Orion enters into exclusive agreement with Jemincare for novel non-opioid drug candidate for the treatment of pain

On May 6, 2022 Orion Corporation reported that it has entered into an agreement with Chinese Jemincare, through which Orion will receive exclusive global development and commersialisation rights, excluding the Greater China area (mainland China, Hong Kong, Macau and Taiwan), for a potent and selective NaV 1.8 blocker for the treatment of acute and chronic pain (Press release, Orion , MAY 6, 2022, View Source [SID1234613783]). Orion will also receive ownership to certain key patent applications relating to the compound within its own territory.

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!

According to the agreement, Orion has the right to develop and commercialise the asset in its territory. Orion will be fully responsible for its own development and commercialisation costs. In addition, Orion will manufacture the products, including active pharmaceutical ingredient, for its markets.

Under the terms of the agreement, Orion will pay Jemincare a EUR 15 million upfront payment, in addition to which Jemincare is upon achievement of certain development, commercialisation and sales targets entitled to receive milestone payments, which may be significant. In addition, Jemincare is eligible to receive tiered royalty of 8% to 15% on future sales in Orion territory.

"We are excited about this agreement and are looking forward to taking this compound to clinical studies later this year. Pain is one of the most frequently reported reasons for a patient to visit a health care provider and it generates a significant societal burden in terms of health care utilisation and lost productivity. There is a high unmet need for new non-addictive treatment options with improved efficacy and safety profiles. NaV 1.8 channel is known pain transmission pathway and is thus a promising target for novel pain treatments", said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Research and Development at Orion.

"JMKX000623 is a potent and selective Nav1.8 blocker independently developed by Jemincare and we have received IND approval in China in March 2022. We are delighted to enter into collaboration with Orion Corporation to bring this promising therapy to benefit patients in the rest of the world. This is our second innovative therapy partnered globally. We look forward to work closely with Orion, a partner having rich experience in the development of therapeutics in neurology and pain area, to take this compound to clinical trials", said Mr. Hong Liang, President of Jemincare Pharmaceutical Group.

About NaV 1.8 as a target for the treatment of pain

Electrical activation of nociceptive sensory neurons is essential physiological process for pain transmission where information is relayed from peripheral tissues to central nervous system and to brain where pain perception takes place. NaV 1.8 is one of the pivotal sodium channel subtypes modulating excitability of pain fibers. The fundamental role NaV 1.8 plays in pain transmission has been demonstrated in preclinical studies and validated genetically and pharmacologically in acute and chronic pain clinical trials investigating selective NaV 1.8 blocking agent. Currently no drugs selectively targeting NaV 1.8 are in the market yet.

Cytovia Therapeutics to Present at AACR Special Conference on Advances in the Pathogenesis and Molecular Therapies of Liver Cancer

On May 6, 2022 Cytovia Therapeutics, LLC ("Cytovia Therapeutics"), a global biotechnology company focused on harnessing the power of natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering, reported that it will be presenting at the AACR (Free AACR Whitepaper) Special Conference on Advances in the Pathogenesis and Molecular Therapies of Liver Cancer, to be held from May 5-8, 2022, at the Westin Copley Place in Boston, Massachusetts (Press release, Cytovia Therapeutics, MAY 6, 2022, View Source [SID1234613804]). The conference is an in-person event and will not live-stream content, but Cytovia Therapeutics’s short poster video will be available for on-demand viewing by conference registrants after the conference and Cytovia Therapeutics’s poster will be available on its website under the "Resources" section.

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!

Details of Cytovia’s poster presentation:
Abstract title: Preclinical activity of glypican-3 (GPC3) and NKp46 directed FLEX-NK engager antibody (CYT-303) in combination with iPSC derived natural killer cells (iNKs) or peripheral blood (PB) NK cells in hepatocellular carcinoma (HCC)

Session: Poster Session/Reception
Session Date and Start Time: Friday, May 6, 5:30-7:30 p.m.

Conclusions from the poster:

The FLEX-NKTM multifunctional engager antibody CYT-303 directed against NKp46 and GPC3 demonstrated potent single agent anti-tumor activity:
potent NK cell cytotoxicity against HCC tumor cells accompanied by cytokine production in an in vitro model indicative of NK cell engagement and activation
HCC tumor growth inhibition in an in vivo model
Favorable cytokine release and immune cell subset safety profile
iNK cells expressed a favorable combination of multiple activation and few inhibitory receptors that facilitated potent cytolytic activity against HCC tumors
The combination of the FLEX-NKTM and iNK cells demonstrated greater in vitro and in vivo anti-tumor activity in HCC tumor models than iNK cells alone
The preclinical proof of concept studies with CYT-303 alone or in combination with iNK cells in HCC warrant clinical development

Cogent Biosciences to Participate in the LifeSci Partners Immunology and Inflammation Symposium

On May 6, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that management will participate in a fireside chat at the LifeSci Partners Immunology and Inflammation Symposium on Tuesday, May 10, 2022 at 3:30 p.m. ET (Press release, Cogent Biosciences, MAY 6, 2022, View Source [SID1234613784]).

