1stOncology™: Cancer Intelligence Service – Page 6393 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Helsinn announces presentation on CINV trial at European Society for Medical Oncology (ESMO) Asia

On November 29, 2022 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases announces, announces its poster presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress, being held in Singapore from 2-4 December(Press release, Helsinn, NOV 29, 2022, View Source [SID1234624536]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Helsinn will be presenting a poster on the ongoing MyRisk international trial, assessing whether the administration of a combined treatment of NEPA (Fixed Combination of Netupitant/Palonosetron) and dexamethasone is more effective than the current standard of care prophylaxis1-2-3 (a combination of 5-HT3 receptor antagonist and dexamethasone) in preventing Chemotherapy-induced Nausea and Vomiting (CINV) in patients at increased risk of emesis receiving moderately emetogenic chemotherapy.

Full details of the poster presentation are below:

Title: Assessing the Benefit of NEPA (Fixed Combination of Netupitant/Palonosetron) for Preventing Chemotherapy-induced Nausea and Vomiting (CINV) in Patients at Increased Emetic Risk Receiving Moderately Emetogenic Chemotherapy
Author: Alex Molassiotis, Matti Aapro, Alessandro Alonzi, Marika Chrápavá, Karin Jordan Eric J. Roeland, Lee Schwartzberg, Carole Terrasanta, Silvia Olivari Tilola, George Dranitsaris
Session: Poster session, 03 December, 18:00 – 18:45
Abstract ID: NCT04817189
Dr Silvia Sebastiani, Helsinn Group Head of Medical Affairs, commented: "We are pleased to present the design of this important ongoing study at the ESMO (Free ESMO Whitepaper) Asia congress. Despite the array of effective antiemetics, CINV still represents a huge unmet need in clinical practice. To further the goal of CINV prevention for all patients undergoing emetogenic chemotherapy, it is important to explore ways to optimize antiemetic selection, including exploring factors that may increase CINV risk for patients."

Prof. Alex Molassiotis, Pro Vice Chancellor and Dean, University of Derby, UK and Scientific Lead of the MyRisk study added: "In patients receiving moderately emetogenic chemotherapy (MEC), antiemetic guidelines generally recommend a setron + dexamethasone (DEX). However, one guideline committee (the National Comprehensive Cancer Network ("NCCN")) recognized that this approach is inadequate prophylaxis for many patients and included an NK1 RA-containing option selectively for those with individual emetic risk factors2. MyRisk is the first study prospectively exploring the role of NK1 RA-containing regimen, Akynzeo in this case, in patients receiving MEC who have additional risk factors."

BigHat Biosciences Announces Research Collaboration with Merck

On November 29, 2022 BigHat Biosciences, Inc., a biotechnology company with a machine learning-guided antibody discovery and development platform, reported a collaboration with Merck, known as MSD outside of the United States and Canada, to apply the company’s technology to design candidates for up to three drug discovery programs (Press release, Merck & Co, NOV 29, 2022, View Source [SID1234624560]).

BigHat’s design platform, Milliner, integrates a high-speed characterization with ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach could help reduce the difficulty of optimizing antibodies and other therapeutic proteins.

Under the collaboration, BigHat and Merck will collaborate to optimize up to three proteins by leveraging BigHat’s platform to synthesize, express, purify, and characterize molecules. Mark DePristo, co-founder and CEO of BigHat, continued, "We are thrilled to be collaborating with Merck’s world-class drug development teams to design safer, more effective antibodies for these important therapeutic programs."

The teams have initiated work on the first program and are looking forward to using the power of the complementary skills sets within each research team to generate high-quality lead antibodies. "We are excited to begin this collaboration to advance next-generation antibody therapeutics to patients," said Elizabeth Schwarzbach, BigHat’s Chief Business Officer. "This agreement with Merck brings us a major step closer to our goal of 3-5 deep collaborations with leading biopharmas to complement our internal therapeutic pipeline."

"This agreement with BigHat expands Merck’s strategy of applying AI/ML across our drug discovery capabilities," said Juan Alvarez, vice president of Biologics Discovery, Merck Research Laboratories. "We look forward to working with the team to leverage BigHat’s technology and expertise in enabling molecular design of novel biologic candidates."

Zymeworks Announces Expiration of Hart-Scott-Rodino Waiting Period for Zanidatamab License Agreement with Jazz Pharmaceuticals

On November 29, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as amended, for the previously announced license agreement of zanidatamab, a HER2-targeted bispecific antibody, with Jazz Pharmaceuticals has expired (Press release, Zymeworks, NOV 29, 2022, View Source [SID1234624559]).

The expiration or termination of the HSR waiting period was a condition to Zymeworks’ receipt of a $50.0 million non-refundable upfront payment from Jazz as part of the agreement. Zymeworks anticipates providing Jazz top-line clinical data from Zymeworks’ HERIZON-BTC-01 study before the end of 2022. Should Jazz decide to continue the collaboration following the data readout, a second, one-time payment of $325.0 million to Zymeworks will be due and payable, which Zymeworks expects to receive before the end of 2022.

Vergent Bioscience Awarded National Cancer Institute Phase 2 Grant to Advance Clinical Development of VGT-309 in Lung Cancer

On November 29, 2022 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported that the National Cancer Institute (NCI) of the National Institutes of Health (NIH) has awarded the company a Small Business Innovation Research (SBIR) grant of nearly $2 million (Award Number R44CA277890) (Press release, Vergent Bioscience, NOV 29, 2022, View Source [SID1234624558]). The grant will help fund a Phase 2 clinical study evaluating the company’s targeted fluorescent imaging agent, VGT-309, for intraoperative imaging of tumors in patients undergoing lung cancer surgery.

