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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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