Keytruda gets accelerated OK in HER2-positive gastric cancer; TwinStrand gets $50M to hunt for 'needles in a haystack'
King Keytruda keeps racking up approvals, earning a new accelerated OK from the FDA on Wednesday.
Regulators handed down the approval for HER2-positive gastric cancer in the first-line setting, in combination with trastuzumab, fluoropyrimidine- and platinum-based chemo. It’s yet another thumbs-up for one of the best-selling drugs in the world.
Wednesday’s OK came on the basis of a 264-patient study with individuals who had not previously received treatment for their disease. Patients were randomized 1-to-1 to receive Keytruda or placebo every three weeks in addition to the chemotherapy regimen.
The drug arm registered an overall response rate of 74% compared to 52% taking the control, good for a p-value of p<0.0001. Researchers also saw a median duration of response of 10.6 months with Keytruda versus 9.5 months in the control arm.
With the approval, regulators gave patients the option of taking 200 mg of Keytruda every three weeks or 400 mg every six weeks. Both are recommended for use by the FDA in other indications. The full indication is for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. — Max Gelman
TwinStrand gets $50M to hunt for genetic ‘needles in a haystack’
A couple months after wrangling a $16 million Series A round, TwinStrand Biosciences has returned to the venture well, this time nearly doubling its last raise to fund the development of technology used to find genetic “needles in a haystack.”
TwinStrand unveiled a $50 million Series B round on Thursday, led by Section 32, with participation from Soleus Capital, Janus Henderson Investors, Madrona Venture Group, Ridgeback Capital, Alexandria Venture Investments and others.
The company’s DNA sequencing tech delivers “a new level of sensitivity, clarity, and accuracy to the exploration of genomic variation,” Section 32’s Michael Pellini said in a statement. TwinStrand says it can identify ultra-low frequency DNA mutations with a resolution 10,000-fold greater than other tools on the market.
“In addition to the commercial launch of our first products, and the build out of our clinical lab, 2020 marked an important milestone in the validation of our expanding intellectual property portfolio as we closed a major deal in liquid biopsy to kick off our out-licensing program,” CEO and CSO Jesse Salk said in a statement. — Nicole DeFeudis
Valneva makes Nasdaq debut two weeks after launching PhIII Covid-19 vaccine trial
The latest overseas biotech developing Covid-19 vaccines has hit the Nasdaq in France-based Valneva. The company raised $94 million and priced Thursday at $26.41, the midpoint of its proposed range.
Valneva made news recently when it announced in late April that it would be giving up vaccine supply discussions with the EU and instead dealing with member states directly. It had been wary of the trade tensions between the UK and rest of the continent since Brexit, noting in its S-1 that export restrictions may affect its ability to deliver those shots promised to the UK.
Valneva has commitments to deliver 100 million vaccines to Britain by 2022, with the UK owning additional options for another 90 million in supply between 2023 and 2025.
In a Phase I/II trial, more than 90% of all study participants developed significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested. They launched their Phase III trial on April 21, looking to enroll 4,000 in a study pitting its own vaccine head-to-head against the AstraZeneca/Oxford University shot. — Max Gelman