Aclaris Has Positive Prelim Topline Data from Phase 2a Trial of Oral Rheumatoid Arthritis Med

 .   Durable Clinical Activity over 12 Weeks was Demonstrated

• Data Support New Oral Approach for the Potential Treatment of Immuno-inflammatory Diseases, such as Rheumatoid Arthritis

• ATI-450, an Investigational Oral MK2 Inhibitor, was Generally Well Tolerated

• Data Support Progression to Phase 2b

• Management Hosted Conference Call at 8:00 AM ET Today

Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive preliminary topline results from a 12-week, Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450, an investigational oral MK2 inhibitor, in subjects with moderate to severe rheumatoid arthritis (RA) (ATI-450-RA-201). ATI-450 was developed internally utilizing Aclaris’ proprietary KINect™ drug discovery platform.

In the trial, 19 subjects were randomized in a 3:1 ratio and received either ATI-450 at 50 mg twice daily or placebo, in combination with methotrexate, for 12 weeks. The primary endpoint was safety and tolerability. Key secondary and exploratory endpoints included the disease activity scores, DAS28-CRP and ACR20/50/70, and the change from baseline in high sensitivity C-reactive protein (hsCRP) and relevant endogenous cytokine levels. As this trial was designed to generate proof of concept, it was not powered to detect statistically significant outcomes on efficacy endpoints.

The mean DAS28-CRP score at baseline was 5.71 for the 16 subjects in the treatment arm and 5.77 for the three subjects in the placebo arm. Seventeen subjects (15 in the treatment arm and two in the placebo arm) completed 12 weeks of treatment.

https://finance.yahoo.com/news/aclaris-therapeutics-announces-positive-preliminary-120000614.html

India’s homegrown vaccine developer warns some to avoid shot

 India’s homegrown coronavirus vaccine developer Bharat Biotech on Tuesday warned people with weak immunity and other medical conditions including allergies, fever or a bleeding disorder to consult a doctor before getting the shot — and if possible avoid the vaccine.

The company said those receiving vaccinations should disclose their medical condition, medicines they are taking and any history of allergies. It said severe allergic reactions among vaccine recipients may include difficulty breathing, swelling of the face and throat, rapid heartbeat, body rashes, dizziness and weakness.

The vaccine developed by Bharat Biotech ran into controversy after the Indian government allowed its use without concrete data showing its effectiveness in preventing COVID-19. Tens of thousands of people have been given the shot in the past three days after India started inoculating health care workers last weekend in what is likely the world’s largest coronavirus vaccination campaign.

India vaccinated 148,266 people on Monday, taking its total to 381,305, the health ministry said.

Indian authorities hope to give vaccines to 300 million people. The recipients are to include 30 million doctors, nurses and other front-line workers, to be followed by 270 million people who either are over 50 or have illnesses that make them vulnerable to COVID-19.

India on Jan. 4 approved the emergency use of two vaccines, one developed by Oxford University and U.K.-based drugmaker AstraZeneca, and the other by Bharat Biotech. The regulator took the step without publishing information about the Indian vaccine’s efficacy.

Bharat Biotech has still not published data on its vaccine’s effectiveness but said it is complying with clinical trial guidelines.

The regulator maintains the vaccine is safe and gave its approval in the belief that it could be more effective in tackling a new variant of the coronavirus found in the U.K. The regulator and the company have said efficacy data will be published after ongoing late clinical trials conclude.

Most hospitals in India are inoculating health care workers with the AstraZeneca vaccine. But turnout, particularly in those hospitals using the Bharat Biotech vaccine, has been relatively low, health officials said.

Hospitals in New Delhi that have been administering the Bharat Biotech vaccine have seen many doctors hesitate to get the shot.

Dr. Vinod K. Paul, a member of NITI Aayog, a government think tank, said concerns about adverse effects of the vaccine seemed to be “unfounded and insignificant.”

“If our healthcare workers, especially doctors and nurses, are declining it, then it’s very unfortunate,” Paul told reporters. “Healthcare workers should have faith in our system.”

The vaccination drive began at a time when coronavirus infections have fallen sharply, and much of life has returned to normal.

India is second only to the U.S. in the number of confirmed cases, with more than 10.5 million. The country ranks third in the number of reported deaths, behind the U.S. and Brazil, with over 152,000.

https://apnews.com/article/asia-pacific-india-coronavirus-pandemic-93d0a4c1e3d4721e92f0c66542b671a2

Lilly gives $60M to Merus, ties in $1.6B in biobucks for next-gen cancer research pact

 Eli Lilly, via its Loxo Oncology biotech unit, is signing up to a three-therapy deal with Merus focused on T-cell redirecting bispecific antibody work.

Netherlands-based Merus gets $40 million upfront and a $20 million equity investment from the Big Pharma as well as $1.6 billion in total for three drugs.

