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MAIA Biotechnology Doses First Patient With THIO in Phase 2 Trial (THIO-101) for Non-Small Cell Lung Cancer

On July 18, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that the first patient has been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating the administration of THIO, in sequence with cemiplimab, in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, JUL 18, 2022, View Source [SID1234616736]).

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The THIO-101 Phase 2 trial is designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (developed by Regeneron), allowing for immune activation and PD-1 sensitivity to take effect. The primary objectives of the trial are to evaluate the safety and tolerability of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration, as well as the clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through treatment with an immune-check point inhibitor alone or in combination with chemotherapy. The first patient in THIO-101 was dosed in Australia in July 2022 after the Company’s application received regulatory approval in March 2022. The Company also plans to submit a similar application in the second quarter of 2022, to conduct the same Phase 2 study in Europe.

"Dosing our first patient in this Phase 2 trial with THIO is an important milestone for MAIA, marking the continued development of our telomere-targeting approach," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Despite the advancements made in the field with checkpoint inhibitors, monoclonal antibodies and newer immunotherapies, very limited treatment options exist for patients that have progressed beyond the standard-of-care regimens. We believe THIO has the potential to hold a significant place in the NSCLC treatment paradigm."

Sergei Gryaznov, Ph.D., Chief Scientific Officer of MAIA, added, "Lung cancer is the second most diagnosed cancer worldwide and NSCLC is the most common form of lung cancer, accounting for more than eighty percent of all lung cancer diagnoses. This represents a significant unmet medical need across the globe, and we remain enthusiastic about THIO’s observed mechanism of action."

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (developed by Regeneron), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety of THIO administered as an anticancer agent and a priming immune system agent prior to cemiplimab administration and (2) to assess the clinical efficacy of THIO followed by cemiplimab using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

Nuvation Bio Appoints David Liu, M.D., Ph.D., as Chief Medical Officer and Kerry Wentworth as Chief Regulatory Officer

On July 18, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported the appointment of David Liu, M.D., Ph.D., as Chief Medical Officer and Kerry Wentworth as Chief Regulatory Officer (Press release, Nuvation Bio, JUL 18, 2022, View Source [SID1234616735]). Dr. Liu will lead Nuvation Bio’s clinical development team and collaborate with the executive committee to provide strategic direction for the Company’s research and drug development programs. Ms. Wentworth will oversee regulatory and quality affairs across the Company’s pipeline.

"I am honored to join Nuvation Bio and oversee the clinical development of innovative therapies for the most difficult-to-treat cancers," said Dr. Liu. "I look forward to working with this experienced and dedicated team to address the unmet needs of cancer patients."

"Nuvation Bio’s mission to bring meaningful cancer treatments to patients who have nearly exhausted all options deeply resonates with me," said Ms. Wentworth. "The Company is taking on this bold challenge with tenacity and urgency, and I am proud to contribute to this important work."

Dr. Liu brings over 20 years of experience leading the discovery and development of oncology therapies, including New Drug Application (NDA) submissions for multiple oncology assets in the U.S., Europe, and China. Most recently, Dr. Liu served as the Chief Medical Officer at a biotechnology company based in Shanghai, China. There, he built and led their clinical research and development organization, including global clinical research, global clinical operations, pharmacovigilance, biostatistics, programming and data management, clinical pharmacology, and drug supply.

Ms. Wentworth has over 25 years of experience in domestic and international regulatory and quality affairs. Her background spans early and late development across multiple therapeutic areas, including oncology, osteoarthritis, pain management, autoimmune disorders, and rare diseases. She also has a broad scope of product knowledge, ranging from injectable small molecules to complex autologous platforms. Ms. Wentworth most recently served as Chief Regulatory Officer at Flexion Therapeutics, which was acquired by Pacira Biosciences in 2021, setting and delivering on regulatory and quality strategies across their product portfolio. Notably, Ms. Wentworth was instrumental in leading the company’s first NDA successfully into commercialization.

"We are pleased for David and Kerry to join the Nuvation Bio team and believe their decades of focused experience at leading global biopharmaceutical companies will significantly contribute to the development of our various programs," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We look forward to working with them as we aim to meaningfully improve the lives of cancer patients."

