Six years af­ter a spec­tac­u­lar de­but, Warp Dri­ve Bio is pow­er­ing down and hand­ing its 'un­drug­gable' am­bi­tions over to Rev­o­lu­tion

Close to six years af­ter Third Rock launched Warp Dri­ve Bio with a big-mon­ey col­lab­o­ra­tion from Sanofi and am­bi­tious plans to drug the un­drug­gable with new tech out of Har­vard, the biotech has reached the end of the line as an in­de­pen­dent op­er­a­tion. 

To­day Warp Dri­ve is dis­patch­ing its pipeline to an­oth­er Third Rock start­up com­pa­ny, Rev­o­lu­tion Med­i­cines, with the CEOs of both com­pa­nies in­sist­ing that this is a win-win for all in­volved, though Warp Dri­ve nev­er ac­tu­al­ly made the leap in­to the clin­ic.

Lau­rence Reid

Pressed on the point, Warp Dri­ve CEO Lau­rence Reid con­cedes that every de­ci­sion like this has its “up­sides and down­sides,” but he in­sists that the de­ci­sion by the board rep­re­sents the best path for­ward for in­vestors as well as the med­i­cines they have been toil­ing on since 2012.

Warp Dri­ve was a biotech child of its time. The com­pa­ny boast­ed of a ”ge­nom­ic search en­gine” that “en­ables hid­den nat­ur­al prod­ucts to be re­vealed on the ba­sis of their dis­tinc­tive ge­nom­ic sig­na­ture.” And with the likes of Greg Ver­dine — who left to do 2 new star­tups — and George Church out of Har­vard be­hind it, there were plen­ty of be­liev­ers.

What­ev­er the two CEOs say to­day about all the pos­i­tives be­hind the deal, any biotech com­pa­ny that goes six years with­out get­ting in­to the clin­ic — or an­nounc­ing plans to — is like­ly to get a thor­ough re­view from in­vestors. Reid, though, says that Third Rock and the oth­er in­vestors were will­ing to go back in­to a Se­ries B, the orig­i­nal plan for fi­nanc­ing the next step, be­fore the board set this new path out.

The fate of the 43 staffers?

Mark Gold­smith

That’s still to be de­cid­ed, says CEO Mark Gold­smith of Rev­o­lu­tion, which on­ly re­cent­ly un­der­went a tran­si­tion to on­col­o­gy af­ter aban­don­ing its ear­ly work on an an­ti-fun­gal. Ob­vi­ous­ly, he added, not every­one will make the jump from the East to the West Coast where Rev­o­lu­tion is based, and that in it­self will mean some re­duc­tion in staff.

The big Sanofi col­lab­o­ra­tions that were her­ald­ed in an­tibi­otics and on­col­o­gy? Those end­ed in 2017 and 2016, says Reid. And the lights went out on those part­ner­ships with­out any of the rah-rah that at­tend­ed their ar­rival.

Sanofi cur­rent­ly has 40% of the eq­ui­ty in Warp Dri­ve, with no rights to any of its prod­ucts.

How much is that worth af­ter the deal goes through, with Rev­o­lu­tion hand­ing out stock to in­vestors?

They aren’t say­ing.

The two oth­er col­lab­o­ra­tions that were formed with Glax­o­SmithK­line and Roche, which front­ed $87 mil­lion for the up­front and pre­clin­i­cal mile­stones? Con­tin­u­ing un­der re­view, to be de­cid­ed on lat­er, af­ter Rev­o­lu­tion’s ex­ec team “de­ter­mines its busi­ness strat­e­gy for the genome min­ing plat­form.”

Gold­smith al­so hit a va­ri­ety of up­beat notes about the deal, say­ing this would bring to­geth­er two high­ly com­ple­men­tary pipelines and al­low a more rapid de­vel­op­ment of the Warp Dri­ve as­sets.

Asked when the most ad­vanced Warp Dri­ve pro­gram could ex­pect to en­ter the clin­ic, Gold­smith replied that they aren’t pro­vid­ing time­lines.

 

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.