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.

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.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Seven years after founding Roivant Sciences as an upstart contender in the world of biotech creation, Vivek Ramaswamy and his recently anointed CEO Matt Gline are gliding into Nasdaq on the gilded wings of a cash-heavy SPAC.

In a carefully crafted SPAC pact aimed at wedding new investors at Montes Archimedes Acquisition Corp. with a syndicate of investors coming back to re-up for the next round of company building, they’ve assembled a fresh $611 million in financing for Roivant — $411 million held in trust from the investors in MAAC with a fresh $200 million from the syndicate.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.