AbbVie and Calico Announce Second Extension of Collaboration Focused on Aging and Age-Related Diseases

On July 27, 2021 AbbVie (NYSE: ABBV) and Calico Life Sciences reported an extension of their leading-edge collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer (Press release, AbbVie, JUL 27, 2021, View Source [SID1234585207]). This is the second extension of the collaboration originally established in 2014.

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Calico is a life sciences company founded by Alphabet together with Calico CEO Arthur D. Levinson, Ph.D., who previously led Genentech as chairman and CEO. With more than 200 employees, Calico has established a world-class research and development facility in the San Francisco Bay Area.

As part of the collaboration, working together with AbbVie, Calico pursues discovery-stage research and development utilizing state-of-the-art technology and advanced computing capabilities. AbbVie provides scientific and clinical development support and will lend its expertise to future commercialization activities. Since 2014, the collaboration has produced more than 20 early-stage programs addressing disease states across immuno-oncology and neurodegeneration and has yielded new insights into the biology of aging. Further, AbbVie and Calico have advanced three neurodegeneration and cancer targets into the clinic, with a deep preclinical pipeline behind it. For instance, the lead immuno-oncology target, currently in Phase I studies, includes two PTPN2 inhibitors, which act at multiple steps in the cancer immunity cycle.

"Our collaboration has evolved into an innovation engine, particularly for novel targets in the oncology and immuno-oncology space, that could break new ground for challenging, age-related diseases," said Tom Hudson, M.D., senior vice president, R&D, chief scientific officer, AbbVie.

"The extension of this collaboration enables Calico’s world-class scientists and the AbbVie Discovery team to continue to build on the transformative research we’ve done and advance more preclinical and clinical programs that have first-in-class potential," said Gerry Fox, Ph.D., vice president, Discovery, AbbVie.

"We set out seven years ago to bring forth a unique partnership with AbbVie that we believed could yield both novel insights into the biology of aging and first-in-class targets for age-related diseases," said Arthur D. Levinson, Ph.D., CEO of Calico.

"Our three clinical initiatives and more than 20 discovery and preclinical programs to date are clear evidence of how productive a partnership we’ve established." Aarif Khakoo, M.D., head of research and development, Calico, added, "This additional extension validates our original vision and is a testament to the collective efforts of many people from both organizations who are working to deepen our understanding of specific disease pathways and develop novel therapies for patients."

Under the terms of the agreement, the collaboration between the two companies will extend in 2022 for an additional three years. Calico will be responsible for research and early development until 2025 and will advance collaboration projects into Phase 2a through 2030. AbbVie will continue to support Calico in its early R&D efforts and, following completion of Phase 2a studies, will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits equally. AbbVie and Calico will each commit to contribute an additional $500 million to the collaboration.

Novartis receives FDA Orphan Drug Designation for NIS793 in pancreatic cancer

On July 27, 2021 Novartis reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer (Press release, Novartis, JUL 27, 2021, View Source [SID1234585224]). NIS793 is a potential first in class novel antibody specific for Transforming Growth Factor Beta (TGFβ), which is known to have an important role in metastatic pancreatic ductal carcinoma (mPDAC) and other solid tumors.

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Pancreatic cancer has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment. The 5-year overall survival rate is approximately 11% in the US1, with few novel approaches advancing in the clinic and targeted and immunotherapy agents having shown limited activity.

NIS793 is a fully human anti-TGF-β IgG2 monoclonal antibody designed to inhibit the TGF-β pathway in tumor cells and to modulate the tumor microenvironment. In preclinical models, inhibiting TGFβ can reduce fibrosis characteristic of pancreatic and other solid tumor types, as well as enhance the response to chemotherapy and immunotherapy.
NIS793 has shown proof of mechanism and acceptable safety profile in a first in-human trial in patients with advanced solid tumors2 and is in development for pancreatic cancer and other solid tumor types. A Phase II study is ongoing, and a Phase III trial in 1L mPDAC is planned to start enrolling patients later this year.

An ODD grants special status to a drug being developed to treat a rare disease or condition, and provides companies certain benefits to encourage the continued development of medicines that bring novel solutions to patients with these diseases.3

VYANT BIO TO PRESENT AT A.G.P.’S VIRTUAL MEDTECH SUMMER CONFERENCE

On July 27, 2021 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging leader in novel drug discovery, reported that Jay Roberts, Chief Executive Officer, will present at A.G.P.’s Virtual MedTech Summer Conference hosted by Alliance Global Partners (A.G.P) on Thursday, July 29, 2021 (Press release, Vyant Bio, JUL 27, 2021, View Source [SID1234585240]). One-on-one partnering meetings will be held via the conference portal.

