AstraZeneca's Enhertu gets BTD for breast cancer; Centessa nabs $300M loan
The FDA has granted breakthrough designation to AstraZeneca’s and Daiichi Sankyo’s HER2 ADC Enhertu, the companies jointly announced today.
The BTD is for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.
Breakthrough therapy designation was based on data from the DESTINY-Breast03 pivotal trial at #ESMO21 just last month, which showed a 72% reduction compared to Roche’s ADC Kadcyla in the risk of disease progression or death in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.
“This is an important step in bringing Enhertu as a potential new option in earlier lines of treatment for HER2 positive metastatic breast cancer, given the urgent need to improve outcomes,” said AstraZeneca EVP of oncology R&D Susan Galbraith in a statement.
Previous BTDs for the drug were in late-line HER2 positive metastatic breast cancer in 2017 and HER2 mutant metastatic non-small cell lung cancer (NSCLC) and HER2 positive metastatic gastric cancer in 2020. — Paul Schloesser
Centessa enters $300m financing deal
Centessa entered a $300 million financing agreement today with New York investment firm Oberland Capital Management.
Oberland will purchase up to $300 million of 6-year, interest-only, senior secured notes, including $75 million purchased today and the next $125 million available in tranches of $75 million and $50 million within two years.
This $300 million facility, combined with Centessa’s existing cash balance as of June 30, gives Centessa access to over $900 million to advance their pipeline of clinical and pre-clinical programs — which rolled out their first data for hemophilia candidate SerpinPC early last month.
“This financing will allow us to further scale up our development activities and provide enhanced balance sheet flexibility for pipeline expansion,” said Centessa CFO Gregory Weinhoff. — Paul Schloesser
Lawmakers introduce FDA-related legislation as Dem plans remain in flux
‘Tis the season for lawmakers to unveil their FDA-related priorities as Democrats continue to fight over what to put into and how to pay for their two major legislative packages.
Just last week, 5 new FDA-related bills were introduced in Congress. Although some or all of these bills may never cross the finish line, some of the ideas contained within them may make it into law.
The bills and their introducers are:
- A bill authored by Rep. David Schweikert (R-AZ) to amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the FDA, and for other purposes.
- A bill from Sen. Tina Smith (D-MN) to amend the 180-day exclusivity period for generic drugs.
- A bill from Rep. Earl Blumenauer (D-OR) to amend the FDCA to establish a Neuroscience Center of Excellence and a Neuroscience Translation Working Group. The goal of adding a neuroscience center for excellence at FDA is also included in the Cures 2.0 draft legislation.
- A bill from Rep. G.K. Butterfield (D-NC) to amend the FDCA to establish additional authorities at FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes.
- A bill authored by Rep. Matthew Rosendale (R-MT) To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program. — Zachary Brennan
Atara and Pierre Fabre join forces for tab-cel commercialization worth up to $365M upfront
Atara Biotherapeutics and Pierre Fabre agreed to an exclusive commercialization agreement for tabelecleucel, or tab-cel in Europe, Middle East, Africa, and other select markets for Epstein-Barr virus (EBV)-positive cancers, according to a statement released today.
Atara will receive $45 million upfront as part of the agreement and up to approximately $320 million in additional milestones, plus royalties. They will also retain full rights to tab-cel in other markets, including North America, the Asia Pacific region, and Latin America. Atara will continue to be responsible for the pivotal ALLELE study in positive post-transplant lymphoproliferative disease, a type of lymphoma.
Alera is on track to submit an application for approval to the EU next month for the drug in EBV-postive PTLD as it continues a Phase II multi-cohort study, evaluating tab-cel in six additional patient populations with the goal of expanding in EBV-driven cancers.
Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel to be paid by Pierre Fabre. — Paul Schloesser
Sage and Biogen unveil new data from depression treatment
Sage Therapeutics and Biogen showed new data today at a European conference on their depression drug zuranolone, showing reductions in depressive symptoms with zuranolone-treated patients. That included consistent improvements in depressive mood, as well as rapid onset of significant effect by Day 3 of treatment, according to their presentations.
“We believe these data represent the potential for a benefit-risk profile for zuranolone that may be differentiated from the most prescribed depression drugs on the market, and may be welcomed by patients, if approved,” said Sage CMO Steve Kanes in a statement. — Paul Schloesser
Dynavax partners with DoD on recombinant plague vaccine
California-based Dynavax and the US Department of Defense signed an agreement for $22 million over the next 2.5 years to develop a recombinant vaccine against the plague, according to a Dynavax announcement today.
The DoD will develop the vaccine using the agency’s rF1V vaccine and its own adjuvant solution. Dynavax also will kick off a Phase II clinical trial next year for the vaccine candidate.
“We are honored to receive this award and to support the U.S. government in developing a plague vaccine to protect the U.S. military members who put their lives at risk every day in service to the country,” said Dynavax CEO Ryan Spencer. — Paul Schloesser
Seqirus to develop Influenza A vaccine candidates for BARDA
Seqirus announced today that BARDA selected the company to develop two Influenza A vaccine candidates for a Phase I clinical study as part of pandemic preparedness.
The first candidate will use a combination of cell-based and adjuvanted technologies, while the second candidate will use self-amplifying mRNA.
“We are proud to be a trusted partner in support of BARDA’s pandemic preparedness objectives,” said Seqirus executive director of pandemic response solutions Marc Lacey. — Paul Schloesser