Cumulus Oncology Ltd. is in the thick of raising a $50 million series A round as its model of sourcing novel drug targets emerging from academia, shaping them up for clinical development, and spinning them into startups, gathers pace. At the same time, Nodus Oncology Ltd., the first spinout created around an acquired asset, has just reached in vivo proof of concept with its lead DNA damage response inhibitor, and it, too, is looking to raise a series A to take the program through to the end of phase I.

Microbiotica Ltd. is poised to advance two of its microbiome-derived products into the clinic after securing regulatory approval and fresh finance. The first live bacterial therapeutic, MB-097, will be tested in combination with Keytruda (pembrolizumab) in patients with advanced melanoma who have not responded to treatment with immune checkpoint inhibitors. The second product, MB-310, is a once-daily oral therapy for treating the inflammatory bowel disease, ulcerative colitis.

Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.

After sparking further interest from investors after the close of its series A, Vandria SA has extended the round and now has the means to advance its lead mitophagy inducer program as far as phase Ib/IIa development in the treatment of mild cognitive impairment.

The U.K. has become the first country in Europe to approve Leqembi (lecanemab), but as the breakthrough decision was announced, the health technology assessment body NICE said the benefits are too small to justify the cost of providing the Alzheimer’s disease therapy on the National Health Service (NHS).

European biopharmas saw a huge surge in new funding in the second quarter of 2024, raising a collective $4.1 billion, compared to $1.9 billion in the same period of 2023. With the IPO market in Europe still virtually non-existent, $1.45 billion of this was venture capital, while $2.64 billion was raised in follow-on funding. The majority of VC funding was raised by companies in five countries, with $799.6 million raised in the U.K., $272.5 million in Switzerland, $201.8 million raised in Germany, $59 million in France and $25.7 million in Sweden.

After decades of being woefully under-diagnosed and all but ignored by the biotech and pharma industry, recent advances in understanding its complex etiology could be opening the way to new treatments for endometriosis. Impetus is coming from (modest) increases in funding for basic research, such as the Biden administration’s $200 million for women’s health research and NIH grants under an ‘Advancing cures and therapies and ending endometriosis diagnostic delays’ call announced in March of this year.

Levicept Ltd. is scoping the options for phase III development after reporting positive results from its phase II trial of LEVI-04 in the treatment of pain caused by osteoarthritis of the knee. The full data are yet to be published, but the company said the potentially first-in-class neurotrophin-3 inhibitor demonstrated significant differences from placebo, with a mean reduction in pain score from baseline of more than 50%, for the three doses tested.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.