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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Alex Martinez, Intrinsic Medicine CEO

They with­drew their IPO. Then, they broke off their SPAC merg­er. Now what?

If at first an IPO doesn’t succeed, try, try a SPAC. But what happens when that fails too?

Intrinsic Medicine and its blank-check partner Phoenix Biotech Acquisition Corp. called off their reverse merger Tuesday night, citing “current market conditions” as the reason it went kaput. The pair decoupled just weeks after agreeing to combine in late October as investors’ appetite for new IPOs and SPACs has been limited, at best.

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Just days be­fore pre­sent­ing at ASH con­fer­ence, Syn­dax out­lines plan to raise $150M

Syndax is banking that upcoming clinical data will be enough to woo investors — to the tune of $150 million.

The biotech kept it short in its announcement Tuesday afternoon, saying it is planning to sell $150 million worth of shares of its stock via a public offering. While no date or exact number of shares was given for the offering, the biotech noted it will be giving underwriters 30 days to purchase up to an additional 15% of shares sold in the public offering.

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Pen­ny stock pulls back on of­fer­ing up more of its shares amid ‘cur­rent mar­ket con­di­tions’

As some biotechs continue to rethink IPOs or SPAC deals in the current market, other companies are pausing on selling off more shares.

The Boston-based RNA biotech TransCode Therapeutics on Tuesday announced that it has withdrawn its S-1 filing with the SEC that it made in late November. TransCode said in a brief press release that the withdrawal is reflective of TransCode’s belief that “current market conditions are not conducive for an offering on terms that would be in the best interests of the company’s stockholders.”