Earlier in his career, Dr. Liu held several roles of increasing strategic responsibility at Bristol Myers Squibb, where he became a leader in Oncology Global Clinical Research, including leading the Global Prostate Cancer Program, Pediatric Clinical Development, and Translational Research for ipilimumab, and development of nivolumab and ipilimumab for China. After Bristol Myers Squibb, Dr. Liu was the Global Lead Physician at Celgene for the revlimid plus rituximab submission program in indolent lymphoma. Dr. Liu earned a Ph.D. from the Massachusetts Institute of Technology, an M.S. from the University of Toledo, and an M.D. from Beijing Medical University (Peking University School of Medicine).

Prior to joining Flexion, Ms. Wentworth served as Vice President, Clinical, Regulatory, and Quality at Agenus, Inc., where she led all global regulatory and clinical development efforts. Previously, Ms. Wentworth led the regulatory and quality function for Genelabs Technologies, Inc., and prior to that held positions of increasing responsibility within Regulatory Affairs at Genzyme. Ms. Wentworth holds a B.S. in pre-veterinary medicine from the University of New Hampshire.

Tiziana Life Sciences Appoints Matthew W. Davis, MD, RPh as Chief Medical Officer and Acting Chief Scientific Officer

On July 18, 2022 Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, reported that it has appointed Matthew Davis, MD, RPh as its Chief Medical Officer and Acting Chief Scientific Officer, effective immediately (Press release, Tiziana Life Sciences, JUL 18, 2022, View Source [SID1234616734]). Dr. Davis will report to Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana.

"Dr. Davis is a proven leader with 25 years in the pharmaceutical industry," said Gabriele Cerrone, Tiziana’s Executive Chairman and interim Chief Executive Officer. "We believe Dr. Davis’ experience with drug approvals is a key asset as the Company focuses more of its resources from discovery to proof-of-concept clinical trials. His broad therapeutic and FDA expertise, along with his in-depth experience with biologics will be invaluable as we pursue our mission to bring breakthrough therapies with the aim of treating Secondary-Progressive Multiple Sclerosis (SPMS), Crohn’s Disease and KRAS+ NSCLC and optimizing health outcomes."

"I am thrilled to join the Tiziana team, and for the opportunity to help advance Foralumab, TZLS-501 and Milciclib. I am energized to work with the passionate and dedicated R&D team and to meet the prestigious Scientific Advisors who are helping to guide the company," said Matthew W Davis, MD, RPh.

Dr. Davis has extensive experience in new drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that Dr. Davis has worked on include Lidoderm, Sculptra, Colcrys and most recently QWO.

Dr. Davis previously served as Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&D department and collaborated to obtain BLA approval for QWO. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys. He also was on the executive team that sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out payments.

Dr. Davis matriculated to the University of Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center.

Chinese health authorities approve lurbinectedin for “urgent clinical use”

On July 18, 2022 PharmaMar (MSE:PHM) reported that its partner in China, Luye Pharma Group Ltd., has obtained permission from the Hainan health authorities to open a compassionate use program for lurbinectedin for the treatment of Small Cell Lung Cancer ("SCLC") (Press release, PharmaMar, JUL 18, 2022, View Source [SID1234616733]).

Lung cancer is a malignant tumor with high morbidity and mortality rates in China, and SCLC is an aggressive high-grade neuroendocrine carcinoma that accounts for 13%–17% of all lung cancer cases. According to the International Agency for Research on Cancer ("IARC"), lung cancer had higher morbidity and mortality rates than other malignant tumors in China in 2020, with 815,000 new lung cancer cases and 714,000 deaths reported that year. The IARC also predicted that in 2022 the number of new SCLC cases in China will exceed 110,000.

The opening of an Expanded Access Program for lurbinectedin to be used in Hainan means that Luye Pharma Group Ltd will be the first company to bring a new treatment option to SCLC patients in China who urgently need effective treatments.

In June 2020, lurbinectedin received "Accelerated Approval" from the FDA for the treatment of adult patients with metastatic SCLC with disease progression and is already the standard of care in the US. Lurbinectedin has also received marketing authorization in the United Arab Emirates, Canada, Australia and Singapore, and more recently in Qatar.

Novo Nordisk A/S – Share repurchase programme

On July 18, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUL 18, 2022, View Source [SID1234616732]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 11 July 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 118 B shares in the period from 11 July 2022 to 15 July 2022. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 16,586,351 B shares of DKK 0.20 as treasury shares, corresponding to 0.7% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 15 July 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 14,846,358 B shares at an average share price of DKK 761.55 per B share equal to a transaction value of DKK 11,306,189,864