Small Penn­syl­va­nia biotech lays off a fourth of its staff as it tries to nav­i­gate com­mer­cial land­scape

Penn­syl­va­nia biotech Treve­na put out word Thurs­day morn­ing that it slashed 25% of its full-time staff and ter­mi­nat­ed a sales force agree­ment with Sy­neos, on top of a da­ta read­out it tout­ed as pos­i­tive.

The biotech’s on­ly ap­proved prod­uct, mar­ket­ed as Olin­vyk, was OK’ed back in 2020 for mod­er­ate to se­vere acute pain. The opi­oid was orig­i­nal­ly spurned by the FDA back in 2018 af­ter ef­fi­ca­cy da­ta was mixed com­pared to mor­phine at key dos­es and the agency want­ed more safe­ty da­ta. Two years lat­er, it got ap­proved for use in a hos­pi­tal set­ting, al­so get­ting a black box warn­ing about ad­dic­tion, abuse, res­pi­ra­to­ry de­pres­sion and more.

The com­pa­ny al­so re­port­ed that it put in­to place oth­er cost-cut­ting mea­sures that ex­ecs be­lieve will help re­duce ex­pens­es and ex­tend the cash run­way to mid-2023. The biotech, as of the end of June, said it has $49.5 mil­lion in cash and equiv­a­lents.

Car­rie Bour­dow

“We al­so re­main fo­cused on ad­vanc­ing the clin­i­cal stud­ies for TRV045, our nov­el S1P re­cep­tor mod­u­la­tor, and our re­cent cor­po­rate re­align­ment will help us in­crease fi­nan­cial flex­i­bil­i­ty to dri­ve for­ward our strate­gic pri­or­i­ties,” Treve­na pres­i­dent and CEO Car­rie Bour­dow added in a state­ment.

TRV045 is be­ing de­vel­oped for acute and chron­ic neu­ro­path­ic pain sec­ondary to di­a­bet­ic pe­riph­er­al neu­ropa­thy, and in part­ner­ship with the NIH. The biotech is ad­vanc­ing a Phase I study of the can­di­date for di­a­bet­ic neu­ro­path­ic pain, which is on track to fin­ish by the end of 2022.

Treve­na al­so not­ed that a deal was reached with an un­named hos­pi­tal group pur­chas­ing or­ga­ni­za­tion (GPO), which will al­low for ac­cess to Olin­vyk for mem­ber hos­pi­tals.

On top of that, the biotech re­port­ed a da­ta read­out with topline re­sults from its post-ap­proval study on cog­ni­tive func­tion in sub­jects treat­ed with Olin­vyk com­pared to IV-ad­min­is­tered mor­phine. The pri­ma­ry end­point was a “sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in se­da­tion ver­sus IV mor­phine,” mea­sured by “sac­cadic eye move­ment peak ve­loc­i­ty.”

Sec­ondary end­points in­clud­ed re­ac­tion time, mo­tor func­tion and hand-eye co­or­di­na­tion. Treve­na de­scribed the re­sults as pos­i­tive.

Shares of $TRVN were up 10% in pre-mar­ket trad­ing, but have been down more than 80% over the last year. The biotech had been trad­ing un­der $1 since last No­vem­ber, re­ceiv­ing a no­tice from Nas­daq back in De­cem­ber that it had six months to get back in com­pli­ance. Treve­na filed for an ex­ten­sion, which was grant­ed by Nas­daq last month and set a new dead­line of Dec. 19, 2022.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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David Hallal (L) and George Daley (Hallal photo: Bertrand Guay/AFP via Getty Images)

David Hal­lal's El­e­vate­Bio launch­es new com­pa­ny to 'dis­rup­t' off-the-shelf cell ther­a­py, but pro­vides few oth­er de­tails

David Hallal’s ElevateBio is launching a new company Thursday as it looks to continue making its mark in the cell and gene therapy spaces. But Hallal is also keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.

The new company comes out of a partnership with Boston Children’s Hospital and research from George Daley, the dean of Harvard Medical School. The triumvirate claims to have found a way to design better off-the-shelf cell therapies using new methods discovered in Daley’s Boston Children’s Hospital lab (Harvard is not involved in the collaboration).

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.