These will come out of Merus’ so-called Biclonics platform, which develops CD3-engaging, T-cell redirecting bispecific antibody therapies.

“CD3-engaging bispecific antibodies are rapidly becoming one of the most transformative immune-modulating modalities used to treat cancer,” said Jacob Van Naarden, M.D., chief operating officer of Loxo Oncology.

“We expect these therapies will become an important component of the Loxo Oncology at Lilly biologics strategy. Merus has built a differentiated platform and one that we believe can enable us to create bispecific antibody therapies with wider therapeutic indexes than those available today. We look forward to working closely with Merus to develop new potential medicines for patients with cancer.”

Merus attracted some buzz a few years back with its impressive list of big-name backers including Novartis, Johnson & Johnson and Pfizer.

It had to dial down its plan to raise $100 million in an initial public offering but still managed to pull in $55 million in May 2016. Later that year, it inked a $200 million deal with Incyte to develop bispecific antibodies. Lilly becomes the latest to team up with its platform.

Merus is working on its own internal pipeline focused on zenocutuzumab (also called MCLA-128), targeting fusions involving the gene NRG1, which can drive the growth of many different types of cancers.

“The collaboration with Loxo Oncology at Lilly and their world class research capabilities opens up exciting possibilities for Merus' Biclonics platform,” added Bill Lundberg, M.D., president and CEO of Merus.

“Our CD3 T-cell engager platform includes over 175 novel and diverse anti-CD3 common light chain antibodies across a wide range of affinities and attributes and enables functional screening of large libraries for optimal performance. We look forward to working together with Loxo Oncology at Lilly to define a new generation of medicines to treat cancer.”

https://www.fiercebiotech.com/biotech/lilly-gives-60m-to-merus-ties-1-6b-biobucks-for-next-gen-cancer-research-pact

Applied DNA COVID-19 Assay Kit Can Detect Multiple SARS-CoV-2 Variants

 - Confirms Assay Kits’ Value in Tracking New SARS-CoV-2 Variants in Surveillance and Diagnostic Testing -

- Vast Majority of PCR and Antigen Testing Unable to Detect Currently Known Variants -

- Multiple-Targets Assay Design Provides for Positive Results for Infected Individuals, while S-Gene "Dropout" Signals the Presence of a Variant –

Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Linea™ COVID-19 Assay Kit (the "Assay Kit") identified COVID-19 positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in the pandemic until now. The variants were identified as part of the Company’s safeCircleTM pooled surveillance testing service, which is powered by the Company’s Assay Kits. The Assay Kits are also available for diagnostic use in third-party laboratories certified for complex molecular diagnostics.

https://finance.yahoo.com/news/applied-dna-linea-covid-19-120000335.html

Biohaven pops the Alzheimer’s bubble

 Troriluzole has failed in an Alzheimer’s trial, reminding the markets that this is par for the course in this disease.

Perhaps Lilly’s early success with donanemab in Alzheimer’s disease had spurred a minor flurry of enthusiasm around Biohaven’s rival asset troriluzole. Clearly there had been hopes of success, however misplaced, otherwise Biohaven would not be off 15% today on its project’s failure, which some will say was highly foreseeable.

Troriluzole put to the test a somewhat broad theory, namely that excessive concentration of the neurotransmitter glutamate is responsible for a variety of CNS diseases, including Alzheimer’s. Not only did some analysts not buy this, as reflected in consensus sales estimates, troriluzole had already failed in three other neurology settings.

Most recently it flunked an obsessive compulsive disorder study, having earlier drawn blanks in spinocerebellar ataxia and generalised anxiety disorder, though Biohaven is pushing on in the first two settings.

Sellside consensus, according to EvaluatePharma, is for troriluzole to post 2026 revenues of $303m, of which Alzheimer’s accounted for $114m. With Biohaven yesterday revealing the unambiguous failure of the T2 Protect AD trial, at best those forecasts will be slashed, and some analysts are removing most troriluzole sales from their models.

The open-label phase II/III study had compared troriluzole against placebo in mild to moderate Alzheimer’s, but failed both its co-primary endpoints, 48-week Adas-Cog and CDR-Sum of Boxes scores, as well as a secondary MRI metric looking at hippocampal volume.

The best Biohaven could say about the data was that a subgroup of 48 subjects with mild Alzheimer’s showed a numerical benefit versus placebo on Adas-Cog and hippocampal volume, but even this did not hit nominal statistical significance. The company accepted that further trials would be necessary to demonstrate any benefit, and additional analyses will determine whether these are warranted.

Prodrug

Troriluzole is a prodrug of riluzole, which as Rilutek is approved for amyotrophic lateral sclerosis. It reduces levels of glutamate by augmenting the expression and function of excitatory amino acid transporters, which increase uptake of the neurotransmitter from synapses.

