cytokine agonists for up to two cytokine targets. Initially, the collaboration will focus on a target that has the potential to treat autoimmune diseases. Merck will make an upfront payment and will make an additional one-time payment if it designates a second target. Synthekine will be eligible for up to $525 million in development, regulatory and commercialization milestones, as well as tiered royalties on net sales, for each target. Merck will provide research funding to Synthekine for programs under the collaboration.

"Emerging insights from immunology and oncology are providing new and different ways to think about treating diseases," said Dr. Dean Y. Li, president, Merck Research Laboratories. "We look forward to collaborating with Synthekine to evaluate new approaches to harness the therapeutic potential of cytokines."

Cytokines are small proteins that allow immune cells to communicate and are central to the body’s response to diseases and to the maintenance of immune homeostasis. Developing cytokines as therapeutics, however, is made challenging by the fact that cytokines are pleiotropic, meaning they can induce a range of responses across different cell types. Cytokine pleiotropy has historically led to the development of wild-type cytokines or mutein based therapies with narrow therapeutic windows, resulting in modest efficacy or dose limiting toxicities. Designed using a combinatorial engineering platform, Synthekine’s surrogate cytokine agonists dimerize or multimerize cytokine receptors in ways wild-type cytokines or mutein based approaches cannot, resulting in a wide range of selective and biased signaling possibilities.

Cyteir Therapeutics to Participate in the Credit Suisse 30th Annual Healthcare Conference

On November 1, 2021 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that its President and Chief Executive Officer Markus Renschler, MD will participate in a presentation at the Credit Suisse 30th Annual Healthcare Conference, being held virtually on November 8, 2021, at 4:20pm ET (Press release, Cyteir Therapeutics, NOV 1, 2021, View Source [SID1234594039]).

A live webcast of the presentation will be available in the Investors & Media section of the Cyteir website at www.cyteir.com. A webcast replay will also be available on the website shortly after conclusion of the event for 30 days.

Rhizen Pharmaceuticals AG Announces First Patient Dosing in a Phase I/Ib Study of Its Novel PARP Inhibitor (RP12146) in Patients With Advanced Solid Tumors

On November 1, 2021 Rhizen Pharmaceuticals AG (Rhizen), a Switzerland-based privately held, clinical-stage oncology & inflammation-focused biopharmaceutical company, reported that it has commenced dosing in a multi-center, phase I/Ib trial to evaluate its novel poly (ADP-ribose) polymerase (PARP) inhibitor (RP12146) in patients with advanced solid tumors (Press release, Rhizen Pharmaceuticals, NOV 1, 2021, View Source [SID1234594038]). This two-part multi-center phase I/Ib study is being conducted in Europe and has been designed to initially determine safety, tolerability, maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of RP12146 and to subsequently assess its anti-tumor activity in expansion cohorts with HRR mutation-enriched ES-SCLC, ovarian and breast cancer patients.

Rhizen indicated that RP12146 has shown preclinical activity and efficacy comparable to the approved PARP inhibitor Olaparib, and shows improved safety as seen in the preclinical IND-enabling toxicology studies; an advantage that Rhizen hopes will translate in the clinical studies. Rhizen also announced that its PARP program is part of a larger DNA Damage Response (DDR) platform effort, which includes a preclinical-stage polymerase theta (Polθ) inhibitor program. Rhizen expects the platform to enable novel proprietary combinations of its PARP and Polθ assets given the mechanistic synergy and opportunity across PARP resistant/refractory settings.

"PARP inhibitors are a great success story in the DNA damage response area, but they are not without safety concerns that have limited realization of their full potential. Although our novel PARP inhibitor is competing in a crowded space, we expect its superior preclinical safety to translate into the clinic which will differentiate our program and allow us to extend its application beyond the current landscape of approved indications and combinations", said Swaroop Vakkalanka, Founder & CEO of Rhizen Pharma. Swaroop also added that "Our PARP program is foundational for our DDR platform efforts and will be the backbone for several novel proprietary combinations that we hope to bring into development going forward."

A2 Bio to Highlight Program Updates in Two Presentations at SITC 2021

On November 1, 2021 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company reported that focused on the development of first-in-class T cell therapies to treat solid tumors (Press release, A2 Biotherapeutics, NOV 1, 2021, View Source [SID1234594037]). A2 Bio will make two presentations at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place virtually and in person on Nov. 10–14, 2021 at the Walter E. Washington Convention Center in Washington, D.C . The first presentation will focus on new preclinical in vitro and in vivo demonstrations of both CEA (A2B530) and MSLN (A2B694) Tmod T cell therapy. The second presentation will discuss an observational study, BASECAMP-1, to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH) for future Tmod CAR T cell therapies (NCT#04981119).

"We are pleased to have been selected to present updates on our progress advancing the novel Tmod platform for the treatment of solid tumors, including supporting pre-clinical evidence for CEA (A2B530) and MSLN (A2B694) and an overview of our observational study BASECAMP-1 to identify patients that may benefit from future Tmod CAR T cell therapy," said Scott Foraker, chief executive officer at A2 Bio. "Our Tmod platform is a truly novel approach that has the potential to transform cancer treatment where current treatment approaches fall short, and we are working diligently to demonstrate this."

Julian Molina, MD, PhD, Professor of Oncology, Mayo Clinic, Rochester MN states, "BASECAMP-1 is a premier example of precision medicine. The goal is to identify incurable metastatic, unresectable locally advanced solid tumor patients that may benefit from future Tmod CAR T cell therapy. The pre-clinical Tmod CAR T cell therapy data is promising and we hope to translate this technology from bench to bedside to offer patients a potential treatment for solid tumors."

The two abstracts accepted for poster presentation at SITC (Free SITC Whitepaper) 2021 are:

Title: A powerful, precise targeting system controlled by tumor deletions transforms CEA and MSLN CAR-T cells into tumor-selective agents
Presenter: Alexander Kamb, PhD
Session: Poster
Date/Time: Saturday, November 13 at 7:00 am to 8:30 pm ET
Location: Hall E, Abstract 122

Title: BASECAMP-1: An observational study to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH) and leukapheresis for future CAR T cell therapy
Presenter: Julian Molina, MD, PhD, Professor of Oncology, Mayo Clinic, Rochester MN
Session: Poster
Date/Time: Friday, November 12 at 7:00 am to 8:30 pm ET
Location: Hall E, Abstract 491