Epitopea Ltd. raised $13.6 million in seed financing to take forward a new cancer immunotherapy platform based on the identification of a new class of tumor-specific antigens encoded by non-canonical genomic sequences.
After rolling out positive, preliminary phase I CAR natural killer cell data, Nkarta Inc. saw its stock (NASDAQ:NKTX) soar to $18.72, up $10.95, or 140.9%, as Wall Street made known its pleasure in results from the small, independent dose-finding studies with Nkarta’s two off-the-shelf lead candidates, NKX-101 and NKX-019, in two groups of blood cancer patients: those with relapsed/refractory (r/r) acute myeloid leukemia (AML) and with r/r non-Hodgkin lymphoma (NHL), respectively.
Isofol Medical AB’s slow reveal of data from its phase III registration trial of arfolitixorin in first-line metastatic colorectal cancer (mCRC) will not reach a conclusion until the fourth quarter of this year. The news follows a December 2021 warning to investors that an unexplained level of therapy switches occurring in the absence of disease progression would impair its analysis of a key secondary endpoint, the rate of progression-free survival.
South Korean companies Ubix Therapeutics Inc. and SK Biopharmaceuticals Co. Ltd. are partnering to develop targeted protein degradation cancer therapies.
Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation.
Genequantum Healthcare Co. Ltd. will work with Aimedbio Inc. to co-develop an antibody-drug conjugate (ADC) to treat brain and other cancers, working toward an IND filing in 2023.
With renewed focus on the U.S. Cancer Moonshot, the price of oncology drugs is more than a satellite issue, especially as new drugs launch with ever-increasing prices and other cancer drugs continue to see price hikes.
Just two weeks after winning U.S. FDA approval for the first orally dissolving formulation of dexmedetomidine for agitation in schizophrenia and bipolar disorders, Bioxcel Therapeutics Inc. has secured commitments for up to $260 million to support the product’s commercial launch, slated for this quarter in addition to a planned European marketing application.
Regeneron Pharmaceuticals Inc. proposes to buy Checkmate Pharmaceuticals Inc. though an all-cash price of $10.50 per share for about $250 million. That’s pretty much on target with Checkmate’s April 19 closing share price (NASDAQ:CMPI) of $10.35, as the stock gained a staggering 326% on the day.
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
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