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Nirogy Therapeutics Appoints Simon Pedder, Ph.D., as Chief Executive Officer

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.

Myovant Sciences to Host Third Fiscal Quarter 2021 Earnings Conference Call at 8:30 a.m. Eastern Time on January 26, 2022

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.

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.

Athenex Announces Agreement with ImmunityBio Regarding Dunkirk Manufacturing Facility

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.

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."

ImmixBio IMX-110 Produced 50% Positive Response Rate in First-Line-Therapy-Resistant Cancer, Surpassing the Standard of Care in Mice Study

On January 12, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported study data showing that ImmixBio’s lead candidate IMX-110 produced a 50% response rate in a first-line-therapy-resistant cancer – soft tissue sarcoma (STS) mouse study, surpassing the STS standard of care doxorubicin’s 0% response rate in the same mouse study (Press release, Immix Biopharma, JAN 12, 2022, View Source [SID1234598622]). The responses were assessed by RECIST 1.1 criteria applied to mice, with progression assessed after one cycle of treatment in a study funded by ImmixBio and conducted by a major STS oncology treatment center.

"We strive to test our drug candidates in the most realistic, challenging animal models available," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We are thrilled to see that in this first-line-therapy resistant STS model that IMX-110 showed significant activity. We believe this study is a preview of what our SMARxT Platform generating Tissue-Specific Therapeutics can do, a distinct alternative to the traditional ‘single target, single mutation’ development model."

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. The FDA has already approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

ImmixBio recently shared IMX-110 clinical data across multiple STS subtypes in several heavily pretreated patients demonstrating median progression-free survival (PFS) of 4 months with zero drug-related severe adverse events and zero dose interruptions due to toxicity. The data can be viewed in the Immix Biopharma Corporate Presentation at View Source

Soft tissue sarcoma is a cancer that begins in the tissues that connect, support, and surround body structures. The global STS market is estimated to reach approximately $6.5 billion by 2030 from the estimated $2.9 billion in 2019. Globally, there are roughly 116,000 new cases of STSs each year, of which 21,500 are in the European Union and 40,500 are in China. According to the American Cancer Society, there were roughly 13,000 new cases of STS in the United States during 2020. Approximately 160,000 people live with soft tissue cancers in the United States.

Heat Biologics Announces New PTX-35 Preclinical Data in Organ Transplantation and Provides Update on HS-110

On January 12, 2022 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported promising new preclinical data regarding PTX-35 has been accepted for publication in the American Journal of Transplantation and is available at: View Source (Press release, Heat Biologics, JAN 12, 2022, View Source [SID1234598621]).

Key Findings:

A single dose of the preclinical version of PTX-35 (mPTX-35), was able to expand regulatory T cells (Tregs) and significantly improve disease and graft survival outcomes.
Chemically induced pancreatic failure (a model for type-1 diabetes) could be partially reversed when mice were transplanted with beta-cell islet allografts and treated with mPTX-35.
Disease protection in preclinical models was correlated with a significant expansion of Tregs and protection of the allograft, resulting in euglycemia and a graft survival benefit.
Long-term surviving grafts showed a marked increase in Treg infiltration which directly correlated with mPTX-35 agonist activity.
PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be manipulated to expand regulatory T-cell subsets. PTX-35 is the Company’s first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors.

Dr. James Shapiro, Professor in the Department of Surgery and Clinical Islet Transplant Program at the University of Alberta, Edmonton, Canada, commented, "The study demonstrated that a single dose of PTX-35 enabled prolonged graft survival in a mouse model of pancreatic islet allotransplantation. Additionally, PTX-35 could contribute to achieving lasting immunological tolerance in organ transplantation."

Jeff Wolf, Chief Executive Officer of Heat, commented, "We are very encouraged by these results showing pronounced Treg expansion and significantly prolonged graft survival compared to control. PTX-35 has the potential to modulate immunological responses and may facilitate minimization of post-transplant immunosuppression, which supports further clinical evaluation in the context of inflammatory disease. Similar preclinical results have also been previously demonstrated for bone marrow, corneal and cardiac transplantation using these and other TNFRSF25 agonists."

Mr. Wolf further noted, "We are also making significant progress with HS-110 and expect to file for an End of Phase 2 meeting with the FDA this quarter. Our goal for this meeting is to discuss potential Phase 3 registration pathways for HS-110. Although this submission is taking longer than expected, we believe we have prepared a very comprehensive package and look forward to the FDA’s feedback."