On October 19, 2022 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with cancer, reported a multi-year agreement with AmplifyBio to use its facilities in South San Francisco, Calif. for Triumvira to manufacture its own cell therapy candidates within the company’s pipeline (Press release, Triumvira Immunologics, OCT 19, 2022, View Source [SID1234622174]).

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The advanced research and manufacturing space features an FDA-compliant GMP facility and will be staffed by Triumvira technical operations experts in cell therapy manufacturing, with plans for additional personnel in the coming years. Triumvira expects the facility to be fully operational in 2023.

"Triumvira’s modular TAC manufacturing process offers the ability to integrate quickly and effectively into this new facility as well as potentially into additional GMP spaces," said Donna Rill, Chief Technology Officer at Triumvira. "Our newly expanded manufacturing team also brings the deep technical expertise required to bring forward TAC T cell therapies as a potential new class of medicines."

The South San Francisco facility is Triumvira’s second manufacturing location and is expected to provide supplemental manufacturing capacity to meet the demand for its ongoing clinical research studies. In 2018, Triumvira entered into a strategic relationship with C3i Center Inc. (C3i) to manufacture cell therapy candidates for its clinical trials at C3i’s state-of-the art GMP facility, with capabilities to manufacture cell therapies from process development to commercialization, located in Montreal.

Once operational, the South San Francisco facility will manufacture TAC01-HER2, which is currently in a Phase 1/2 trial for solid tumors, and manufacture additional candidates for subsequent clinical studies. Manufacturing of Triumvira’s second most advanced candidate, TAC-Claudin 18.2 – in preclinical development for the treatment of gastric cancer – will start at C3i in 2023.

"We are excited to expand our manufacturing footprint in the U.S., which is an important component of our overall strategic growth plan and accelerates our ability to launch new programs into the clinic over the next few years," said Paul Lammers, M.D., M.Sc., President and CEO of Triumvira. "South San Francisco is home to the largest biotech cluster in the world and we look forward to establishing our presence among the world’s most prolific biotech companies, as well as gaining access to the highly-skilled talent in the area."

On October 19, 2022 Hemispherian AS ("Hemispherian” or the "Company"), a Norwegian preclinical pharmaceutical company focused on small molecule cancer therapeutics targeting the DNA damage response, reported a successful European Innovation Council (EIC) Accelerator grant application (Press release, Hemispherian, OCT 19, 2022, View Source [SID1234622173]). This grant will provide EUR 2.5M in grant funding and the jury recommends an additional EUR 7.5M in equity financing from the EIC fund. Financing from the EIC accelerator will be used to advance GLIX1, one of Hemispherian’s lead assets, through a phase I and phase II clinical trial.

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"We are pleased to accept funding through the EIC accelerator program. This funding will ensure the successful development of Hemispherian’s lead asset, GLIX1, through phase I and phase II clinical trials."
— Adam Robertson, PhD, Chief Scientific Officer, Hemispherian

On October 19, 2022 Orionis Biosciences, a life sciences company pioneering innovation of highly selective and tunable therapeutics for cancer and beyond, reported it has completed a $55 million financing round and expanded its team, naming Robert Petit, Ph.D., as Senior Vice President, Early Clinical Development and Bihua Chen to the Orionis Board of Directors (Press release, Orionis Biosciences, OCT 19, 2022, View Source [SID1234622172]).

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Founded in 2015, Orionis has since developed its proprietary technology platforms, grown a deep pipeline and cemented a drug discovery deal with Novartis. This latest financing round provides the company with additional capital for R&D expansion, pipeline growth and advancement of its lead cancer immunotherapy programs into clinical trials. Existing and new investors participated in the round, including Cormorant Asset Management, Novartis and a series of high-caliber investment funds.

"We are grateful for the strong support of a world-class investor syndicate that shares our passion for advancing new modalities in cancer and other diseases," said Nikolai Kley, Ph.D., Co-founder, President and Chief Executive Officer at Orionis. "As we near the clinic, we are thrilled to bring on Robert Petit, Ph.D., a pioneer in the development of cancer immunotherapies, as our Head of Early Clinical Development. In addition, we are pleased to welcome industry veteran Bihua Chen to our Board as we enter this next stage of growth. With two distinct precision medicine platforms, which focus on expanding druggability through genome-scale molecular glue discovery and on selectively targeting immune cells with conditionally active cytokines to reactivate the cancer immunity cycle, we are well-positioned to advance a diverse pipeline and translate our innovative approaches into new therapies."