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Mr. Roberts will highlight the Company’s updated business strategy, including progress related to integrating and accelerating the recent merger with StemoniX, Inc. to increase shareholder value. He will also elaborate on the broader corporate vision of Vyant Bio as it pertains to recent progress with biopharma companies, strategic partners, and members of the investment community. Additionally, Mr. Roberts will review the Company’s approach to identify unique therapeutics through the integration of novel human-derived biology with internally developed data science technologies and IND-enabling expertise.

For questions and inquiries regarding the conference or to register for a one-on-one meeting, please contact a registered A.G.P. representative or email A.G.P. events at [email protected].

Vyant Bio will also be available for outside virtual 1:1 meetings both during and after A.G.P’s Virtual MedTech Summer Conference. Please contact Jennifer K. Zimmons, Ph.D. [email protected] or +1 917.214.3514 for scheduling.

SpringWorks Therapeutics Appoints Dr. James Cassidy as Chief Medical Officer

On July 27, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that James (Jim) Cassidy, M.D., Ph.D., has been appointed Chief Medical Officer (Press release, SpringWorks Therapeutics, JUL 27, 2021, View Source [SID1234591662]). Dr. Cassidy brings over 30 years of experience in oncology as an academic physician-scientist and a drug development leader in both biotechnology and pharmaceutical companies, with experience spanning from early-stage research to translational and clinical development to post-marketing medical affairs strategy and lifecycle management. Dr. Cassidy succeeds Jens Renstrup, M.D., MBA, who will be leaving the company.

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"Jim brings significant oncology experience as a physician-scientist and industry leader to our efforts at SpringWorks, where we remain intensely focused on continuing to build a leading targeted oncology company with a diversified portfolio of differentiated programs," said Saqib Islam, Chief Executive Officer of SpringWorks. "I am delighted to welcome Jim to SpringWorks. I would also like to thank Jens for his contributions to SpringWorks and wish him well in his future endeavors."

"Having had the pleasure of working closely with Jim several times throughout our careers, I am confident that the energy and expertise that he brings to developing drugs on behalf of cancer patients will prove exceptionally valuable to our efforts at SpringWorks," added Mike Burgess, M.B.Ch.B., Ph.D., Head of Research and Development at SpringWorks.

Dr. Cassidy joins SpringWorks from Regeneron Pharmaceuticals, where he was Vice President of Oncology Strategic Program Direction. Prior to Regeneron, Dr. Cassidy was Corporate Vice President of Translational Development at Celgene, where he oversaw translational science efforts for the company’s entire portfolio of programs addressing both hematological malignancies and solid tumors. Before that, he was Vice President of Oncology at Bristol-Myers Squibb, where he was responsible for all oncology assets from development candidate nomination through clinical proof-of-concept studies, including biomarkers and translational research, and was closely involved with late-stage development, commercial, and business development efforts as well. Prior to Bristol-Myers Squibb, Dr. Cassidy held several roles of increasing responsibility at Hoffmann La-Roche, including Global Head of Translational Research for Oncology and Acting Head of the Oncology Therapy Area. Before joining Roche, Dr. Cassidy had been a leading academic physician-scientist, most recently having served as Professor of Oncology, Head of the Department of Cancer Research and Head of the Division of Cancer Sciences and Molecular Pathology at the University of Glasgow in Scotland. Dr. Cassidy received his medical degree and doctorate from the University of Glasgow.

"I am very pleased to be joining SpringWorks during this important time of growth and evolution for the company and am excited by the breadth of oncology opportunities being advanced on behalf of patients with solid tumors and hematologic malignancies," said Dr. Cassidy. "I look forward to working with this talented team to continue accelerating the development of our pipeline with the goal of bringing innovative new medicines to cancer patients."

Quarterly Activities Report and 4C

On July 27, 2021 Avecho Biotechnology Limited (ASX:AVE) reported its Quarterly Activities Report and 4C for the quarter ended 30 June 2021 (Press release, Phosphagenics, JUL 27, 2021, View Source [SID1234585208]).

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The continued development of our soft-gel CBD product has been the main focus for the Company during this period, resulting in the achievement of a number of key milestones:

CBD soft-gel capsule design finalised by Catalent Pharma Solutions
TGA meeting activities planned to gain feedback on CBD program
Recruitment on the CACOS observational clinical trial continued – 130 patients were enrolled in the trial by the end of June.
Independent of our CBD program, Avecho also made progress in the animal health space, with our potential partner AB Vista looking at opportunities to take our TPM technology to the animal feed market.

Our cash balance at the close of the quarter was $4.8m.

Avecho remains committed to its R&D programs, while continuing to demonstrate prudent cash management and adapt its operational policies and procedures in line with COVID-19 mitigation measures.