Takeda snaps up the Japanese rights to an old Shire cast-off; Boehringer Ingelheim acquires Abexxa Biologics
A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.
Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).
Mirum submitted an NDA for the candidate to treat itchiness in patients with ALGS in March, and regulators assigned a PDUFA date of Sept. 29.
“As we approach potential commercialization in the United States and complete the recent filing for Alagille syndrome in Europe, our goal is to partner with top companies outside of North America and Europe to ensure global reach for patients with these terrible diseases,” CEO Chris Peetz said in a statement.
For an undisclosed amount, Takeda is getting development and commercialization rights to maralixibat in ALGS, PFIC and BA in Japan. The pharma will be responsible for regulatory approval and commercialization in that country, as well as development, including clinical studies in cholestatic indications. — Nicole DeFeudis
Boehringer Ingelheim acquires Abexxa Biologics
German biopharma Boehringer Ingelheim announced today that it bought precision oncology firm Abexxa Biologics. The deal includes an undisclosed upfront payment, along with milestones and other payments.
Boehringer Ingelheim has been busy, having just agreed less than two weeks ago to dole out more than $700 million in milestones to Twist Bioscience for access to its antibody library.
“The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens,” said Boehringer Ingelheim’s corporate SVP and head of discovery research, Clive Wood, in a prepared statement.
In 2016, Boehringer Ingelheim’s Venture Fund awarded Abexxa initial investment funding. Later that year, Abexxa won Ingelheim’s Innovation Prize, which allowed Abexxa to expand operations into a shared lab space in Cambridge, Massachusetts.
Abexxa will continue to operate in Arlington, Texas, collaborating with their US-based colleagues at Boehringer Ingelheim’s facility in Ridgefield, Connecticut. — Paul Schloesser
Black Diamond Therapeutics strikes discovery deal with software company OpenEye Scientific
Black Diamond Therapeutics announced this morning that it is entering into a strategic partnership with science software firm OpenEye, integrating the software company’s in-house molecular design platform into Black Diamond’s drug discovery engine.
According to a statement released by the two companies, Black Diamond and OpenEye will work to co-develop sampling capabilities and deliver information more quickly. Ultimately, their goal is to advance Black Diamond’s efforts to develop cancer therapies that can target an entire family of mutations — what they call a “MasterKey” inhibitor, according to a prepared statement.
The deal follows a recent personnel move at Black Diamond, as then-CMO Rachel Humphrey was fired and CSO Christopher Roberts resigned from the precision oncology firm in mid-July.
The arrangement between OpenEye and Black Diamond involves an undisclosed upfront payment, along with potential downstream economics for OpenEye.
“We are beginning to see the marriage of computation and genomics not just through sequence analysis, but at the structural level,” said OpenEye CEO and founder Anthony Nicholls in a statement. “We’re very proud to be able to work with Black Diamond to combine molecular simulation on our cloud platform, Orion, with their MAP drug discovery engine to accelerate their search for novel cancer therapeutics.” — Paul Schloesser
Peter Thiel joins the board of a Medicare advisory group
As proposals for drug pricing reforms make their way through Congress, Silicon Valley power player Peter Thiel is jumping on the board of Chapter, a Medicare advising group that helps Americans find the best coverage plans.
Chapter unveiled a $17 million Series A round Tuesday, led by Narya Capital with a hand from Susa Ventures, Maverick Ventures, XYZ Venture Capital, Core Innovation Capital and Health2047 Capital Partners. Along with the round, the company added Thiel to its board of directors.
“It is…commonplace that dealing with the government is difficult. It is uncommon that anyone does anything about it,” Thiel said in a statement. “Chapter’s ability to help people navigate Medicare’s bureaucratic maze makes it both admirable and valuable.”
While legacy Medicare brokers aren’t required to search a minimum number of plans or disclose the number they do search, Chapter promises to search every plan — including Medicare Advantage, Medicare Supplements and standalone Part D prescription plans. To do so, it’s partnered with Thiel-founded Palantir Technologies to develop a comprehensive Medicare data platform.
The news comes a couple of weeks after President Joe Biden’s administration called for new reforms to include Medicare drug price negotiations, as well as measures to slow price increases over time on existing drugs.
“Most Americans navigate Medicare alone or unintentionally use resources that limit their options,” Chapter CEO Cobi Blumenfeld-Gantz said in a statement. “Medicare coverage is too important to get wrong: signing up too late can result in lifetime penalties. Furthermore, plans have such significant differences in benefits and premiums that it’s critical to search every single option.” — Nicole DeFeudis
Illumina expects EU order to keep Grail a separate company
Illumina said on Monday that it expects the European Commission to issue an order to keep recently acquired Grail as a separate company — a handful of hours after EU antitrust regulators warned of interim measures for closing the deal before their approval.
While Illumina finalized the Grail takeover last month despite protest from the Commission, the biotech said it would hold the company separate while waiting for a decision on the deal.
“We had anticipated that the Commission would seek to impose a hold separate order, and this is the reason why it has already voluntarily agreed to such an arrangement; their proposals are based on Illumina’s voluntary undertakings,” Illumina said in a statement. The company said it would discuss certain changes suggested by the EU in the coming days.
Under EU merger rules, a competition watchdog can order companies to unwind their deals or sell off shares or assets acquired for violations.
Commission VP Margrethe Vestager emphasized Illumina’s actions, saying it was the first time companies had openly implemented a deal while regulators were still investigating. She noted the company’s actions were serious.
“The standstill obligation is a cornerstone of our ex-ante merger control regime which aims at preventing harmful effects to competition while our review is ongoing,” she said in a statement.
The Commission said the interim measures aim to restore and maintain effective competition pending a final decision on the deal, which will be made after receiving the companies’ response to the statement of objections. — Paul Schloesser
Stoke Therapeutics sees early signs of efficacy for Dravet syndrome candidate
The numbers are in on Stoke Therapeutics’ lead antisense oligonucleotide for Dravet syndrome.
Single doses of STK-001 up to 30 mg and multiple doses at 20 mg were found to be well-tolerated in a Phase I/IIa study, Stoke announced on Tuesday. The interim analysis was based on 21 patients treated in single-dose cohorts who were followed for at least three months, and six patients in the 20 mg multiple-dose cohort, most of whom had received three monthly doses.
Dravet syndrome is a severe and progressive epilepsy that begins within a newborn’s first year of life. Patients in the Phase I/IIa study had a median of 17 convulsive seizures in the four-week screening period leading up to treatment, according to Stoke.
While there were no serious side effects related to STK-001, the most common lower-grade events were headache, irritability, vomiting, seizure and back pain.
In addition, primary analyses suggest a trend toward a reduction in seizure frequency in the single-dose group, Stoke announced. The trend was more evident in the 2- to 12-year-old age group.
“The initial positive safety data from MONARCH are highly encouraging and we now have greater clarity on the dose levels that are likely to be pharmacologically active in patients,” CMO Barry Ticho said in a statement.
The company plans on giving another update at the American Epilepsy Society meeting in December and sharing data from the patients given multiple doses of 30 mg in the second half of next year. — Nicole DeFeudis