"I have spent my career working to develop new and better cancer therapies, so I’m incredibly excited to have joined to lead the team’s translational and clinical development efforts," said Dr. Petit. "We are moving quickly to advance and expand our pipeline of first-in-class immunotherapies. The extraordinary technology platforms at Orionis have the potential to create a new class of more effective and better-tolerated cancer treatments that could significantly extend the potential of immunotherapy. I look forward to supporting Orionis in its path toward a clinical-stage company."

Dr. Petit brings decades of experience in drug development, including at Bristol Meyers Squibb, where he led U.S. Medical development of the first FDA-approved immune checkpoint therapy. He has deep experience across medical and scientific aspects of pharmaceutical development and has directed programs in discovery, translational development and intellectual property development. Dr. Petit received his Ph.D. from The Ohio State University College of Medicine and a B.S. from Indiana State University.

"With its proprietary platform technologies, Orionis has the opportunity to solve some of the biggest challenges in oncology and beyond," said Ms. Chen. "I am honored to join the Board of Directors at Orionis and to work with such an accomplished team."

Ms. Chen is founder and CEO of Cormorant Asset Management, where she manages investments in public and private biopharmaceutical companies. She previously served as a sub-adviser to a large, multi-strategy hedge fund based in New York. Ms. Chen earned an MBA from The Wharton School of the University of Pennsylvania, an M.S. in molecular biology from the Graduate School of Medical Sciences at Cornell Medical College and a B.S. in genetics and genetic engineering from Fudan University.

Orionis is rapidly advancing a deep pipeline of biologics for the treatment of cancer based on its A-Kine platform, which engineers target-selective, conditionally active cytokines designed to trigger anti-tumor immune responses even in "cold" tumors that lack prevalent immune involvement and are refractory to checkpoint inhibitor therapies. A-Kines aim to avoid the systemic toxicities observed with traditional cytokine therapies.

In addition, Orionis is developing a diverse spectrum of small molecule molecular glues using its Allo-Glue platform, harnessing a first-in-class, genome-scale approach to discovery and rational design of molecular glues in order to reach previously intractable targets. Orionis will present preclinical data from its molecular glue platform in October at the following conference:

5th Annual Targeted Protein Degradation, October 25-28, 2022, Boston, Massachusetts

Title: Monovalent Molecular Glues: Cereblon and Beyond
Date and Time: Wednesday, October 25, 5:00 p.m. ET
Presenter: Riccardo Sabatini, Chief Data Scientist, Orionis Bio

On October 19, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will host a webcast and conference call to provide a corporate and financial update for the third quarter of 2022 on Wednesday, November 2, 2022, at 8:30 a.m. ET (Press release, G1 Therapeutics, OCT 19, 2022, View Source [SID1234622171]).

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Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On October 19, 2022 Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that it has added two near-term generic products to its portfolio in an exclusive agreement with CorePharma, LLC (CorePharma) (Press release, Upsher-Smith Laboratories, OCT 19, 2022, View Source [SID1234622169]). Under the terms of the agreement, CorePharma will secure FDA approval and manufacture both products at its New Jersey manufacturing facility. Upon FDA approval, Upsher-Smith will market and distribute the products under its own label in the US.

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This collaboration supports Upsher-Smith’s company-wide effort to grow the Company’s portfolio of products through strategic partnerships and product acquisitions.

"Our partnership with CorePharma, a leader in product development and manufacturing, is especially significant as it provides Upsher-Smith with two near-term product opportunities that will help maximize top-line revenue in FY2022," said Arun Nataraj, Vice President, Corporate Development, Upsher-Smith. "This is the latest of four recently completed strategic partnerships, reflecting the rapid execution of our external development strategy to expand our generic portfolio."

Rich Fisher, President and COO, Upsher-Smith added, "Over the past six months, our corporate development team has had great success expanding our portfolio of high-quality generic products and positioning Upsher-Smith for both near-term and future growth. We look forward to a productive partnership with CorePharma."

"CorePharma is extremely happy to partner with a world class organization such as Upsher-Smith," said Arpit Patel, Chief Executive Officer, CorePharma. "With their strong commercial experience in the US Market, we are confident of the success of these product launches and are looking forward to expanding our partnership across many other future opportunities."

Upsher-Smith will open its world-class manufacturing facility in Maple Grove, MN early next year. The new, 270,000 square foot facility will have fully up-to-date serialization and packaging capabilities and has capacity and capabilities that can support contract manufacturing for third parties. To learn more, visit www.upsher-smith.com.