On January 12, 2022 Targovax ASA (OSE: TRVX) a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that Innovation Norway has awarded Targovax an NOK 8.2m grant to accelerate product development activities related to the company’s TG mutant RAS vaccine program and planned clinical trials (Press release, Targovax, JAN 12, 2022, View Source [SID1234598627]).

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Awarded by: Innovation Norway
Granted amount: NOK 8.2m
Time frame: 2022-2024

Kristin Willoch Haugen, Director of Innovation Norway Oslo Viken, commented: "Through this project Targovax and their partners aim to solve an important part of the great, international societal challenge that cancer represents. Innovation Norway has awarded a significant grant to reduce the development risk in the project, which we believe has a high level of innovation and a great potential for value creation in Norway. The Research Council of Norway has also contributed with funding to this exciting project. "

Dr. Erik Digman Wiklund, CEO of Targovax, added: "We are very pleased to be awarded yet another prestigious grant towards our mutant RAS vaccines, this time from Innovation Norway. Targovax’s TG program is set up to develop innovative novel immunotherapies that target critical mutations in KRAS, a key driver of around 30% of all cancers. With the support from Innovation Norway, we have now secured a total of up to NOK 18m in grant funding, which will allow us to move the TG program forward faster and more broadly, and thus bring benefit to a patient group with poor prognosis and few available treatment options."

On January 12, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported a first patient dosed in the VITALIZE Phase 2B clinical trial (Press release, IMV, JAN 12, 2022, View Source [SID1234598626]). VITALIZE will further evaluate the clinical benefit of IMV’s lead compound, maveropepimut-S (MVP-S), in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL). The contribution of low dose cyclophosphamide (CPA) as an immune modulator will also be evaluated in this trial.

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"The VITALIZE study represents a critical step in advancing MVP-S toward registration," said Jeremy Graff, PhD, Chief Scientific Officer at IMV. "We believe this study should help affirm and extend our understanding of the clinical benefit previously seen in r/r DLBCL patients in the SPiReL trial and may support the use of PD-L1 as a biomarker for MVP-S in combination with KEYTRUDA. Importantly, this is an open label study, so we expect to review early data in the summer 2022."

In December 2020, results of the SPiReL study were presented at the ASH (Free ASH Whitepaper) annual meeting. In his presentation, Dr. Neil Berinstein, Principal Investigator of the SPiReL study and hematologist at Sunnybrook Health Sciences Center, describes that MVP-S in combination with KEYTRUDA induced durable clinical benefit and grade 1 or 2 adverse events. PD-L1+ patients demonstrated an objective response rate (ORR) of 75%.

About the VITALIZE Study

The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess MVP-S in combination with KEYTRUDA with or without CPA. Across the arms of this study, the combination will be evaluated in up to 150 subjects with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.

The primary endpoint is Objective Response Rate (ORR), centrally evaluated per Lugano (2014) and measured by the number of subjects per arm achieving a best response of Partial or Complete Response (PR+CR) during the 2-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression. Exploratory endpoints include cell mediated immune response, tumor immune cell infiltration, and biomarker analysis.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On January 12, 2022 Nirogy Therapeutics ("Nirogy" or "the Company"), a privately-held biotechnology company developing novel small molecules to target cellular transporters, reported that it has appointed life science veteran Simon Pedder, Ph.D., as Chief Executive Officer (CEO) and to the Company’s Board of Directors (Press release, Nirogy Therapeutics, JAN 12, 2022, View Source [SID1234598625]). Dr. Pedder takes over the position from the founding CEO, Vincent Sandanayaka, Ph.D., who will be transitioning to the role of President and Chief Scientific Officer (CSO). Dr. Pedder brings over 30 years of drug development and commercialization experience to Nirogy.

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"We are delighted to have Simon join us as CEO and on the Board. He brings considerable development know-how to the team at a pivotal time in the Company’s growth, as we prepare to file our first IND for our lead oncology candidate in the next 12 months," said Dennis McWilliams, a Partner at Santé Ventures and member of Nirogy’s Board of Directors. "Simon’s guidance and expertise in clinical development, regulatory processes, and the commercialization of products in the oncology and autoimmune spaces will be critical as we advance our pipeline and grow the company."

