Iain Dukes, Theseus interim CEO

Or­biMed-backed The­seus de­buts with $100M round in hero­ic quest for 'pan-vari­ant' ki­nase in­hibitors

De­spite the promise of ki­nase in­hibitors in treat­ing rare tu­mors, nar­row ther­a­peu­tic tar­gets for most can­di­dates can halt ef­fi­ca­cy the mo­ment a pa­tient’s tu­mor cells mu­tate. Now, an Or­biMed-backed start­up will take a nine-fig­ure fundrais­ing round to ad­vance its pur­pose­ful­ly broad can­di­dates against treat­ment-re­sis­tant tu­mors.

Boston-based The­seus Phar­ma­ceu­ti­cals has bagged a $100 mil­lion Se­ries B round it will use to ad­vance a suite of “pan-vari­ant” ty­ro­sine ki­nase in­hibitors (TKI), in­clud­ing a lead com­pound tar­get­ing KIT-mu­tant gas­troin­testi­nal stro­mal tu­mors, the com­pa­ny said Tues­day.

The­seus’ plan is to cre­ate a pipeline of next-gen TKIs that at­tack sol­id tu­mors across a broad range of vari­ants, po­ten­tial­ly putting an end to treat­ment re­sis­tance, the com­pa­ny said. The emerg­ing biotech was kick­start­ed by Or­biMed with a Se­ries A round back in 2018.

The biotech’s lead com­pound, dubbed THE-630, is a broad TKI tar­get­ing KIT-mu­tant GIST, and The­seus plans to file an IND for that mol­e­cule by the end of the year. Mean­while, the com­pa­ny’s pipeline in­cludes an EGFR in­hibitor de­signed to beat C797S-me­di­at­ed re­sis­tance to first- or lat­er-line Tagris­so treat­ment for pa­tients with non-small cell lung can­cer. The com­pa­ny is al­so work­ing on a third ki­nase-tar­get can­di­date for which it has yet to dis­close an in­di­ca­tion.

William C. Shake­speare

The com­pa­ny’s sci­ence is led by co-founder and pres­i­dent of R&D William C. Shake­speare, for­mer­ly the head of drug dis­cov­ery at Ari­ad Phar­ma­ceu­ti­cals. In a state­ment, co-founder and in­ter­im CEO Iain Dukes said Shake­speare’s Ari­ad team was re­spon­si­ble de­vel­op­ing two mol­e­cules that even­tu­al­ly made it to mar­ket — RTK in­hibitor Iclusig and ALK tar­get­ing small mol­e­cule in­hibitor Alun­brig — and a third, Take­da’s TKI can­di­date mobo­cer­tinib, that is cur­rent­ly in Phase III tri­als to tack­le EGFR and HER2 ex­on 20 in­ser­tion mu­ta­tions.

In ad­di­tion to Fore­site Cap­i­tal, the Se­ries B gath­ered a syn­di­cate of oth­er in­vestors, in­clud­ing Adage Cap­i­tal Man­age­ment, Box­er Cap­i­tal, Far­al­lon Cap­i­tal Man­age­ment, Lon­gi­tude Cap­i­tal, Nex­tech Ven­tures, Omega Funds, Pon­tif­ax Ven­ture Cap­i­tal, Rock Springs Cap­i­tal, and T. Rowe Price, as well as Or­biMed. As part of the round, Fore­site man­ag­ing di­rec­tor Michael Rome will join the The­seus board.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Terrie Curran, Phathom CEO (Credit: Arcutis)

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

There’s no time for rest in biopharma — at least not at Phathom Pharmaceuticals. Just over a month after submitting two NDAs for its lead acid-fighter vonoprazan, the biotech is already lining up a third, and collecting an extra $50 million to push things along.

Vonoprazan met its primary non-inferiority endpoints in a Phase III study comparing it to standard-of-care Prevacid in a type of gastroesophageal reflux disease (GERD) called erosive esophagitis (EE). It also proved superior to the popular heartburn drug by multiple measures, including healing rate and maintenance of healing.