Adamas new data: GOCOVRI more than doubled time without dyskinesia in Parkinson’s

 Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the publication of an article entitled "Amantadine ER (Gocovri®) significantly increases ON time without any dyskinesia: Pooled analyses from pivotal studies in Parkinson’s disease" in the peer-reviewed journal Frontiers in Neurology. GOCOVRI® (amantadine) extended release capsules is the first and only medicine approved as a treatment both for dyskinesia in patients with Parkinson’s disease (PD) receiving levodopa-based therapy and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing OFF episodes.

The publication examined data from two pivotal, placebo-controlled Phase 3 clinical studies evaluating a total of 196 patients. The results demonstrated that treatment with GOCOVRI more than doubled the daily time patients spent ON without any dyskinesia (whether troublesome or non-troublesome), from 3.9 hours a day at baseline to 8.4 hours at Week 12. Compared to placebo, those treated with GOCOVRI experienced an additional 2.9 hours ON time without dyskinesia, an increase driven by a reduction in both OFF time and dyskinesia. Typically, PD clinical trials for the treatment of motor complications differentiate dyskinesia into ‘troublesome’ and ‘non- troublesome’ categories. This analysis is unique in evaluating treatment impact by measuring the increase in ON time without any dyskinesia. GOCOVRI-related adverse events were consistent with the known safety profile of amantadine.

https://finance.yahoo.com/news/adamas-publishes-data-analyses-demonstrating-131500103.html

Gritstone begins clinical trial of COVID-19 vaccine

 The first patient has been dosed in a phase I clinical study investigating the immunogenicity and safety of Gritstone Oncology's COVID-19 vaccine candidate.

Gritstone's Coral second-generation COVID-19 vaccine program evaluates the use of self-amplifying messenger RNA (SAM) and/or adenoviral vectors to deliver SARS-CoV-2 viral antigens from the spike protein of the virus, as well as other proteins outside of the spike protein.

The phase I trial is a multicenter, open-label, and dose- and age-escalation study of Coral in healthy adult volunteers. Both heterologous and homologous prime-boost vaccinations of the adenoviral vector and/or SAM vector expressing either the SARS-CoV-2 spike protein alone or the spike protein plus additional SARS-CoV-2 T-cell epitopes are being studied in a parallel design. Preliminary data from the study is expected in mid-2021.

The study is supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and is being conducted through the Infectious Diseases Clinical Research Consortium (IDCRC).

The company anticipates initiating a phase II trial later in 2021 examining the vaccine as a boost for people who have received a first-generation vaccine. The firm hopes that the vaccine will generate strong CD8+ T-cell responses against nonspike gene fragments, which will provide protection against SARS-CoV-2 variants.

https://www.scienceboard.net/index.aspx?sec=ser&sub=def&pag=dis&ItemID=2403

Co-Diagnostics cut to Hold from Buy by Maxim

 https://finviz.com/quote.ashx?t=CODX

Bristol Myers, Bluebird bio set multiple myeloma therapy list price at $419,500

 Bristol Myers Squibb Co and partner bluebird bio Inc set the wholesale list price of their newly approved multiple myeloma therapy at $419,500, the companies said on Monday.

The U.S. FDA on Friday approved the treatment, Abecma, for adult patients with multiple myeloma after four or more prior lines of treatment, making it the first CAR-T therapy approved for the cancer that affects plasma cells.

CAR-T therapies take immune system cells from a patient and re-engineer them to better fight certain blood cancers.

The therapy has the potential to assume "leadership position" in the multiple myeloma space as the closest competition, Johnson & Johnson and Legend Biotech's cilta-cel, is at least 9-12 months behind, brokerage Cowen and Co said in a note.

Brokerage Piper Sandler expects the treatment to bring in sales of over $2.5 billion by 2030.

Bluebird bio shares were up 4.3% at $31.2 in mid-day trading, while Bristol's stock was flat at $64.

The list price is not necessarily what patients actually pay and "out-of-pocket" costs vary based on the duration of the treatment and individual healthcare plans.

Abecma is being jointly developed and commercialized in the United States as part of an agreement between Bristol Myers Squibb and bluebird bio. 

https://www.marketscreener.com/quote/stock/LEGEND-BIOTECH-CORPORATIO-107863240/news/Legend-Biotech-nbsp-Bristol-Myers-Bluebird-bio-set-multiple-myeloma-therapy-list-price-at-419-50-32829739/

