LONDON – Cases of the new variant of SARS-CoV-2, which has an unprecedented number of mutations in the Spike protein that is the target of most COVID-19 vaccines, have now been reported across Europe and in Canada, following its initial detection in South Africa. The variant, first labeled B.1.1.529, was officially named Omicron by the World Health Organization (WHO) on Nov. 26, after its expert group on virus evolution concluded it “has a large number of mutations, some of which are concerning.” The WHO expert group said preliminary evidence indicates Omicron may be able to infect people who are vaccinated or who have recovered from infection with a different SARS-CoV-2 variant, and that the steep rise in cases in South Africa suggests it has a growth advantage. The group underlined how worrying this is by sidestepping the usual process of designating Omicron as a variant of interest and escalating it directly to a variant of concern. 

Moderna and Adagio charge ahead against Omicron

While the world grapples for a clear picture of the omicron variant and how to handle it, Biontech SE and Adagio Therapeutics Inc. are stepping out with stock advances, building on momentum from the end of last week. Moderna stock (NASDAQ:MRNA) was up about 10% at midday on Nov. 29. Moderna said it is working rapidly to test the ability of a vaccine dose of its mRNA-1273 vaccine to neutralize the Omicron variant and said it expects data “in the coming weeks.” Adagio’s chief scientific officer, Laura Walker, said its lead monoclonal antibody, ADG-20, will retain activity against Omicron, “as we have observed in in vitro models with all other variants of concern identified previously.” Further, she added, none of the mutations present in the spike protein of the Omicron variant have been associated with escape from ADG-20 neutralization. Adagio shares (NADAQ:ADGI) had soared 75% at midday.

Omicron could shadow molnupiravir adcom

With Omicron all the COVID-19 buzz right now, the FDA’s concern that the antiviral drug molnupiravir might enhance SARS-CoV-2 evolution could take on added weight when the Antimicrobial Drugs Advisory Committee meets Nov. 30 to advise on Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s emergency use authorization request for the oral drug. In clinical trials, molnupiravir was associated with amino acid changes at regions of the virus’ spike protein that are likely under immune or other evolutionary pressure, the FDA said in its briefing document for the adcom. While the agency said it remains unclear if the potential for those changes in the spike protein presents a public health risk, it pointed out that amino acid changes at those sites have been found in some SARS-CoV-2 variants of public health importance.

Merck posts disappointing data from COVID-19 pill ahead of key FDA meeting

Molnupiravir, the drug from Merck & Co. Inc. hailed as a potential game-changer against COVID-19, is not as effective as previously thought, according to newly released trial data from the company. The U.S. pharma, along with its development partner, Ridgeback Biotherapeutics Inc., announced the updated figures after the FDA published briefing documents that could pave the way for an emergency approval. Merck’s latest data from the MOVe-OUT study from all 1,433 enrolled participants showed the drug reduced the risk of hospitalization or death from 9.7% in the placebo group to 6.8% in the molnupiravir group

Quell’s Treg cell therapy heading to clinic with $157M series B

LONDON – Quell Therapeutics Ltd. has raised $157 million in an oversubscribed series B, enabling it to start a phase I/II trial of its engineered T regulatory (Treg) cell therapy for promoting long-term immune tolerance in liver transplant patients, averting the need for chronic immunosuppression. The U.K. trial of QEL-001 is expected to begin recruitment before the end of the year, after the U.K. Medicines and Healthcare products Agency gave its approval in October.

Krystal nears BLA filing for potential EB therapy, buoyed by pivotal trial success

Shares of Krystal Biotech Inc. (NASDAQ:KRYS) rocketed 115% higher by midday after top-line data showed its investigational gene therapy for dystrophic epidermolysis bullosa (EB) achieved the primary endpoint of a pivotal phase III trial, healing 67% of skin wounds associated with the disease vs. placebo at six months. A BLA for the candidate, beremagene geperpavec, is "on track" to be submitted to the FDA in the first half of 2022, with an MAA to be filed with the EMA shortly thereafter, the company said.

Ascentage’s olverembatinib approved in China, marking the first domestic third-gen Bcr-Abl inhibitor

Ascentage Pharma Group International’s olverembatinib has received marketing approval from China’s NMPA for the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML) or accelerated-phase CML harboring the T315I mutation. The Suzhou, China-based firm said it marks the country’s first third-generation Bcr-Abl inhibitor for the treatment of TKI-resistant CML. Olverembatinib will be co-commercialized by Ascentage and Innovent Biologics Inc. in China.

Zenas in-licenses obexelimab from Xencor in $480M deal

Zenas Biopharma LLC in-licensed global rights to develop, manufacture and commercialize the antibody obexelimab from Xencor Inc. to treat autoimmune diseases in a deal worth up to $480 million. Under the agreement, Monrovia, Calif.-based Xencor gained the rights to acquire additional shares in U.S. and China-based Zenas, which will bring its total equity up to 15%. Xencor already has shares in Zenas from a previous licensing deal.

Also in the news

Ablaze, Adial, Atai, Athenex, Avacta, Avenue, Betterlife, Biocryst, Biofrontera, Biontech, Biotron, Blueprint Medicines, Bone, Brainstorm, Bristol Myers Squibb, Celltrion, Celularity, Clover, Eisai, Essential, Fennec, G1, Genenta Science, Gilead, GSK, Help, Henlius, Hotspot, Iaso, Immunome, Immusoft, Inhibikase, Ix, Johnson & Johnson, Kaléo, Kineta, Kintor, Kronos, Krystal, Link Health, Lysogene, MD Andersen, Merck, Nabriva, Nervgen, Neurana, Northwest, Novo Nordisk, Nrx, Ocugen, On Target Labs, Pfizer, Ranok, RDIF, Regenerx, Regulus, Respirerx, Ridgeback, Rosemont, Scorpion, Selecta, Sigilon, Sosei Heptares, Springworks, Starpharma, Supernus, Tetra, Todos Medical, Tracon, Turnstone, Ultragenyx, Unicycive, Valeo, Variant, Verrica, Viracta

Holiday notice

BioWorld's offices were closed in observance of Thanksgiving in the U.S. No issue was published Thursday, Nov. 25, or Friday, Nov. 26.