"I am thrilled to join Nirogy as it pioneers a new approach to drug development by targeting cellular transporters. The breadth of targets that Nirogy’s platform has the potential to reach is exciting as we look to develop new potential medicines to address significant unmet medical needs for people suffering from cancer and autoimmune diseases," said Dr. Pedder.

"It has been a pleasure to lead Nirogy since its inception. I look forward to focusing on the science as CSO and working with Simon to advance our new potential modality of treating cancer and autoimmune diseases," said Vincent Sandanayaka, Founder, President and CSO of Nirogy. "Simon brings a wealth of team-building and development experience that will help shepherd our company into clinical development and beyond."

Dr. Pedder joins Nirogy from Athenex Pharmaceuticals, where he served as served as Chief Business and Strategy Officer. Prior to Athenex, he was President and CEO of Cellectar Biosciences and of CEO of Chelsea Therapeutics before that. Earlier in his career, Dr. Pedder held senior leadership roles of increasing responsibility at Hoffmann-LaRoche, including as an Officer of the Company, Vice President of Oncology Pharma Business, Life Cycle Leader and Global Project Leader of Pegasys/IFN, and as global Head of the Hepatitis Franchise. Under Dr. Pedder’s leadership, he oversaw the development and commercialization of numerous global brands, such as Tasmar, Copegus, Northera, and Kliseryi and Pegasys, which became the standard of care for Hepatitis B and C for over a decade.

Dr. Pedder began his career as a faculty member in the Department of Pharmacology in College of Medicine in the University of Saskatchewan, where he obtained his Ph.D. in Clinical Pharmacology. In addition to his Ph.D. in Pharmacology, Simon obtained a Master of Science in Toxicology from Concordia University, a Joint Honors Bachelor of Science in Environmental Studies/Biology from the University of Waterloo and completed the Roche-sponsored Pharmaceutical Executive Management Program at Columbia Business School.

On January 12, 2022 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported it will host a webcast and conference call to discuss corporate updates and financial results for its third fiscal quarter 2021, ended December 31, 2021 (Press release, Myovant Sciences, JAN 12, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-third-fiscal-quarter-2021-earnings [SID1234598624]). The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on January 26, 2022.

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Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

A replay of the webcast, along with the earnings press release and presentation materials, will be archived on Myovant’s investor relations website.

On January 12, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into a definitive agreement for ImmunityBio, Inc. (NASDAQ: IBRX) to assume its leasehold interest in a manufacturing facility in Dunkirk, New York, and certain related assets for approximately $38 million, subject to adjustment at closing. Proceeds from the sale will be used to service the Company’s debt obligations and for other general corporate purposes (Press release, Athenex, JAN 12, 2022, View Source [SID1234598623]). The transaction is subject to customary closing conditions and is expected to close in the first quarter of 2022.

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Upon the closing, ImmunityBio will assume all capital expenditure and hiring obligations of Athenex pursuant to its agreements with New York State. Athenex will continue to operate its existing Athenex Pharmaceutical Division (APD) and Athenex Pharmaceutical Solutions (APS) divisions. Athenex has not assigned any of its rights to its corporate headquarters in Buffalo, New York and will retain all of its rights and obligations with respect to its corporate headquarters. ImmunityBio has entered into a preliminary agreement with Athenex to allow APS the ability to manufacture its 503B products at the Dunkirk facility and the parties plan to enter into a definitive preferred contract manufacturing agreement.

Jeffrey Yordon, Chief Operating Officer, President Athenex Pharmaceutical Division, said, "We are pleased to announce this agreement regarding the Dunkirk facility, which we believe will allow us to execute on our strategy and create value for the specialty pharmacy division of Athenex. We look forward to continuing our strong relationship with the Dunkirk team as a contract manufacturing partner. We believe this transaction is aligned with Athenex’s commitment to unlock value for its shareholders and will put Athenex in a better financial position to deliver on its goals in the upcoming year."

Patrick Soon-Shiong, M.D., Executive Chairman of the Board of ImmunityBio commented, "We are pleased to expand our global manufacturing capacity of biologics and vaccines with the addition of this state-of-the-art facility to our ecosystem of manufacturing facilities. The Dunkirk facility will establish a global pandemic preparedness manufacturing plant for novel vaccines and immunotherapy products. We are looking forward to working with the Dunkirk community and State of New York to make western New York a global biotech manufacturing center."