Ipsen SA, of Paris, struck a $461 million deal with Day One Biopharmaceuticals Inc. for ex-U.S. rights to tovorafenib, an oral drug for pediatric brain tumor that gained U.S. FDA accelerated approval April 23 as Ojemda (tovorafenib).
Even as U.S. lawmakers continue to push back against the rising price of prescription drugs and patients with life-threatening diseases clamor for access to new treatments, the FDA is considering a step that could increase the cost and lengthen the development time of therapies targeting non-small-cell lung cancer and perhaps other solid tumors.
A new collaboration with Dren Bio Inc. means Novartis Pharma AG has negotiated two of the biggest deals of 2024, with its parent company Novartis AG signing a third. Privately held Dren is getting $150 million up front and the chance to ultimately bring in $2.85 billion. The $150 million up-front payment includes a $25 million equity investment.
The July 25 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) could impact the future development of immune checkpoint inhibitors, such as Astrazeneca plc’s Imfinzi, to treat patients with non-small-cell lung cancer (NSCLC) both before and after surgery. Although much of the discussion will focus on an sBLA for Imfinzi (durvalumab), the committee will be asked to vote on whether the FDA should require that new trial design proposals for perioperative regimens for resectable NSCLC include adequate within-trial assessment of the contribution of the treatment phase to efficacy results.
Triastek Inc., of Nanjing, China, scored a potential $1.2 billion collaboration and platform technology license deal with Biontech SE to manufacture oral RNA therapeutics with 3D printing technology.
The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer.
After reaching a height in 2021, seed and series A rounds have fallen in recent years, and 2024 is no exception, although amounts raised are tracking slightly ahead of last year. On July 23, the numbers were given a boost when two new companies – namely Dover, Del.-based Brenig Therapeutics Inc. and Boston-based Third Arc Bio Inc. – raised $65 million and $165 million, respectively, in series A financings. A third new company, Abiologics Inc., also received $50 million in initial funding.
With $50 million in hand from Flagship Pioneering, Abiologics Inc. is pairing generative artificial intelligence with high-throughput chemical protein synthesis to attack oncology and immunology indications with Synteins, synthetic proteins that represent a new class of programmable medicines. Avak Kahvejian, co-founder and CEO of Abiologics and general partner at Flagship, told BioWorld that Abiologics stands “at the precipice of a completely new modality.”
Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”
Artiva Biotherapeutics Inc. raised $167 million through an upsized IPO, with funds aimed at the development of its lead AlloNK program for systemic lupus erythematosus and other autoimmune indications. Just a few days ago, the San Diego based company had aimed to sell 8.4 million shares between $14 and $16 each, but it raised the number of shares offered to 13.92 million and lowered the price to $12 each. The upsize brings Artiva’s shares outstanding following the IPO to about 22.8 million, giving the company a market cap of $273.6 million based on the IPO price.
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