Shares of Nkarta Inc. skyrocketed on positive preliminary phase I data from small, independent dose-finding studies of its two lead CAR natural killer (NK) cell therapy candidates, NKX-101 and NKX-019, in two groups of blood cancer patients: those with relapsed/refractory (r/r) acute myeloid leukemia and with r/r non-Hodgkin lymphoma (NHL), respectively. The stock (NASDAQ:NKTX) was trading midday at $16.26, up $8.62, or 111%. With NKX-101, three of five patients given a three-dose regimen consisting of 1 billion or 1.5 billion CAR NK cells per dose achieved complete response (CR) with full hematologic recovery, for a 60% CR rate. NKX-019 in NHL yielded a 50% CR, hitting the mark in three of six patients.

Eliem tanks on pipeline setbacks for pain, epilepsy drugs

Shares of Eliem Therapeutics Inc. fell 56% in morning trading on the company’s announcement that it would end development of its non-opioid palmitoylethanolamide prodrug, ETX-810, in diabetic peripheral neuropathic pain following a phase IIa failure. It was the first of a double dose of bad news reported by Seattle-based Eliem, which also is delaying phase II development of depression candidate ETX-155 to resolve issues of lower-than-expected drug exposure in a phase I study of the neuroactive steroid GABAA receptor positive allosteric modulator in photosensitive epilepsy.

European regulators delay decision on Valneva COVID shot again, asking for antibody data

Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee.

Cambridge Innovations raises £225M fund amid high interest in university spinouts

Cambridge Innovation Capital (CIC) has closed its oversubscribed Fund II at £225 million (US$287 million) and is moving from its previous model of open-ended investing to a traditional fixed-term venture capital fund. The money will be dedicated to spinouts from Cambridge University, with CIC investing in series A rounds, but also following on as companies mature and their capital requirements increase.

Epitopea closes $14M seed round for tumor antigen discovery

Epitopea Ltd. raised $13.6 million in seed financing to take forward a new cancer immunotherapy platform based on the identification of a novel class of tumor-specific antigens, which are encoded by non-canonical genomic sequences.

Forcefield raises £5.5M for protein-based heart attack drug

Forcefield Therapeutics Ltd. has arrived on the scene with £5.5 million (US$7 million) funding to advance development of naturally occurring proteins that have been shown to arrest the loss of cardiomyocytes in the immediate aftermath of myocardial infarction. The aim is to develop an intravenous drug that could be administered in an ambulance or on arrival at the emergency room.

Cancer and infectious disease top clinical reports, though volume falls

More than a quarter of all clinical data reported this year are targeting cancer indications, as pandemic news dips and overall activity drops by 12.5%.

Filling in the gaps, US FDA to look at drug tradeoffs for patients, doctors

Recognizing that patient views about the tradeoffs of using one drug over another may differ from those of doctors, the U.S. FDA’s Office of Prescription Drug Promotion is proposing to examine those tradeoffs in an analysis involving fictitious prescription drugs for type 2 diabetes and psoriasis. Noting that little research has been done to directly compare the treatment preferences of patients vs. doctors, the FDA said understanding the differing tradeoffs “will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions.”

Health Canada lays out rules for labeling links

Links to electronic information may become a more common feature on Canadian prescription drug labeling, but electronic labeling is not expected to replace paper labels anytime soon. Taking what it calls an interim approach to electronic labeling, Health Canada said links used on physical labels must direct to electronic platforms limited to the most up-to-date approved product monographs, risk management plans or other risk communications approved by the agency.

Also in the news

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