On March 15, 2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported an update on its lead dovitinib program (Press release, Allarity Therapeutics, MAR 15, 2022, View Source [SID1234610125]).

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On February 18, 2022, the Company announced that the U.S. Food and Drug Administration ("FDA") had provided the Company with Refusal to File ("RTF") letters regarding the new drug application ("NDA") for dovitinib, and its accompanying pre-market approval ("PMA") application for the DRP-Dovitinib companion diagnostic, for the third-line treatment of metastatic renal cell carcinoma ("mRCC"). In its announcement, Allarity stated that it intends to seek guidance concerning information, data, and specific deliverables that the agency would require for a resubmitted NDA and PMA to be deemed complete. The Company also stated that it anticipates that a new prospective clinical trial will be required to overcome the FDA’s outstanding objections.

Following several weeks of analysis by Company leadership together with clinical and regulatory experts, Allarity has now filed a formal request with the FDA for a "Type C" meeting to further discuss potential clinical paths to support approval of dovitinib, together with its DRP-Dovitinib companion diagnostic, in view of the FDA’s recent RTFs. According to FDA guidelines, "A Type C meeting is any meeting other than a Type A or Type B meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product." The Type C meeting is typically scheduled within 75 days of FDA receipt of the written meeting request. The Company anticipates providing a further update on the outcome of its FDA meeting and the future of the dovitinib program before the end of the third quarter of this year.

"Welook forward to working closely with the FDA and we remain highly confident in the clinical profile of dovitinib, together with the DRP-Dovitinib companion diagnostic. We are determined to further advance this product candidate as a potential new treatment option for cancer patients," said Allarity’s CEO Steve Carchedi. "With clarification fromthe FDA following our requested Type C meeting, we hope to have a clinical path forward with the goal of refiling our NDA and PMA once additional clinical data are in hand ."

" I remain enthusiastic about dovitinib, together with its DRP – Dovitinib companion diagnostic, as a promising new treatment option for mRCC patients , " stated Professor Roberto Pili, M.D., Associate Dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences. "These patients, and their treating oncologists, are greatly in need of new precision medicines, coupled with validated companion diagnostics, to help select and treat the most likely responders. Although the landscape of treatment options for later-stage mRCC is evolving to include combination therapies, I continue to see a potential place for dovitinib with its DRP companion diagnostic in the treatment of these patients."

On March 15, 2022 Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, reported that Mustafa Noor, MD, FACP, joins the Company as Chief Medical Officer (CMO), following the decision of current CMO, Dr. Curt Scribner, to retire from the position (Press release, Olatec Therapeutics, MAR 15, 2022, View Source [SID1234610141]).

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Dr. Noor remarked: "I believe this is a great time to be joining the Olatec team. I see Olatec at a major value inflection point and am excited to not only build on the world class translational science that has been elucidated, but help this exceptional team take dapansutrile through late-stage development and prospectively its approval in the lead indications." Dr. Noor continued, "Olatec is at the forefront of a compelling new inflammation target across multiple disease areas, which creates many opportunities for dapansutrile and the OLT Analogue compounds."

Dr. Charles Dinarello, Olatec’s Chief Scientific Officer, commented: "we are so pleased to welcome Dr. Noor to our team. He brings to Olatec extensive clinical trial expertise and experience as a clinician treating patients that will be valuable to the development of OLT1177 and its analogues."

Dr. Mustafa Noor’s remarkable career spans over two decades of industry experience. At both large and small pharma companies, Dr. Noor has contributed to numerous clinical drug development programs, leading and collaborating with teams in the development of novel therapeutics for inflammation, cardiometabolism, lipid and endocrine disorders as well as rare diseases. From 2001 to 2006, as medical director at Bristol-Myers Squibb, Dr. Noor held positions of increasing responsibility in metabolic, cardiovascular, and antiviral programs. From 2006 to 2014 at GSK and at Pfizer he served as vice president and clinical head for GSK’s Center of Excellence in External Drug Discovery and for Pfizer’s Centers for Therapeutic Innovation focusing on open innovation, translational research and collaboration with biotech and academic partners on a portfolio of early-stage programs in indications for inflammatory diseases, including inflammatory bowel disease, rheumatoid arthritis, lupus and sarcoidosis. For the last several years Dr. Noor has been a consultant CMO to emerging companies in the Boston/Cambridge area. Dr. Noor completed his medical training at the University of Chicago and fellowship training in Endocrinology and Metabolism at the University of California, San Francisco. He holds a Master of Science in Clinical Investigation from Vanderbilt University and is a board-certified Internal Medicine specialist in Endocrinology and Metabolism.

Olatec CEO, Damaris Skouras, said: "this appointment marks an important step in the continued development of dapansutrile and our portfolio of OLT Analogue compounds. Given Dr. Noor’s medical and drug development expertise, I am confident that Dr. Noor will make substantial contributions to the strategic direction and oversight of dapansutrile as it advances to late-stage studies and as our product pipeline of OLT Analogues also advances." Ms. Skouras continued, "I also extend my sincerest gratitude to Dr. Scribner whose contributions as CMO during the early stages of dapansutrile’s clinical development were significant. While retiring from his CMO function, we are pleased that Curt will remain on Olatec’s Scientific Advisory Board and continue to support dapansutrile’s development."

