Drug development

Michael J. Fox Gets Serious

Tuesday, November 30, 2021 - 6:06pm

Fox is always positive, always optimistic, always inspiring -- until he's not.

Key Points: 
  • Fox is always positive, always optimistic, always inspiring -- until he's not.
  • As he approaches the 30-year anniversary of his Parkinson's Disease diagnosis, Fox still finds new ways to enjoy life and make a difference.
  • Fox spent several decades of his celebrated career telling stories on screens, but as he approached his 60th birthday this June, his increasingly unreliable speech forced him to retire from acting.
  • The following are excerpts from ATM's December/January 2022 cover story featuring Michael J.

Todos Medical Enters into Binding Agreement to Acquire All 3CL Protease Biology-Related Assets and Intellectual Property from NLC Pharma

Tuesday, November 30, 2021 - 3:35pm

We believe this acquisition will solidify Todos Medicals position as a key player in the development and commercialization of 3CL protease-related products.

Key Points: 
  • We believe this acquisition will solidify Todos Medicals position as a key player in the development and commercialization of 3CL protease-related products.
  • Under the terms of the agreement, Todos Medical will own 60% of 3CL Sciences, and the shareholders of NLC Pharma will own 40% upon the execution of definitive agreements (the Closing) to acquire all intellectual property and assets related to 3CL protease biology-related products to which NLC Pharma has rights.
  • Todos Medical will assign its European licensing agreement T-Cell Hellas Protect S.A. to 3CL Sciences.
  • Tollovid's 3CL protease inhibition activity release criteria is at least twice as stringent as Tollovid Daily's 3CL protease inhibition release criteria.

Nyheim Hines of the Indianapolis Colts to Wear Cleats for Muscular Dystrophy Association on Game Day Sunday, December 5

Tuesday, November 30, 2021 - 2:23pm

Players from across the NFL have supported the Muscular Dystrophy Association (MDA), and Nyheim Hines, 2021 MDA National Spokesperson, and running back for the Indianapolis Colts will be wearing his cleats for MDA on game day, Sunday, December 5 for Colts vs Texans.

Key Points: 
  • Players from across the NFL have supported the Muscular Dystrophy Association (MDA), and Nyheim Hines, 2021 MDA National Spokesperson, and running back for the Indianapolis Colts will be wearing his cleats for MDA on game day, Sunday, December 5 for Colts vs Texans.
  • NFL's My Cause My Cleats charitable campaign features cleats raising awareness for Muscular Dystrophy Association.
  • Pictured: Cleats Nyheim Hines of the Indianapolis Colts will be wearing Dec. 5 game day.
  • "Raising awareness for the Muscular Dystrophy Association is important to me because I have seen my mother, grandmother and uncle live with a neuromuscular disease," said Indianapolis Colts running back Hines.

Diamond Therapeutics Announces Four Critical Hires to Further Accelerate Drug Development

Tuesday, November 30, 2021 - 1:05pm

Working with Dr. McDonnell is Dr. Jeffrey Sprouse, Diamond's Director of Pipeline Development and Jamie Jarecki-Smith, the company's new Director of Clinical Operations.

Key Points: 
  • Working with Dr. McDonnell is Dr. Jeffrey Sprouse, Diamond's Director of Pipeline Development and Jamie Jarecki-Smith, the company's new Director of Clinical Operations.
  • Dr. Sprouse brings more than 20 years of experience leading successful preclinical drug efforts for top-tier pharmaceutical organizations in neuroscience and psychiatry-based disease.
  • "These additions to our executive bring expertise that will be key to furthering our intellectual property portfolio while accelerating our drug development efforts.
  • Diamond Therapeutics is a drug development company based inToronto, Ontario.

Zai Lab Announces Positive Topline Results from Phase 3 PRIME Study of ZEJULA® (Niraparib) as First-Line Monotherapy Maintenance Treatment in Chinese Women with Platinum-Responsive Advanced Ovarian Cancer

Tuesday, November 30, 2021 - 12:30pm

SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., Nov. 30, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy met its primary endpoint. ZEJULA demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit with a tolerable safety profile in Chinese patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status.

Key Points: 
  • Importantly, the PRIME study further underscores the status of ZEJULA as the first and only PARP inhibitor approved globally, including in China, as monotherapy for all-comer patients in the first-line maintenance treatment settings.
  • The study evaluated the efficacy of ZEJULA as a maintenance treatment, with the primary endpoint of PFS as assessed by blinded independent central review.
  • While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women.
  • A Phase 1 pharmacokinetic (PK) study of ZEJULA was conducted in Chinese patients with ovarian cancer.