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!

A live audio webcast will be available through the Investors and Media section of the Cogent website at View Source An archived replay will be available on the Company’s website for 30 days.

Bausch Health Announces Thomas J. Appio As Chief Executive Officer

On May 6, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) (Bausch Health) reported its full leadership team and Board of Directors, including Chief Executive Officer (CEO) Thomas J. Appio.1 Upon completion of the initial public offering (IPO) of the Bausch + Lomb eye health business,2 former CEO Joseph C (Press release, Bausch Health, MAY 6, 2022, View Source [SID1234613805]). Papa will assume the role of chairman and CEO of Bausch + Lomb.

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!

"It is an honor and privilege to lead Bausch Health at this pivotal time in its history, and I am excited for our future," said Mr. Appio. "We are a global specialty pharmaceutical company with deep expertise in gastroenterology, hepatology, neurology, dermatology and international pharmaceuticals serving patients for more than 60 years."

"As we begin operating as a separate organization, we will leverage our commercial capabilities to grow access to our therapies and expand our market reach, and we will invest in innovation and new business development to build a future product pipeline to address unmet needs. I look forward to leading our talented team of 7,000 global employees toward the exciting opportunities ahead," continued Mr. Appio.

Strong, Experienced Leaders Selected for Executive Management Team1
The Bausch Health executive management team, which is comprised of experienced leaders with years of expertise in their respective areas, includes:

Thomas J. Appio, Chief Executive Officer
Thomas (Tom) Vadaketh, Executive Vice President, Chief Financial Officer
Seana Carson, Executive Vice President, General Counsel
Mirza Dautbegovic, Senior Vice President, Chief Operating Officer
Kathleen Fitzpatrick, Senior Vice President, Chief Human Resources Officer
Jeff Hartness, Senior Vice President, Market Access, Commercial Operations & Government Affairs
Cees Heiman, Senior Vice President, Europe and Canada
Graham Jackson, Senior Vice President, Chief Quality Officer
Tage Ramakrishna, M.D., Chief Medical Officer and President of R&D
Robert Spurr, President of the U.S. business
Fernando Zarate, Vice President, Latin America
Bausch Health to Appoint Dr. Richard Mulligan to the Board of Directors1
In addition to the appointment of Mr. Appio as CEO and a member of the Board of Directors, Richard Mulligan, Ph.D., will be appointed to the Bausch Health Board of Directors.

Dr. Mulligan is currently the Mallinckrodt Professor of Genetics, Emeritus, at Harvard Medical School, after serving as the Mallinckrodt Professor of Genetics and director of the Harvard Gene Therapy Initiative from 1996 to 2013. He also serves as executive vice chairman of the Board of Sana Biotechnology, Inc. From March 2017 to October 2018, he served as a portfolio manager at Icahn Capital LP. Prior to that, he was a professor of Molecular Biology at the Massachusetts Institute of Technology, a member of the Whitehead Institute for Biomedical Research and chief scientific officer of Somatix Therapy Corporation, a drug discovery and development company that he founded. Dr. Mulligan was a founding partner of Sarissa Capital Management LP from 2013 to 2016. He was named a MacArthur Foundation Fellow in 1981.

Mr. Papa will remain in the role of chairman of the Board of Directors for Bausch Health until the full separation of Bausch + Lomb, at which time Robert N. Power will succeed as chairman.

Upon completion of the IPO, the Bausch Health Board of Directors will include the following individuals:

Joseph C. Papa, Chairman
Robert N. Power
Thomas J. Appio
Richard U. DeSchutter
Brett Icahn
Argeris (Jerry) N. Karabelas, Ph.D.
Sarah B. Kavanagh
Steven D. Miller
Richard Mulligan, Ph.D.
Russel C. Robertson
Thomas W. Ross, Sr.
Amy B. Wechsler, M.D.
For more information about the company’s leadership and Board of Directors, please visit www.bauschhealth.com.

Bausch Health will continue to be headquartered in Laval, Quebec, and will continue to trade on the New York Stock Exchange and Toronto Stock Exchange under its present symbol, "BHC".

AFFIMED PROVIDES UPDATE ON ASCO AFM13-104 ORAL PRESENTATION

On May 6, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has informed the Company’s collaborator that it has removed the previously announced oral presentation on AFM13-104, the investigator sponsored trial that evaluates AFM13 pre-complexed with NK cells in patients with relapsed/refractory CD30-positive lymphomas, from the upcoming conference program (Press release, Affimed, MAY 6, 2022, View Source [SID1234613847]).

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!

Per ASCO (Free ASCO Whitepaper), the decision was solely based on its embargo policy which restricts data in submitted abstracts from presentation at any prior conference or forum. Data from AFM13-104 was recently presented in an oral session at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) on April 10, 2022, in New Orleans, Louisiana.

The removal of the presentation is not related to the status or results of the ongoing trial. Affimed respects ASCO (Free ASCO Whitepaper)’s decision and is working with The University of Texas MD Anderson Cancer Center on plans to submit additional data on AFM13-104 to a future scientific forum.