World’s first multiple myeloma cell therapy has it all to do

 With Bristol Myers Squibb/Bluebird’s ide-cel, now branded Abecma, making it across the US finish line, investors might glance nervously at how much this BCMA-targeted Car-T therapy is expected to sell. The 2026 forecast is $1.2bn, according to sellside consensus compiled by Evaluate Pharma, a seemingly tall order given that Abecma has surprisingly been indicated for fifth-line use, even though its KarMMa study was in fourth-line patients. Of course, much of the number will be down to Abecma breaking into earlier lines of multiple myeloma therapy, but here toxicity could trip the therapy up: the label lists hamophagocytic lymphohistiocytosis/macrophage activation syndrome and cytopenia in a boxed warning in addition to the cytokine release and neurotoxicities that are standard with Car-T. There is also an impressive list of BCMA-targeting antibodies and cell therapies, including Johnson & Johnson’s cilta-cel, that could soon compete against Abecma. Not that any of this matters for holders of contingent value rights derived from Bristol’s 2019 takeover of Celgene; since the CD19-targeted Car-T therapy Breyanzi failed to be approved before the end of last year, that security has already lapsed.

Selected BCMA-targeted multiple myeloma therapies
Project	Company	Modality	2026e sales ($m)	Status
Blenrep (belantamab mafodotin)	Glaxosmithkline	ADC	1,462	Marketed
Abecma (ide-cel)	Bristol Myers Squibb/Bluebird	Car-T therapy	1,198	Approved
Cilta-cel	Johnson & Johnson/Legend	Car-T therapy	500	Filed
ALLO-715	Allogene Therapeutics	Car-T therapy	479	Phase 1
CTX120	Crispr Therapeutics	Car-T therapy	171	Phase 1
C-CAR088	Cellular Biomedicine Group	Car-T therapy	74	Phase 1
HPN217	Harpoon Therapeutics	Trispecific MAb	46	Phase 2
AUTO8	Autolus Therapeutics	Bispecific Car-T	46	Preclinical
AMG 420	Amgen/Boehringer Ingelheim	Bispecific MAb	19	Phase 1
bb21217	Bristol Myers Squibb/Bluebird	Car-T therapy	13	Phase 1
Source: Evaluate Pharma sellside consensus. https://www.evaluate.com/vantage/articles/news/snippets/worlds-first-multiple-myeloma-cell-therapy-has-it-all-do

Nymox eyes filing for approval for Fexapotide Triflutate this summer

 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to provide the latest update on the Company's regulatory filing preparation activities. The Company expects to file for approval for its first in class BPH treatment Fexapotide Triflutate, during the summer of this year. Management will provide a firm exact date for the filing in a subsequent disclosure. This communication of the exact date for the filing will be announced by the Company within the next 6 weeks. If there are any unexpected events that delay that announcement, the Company will provide immediate relevant updates.

Paul Averback MD, CEO of Nymox, said, "We are very pleased to be able to provide a clear guidance on dates at the above noted schedule within the next 6 weeks. We are grateful to our strong supporters who have understood that the process is not always conducive to fully predictable timelines. At this point however we are confident that we will be providing very specific details in that regard in the near future. Our product is capable of producing major improvements in men's health and it is remarkably safe and convenient to administer. We are working diligently toward the goal of making it available to men throughout the world."

Dr. Averback added, "The last major drug innovations for BPH (alpha blockers and 5-ARIs) were first introduced over 30 years ago. If our work was an easy task, others would have accomplished this decades ago."

https://finance.yahoo.com/news/nymox-provides-regulatory-activities-132000788.html

Glaxo to fill up to 60M Novavax vaccine doses for Britain

 GlaxoSmithKline has agreed in principle to handle the final part of the manufacturing process for up to 60 million doses of Novavax's COVID-19 vaccine for use in Britain, widening the company's role in the fight against the pandemic.

GSK said in a statement on Monday it would step in from May for the final production steps and bottling into vials known as 'fill and finish' at its Barnard Castle facility in the northeast of England, without compromising supply of other vital medicines and vaccines.

A detailed agreement with the U.S. biotech firm Novavax and the UK government's Vaccines Taskforce has yet to be signed, it added.

Britain struck a deal to buy 60 million doses of Novavax’s vaccine candidate last August.

Novavax will manufacture some of the vaccine using Fujifilm Diosynth Biotechnologies facilities in Stockton-on-Tees, northern England.

GSK and partner Sanofi suffered a development setback in December, delaying the planned launch of their jointly developed vaccine. But the British group has since widened its efforts to fight the pandemic, agreeing to collaborate on production and vaccine development with Germany's CureVac.

It is also working on treatments against COVID-19.

Novavax Inc's COVID-19 vaccine was shown this month to be 96% effective in preventing cases caused by the original version of the coronavirus in a trial in Britain.

The vaccine was also found at the time to be 86% effective in protecting against the more contagious B117 variant, which was first identified in Britain and is now spreading globally.

If authorised, it would follow three COVID-19 vaccines previously approved for use in Britain from Pfizer PFE.N and partner BioNTech, Moderna Inc and the AstraZeneca shot developed with Oxford University. 

https://finance.yahoo.com/news/gsk-fill-60-mln-novavax-160001949.html