Pharmaceutical Technology Editors

Pure Extracts, a plant-based extraction company, and Psyence Group, a biotechnology company specializing in natural psychedelics, announced the formation of a joint venture company on Sept. 28, 2021. The new company, Pure Psyence, will develop nature-derived psilocybin extracts and advanced psilocybin formulations.

Pure Extracts is known for its full spectrum oil extracts and has experience working with cannabis, hemp, functional mushrooms, and psychoactive mushrooms. Their new partner, Psyence, operates one of the first federally-licensed commercial psilocybin cultivation and production facilities in the world.

Pure Psyence will look to develop long-term mental health treatments in the form of psilocybin products. It will leverage Psyence’s supply of psilocybin mushrooms and Pure Extract’s extraction technologies to produce medicinal mushroom extracts and formulations on a commercial pharmaceutical scale.

“Pure Psyence sits at the intersection of evidence-based science and nature,” said Ben Nikolaevsky, CEO, Pure Extracts, in a company press release. “The researchers, scientists, and physicians at Pure Psyence will now be uniquely positioned to bring psilocybin whole mushroom in measurable pharmaceutical dosages to market; a first.”

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Pure Psyence, Pure Extracts and Psyence’s joint venture company, will develop psilocybin-derived treatments.

Pure Extracts and Psyence Form Joint Venture Corporation Pure Psyence

Merck, known as MSD outside of the United States and Canada, announced on Sept. 30, 2021, that it had agreed to acquire Acceleron, a biopharmaceutical company, for approximately $11.5 billion. Acceleron is focused on the transforming growth factor (TGF)-beta superfamily of proteins, which play a key role in the regulation of cell growth, differentiation, and repair.

Acceleron’s lead therapeutic candidate is sotatercept, which has a novel mechanism of action with the potential to help patients with pulmonary arterial hypertension (PAH), a progressive and life-threatening blood disorder. It is currently in Phase III trials as an add-on to the current standard of care for PAH treatment.

Accleron’s portfolio also includes Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation fusion protein approved in the US, Europe, Canada, and Australia for the treatment of anemia in certain rare blood disorders. Reblozyl has been developed and commercialized in a collaboration with Bristol Myers Squibb.

“Strategic business development is a top priority for Merck as we look to drive sustainable growth and further bolster and balance our pipeline with breakthrough science,” said Rob Davis, CEO and president, Merck, in an Acceleron press release. “Acceleron’s innovative research has yielded an exciting late-stage candidate that complements and strengthens our growing cardiovascular portfolio and pipeline and holds the potential to build upon Merck’s proud legacy in cardiovascular disease.”

“This agreement with Merck represents the culmination of decades of work by Acceleron researchers successfully leveraging our company’s deep scientific expertise in the biology of the TGF-beta superfamily and driven by an unwavering dedication to delivering life-changing medicines for patients,” said Habib Dable, CEO and president, Acceleron, in the press release. “We believe Merck is well-positioned to apply its industry-leading clinical and commercial capabilities to harness the potential of sotatercept as we join together to help make an impact on cardiopulmonary disease for the benefit of patients.”

Merck’s 11.5 billion acquisition of Acceleron gives them access to their lead therapeutic candidate, sotatercept.

Merck Acquires Acceleron for $11.5 Billion

Regeneron announced that a trial assessing investigational REGEN-COV (casirivimab and imdevimab) in hospitalized COVID-19 patients met its primary endpoint on Sept. 30, 2021. Additionally, the company indicated that it noted improvements across all clinical endpoints.

REGEN-COV is an investigational medicine for the treatment of people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. It was granted emergency use authorization by FDA, but it is still in FDA’s review process for use in hospitals.

According to a company press release, REGEN-COV significantly reduced viral load in patients who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen. Patients who received REGEN-COV in this trial experienced a 36% reduced risk of dying within 29 days of receiving treatment, while those who were seronegative when they entered the trial had a 56% reduced risk.

Serious adverse events occurred in 21% of REGEN-COV patients (n=285) and 26% of placebo patients (n=174). While doses of both 2400 and 8000 mg were administered to patients, researchers did not notice any clinical difference between dosage groups.

“These data show that REGEN-COV can benefit certain patients even after they are hospitalized, reducing the amount of virus and clinical consequences,” said Eleftherios Mylonakis, primary investigator of the trialand professor of Medicine, Molecular Microbiology, and Immunology, and director of Infectious Disease at Brown University and the Lifespan hospitals, in the press release. “Taken together with results announced earlier this year from the 

 and other studies, these results have the potential to inform personalized care for hospitalized patients with this protean disease that presents with such high clinical variability."

