Bausch Health Companies (NYSE:BHC) perks up 7% after hours on the heels of a regulatory filing from Glenview Capital Management disclosing a 5.9% stake of ~20.9M shares.
Monday, July 27, 2020
Chiasma’s octreotide shows sustained benefit in acromegaly extension study
Chiasma (NASDAQ:CHMA) announces 48-week data from the open-label extension (OLE) from the Phase 3 OPTIMAL trial evaluating Mycapssa (octreotide) in acromegaly patients.
In patients that completed the 36-week randomized trial and responded to treatment, insulin-like growth factor 1 (IGF-1) levels were maintained within normal limits for an additional 48 weeks (IGF-1 is elevated in the growth hormonal disorder).
No new safety signals were observed.
The OLE is ongoing.
The FDA approved Mycapssa for acromegaly on June 26.
MediciNova announced collaboration to develop coronavirus vaccine
Shares of MediciNova (NASDAQ:MNOV) jumped over 65% today after the company announced a collaboration with BioComo and Mie University to develop a vaccine against SARS-CoV-2. The partners, both based in Japan, have developed a novel vector for delivering viral genes and proteins into human cells. The technology platform has been used to develop experimental vaccines against Ebola virus and respiratory syncytial virus (RSV).
Under the agreement, MediciNova will gain exclusive worldwide development rights to use the vector technology for an experimental SARS-CoV-2 vaccine. Although there are inherent advantages to the technology platform (on paper), the collaboration is certainly a little late to the global effort to develop safe and effective vaccines against the novel coronavirus. Does that matter?
As of 11:26 a.m. EDT, the small-cap stock had settled to a 64.7% gain.
So what
For all of the hype surrounding genetic medicines such as gene therapies and CRISPR gene-editing tools, much less attention is given to the most important aspect of these experimental drugs: delivery. Inadequate delivery technology has tripped up RNA interference (RNAi) and gene therapy drug candidates in the past, and it’s bound to present obstacles to gene-editing tools now making their way through clinical trials.
It matters for vaccines, too. For example, China’s CanSino recently reported early-stage results for its SARS-CoV-2 vaccine candidate. Investors were disappointed to learn the experimental therapy wasn’t very effective. That’s because over half of the trial participants had at least partial immunity to the viral vector chosen to deliver the vaccine payload. It essentially means CanSino’s vaccine won’t be competitive globally, even if the Chinese government forces it to be commercialized domestically.
The collaboration between MediciNova, BioComo, and Mie University puts delivery front and center. The SARS-CoV-2 vaccine candidate to be developed will utilize a viral vector called BC-PIV, which is based on recombinant human parainfluenza virus type 2 (HPIV-2). In simpler terms, BC-PIV is able to carry multiple viral proteins on its surface and within its membrane, can maintain proper structure of the proteins comprising the therapeutic payload, and won’t cause secondary immune responses (HPIV-2 itself doesn’t activate the immune system).
The vector’s effectiveness means vaccines based on it wouldn’t need efficiency-boosting adjuvants, which will likely be in short supply globally for the next few years. A BC-PIV vaccine can also be formulated as a muscular injection or as a nasal spray, although effectiveness would vary.
Now what
Investors should be pleased that MediciNova’s efforts to develop a SARS-CoV-2 vaccine are beginning with a significant focus on delivery. The chosen viral vector, BC-PIV, has inherent advantages over competing methods that should lower risk surrounding the safety and efficacy of resulting vaccines. That doesn’t guarantee success, but it’s a solid start.
Of course, investors might not want to get too carried away right now. MediciNova sports a market valuation of only $400 million after today’s pop. The world will need as many safe and effective SARS-CoV-2 vaccines as possible to reduce risks from manufacturing and distribution, but the company has a long way to go before it has a vaccine ready for commercialization.
Amyris partners with IDRI to create adjuvants for COVID-19 vaccine
Amyris (AMRS +4.7%) and Infectious Disease Research Institute (IDRI) has signed a binding term for a planned COVID-19 RNA (ribonucleic acid) vaccine technology program.
The program combines IDRI’s RNA vaccine platform with Amyris’ fermentation platform technology, with the goal to create semi-synthetic squalene-based vaccine adjuvants at scale.
Amyris expects first commercial supply of vaccine adjuvant by the end of this year and, assuming successful trials, could have a successful vaccine platform next year.
Additional details of the proposed program will be disclosed
Nemaura poised to acquire diabetes prevention app developer
Nemaura Medical (NMRD +4.3%) has signed a letter of intent with privately held Healthimation, LLC related to a possible acquisition.
The Boston, MA-based company is commercializing an app-based diabetes prevention program aimed at maintaining patients’ muscle mass and enhancing metabolism to improve overall health while preventing weight gain.
Nemaura believes the app would be a “strong complement” to its proBEAT subscription service that it plans to offer in the U.S.
BeiGene nabs accelerated review in China for pamiparib application
China’s National Medical Products Administration has granted priority review status to BeiGene’s (BGNE -0.5%) marketing application seeking approval of dual PARP inhibitor pamiparib for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
Priority review status in China, similar to the U.S., allows for accelerated review and approval timelines.
PDS Biotech COVID-19 vaccine candidate shows encouraging preclinical action
PDS Biotechnology (PDSB +14.5%) announces positive preclinical data on Versamune-CoV-2 (PDS0203), its COVID-19 vaccine candidate.
Results showed that the candidate elicited induction of virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment and a 30-45 fold increase in COVID-19 specific T-cells and a 20-25-fold increase in neutralizing antibodies by day 14 when compared to the vaccine without Versamune.
The studies also showed substantial increase in neutralizing antibody levels continuing for over 30 days after vaccination.
As previously announced, the Company has also initiated preclinical development of Versamune-CoV-2FC (PDS0204), a COVID-19 vaccine candidate underdevelopment in partnership with Farmacore Biotechnology.
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