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.

 

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

Janet Woodcock and Joshua Sharfstein (AP, Images)

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As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

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The IPO flood keeps ris­ing with 4 more biotechs and a SPAC on their way to Nas­daq

After a record year for biotech IPOs in 2020, forecasts were bullish on another strong year showing for public offerings — and 2021 hasn’t disappointed so far. Now, a clutch of four biotechs chasing rare disease and cancer and a New York SPAC are ready to join the party.

Three more companies filed to head to Nasdaq on Tuesday, as well as a SPAC, with an additional Dutch biotech filing Friday. All in all, early days indicate another big year, at least to start, with 12 companies either pricing or filing their IPOs in the first 20 days of January.