Cut­ting back in the UK, Take­da spins out its top neu­ro­science team in­to a transat­lantic biotech

Mark Carl­ton

As Take­da con­tin­ues a glob­al R&D over­haul that in­cludes a wind down of UK op­er­a­tions, the Japan­ese phar­ma com­pa­ny is spin­ning out its neu­ro­science team in­to a new biotech called Cere­vance, which will have roots in the two Cam­bridges on both sides of the At­lantic.

Mark Carl­ton, the for­mer pres­i­dent and CSO of Take­da Cam­bridge (UK), and his 25-mem­ber team — com­plete with a well equipped lab — have be­come the core group be­hind Cere­vance. The new biotech is get­ting start­ed with $36 mil­lion in fund­ing, in­clud­ing $21.5 mil­lion from Take­da and Light­stone Ven­tures. And it will jump in­to ex­is­tence with a port­fo­lio of pre­clin­i­cal and clin­i­cal pro­grams un­der­way.

Nathaniel Heintz, Ph.D. at the Rock­e­feller Uni­ver­si­ty, a Howard Hugh­es Med­ical In­sti­tute in­ves­ti­ga­tor, is pro­vid­ing some of the tech­ni­cal in­sights that the com­pa­ny will be fo­cused on. And Brad Mar­gus, who is based in the Cam­bridge, MA hub and who co-found­ed an­oth­er CNS start­up, En­voy Ther­a­peu­tics, with Take­da in 2009 will be the CEO.

Take­da has been shut­ter­ing its UK op­er­a­tions as part of a re­or­ga­ni­za­tion that we’ve been cov­er­ing close­ly at End­points News. CEO Christophe We­ber has been ex­it­ing the UK in fa­vor of hubs in Boston and Japan. And the com­pa­ny has been fol­low­ing a path tak­en by a num­ber of the phar­ma gi­ants, spin­ning out the valu­able bits of what it no longer wants to keep. As­traZeneca did the same with its an­tibi­otics unit in Waltham a cou­ple of years ago, cre­at­ing En­ta­sis.

An­drew Plump, Take­da CSO

Neu­ro­sciences has been a tough field for the big play­ers, as Eli Lil­ly and oth­ers can at­test to. With As­traZeneca, GSK and oth­ers in re­treat, a new wave of up­starts — in­clud­ing De­nali — have come along to pur­sue new tech­nolo­gies and new in­sights in­to how CNS ail­ments can be treat­ed.

And as Take­da il­lus­trates, what fal­ters at a phar­ma com­pa­ny can be used to found new play­ers.

An­drew Plump, the Boston-based R&D chief of Take­da, had this to say:

“When we an­nounced the clo­sure of our re­search site in Cam­bridge, UK, our goal was to find an in­no­v­a­tive ex­ter­nal­iza­tion home for our most promis­ing CNS pro­grams and sci­en­tists in an en­tre­pre­neur­ial set­ting. Cere­vance is a great ex­am­ple of our new R&D strat­e­gy.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.