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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Stéphane Bancel, Moderna CEO

UP­DAT­ED: 'The biggest in­flec­tion point ever': On R&D day, Mod­er­na CEO Stéphane Ban­cel dou­bles down on vac­cines and lays out a vi­sion for a '40, 50'-drug biotech

The stakes have always been different for Moderna. They didn’t invest more in the Covid-19 vaccine race than Pfizer, Sanofi or AstraZeneca, and they didn’t have more to lose than Novavax — a $100 million biotech that became a $7 billion company virtually overnight. But they had considerably more to gain than anyone.

Born with grand ambitions and the checkbook to match, Moderna spent its first decade of life attracting as many critics of its vision to remake drug development as it did backers. But the pandemic presented a twin opportunity: to prove its technology on a global stage and to give a still-young biotech billions in annual revenue years before anticipated.

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Steve Hurly, Lava CEO

La­va breaks pro­longed si­lence with an $83M Se­ries C and two I/O pro­grams set for the clin­ic

Lava debuted in May of 2018 with $18.9 million, a platform built around something called gamma delta cells and a plan, apparently, of saying nothing else for the next two years. They never announced a program and they did not issue another press release for the next 20 months.

In May, though, the Dutch-American biotech announced a partnership on cancer bispecifics with J&J. And today, CEO Steve Hurly is ready to talk about what they’ve been working on for the last two years in Utrecht and Philadelphia – as well as the $83 million they raised from Novo, Sanofi and others to bring that work into the clinic next year.

Seat­tle Ge­net­ic­s' Astel­las-part­nered ADC nails con­fir­ma­to­ry PhI­II in urothe­lial can­cer

Nine months after Seattle Genetics nabbed an accelerated approval for its Astellas-partnered antibody-drug conjugate Padcev, the partners said the therapy has nailed a confirmatory Phase III, proving its worth in locally advanced or metastatic urothelial cancer.

Padcev, which has widely been tapped as a potential blockbuster, scored improvements in both overall survival and progression-free survival compared to chemotherapy, causing a 30% reduction in risk of death (p = 0.001) and 39% reduction in risk of disease progression or death (p<0.00001).