LONDON – Controversy has erupted over COVID-19 vaccines dosing after the U.K. said it is to prioritize giving as many people as possible a single dose of the two currently approved products, rather than two doses three or four weeks apart, as scheduled on their labels. The move prompted a sharp rebuke from FDA Commissioner Stephen Hahn and Peter Marks, director of FDA’s Center for Biologics Evaluation, who said any such change “is not rooted in the science.” The U.K.’s Joint Committee on Vaccination and Immunization, meanwhile, made its recommendations in the face of a rapid increase in the number of SAR-CoV-2 cases in the U.K. during December, as B.1.1.7, a new more transmissible variant spread around the country.
Cerecor reports phase II progress in COVID-19 treatment; Atyr, too
San Diego-based Atyr Pharma Inc. and Cerecor Inc., of Rockville, Md., separately unveiled positive news on the COVID-19 treatment front. The former’s fusion protein, ATYR-1923, yielded top-line phase II results in patients with severe respiratory complications who do not require mechanical ventilation. Cerecor’s CERC-002, a human anti-LIGHT (tumor necrosis factor superfamily member 14) monoclonal antibody, turned up phase II proof-of-concept data in patients hospitalized with COVID-19-associated pneumonia and mild to moderate acute respiratory distress syndrome. Shares of Cerecor (NASDAQ:CERC) were trading midday at $2.94, up 29 cents, or 11%. Atyr’s stock (NASDAQ:LIFE) was selling for $3.72, down 25 cents.
India’s speedy approval of domestic COVID-19 vaccine raises concerns
HONG KONG – The conditional approval in India on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. that is still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to Covaxin, along with Covishield, developed by Astrazeneca plc and Oxford University. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve Covaxin has created controversy and confusion.
Despite rising vaccine access, therapeutic research essential as SARS-CoV-2 mutates
Relief spread across the world in December when the first two mRNA COVID-19 vaccines received conditional and emergency use approvals, although that deep sigh was short-lived as a mutation that increased the transmissibility of SARS-CoV-2 began to make its rounds, all the more necessitating the need for therapeutic options. As vaccines were first administered to front-line health care workers, the World Health Organization, as of Jan. 5, reported 84.2 million confirmed cases of the infection and 1.84 million deaths, with the U.S. numbers representing about 24% and 19%, respectively. This contrasts with well over 800 therapeutics and vaccines in development to target the relentless virus.
European biopharma scales new heights in 2020 with $12.7B equity investment
DUBLIN – European biotechnology, like the rest of the global industry, scaled new heights in 2020 from an investment perspective. European firms collectively raised $12.682 billion from the private and public equity markets, as well as substantial levels of debt and grant funding. It was a bumper year for both venture capital investment and for Europe’s growing cadre of listed companies. On the IPO front, the performance was less exceptional – not a single transaction was completed in Q1 – but the final tally of $1.559 billion was still higher than those of the last two years. The COVID-19 pandemic has had a dual effect. It has prompted a rush of funding into biopharma companies developing vaccines and therapies intended to prevent or to treat infection and its consequences. The pace of investing slowed somewhat in the fourth quarter. The COVID-19 opportunity is limited, and much of the emphasis is now switching from the development of novel therapies – which has so far yielded only modest levels of success – to vaccines.
Iconovir raises $77M to develop oncolytic virus candidates
Iconovir Bio Inc., of San Diego, raised $77 million in a series A financing to develop differentiated oncolytic virus candidates the company said it believes could potentially be I.V.-administered, tumor-selective and could broadly infect tumor cells. Its lead candidate, OV-0142, derived from the common cold virus, comes with preclinical data showing it can infect and kill a range of tumor cells that include head and neck, bladder, lung and breast cancers. There is also the possibility, the company added, that it could be effective in treating solid tumors. Mark McCamish, Iconovir’s president and CEO, said the series A gives the company enough power to put its product candidates into the clinic within the next 18 to 24 months. The financing was co-led by Nextech and Vida Ventures, along with Two River Group, Bellco Capital, Polaris Partners, GV, Wellington Partners Venture Capital and Logos Capital.
Immuneering secures $62M series B to advance tech-driven pipeline
Immuneering Corp., a Cambridge, Mass.-based developer of new drugs targeting a cellular signaling pathway commonly activated in many tumor types and cancers, has raised $62 million to help advance its top candidates to the clinic. Additional programs in neuroscience and immuno-oncology and its Disease Cancelling Technology platform will also gain support from the series B round, it said. Cormorant Asset Management led the round, with participation from Surveyor Capital, Rock Springs Capital, existing investors and others.
Investors bullish on drug developers in 2020
The exceptional and speedy response in bringing safe and effective vaccines and therapeutics to combat COVID-19 has kept investors engaged and supportive. As a result, not only have companies involved in this research and development benefited, but also the sector as a whole, in particular small- and medium-sized drug developers. These biopharma companies have enjoyed significant jumps in their share values, with the BioWorld Drug Developers index closing up 4.6% in December and up 29% for 2020, well ahead of the general markets.
U.S. price increases unstopped by COVID-19
A New Year tradition in the U.S. is the inevitable price increase for a multitude of brand drugs. 2021 isn’t breaking with that tradition, despite the economic ravages families are dealing with after nearly a year of the COVID-19 pandemic. More than 600 brand drugs had price increases in the first week of January, according to data compiled by 46brooklyn, a nonprofit that focuses on U.S. drug pricing data. With two exceptions, the increases were in the single-digit range, keeping with the “social contract” Allergan plc proposed in 2016. But some drug companies pushed that contract to the limit this year, with increases of 9.4% to 9.9% on several drugs.
Also in the news
3D Medicines, 89bio, Abbvie, Adamas, Akston, Allergy, Antengene, Arch Biopartners, Arcturus, Aro, Ascentage, Asclepix, Atriva, Atyr, Bavarian Nordic, Bio-Manguinhos, Bioxcel, Bristol Myers Squibb, Cerecor, Chemomab, Cheplapharm, Chipscreen, Cure, Cyclo, Destiny, Dicerna, Emergex Vaccines, Endo, Evotec, Galapagos, Genentech, Genmab, Hemogenyx, Hoth, Ideaya, Ikena Oncology, Immunitybio, Inflarx, Inhibrx, Innate, Janssen, Lakepharma, Ligature, Marius, Marker, Merck, Metacrine, Moderna, Morphic, Motif, NGM, Novo Nordisk, Ocuphire, Ovoca, Paladin Labs, Paratek, Phoenix Pharmalabs, Precigen, Prelude, Qpex, Replimune, Revitope Oncology, Rhythm, Roche, Sanbio, Sanofi, Selvita, Sosei Heptares, Spinogenix, Symvivo, Takeda, Terns, Tonix, Vaxiion, Vigeneron, Xbrane, Y-Biologics, Zosano