Organovo On Track to Establish Human 3D Disease Model in Inflammatory Bowel Disease in 2022

Tuesday, November 30, 2021 - 1:05pm

Organovo believes that using human cells in 3D tissue models of disease offers the opportunity to understand and treat disease in a superior way to the use of animal models.

Key Points: 
  • Organovo believes that using human cells in 3D tissue models of disease offers the opportunity to understand and treat disease in a superior way to the use of animal models.
  • Organovo plans to pursue novel drug therapies in inflammatory bowel disease (IBD) discovered in its 3D tissues.
  • The company believes that its results thus far suggest that it is on track to establish the necessary disease models of inflammatory bowel disease in 2022.
  • Organovo believes that it can achieve a significantly better success rate than that by using its 3D human tissue models of disease.

Ensysce Biosciences Announces Clinical Trial Progress of its New Class of Opioids

Tuesday, November 30, 2021 - 1:00pm

TAAP chemical modification inactivates the active ingredient in Ensysces opioids products including PF614.

Key Points: 
  • TAAP chemical modification inactivates the active ingredient in Ensysces opioids products including PF614.
  • Dr. William Schmidt, Chief Medical Officer of Ensysce, commented: We are encouraged by the results of our trials to date.
  • With our expertise in drug development, we are advancing as expected toward bringing our lead next generation opioids products to market.
  • Ensysce Biosciences, San Diego, CA is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs.

Chinook Therapeutics Announces Formation of SanReno Therapeutics, a Joint Venture to Develop Kidney Disease Therapies in China

Tuesday, November 30, 2021 - 1:00pm

Chronic kidney disease is a major public health concern in China, affecting over ten percent of the population, including several million patients with IgAN.

Key Points: 
  • Chronic kidney disease is a major public health concern in China, affecting over ten percent of the population, including several million patients with IgAN.
  • The establishment of SanReno is a testament to our commitment to making dialysis and transplant unnecessary for people living with kidney disease around the world.
  • Under the terms of the joint venture, Chinook has granted SanReno exclusive rights to develop and commercialize atrasentan and BION-1301 in the Territory in exchange for 50 percent ownership of SanReno.
  • Chinook and SanReno also have reciprocal rights of first negotiation in their respective territories for certain future kidney disease products developed or in-licensed by either company.

Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH

Tuesday, November 30, 2021 - 1:00pm

The FDA Fast Track designation allows sponsors to gain access to expedited drug approval reviews for medical conditions that are serious and potentially life-threatening, and where there is an unmet medical need.

Key Points: 
  • The FDA Fast Track designation allows sponsors to gain access to expedited drug approval reviews for medical conditions that are serious and potentially life-threatening, and where there is an unmet medical need.
  • We are now looking forward to initiating our larger Phase 2b NASH study, called ASCEND-NASH, in biopsy confirmed F2 and F3 NASH subjects in the coming months.
  • As such, we are very pleased to receive the FDAs Fast Track designation and are looking forward to working closely with the Agency as we advance development of CRV431.
  • Additionally, as part of the FDA Fast Track designation for CRV431 in NASH, Hepion will make its expanded access policy publicly available in the coming weeks.

Bright Minds Biosciences Provides Scientific Update on its Novel 5-HT2A Psychedelic Program for the Treatment of Mental Diseases

Tuesday, November 30, 2021 - 12:30pm

VANCOUVER, British Columbia, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Bright Minds Biosciences (“Bright Minds,” “BMB” or the “Company”) (Nasdaq: DRUG) (CSE: DRUG), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain, today provided a scientific update on the advancement of its novel 5-HT2A psychedelic program for the treatment of mental diseases.

Key Points: 
  • Our 5-HT2A psychedelic drug discovery program is showing clear signs of success, stated Dr. Alan Kozikowski, Ph.D., Chief Scientific Officer and Co-founder of Bright Minds.
  • This data-driven decision process de-risks Bright Minds proprietary compounds and maximizes the chance of success in clinical trials.
  • Ian McDonald, Bright Minds Chief Executive Officer and Co-founder, stated, Bright Minds has, what we believe to be, the largest and most advanced psychedelic drug discovery program in history.
  • Bright Minds novel psychedelic compounds comprise a variety of different chemical scaffolds, and not just those comparable to psilocybin.