Rengeron’s trial found that REGEN-COV significantly reduced viral load of patients with COVID-19.

REGEN-COV Shows Promising Results in Hospitalized COVID-19 Patients

Novartis and Medicines for Malaria Venture (MMV) have reported, in a Sep. 29, 2021 press release, positive results from the Phase IIb study, evaluating a new non-artemisinin combination to treat uncomplicated malaria in children.

The Phase IIb study, which was conducted in children less than 12 years of age, evaluated a novel agent, ganaplacide, in combination with a new formulation of lumefantrine that has been optimized for once daily dosing. This novel combination therapy has the potential to clear malaria infection and block the transmission of the malaria parasite.

“The world needs a diversified pipeline of anti-malarial medicines, especially as we are faced with emerging resistance to current treatments,” said Sujata Vaidyanathan, head Global Health Development Unit, Novartis, in the press release. “These results are definitely good news, but much more work remains.”

“This is a truly exciting step forward in the development of next-generation antimalarials,” added David Reddy, CEO of MMV, in the press release. “With this Phase IIb data we remain cautiously optimistic that ganaplacide/lumefantrine could one day be saving the lives of those at greatest risk of malaria—young children. MMV is proud to have partnered with Novartis in this project right from the discovery of the compound through to its clinical development and look forward to the next steps.”

Novartis and Medicines for Malaria Venture have reported positive results from the Phase IIb study, evaluating a new non-artemisinin combination to treat uncomplicated malaria in children.

Novartis and MMV Report Positive Results for Next-Generation Antimalarial Therapy

Global specialist HIV company, ViiV Healthcare, has presented three-year data from the TANGO study, which further reinforce that the two-drug regimen (2DR) Dovato (dolutegravir/lamivudine) can be used as a viable switch option for people living with HIV.

The results, which were reported in a Sep. 29, 2021 press release, demonstrated that the 2DR Dovato continued to display non-inferior efficacy and a high barrier to resistance compared to continuation of tenofovir alafenamide fumarate (TAF)-based regimens of at least three drugs in virologically suppressed adults living with HIV-1 who have not experienced prior virologic failure. There were no instances of confirmed virologic failure in the dolutegravir/lamivudine arm of the study, whereas there were three instances in the TAF-based regimen.

“These data provide us with further long-term evidence that switching virologically suppressed people living with HIV from TAF-based 3-drug regimens to dolutegravir/lamivudine will not only maintain virologic suppression, but offers a treatment option consisting of fewer medicines,” said Olayemi Osiyemi, MD, founder, CEO, and president of Triple O Medical Services and Triple O Research Institute PA, United States, lead author and one of the investigators of the TANGO study, in the press release. “As we now consider HIV a long-term condition requiring life-long medication, these results give physicians the data they need to have more confidence in switching their virologically suppressed patients who are taking three or more medicines. Additionally, these data show no confirmed virologic failures, which is important over a long-term study.”

“The latest results from the TANGO study further reinforce Dovato’s role in the HIV treatment landscape, allowing people living with HIV to maintain virologic suppression over the long-term with fewer medicines,” added Kimberly Smith, MD, MPH, head of Research & Development at ViiV Healthcare, in the press release.

ViiV Healthcare is majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders. Dovato is a once-daily, single-pill, 2DR that is approved for use in the US, Europe, Japan, Australia, and other countries worldwide.

ViiV Healthcare has presented three-year clinical trial, reinforcing that the two-drug regimen Dovato can be used as a viable switch option for people living with HIV.

Three-Year Data Demonstrates Further Evidence for Dovato as a Switch Option for HIV

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax (the company’s COVID-19 vaccine).

According to a Sep. 27, 2021 press release, Moderna has applied to the regulatory authority for the use of a booster dose of Spikevax to be given at least six months after the second dose of the vaccine in people 12 years old and older. Based on its review of available data, CHMP will recommend whether or not updates to the product information are appropriate.

In a separate communication, EMA and the European Centre for Disease Prevention and Control (ECDC) have specified that the need for additional and booster doses of COVID-19 vaccines is not urgent for the general population. However, Moderna’s application is being considered to ensure evidence is available to support further doses as necessary.

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax. 