Backed by neu­ro en­thu­si­ast Arch, up­start Black­Thorn tack­les some tough tar­gets with $40M round

Mark Cor­ri­g­an

Arch Ven­ture Part­ners has fos­tered a new neu­ro­sciences biotech com­pa­ny that will now fol­low a sim­i­lar trail to the one be­ing blazed by the high-pro­file start­up De­nali. Work­ing with John­son & John­son In­no­va­tion, Al­ti­tude Life Sci­ence Ven­tures, Mer­cury Fund, Alexan­dria Re­al Es­tate Eq­ui­ties as well as an “undis­closed crossover fund,” the VC is un­veil­ing Black­Thorn Ther­a­peu­tics to­day, which will now have a $40 mil­lion Se­ries A to play with as it looks to help re­vive a com­plex and chal­leng­ing field.

Black­Thorn in­tends to tar­get neu­robe­hav­ioral dis­or­ders such as autism spec­trum dis­or­der, ob­ses­sive com­pul­sive dis­or­der, de­pres­sion and schiz­o­phre­nia, fields that de­fied a gen­er­a­tion of Big Phar­ma clin­i­cal ef­forts and saw many of the biggest play­ers like As­traZeneca or Glax­o­SmithK­line ei­ther drop out or scale far back.

Big Phar­ma’s re­treat, though, was fol­lowed by rapid progress in ge­nomics. And Black­Thorn, de­scribed by Ex­ec­u­tive Chair­man Mark Cor­ri­g­an as a “broth­er com­pa­ny to De­nali,” plans to fol­low up on that progress by ad­vanc­ing new tech­nolo­gies that can help iden­ti­fy spe­cif­ic pa­tient pop­u­la­tions that can be helped by spe­cif­ic ther­a­pies. And it’s start­ing out with a well ad­vanced pro­gram, pick­ing up a failed drug from Eli Lil­ly with plans to launch Phase II study.

The treat­ment – a no­ci­ceptin re­cep­tor an­tag­o­nist – is now dubbed BTRX- 246040.

Lil­ly “had put it in a cou­ple of ear­ly Phase II pro­grams,” says Cor­ri­g­an. “It failed in ma­jor de­pres­sive dis­or­ders,” but there were al­so in­trigu­ing re­sults to fol­low up on.

Cor­ri­g­an is care­ful to note, though, that this is just the be­gin­ning of build­ing a se­ri­ous pipeline of new drugs for neu­robe­hav­ioral con­di­tions. The big idea at the com­pa­ny is that they can ad­vance new tools for imag­ing and as­sess­ment that will al­low the biotech to do a much bet­ter job at track­ing the im­pact of a new drug on pa­tients. Done the right way, Black­Thorn ex­pects it can skirt the pit­falls that claimed so many projects be­fore.

At the same time, Cor­ri­g­an says that reg­u­la­tors will be asked to look at these dis­eases and the ways they can be treat­ed dif­fer­ent­ly, adapt­ing to the progress in or­der to avoid see­ing a re­peat of the same mis­takes. But at this stage, he adds, “I think the FDA is open to some of these dis­cus­sions.”

The biotech has a cast of sci­en­tif­ic ad­vis­ers in its cor­ner with an im­pres­sive set of re­sumes. The Scripps team of Ed­ward Roberts, PhD, and Hugh Rosen, MD, PhD, who co-found­ed Re­cep­tos, are on board. And the ad­vi­so­ry group in­cludes Steven Hy­man, MD, di­rec­tor of the Stan­ley Cen­ter for Psy­chi­atric Re­search and core mem­ber at the Broad In­sti­tute of MIT and Har­vard Uni­ver­si­ty, and Matt State, MD, PhD, chair of the UCSF De­part­ment of Psy­chi­a­try and di­rec­tor of the Lan­g­ley Porter Psy­chi­atric In­sti­tute.

For­mer Cel­gene re­search ex­ec Tom Daniel is ad­vis­ing the com­pa­ny.

Cor­ri­g­an says you can ex­pect to see Black­Thorn start adding staffers to the 13-mem­ber team which has al­ready signed on. And there are plans afoot to link up with tech part­ners, much like De­nali has done, as it builds its plat­form. That’s some­thing that Daniel al­so knows some­thing about.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

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.