Eli Lilly and Co.’s first foray into inflammatory bowel disease with Omvoh (mirikizumab-mrkz) for infusion (300 mg/15 mL) and injection (100 mg/mL) gained the blessing of the U.S. FDA, which approved the interleukin-23p19 antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. The drug is designed to provide relief for three key symptoms of the disorder, regardless of past use of biologics: stool frequency, rectal bleeding, and bowel urgency. Shares of Indianapolis-based Lilly (NYSE:LLY) were trading at $565.11, down $2.99.

Santhera offers improved steroid therapy with FDA nod in DMD 

Less than two weeks after getting a thumbs-up from the EMA’s Committee for Medicinal Products for Human Use, Santhera Pharmaceutical AG’s vamorolone secured U.S. FDA approval for use in patients, 2 and older, with Duchenne muscular dystrophy (DMD). A first-in-class drug, vamorolone, branded Agamree, is expected to offer a safer alternative to standard-of-care steroid therapies, which the company has said will remain a foundational treatment of DMD. U.S. licensing partner Catalyst Pharmaceuticals Inc. plans to make the drug available to patients in the first quarter of 2024. Despite the positive news, shares of both companies dropped Oct. 27. Santhera (SANN.SWX) closed at CHF11.52, down 13.4%, while Catalyst was trading at $12.13 midday, down nearly 10%.

No red flags flying ahead of adcom on Vertex’s SCD therapy

It’s just a discussion next week of Vertex Pharmaceuticals Inc. and Crispr Therapeutics AG’s sickle cell disease (SCD) therapy, with no vote expected from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. The adcom meets Oct. 31 to hear about exagamglogene autotemcel (exa-cel), an autologous, ex vivo CRISPR/Cas9 gene-edited therapy with a priority BLA and a Dec. 8 PDUFA. The FDA notes in its briefing document that the data support exa-cel’s efficacy despite them coming from a single “uncontrolled and small” primary study. However, the FDA continued that, given the strongly positive results, the agency does not believe the study design limitations call the efficacy of exa-cel into question.

Angitia advancing musculoskeletal pipeline with $46M series B

Angitia Biopharmaceuticals raised $46 million in a series B round extension, bringing the total raised under the series B to $170 million led by Morningside Group, and will enable the company to advance its pipeline of musculoskeletal therapies. “We are eager to advance our pipeline of novel biologics to potentially address the large unmet needs of patients with serious musculoskeletal diseases, an area that deserves greater investment and innovation in new therapeutic approaches,” said Angitia founder and CEO David Ke.

Oncolys’ Telomelysin hits phase II endpoints in esophageal cancer 

Oncolys Biopharma Inc.’s lead compound Telomelysin (suratadenoturev, OBP-301) met the primary endpoint of exceeding the predefined threshold of local complete response (L-CR), confirming clinical benefit in a phase II study in locally advanced esophageal cancer combined with radiation. Conducted at 17 clinical sites in Japan, the study enrolled 37 patients with locally advanced esophageal cancer who were not eligible for curative resection or chemoradiation therapy. OBP-301 was endoscopically administered to the local tumor area via endoscope three times every two weeks during six weeks of radiation. The primary endpoint of L-CR was 41.7%, which exceeded the predefined threshold of 30.2% derived from historical data.

Automera launches with $16M series A funding to tackle protein degradation

Fledgling biotechnology company Automera has launched in Singapore with $16 million in series A funding to develop its autophagy-targeting chimera small molecules (AUTACs) platform technology. Automera co-founder and chief technology officer Loong Wang told BioWorld that he and his business partner, Taiyang Zhang, decided to move into the biotechnology space in 2021. With a background in the deep technology space, Wang said he and Zhang had a number of earlier successes and were able to explore potential biotech opportunities. “We didn’t really have an idea about what we wanted to do in the space specifically, but we did know that we wanted to work on a platform technology. We didn’t want to just work on a specific disease or a specific target. We really wanted to bring some kind of new modality to the table,” he said.

In HIV, gene therapy could be alternative path to functional cure

At the 30th Annual Congress of the European Society for Gene and Cell Therapy in Brussels this week, researchers presented both preclinical and clinical strategies for applying gene therapy to a functional HIV cure. At a Wednesday session on Infectious Diseases & Vaccines, Alessio Nahmad, co-founder and chief scientific officer of seed-stage startup Tabby Therapeutics Ltd., described using B cells edited to express broadly neutralizing antibodies 3BNC117 to deliver high titers of antibodies in mice. “HIV is the king of escape,” Nahmad told the audience, and so far, has managed to outmutate every attempt to develop a vaccine against it.

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