Biohaven had earlier argued that excessive glutamate levels in synapses, owing to overproduction and insufficient uptake and breakdown, had a range of deleterious downstream effects; unfortunately, it has been unable to prove that reversing this was relevant in a clinical trial setting.

Numerous other projects are in development targeting glutamate modulation, but none appears to be in development for dementia, according to EvaluatePharma. Earlier work included Aquestive Therapeutics’ oral film form of riluzole, Glialogix’s GLX1112 and Roche’s R449, but all appear now to be discontinued in Alzheimer’s.

Analysts at Mizuho and Leerink alike said Biohaven’s failure was not surprising, and stressed that the company’s investment case remained centred on its recently launched acute migraine treatment, Nurtec ODT.

Mizuho says uptake has been impressive, and expects additional approval in the second quarter in migraine prevention. Indeed, Nurtec ODT achieving consensus 2026 sales of $1.6bn seems more realistic than a win for troriluzole in Alzheimer’s ever was.

https://www.evaluate.com/vantage/articles/news/trial-results/biohaven-pops-alzheimers-bubble

Thermo Fisher to Acquire Point-of-Care Molecular Diagnostics Provider

 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it has entered into a definitive agreement to acquire Mesa Biotech, Inc., a privately held molecular diagnostic company, for approximately $450 million in cash. Under the terms of the agreement, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction.

Mesa Biotech has developed and commercialized a PCR-based rapid point-of-care testing platform available for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV) and Strep A. Mesa Biotech's patented technology expands the availability of gold standard nucleic acid PCR amplification to point-of-care diagnostics. The company is based in San Diego, California and has approximately 500 employees and revenues in 2020 of approximately $45 million.

Mesa Biotech's Accula™ Flu A/Flu B, RSV and Strep A tests have obtained 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the U.S. Food and Drug Administration (FDA). Additionally, the Accula System has received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing and is now available for use in patient care settings, providing results within 30 minutes, with higher accuracy than other rapid tests on the market.

https://www.prnewswire.com/news-releases/thermo-fisher-scientific-to-acquire-point-of-care-molecular-diagnostics-provider-mesa-biotech-301210467.html

Gritstone Advances Second Generation COVID-19 Vaccine

--Gritstone to Host Conference Call Today at 8:00 a.m. ET--

Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, today announced that it is advancing development of a second generation vaccine against SARS-CoV-2, the virus that causes COVID-19, with potential for both prolonged protection and potency against Spike mutants. Gritstone and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have entered into a clinical trial agreement to initiate clinical testing. A Phase 1 clinical trial, expected to be conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), is in development. The Bill & Melinda Gates Foundation (Gates Foundation) is supporting the preclinical evaluation of the vaccine.

Through a license agreement with the La Jolla Institute for Immunology (LJI), one of the leading global organizations dedicated to studying the immune system, Gritstone has access to validated SARS-CoV-2 epitopes that have been identified through LJI’s studies of hundreds of patients recovering from COVID-19. Using these epitopes and the company’s proprietary Gritstone EDGETM and vaccine platform technologies, Gritstone is developing a novel vaccine against COVID-19, containing Spike (similar to first generation vaccines) but also additional viral epitopes that offer good targets for T cell immunity. Gritstone uses both self-amplifying mRNA and adenoviral vectors to deliver the SARS-CoV-2 viral antigens. The vaccine may have pan-SARS/coronavirus potential to protect against future coronavirus pandemics.

“Gritstone’s vaccine may provide more comprehensive viral protection by inducing a better combination of T cell responses and neutralizing antibodies as compared to the currently available vaccines,” said Daniel Hoft, M.D., Ph.D., director of Saint Louis University’s Center for Vaccine Development and Division of Infectious Diseases, Allergy and Immunology, National Vaccine Advisory Committee member, and protocol chair and lead principal investigator of Gritstone’s COVID study. “It is important that we move forward with developing these next generation vaccines because we do not yet know whether the existing vaccines that have been granted emergency use authorization will provide long-term immunity or prevent transmission. Improved vaccines that can accomplish these additional benefits may be needed to continue mitigating the ongoing pandemic.”

The company has received a grant from the Gates Foundation to support the preclinical evaluation of the vaccine. NIAID is supporting development of the Phase 1 clinical trial through the IDCRC.

To participate in the teleconference, please dial (866) 866-1333 (domestic) or (404) 260-1421 (international) and refer to conference ID 50081021. Live audio of the teleconference and accompanying slides will be simultaneously webcast and will be available within the Investors & Media section of the Gritstone Oncology website at https://ir.gritstoneoncology.com/investors/events. An archived replay will be accessible for 30 days following the event.

https://finance.yahoo.com/news/gritstone-advances-second-generation-covid-110000710.html