About Dapansutrile

Dapansutrile (lab code: OLT1177) is an investigational small molecule, new chemical entity that specifically binds to and blocks NLRP3 (nucleotide-binding and oligomerization domain [NOD]‑, leucine rich repeat-, pyrin domain-containing 3), the sensor molecule integral in the formation of the NLRP3 inflammasome. Inflammasomes are multiprotein complexes involved in intracellular surveillance of danger signals that trigger an intense inflammatory response, via generation of bioactive IL-1β and IL-18 through caspase-1 activation. Dapansutrile has been shown to prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL‑18. NLRP3 is one of the most characterized inflammasome sensors due to its involvement in a wide range of disorders, including sterile inflammation, infections, and rare genetic autoimmune syndromes. Dapansutrile has been well tolerated and shown to improve clinical outcomes in patients with acute gout flare (see The Lancet Rheumatology) and heart failure (see Journal of Cardiovascular Pharmacology). Dapansutrile has also been observed to have anti-inflammatory properties and other promising activity in a broad spectrum of over 20 preclinical animal models including arthritis, asthma, acute myocardial infarction (AMI), heart failure, contact dermatitis, multiple sclerosis, melanoma, pancreatic and breast cancers, spinal cord injury (SCI), Parkinson’s and Alzheimer’s disease.

On March 15, 2022 Mission Therapeutics ("Mission"), a drug discovery and development company focused on protein homeostasis by selectively inhibiting deubiquitylating enzymes (DUBs), reported that Dr Paul Thompson, the Company’s Chief Scientific Officer, will present at the 2nd Annual Target Protein Degradation (TPD) Europe Summit in London (15-17 March) (Press release, Mission Therapeutics, MAR 15, 2022, View Source [SID1234610090]).

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At 9.00 AM GMT on 17 March, Dr Thompson will present on Mission’s "Novel DUB Inhibitor Platform Addressing Protein Homeostasis". Currently Mission’s CSO, Dr Thompson joined Mission in 2016. He has over 15 years of experience in translational research and early clinical development.

The annual TPD Europe Summit provides a platform of learning, discovery, and networking opportunities, to hear about the latest developments and advancements in protein degradation from experts in the field.

On March 15, 2022 Enochian BioSciences, a company focused on gene modified cellular and immune therapies for infectious diseases and cancer, reported that has issued an exclusive sub-license of one of its proprietary technologies that could improve the effectiveness of a potential cure for HIV with an anti-HIV CAR-T therapy that Caring Cross is studying in a clinical trial (Press release, Enochian BioSciences, MAR 15, 2022, View Source [SID1234610110]). Caring Cross is an innovative non-profit that partners with others, including for-profit companies, to increase access to new technologies and medicines under a collaborative value sharing model. Caring Cross and Enochian BioSciences entered into a profit-sharing agreement as part of the sub-license.

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The CAR-T approach being studied in humans was shown to cure HIV infection in an animal model that was published in the prestigious scientific journal, Science Translational Medicine View Source). Based on those and other key data, Caring Cross received approval from the US Food and Drug Administration to advance to clinical studies that are being conducted by researchers from the University of California, San Francisco and the University of California, Davis with funding from the California Institute of Regenerative Medicine. More details of the trial can be found at clinicaltrials.gov with the identifier NCT04648046.

"We are very excited that our clinical trial has now begun. Combining innovative technologies could significantly increase the effectiveness of our therapy in the future and therefore improve its access and affordability said Dr. Boro Dropulic, the Executive Director of Caring Cross. "The technology acquired from Enochian BioSciences is an innovative strategy that could enhance the selection of the anti-HIV CAR-T cells, potentially increasing effectiveness, lowering cost and side effects, and increasing access to those in need. If it is shown to work in laboratory and animal evaluations, we would hope to pursue additional clinical studies combining our CAR-T therapy with Enochian BioSciences’ technology."

Dr. Mark Dybul, CEO of Enochian BioSciences, said: "Our Co-Founder and Inventor, Dr. Serhat Gumrukçu, has presented data at scientific meetings showing that our proprietary approach substantially increased the selection of different cell types, including in an animal model. We have seen similar results in the laboratory with T-cells, the key to CAR-T therapy. Therefore, we are enthusiastic that the exclusive sub-license issued to Caring Cross will prove to be effective, offering hope to many people living with HIV. While these studies proceed, we continue to pursue several other novel approaches to potentially cure HIV." View Source

On March 15, 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported that the company will release its 2021 fourth quarter and full year financial results after the market closes on Tuesday, March 29, 2022 (Press release, CohBar, MAR 15, 2022, View Source [SID1234610126]). Management will host a conference call and webcast at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Details for the Conference Call:

Webcast
– A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.
For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 29, 2022, through 11:59 p.m. Eastern Time on April 19, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13726040. The audio recording will also be available at www.cohbar.com during the same period.