| | | |   | Good morning, all. Damian here with news on a quiet giant in biotech venture, pivotal but vague results from Amgen, and the flattening of biotech's August boom. | | | The sovereign wealth fund elbowing its way into biotech VC Unsatisfied with parking its money in the vaults of venture capitalists, Mubadala Capital Ventures, owned by the United Arab Emirates, is making biotech investments of its own.
As STAT’s Allison DeAngelis reports, Mubadala has pivoted away from being a limited partner to VCs and moved to compete with them instead. Roughly 70% of its portfolio is in biotech, and the firm is now leading investment rounds, setting valuations and term sheets, and planning to create startups from scratch.
“They’re at the cusp of being the breakout star,” said Kristina Burow, managing partner at Arch Venture, which has worked with Mubadala on company creation. “They’re a fund that’s on the make, that’s growing up.”
Read more. | Amgen declares success, and little else, in Phase 3 cancer trial Amgen’s cancer treatment Lumakras met its primary endpoint in a pivotal lung cancer study, the company said yesterday in a statement that divulged almost no other information on the closely watched therapy.
The study, designed to confirm an earlier trial that won Lumakras FDA approval, enrolled 345 patients with a specific form of non-small cell lung cancer who had already been treated with chemotherapy and a checkpoint inhibitor like Keytruda. Amgen’s drug met its goal of beating the standard of care on the measure of progression-free survival, the company said. Details — including the size of Lumakras’ benefit — will have to wait for a later medical meeting, Amgen said.
Lumakras, approved last year as the first treatment for patients with lung cancer caused by a specific genetic mutation to the KRAS protein, has been a commercial disappointment thus far. Earlier this month, a study combining Lumakras with checkpoint inhibitors ran into serious liver side effects, forcing lung cancer patients to abandon treatment and leading to substantially lower tumor response rates. | The Inflation Reduction Act: What biopharma manufacturers need to know Significant changes are coming for drug pricing and payment in the U.S. as a result of the passage of the Inflation Reduction Act. What do biopharma manufacturers need to know? ZS experts describe key elements of the new law, important unknowns and areas where industry leaders will need to reassess their strategies. Discover the implications. | Beam’s first cancer treatment might not be sidelined for long Beam Therapeutics, whose first genome-editing treatment for cancer has been on an FDA-imposed hold since July, expects to answer the agency’s outstanding questions before the end of the year, potentially clearing the way for clinical testing in 2023.
In an SEC filing yesterday, the company said the FDA requested additional preclinical data on BEAM-201, an off-the-shelf CAR-T treatment. Beam expects to submit a complete response in the fourth quarter.
Approved CAR-T therapies rely on the costly, time-consuming process of taking someone’s own T cells, genetically engineering them to target tumors, and then transplanting them back into the patient. Beam’s approach takes T cells from a healthy donor and uses genome editing to silence the genes that would trigger an immune rejection. | Biotech’s August boom ended up flat  After a spate of stock-boosting news buoyed biotech upward in early August, the sector’s most-watched index is ending the month pretty much where it began.
The XBI, which was up as much as 20% in mid-August, has fallen nearly 15% in the weeks since, closing yesterday at its lowest level since Aug. 3. The same index is down 28% for the year, as biotech has struggled to match the all-time highs set in 2021. | More reads - Despite industry-wide stock slump, Mass. biotech startups raised $5.1 billion in the first half of 2022. Boston Globe
- AstraZeneca’s Soriot on cures for pharma ills. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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