INmune Bio Inc., a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials. XPro /Xpro1595 is considered as a next-generation inhibitor of tumor necrosis factor (TNF) which is based on dominant-negative TNF technology. Also information about their biomarker Phase 1b trial indicated improvement in white matter (myelinated axons) that degrades in AD patients.
Cognito Therapeutics located in Cambridge is a clinical-stage company developing novel digital therapeutics that presented clinical data on gamma frequency neuro-modulation on cognitive function from its lead digital therapeutic candidate in AD. It exhibited sleep improvement, betterments in memory and cognition, and lowered brain atrophy. It was a Phase 2 OVERTURE study with a potential 6 month study in patients experiencing mild-to-moderate AD. The study was based upon reduction in brain atrophy induced from gamma frequency neuro-modulation.
Cortexyme, a clinical stage biopharmaceutical company based in South San Francisco, CA introduced their clinical studies for biomarker data in AD. Escalated levels of p-tau 217 when linked with P. gingivalis acted as a firm biomarker in patients. Around 643 patients’ participation in Phase 2/3 GAIN Trial study resulted in acknowledging that intracellular pathogen P. gingivalis, was present in the brain of more than 90% of Alzheimer’s patients. Cortexyme’s own drug candidate, atuzaginstat, is an oral, brain penetrant small molecule targeting P. gingivalis.
Expanded Approval in GSK’s Pocket for Shingles Expected to Generate High Sales
GlaxoSmithKline announced the US Food and Drug Administration approval for its vaccine, Shingrix (Zoster Vaccine Recombinant, Adjuvanted) under trials in 18+ adults who are vulnerable or at an increased risk to Shingles, which is already commercialized for patient group aged 50 and above.
FDA’s first green signal to Shingrix was given in 2017, where it was approved for prevention of Shingles in populations aged 50 and above. The clinical studies were based on adults who went through an autologous hematopoietic stem cell transplant (auHSCT) and those currently under treatment for hematological malignancies (post-hoc analysis). Additional data for safety and immunogenicity was generated considering adults who were immunodeficient or immunosuppressed due to any known disease or therapy (HIV, solid tumors, and renal transplants).
Shingles is a viral infection that results in blisters and painful rashes, also it is caused by the same virus responsible for chickenpox i.e. varicella-zoster virus. It can be due to immunodeficiency/immunocompromisation caused by a familiar disease or therapy in the body, putting individuals with compromised immune systems at a risk of developing it.
Now, Shingrix is administered intramuscularly in two doses and provides exclusive protection only against Shingles, not chickenpox.
Shingrix was earlier approved by the European Commission (EC) for prevention of shingles and postherpetic neuralgia (PHN) in Shingles vulnerable 18+ adults. Afterwards on August 25, 2020 Shingrix received a proper commercial marketing authorization. In 2019 as the uptake increased, Shingrix sales double folded.
An Exclusive Collab Between Pfizer and BioNTech Alongside South Africa’s Biovac
With a cumulative data of only 1.5% were administered with COVID-19 shot out of Africa’s total population i.e. 1.3 billion people. Africa currently holds one of the lowest rankings in continents with countries with lowest vaccination rate worldwide. It comes as a huge concern for WHO and several other health organizations. To deal with this challenge, a collaborative partnership between Pfizer, BioNTech and a South African local vaccine producer Biovac entered the scenario. This joint venture will account for around 100 million doses per year production.
This globalized COVID-19 vaccine supply chain and manufacturing network, incorporates 3 continents and will contain around 20 manufacturing facilities. As suggested by analysts, the most rapid, cost-effective and easiest way of vaccine development is regional partnership with prominent vaccines developers. Biovac’s Cape town’s facility shall immediately begin processing, technical transfer, on-site development and installation of equipment.
Johnson & Johnson, another major manufacturer in the COVID-19 vaccine market landscape is also not at all lagging behind in the race for African vaccine production. A deal occurring for around 400 million doses of its single shot COVID-19 vaccine will be produced from a facility in Port Elizabeth which is the resultant of an agreement with J&J’s African manufacturing partner – Aspen Pharmacare.
An Awaited Ulcerative Colitis Phase 2 Seres Therapeutics Trial Drug Crashed Down
When positive results were observed in the early stages by an experimental drug from Seres Therapeutics, many expectations were built up; however, the hopes lie flat now. An emerging drug in trial in the Ulcerative Colitis (UC) market falls short after failed Clinical Phase 2 trials. This drug was dealing with a novel kind of therapy, namely microbiome therapeutics.
A study with 203 participants in comparison with placebo was under effect, with the main aim of limiting inflammation in patients dealing with UC, medicine did not outperform the placebo. Another impact was supposed to eliminate a few symptoms related with the disease, where more side effects associated with the drug could be seen.
Seres was in a joint partnership with Nestlé Health Science (NHS) for development of different bacteria-based drugs, many of which are under clinical development.
However, Seres is not planning on abandoning the treatment for the same. With another type of treatment already in the developing phase, there are still hopes for carrying the drug forward. An early phase, second treatment may prove fruitful as assumed by the company’s researchers & scientists.
Share prices still faced an abrupt downward trend after the announcement of failed emerging drug news throughout. The company’s total gain from previous year was wiped out completely.
Few other companies like Finch and Vedanta Biosciences are also working on developing microbiome drugs associated with inflammatory bowel disease (IWD). Vedanta is developing a Phase 2 clinical trial for it’s novel UC drug whereas Finch is in pre-clinical testing phase.