"This Phase 2 SBIR award further validates the promise of VGT-309 to help surgeons realize the full potential of minimally invasive and robotic-assisted surgical procedures by improving the visibility of tumors during surgery," said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. "We are grateful to the NCI for their support and to the team at the University of Pennsylvania’s Perelman School of Medicine for conducting this Phase 2 study."

The majority of lung cancer surgery is now performed using minimally invasive approaches, which have multiple advantages for patients, but require that surgeons work in a small area with a restricted view and limited tactile clues, presenting the potential for tumor to be missed and left behind. Early Phase 1 and 2 clinical trials evaluating VGT-309 in lung cancer yielded compelling safety and efficacy data that support the agent’s ability to help surgeons see previously undetected or difficult-to-find tumors in real-time, ensuring all tumor tissue is removed during minimally invasive (MIS) and robotic-assisted surgical procedures.

The NCI SBIR grant will support a Phase 2 clinical study of VGT-309 led by Sunil Singhal, M.D., the William Maul Measey Professor of Surgical Research and the chief of the Division of Thoracic Surgery at Penn (NCT05400226). The study will evaluate the safety and efficacy of VGT-309 to locate and identify tumor tissue that may have otherwise been missed during lung cancer surgery.

"As minimally invasive surgical approaches are increasingly becoming the standard of care for treatment of many solid tumors, surgeons urgently need imaging agents that will support better tumor visualization," said Dr. Singhal. "We’re encouraged by early data from studies evaluating VGT-309 and look forward to further exploring its utility in this trial."

The NIH’s SBIR program is a congressionally mandated set-aside program to encourage research and development that has a strong potential for technology commercialization. The program allows small business entrepreneurs a chance to obtain non-dilutive funding for early-stage R&D.

About VGT-309
VGT-309 is a tumor-targeted imaging agent intentionally designed to enable a complete solution for optimal tumor visualization during open, MIS, and robotic-assisted surgical procedures. VGT-309 is delivered to patients via a short infusion several hours before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are highly overexpressed across a broad range of solid tumors. This approach provides distinct clinical advantages and positions VGT-309 as an ideal tumor imaging agent. VGT-309’s imaging component is the near infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is the preferred dye to minimize confounding background autofluorescence.

Turnstone Biologics Enters Cooperative Research and Development Agreement with the National Cancer Institute to Study TIL Therapy in Combination with Viral Immunotherapy

On November 29, 2022 Turnstone Biologics Corp, a clinical-stage biotechnology company developing next-generation immunotherapies to treat and cure solid tumors, reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to evaluate the generation of tumor-reactive T-cells, which form the basis of Turnstone’s tumor-infiltrating lymphocyte platform (Selected TILs), from clinical tissue samples obtained from patients treated with Turnstone’s proprietary viral immunotherapies (Press release, Turnstone Biologics, NOV 29, 2022, View Source [SID1234624557]). The combination of Selected TILs and viral immunotherapy have the potential to enhance the efficacy of TILs and to extend their benefit to patients with a broad array of solid tumors. The collaboration will be co-led by Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone Biologics, and Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research and a pioneer in the fields of immunotherapy and cell therapy.

"I believe TIL therapy is one of the most exciting areas of modern research in the cancer arena," notes Dr. Abbot. "The low concentration of functional tumor-reactive T-cells in many solid tumors is a key challenge to immunotherapy of cancer, and better methods to generate these immune cells are needed to prevail against solid tumors. Viral immunotherapy has the potential to synergistically drive infiltration of tumor-reactive T-cells and modulate immune responses, and thereby deepen the activity and durability of TIL therapy to reach new frontiers for this highly promising field."

Selected TILs represent the foundational therapeutic modality driving Turnstone’s cancer immunotherapy pipeline and leverage decades of published work grounded in academia that have demonstrated the promise of treating solid tumor cancers through the identification, selection, and expansion of the most potent patient specific tumor-reactive T-cells. Turnstone’s viral immunotherapies are designed to enhance trafficking of these Selected TILs directly to the site of the tumor and modify the immunosuppressive microenvironment to support the anti-tumor functions of infiltrating immune cells. Through this novel combination, Turnstone aims to improve and broaden the clinical efficacy of Selected TILs and overcome the limitations of current treatment options to achieve positive outcomes in intractable solid tumors.

Under the terms of the CRADA, the parties will evaluate the impact of Turnstone’s proprietary oncolytic viruses on increasing the immune response to tumor neoantigens in clinical patient samples. Turnstone will be responsible for manufacturing and administering its viral immunotherapies to patients and subsequent tissue collection. NCI investigators will use NCI-developed methods and proprietary in vitro techniques to study lymphocytes derived from these patients, characterize their specificity and evaluate their persistence. The parties will jointly analyze data and exchange information and expertise to advance the development of oncolytic viruses as an improved method for the generation of Selected TILs.

"Dr. Rosenberg pioneered cancer immunotherapy and cell therapy and we are honored to have him and the NCI as collaborators for this study," said Sammy Farah, Ph.D., M.B.A., President and Chief Executive Officer, Turnstone Biologics. "Turnstone’s combination strategies with TIL and viral immunotherapy are designed to improve TIL harvest and overcome the immunosuppressive tumor microenvironment for better trafficking and expansion of our Selected TILs. This CRADA with the highly distinguished team at the NCI provides us with an optimal path towards demonstrating the value of this innovative approach and translating our scientific advances into more effective treatments."