Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved the first interchangeable biosimilar and the first U.S. biosimilar in the insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s Lantus (insulin glargine), a long-acting insulin analogue. The approval qualifies Semglee, developed through a partnership with Biocon Ltd., for 12 months of exclusivity in which the FDA will not approve another interchangeable biosimilar to Lantus. Originally developed as a 505(b)(2) drug referencing Lantus and then deemed a biologic upon approval in 2020, Semglee will be transitioned over the next few months to reflect its new status as an interchangeable, which enables automatic pharmacy substitution, Viatris said.

Annovis presents new AD/PD data and shares fall

Annovis Bio Inc. presented new clinical efficacy and biomarker data from two phase II studies of its lead candidate, ANVS-401 (posiphen), at the 2021 Alzheimer's Association International Conference that saw the stock sink soon afterward. The company released results from the studies, for treating Alzheimer’s disease (AD) and Parkinson’s disease, showing an ANVS-401-treated AD group compared to a placebo group at baseline and at 25 days had an improvement of 3.3 points, or 22% (p=0.13), in ADAS-Cog11. The data also showed that from baseline to 25 days in the ANVS-401-treated group, ADAS-Cog11 scores improved by 4.4 points, a statistically significant improvement of 30% (p<0.05). The Berwyn, Pa.-based company’s shares (NYSE:ANVS) took a powerful hit as shares had plunged a dramatic 55% at midday.

Lilly seeks fruit from Kumquat I-O platform in potential $2B+ deal

Eli Lilly and Co. has established a multiyear collaboration with Kumquat Biosciences Inc. for the discovery, development and commercialization of new small molecules for stimulating tumor-specific immune responses. Kumquat will receive $70 million up front, including an equity investment, and is eligible for more than $2 billion in potential milestone payments plus royalties on any marketed products.

Is the finish line in sight for DNA vaccines?

Zydus Cadila could make history after applying for approval for the first ever human DNA vaccine in India. But that could be just the start for a technology that could treat a vast array of diseases including cancer, infectious diseases and chronic diseases. But it may come as a surprise that it’s more than 15 years since the first DNA vaccine was approved to counter the West Nile virus in horses. Since then, pharma and biotech firms have been working on the technology for human use, hoping that it could confer a huge advantage over conventional vaccines.

Aiming to ‘re-educate’ the immune system, Topas adds $48M in series B

LONDON – Topas Therapeutics GmbH announced the close of a series B round at €40 million (US$47.5 million), to take forward its two lead immune tolerizing programs. The first, TPM-203, is in clinical development for the treatment of the rare, severe autoimmune skin disorder pemphigus vulgaris, while the second, TPM-502, is due to enter the clinic in celiac disease before the end of the year. These programs represent a novel approach to treating autoimmune diseases by targeting specialized liver cells that are involved in inducing tolerance to blood-borne antigens.

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