Hello everyone and welcome to MedNess: At the frontier of healthcare news. I am back with the news from healthcare business that had the most impact this month Read below to find out more.
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Neurotrope’s Alzheimer’s candidate fails to yield statistically significant results
Earlier this month Neurotrope reported results from its Phase 2 Alzheimer’s study of Bryostatin. The trial involving 147 patients with moderate to severe Alzheimer’s met its primary endpoint in patients that completed the full course of treatment. Bryostatin improved outcomes in cognition and ability to handle daily activities but failed to achieve statistical significance over placebo (FierceBiotech).
Neurotrope is hopeful of its candidate and plans to take the study forward.
MedNess: This is yet another Alzheimer’s candidate that failed in Phase 2 testing. The successful treatment of dementia is an enigma, and most drug candidates fail larger phase 2 trials. No new drug has been approved for Alzheimer’s for more than a decade. Neurotrope’s shares fell by 63% (Biospace)
Moderna Therapeutics reports interim Phase 1 results from mRNA based H10N8 flu vaccine
The private biotech company; Moderna Therapeutics reported positive interim results from phase 1 study of mRNA-1440 vaccine against avian H10N8 flu. The complete data and results were published in the journal Molecular Therapy.
31 subjects were enrolled in the Phase 1 study, and 23 received 100 µg of the vaccine. All participants achieved HAI titers suggesting seroprotection against seasonal flu. No response was achieved in the placebo arm (8 subjects). (FiercePharma)
MedNess: Since the company is still private, the only investment that can be made in Moderna Therapeutics is through venture capital funds. The company’s valuation is $3B, and primary sources of funding are grants and private investments (Investopedia and The Motley Fool).
Sanofi against affordable pricing for Zika vaccine
Sanofi Pasteur, the leader in vaccine manufacture, was under fire by US army officials and Senator Bernie Sanders after refusing the US Army’s plea for affordable US price for a Zika virus vaccine. Sanofi boasts of about $43 million US research grant money. Sanders and lawmakers have been requesting the US Army to reconsider its term of negotiations with Sanofi that could provide the latter an exclusive license to make and sell Zika vaccine in the US. The vaccine is being developed with the American taxpayer funds, thus prompting both the US Army and Sanders to request an affordable price for the American population.
The spokesperson from the Army states that the decision to provide Sanofi an exclusive licensing is still under consideration and the final decision will be made in the summer (STAT).
Corbus Pharma’s anabasum denied BTD for systemic sclerosis; enrolls the last patient for mid stage-study dermatomyositis
Corbus Pharma’s anabasum (Resunab) was previously provided Orphan Drug designation for Fast Track review by the FDA for systemic sclerosis. However, this month Corbus Pharmaceuticals was trying to gain Breakthrough Therapy status for the drug. The plea was rejected by the FDA. The BTD designation entails recurrent meetings with senior personnel and a rolling review of the New Drug Application. Meanwhile, in another phase 2 clinical trial where anabasum is being tested for dermatomyositis, the last patient was enrolled
MedNess: The failure to gain BTD designation by the FDA worried the investors, slipping shares down by 12%. However, with the news of last patient enrollment, the shares moved up by 3%.
The Belgian-Dutch Biotech Argenx draws $115M post-IPO filing
Argenx filed for IPO last month to draw cash from American investors; in order to push its lead candidate ARGX-113, an antibody directed against autoimmune disorders myasthenia gravis and primary immune thrombocytopenia, to phase 3 trials. It also proposed moving its lead cancer candidate ARGX-110 through mid phase studies. The biotech was able to rope in $115M, 50% above its target goal of $75M.
The biotech started their phase 2 studies with ARGX-113 earlier this year, and the results are expected in the first quarter of next year. A 30% drop in the IgG antibody level would be considered clinically significant (Fierce Biotech, Market Watch).
Incyte reports positive results from selective IDO1 enzyme inhibitor, epacadostat in two separate combined trials
Incyte reported first set of positive results from ongoing combined trials; ECHO-202 in combination with Merck (epacadostat+ Keytruda) and ECHO-204 in combination with BMS (epacadostat + Opdivo). The full sets of results will be announced at American Society of Clinical Oncology (ASCO) meeting next month.
The ECHO-202 trial is assessing epacadostat (selective IDO1 enzyme inhibitor) in combination with Merck’s Keytruda (anti-PD1 immunotherapy). The efficacy and safety results from the phase I/II trial showed that epacadostat in combination with Keytruda was well-tolerated in the following cohorts: non-small cell lung cancer, renal cell carcinoma, ovarian cancer, triple-negative breast cancer, bladder cancer, and head and neck squamous cell carcinoma.
Alternatively, data from the ECHO-204 trial evaluating the safety and efficacy of epacadostat, in combination with Bristol-Myers Squibb’s PD-1 inhibitor Opdivo showed the combination was well tolerated in melanoma, head and neck squamous cell carcinoma, ovarian cancer, and colorectal cancer (Incyte.com).
MedNess: Following the positive results, Incyte’s shares gained 2.3%, rose by 6% by mid-day which rose by 8% towards the end of the day (Thursday, May 18, 2017) with the overall increase of 14.10% by the end of the week (Zacks, Investor Place, The Street, and CNN Money).
About the Author:
Imit Kaur is a freelance medical writer, editor, and an active science blogger. She pursued her Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.
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