FDA accepts Intellia's IND for CRISPR and TCR-T cell therapy; Santé closes Fund IV at $260M
Riding the coattails of a massive $600 million cash raise in June, Intellia announced that the FDA accepted their IND application for their gene editing treatment NTLA-5001, built as a treatment for acute myeloid leukemia.
The Cambridge, MA biotech said that they have plans to start patient screening in a Phase I/IIa study by the end of 2021. The study will evaluate the effects of a single dose of the treatment in adults who have detectable AML after having received standard first-line therapy. The study will contain a dose escalation and expansion phase, with up to 54 participants.
“The FDA’s acceptance of our IND for NTLA-5001 is an important milestone in our pursuit of developing advanced cell therapies utilizing Intellia’s proprietary engineering platform to treat patients with cancer,” said Intellia president and CEO John Leonard.
Outside of the US, Intellia also submitted a regulatory application to the UK for NTLA-5001.
Santé closes oversubscribed Fund IV after raising $260 million
Texas healthcare investment firm Santé finally closed its oversubscribed Fund IV. The $260 million fund will make investments across early-stage biotech, healthtech and medtech companies, according to a company statement.
Fund IV secured commitments from more than two-dozen partners, including new institutional investors in Asia and Latin America. Returning partners accounted for nearly 90% of the raised funds.
Santé co-founder and managing director Kevin Lalande said in a statement: “The confidence and commitment of our investors led to the quickest fundraise since inception. We are grateful for their partnership as we deploy this next fund to capitalize on significant healthcare opportunities and nurture cutting-edge technologies.”
Zai Lab expands US operations with office in Cambridge
Zai Lab is expanding its presence in the United States — by opening an office in biotech hub Cambridge. The new office will be the headquarters of different business operations such as alliance management, along with legal and governance functions.
“We are excited to expand our presence in the U.S. by opening a new Zai Lab office in Cambridge,” Zai Lab CEO and chair Samantha Du said in a statement. “This is an important step in Zai Lab’s journey to become a global biopharmaceutical company, a partner of choice and a place where our employees can do their best work.”
This announcement comes almost immediately after Zai Lab announced on Tuesday that they received BTD for bemarituzumab from the NMPA. They are now looking to advance the drug into registrational trials.
Biogen releases results from Phase II study on neuropathy pain drug
Cambridge, MA biotech Biogen announced positive topline results from its Phase II study of vixotrigine, a non-opioid oral pain drug being evaluated for the treatment of small fiber neuropathy (SFN).
The CONVEY study had a double-blind period, where patients were administered 200 mg of vixotrigine twice daily. That arm met its primary endpoint of change from baseline to week 12 of the double-blind period in mean average daily pain (ADP) score.
In the same study, there was an open-label period where all participants who enrolled received a higher dose of the drug — 350 mg twice daily. This preceded the double-blind portion of the study.
While the 350 mg twice daily arm did not meet the primary endpoint, it met statistical significance in the Patient Global Impression of Change (PGIC) at week 12. Data from the study will inform potential doses for study in future Phase III clinical trials.
“We are encouraged by the overall results of the CONVEY study,” said Biogen SVP and head of the therapeutics development unit Katherine Dawson. “We are grateful to all the participants, investigators and study staff who contributed to this study and allowed us to evaluate vixotrigine as a non-opioid treatment option.”
Nigerian startup 54gene raises $25 million in Series B — Report
Genomics startup 54gene recently raised $25 million in a Series B round to advance its precision medicine capabilities.
According to TechCrunch, the round comes a year after the company, founded by Abasi Ene-Obong in 2019, raised $15 million in a Series A and two years after it closed a $4.5 million seed round.
The company launched a genetic sequencing and microarray lab in Lagos, Nigeria last September through a partnership with Illumina.
According to a press release issued by Illumina last year, the facility will look at genetic information for health research and drug development — and Ene-Obong further said that the lab will do whole-genome sequencing and whole-exome sequencing as part of the lab’s work.
New York biotech Bantam completes $25 million in seed funding
Bantam Pharmaceutical completed a $25 million seed funding round to finalize activities for its lead program BTM-3566. The funds are intended to finish preparations so the company can file its IND, which it plans to do in February — along with making preparations for first-in-human clinical trials.
The funding was co-led by Bantam’s current investors.
Bantam is looking to start Phase I clinical studies in patients with B-cell hematological malignancies in Q2 of 2022. Bantam has established its operations in the North Carolina Research Triangle.
“This funding enables Bantam Pharmaceutical to be fully prepared to enter the clinic for first in human studies in early 2022, representing a major milestone. We are excited about moving to the next stage of development,” said co-founding investor and board member Lionel Goldfrank in a statement.