NK cell biotech Cytovia and gene editing firm Cellectis are expanding upon their previous team-up.
The two biotechs announced yesterday they have expanded their collaboration of gene-edited, iPSC-derived NK and CAR-NK cells to include new CAR targets and development in China by Cytovia’s joint venture entity, CytoLynx Therapeutics.
The amended deal, which was originally agreed to in February, now includes a $20 million equity stake in Cytovia stock by Cellectis, up from $15 million, alongside up to $805 million in milestones and royalty payments.
Cellectis is granting Cytovia a worldwide license to use Cellectis’s custom-built TALENs — a gene editing system that was developed before the advent of CRISPR — under certain patent rights. This includes in China, enabling Cytovia to modify NK cells and address multiple gene-targets for several already-discussed oncology indications.
‘We are pleased to expand the collaboration with Cellectis to enable Cytovia to develop iNK products,’ said Cytovia’s CEO Daniel Teper in a prepared statement. — Paul Schloesser
BridgeBio, Helsinn announce first program from multibillion-dollar R&D pact
BridgeBio and Helsinn will co-develop and co-commercialize a GPX4 inhibitor the partners hope could be a first-of-its-kind drug across multiple tumor types as part of an overarching R&D pact between the two companies, according to a release.
The partners say the drug could eventually be used to treat more than 500,000 US cancer patients, though any potential market there is a long way off. The program is the first designated under a non-exclusive R&D pact signed between the two companies back in March with $2.45 billion in milestones on the line.
The two companies will split R&D and commercial costs for the GPX4 inhibitor program, assuming it gets there. — Kyle Blankenship
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
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Jean-Jacques Bienaimé (BioMarin via Youtube)
The FDA on Friday signed off on an accelerated approval for Biomarin’s Voxzogo (vosoritide) injection, the first treatment to target the underlying genetics of dwarfism, which can increase the height of children five years of age and older with the condition.
The injection, first approved in Europe with a $300,000 annual price tag, works by binding to a specific receptor called natriuretic peptide receptor-B, which reduces the growth regulation gene’s activity and stimulates bone growth in children.
The European Medicines Agency on Friday said that Merck’s antiviral molnupiravir can now be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe disease.
The pill, known commercially in Europe as Lagevrio, has not yet been authorized in the US and has to be taken twice a day for 5 days. The EMA said it should be administered as soon as possible after diagnosis of Covid, and within 5 days of the start of symptoms. The quick authorization is based on data showing the drug reduced the chance that a newly diagnosed Covid-19 patient would be hospitalized or die by 50%, according to data presented by the company in October.
Peter Marks (Jim Lo Scalzo/Pool via AP Images)
All US adults who received two doses of an mRNA Covid-19 vaccine are now eligible for a booster shot, the FDA announced Friday.
The moves will amend the existing EUAs for the Pfizer/BioNTech and Moderna boosters, which had previously been limited to immunocompromised individuals, those older than 65 and adults at high risk for severe disease through certain comorbidities or occupational exposure. For Moderna in particular, the booster shots come in a half-dose of the original vaccine series — 50 µg instead of 100 µg — while Pfizer’s remains at 30 µg for each shot.
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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
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Last week, Bristol Myers Squibb marched out long-term data for its heart drug mavacamten ahead of what execs had hoped would be a positive FDA decision in January. But regulators are saying they need a bit more time to think.
The FDA has extended mavacamten’s PDUFA date three months, from Jan. 28 to April 28, Bristol Myers announced on Friday. The news came just a few days after independent drug pricing watchdog ICER raised concerns about the candidate’s long-term safety in its final evidence report.
Zheng Wei, Connect Biopharma CEO
A suite of drugmakers is looking to topple Dupixent in the eczema market — and on Thursday, China-based Connect Biopharma uncorked some mid-stage results it says will pave the way to a pivotal trial. But investors want hard numbers, and without any to share, the company’s stock $CNTB plunged more than 50% on Friday.
Connect’s monoclonal antibody CBP-201 met the primary endpoint in a Phase II trial, showing significant improvements in Eczema Area and Severity Index (EASI) scores in all three dose groups, according to the biotech. The treatment arms — 300 mg every two weeks, 150 mg every two weeks, or 300 mg every four weeks — were all statistically superior to placebo at Week 16, and all showed significant improvements in the proportion of patients achieving at least a 50% or 75% reduction in EASI score (EASI-50 or EASI-75, respectively).
Daiichi Sankyo was on the receiving end of an FDA slapdown more than two years ago for FLT3 drug quizartinib and some flimsy data in acute myeloid leukemia. Looking to salvage a bad situation, Daiichi is now touting results in earlier AML patients with hopes for a better outcome with regulators.
Quizartinib added to a chemo regimen and then continued solo significantly extended the lives of patients with newly diagnosed acute myeloid leukemia with the FLT3-ITD mutation over chemo alone, according to topline results from the Phase III QuANTUM-FIRST study released Friday.
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https://endpts.com/cytovia-cellectis-add-car-t-targets-to-preexisting-cell-therapy-pact-bridgebio-helsinn-unveil-first-program-in-rd-tie-up/
