Stephen Yoder, Pieris CEO

As­traZeneca part­ner Pieris ends work on HER2 drug test­ed in com­bo with Eli Lil­ly, Seagen can­cer meds

As Pieris Phar­ma­ceu­ti­cals fa­vors an As­traZeneca-part­nered pro­gram in asth­ma, and be­cause the mid-stage study is tak­ing longer than ex­pect­ed, the biotech is de­cid­ing to end work on a HER2 drug.

The Boston biotech put out word Thurs­day that it’s end­ing the de­vel­op­ment of cin­re­ba­fusp al­fa (PRS-343), which was in a Phase II study for cer­tain HER2 gas­tric can­cers. Ear­li­er in its de­vel­op­ment, the 4-1BB/HER2 fu­sion pro­tein drug ran in­to a par­tial clin­i­cal hold in its Phase I in the sum­mer of 2020. De­spite that, Eli Lil­ly came to the ta­ble a month lat­er to con­tribute its ra­mu­cirum­ab (Cyra­mza) and pa­cli­tax­el for the Phase II study.

Shares $PIRS dipped al­most 11% be­fore Thurs­day’s open­ing bell.

Pieris was test­ing cin­re­ba­fusp al­fa in com­bo with Cyra­mza and the chemo drug pa­cli­tax­el in pa­tients with HER2 high gas­tric or gas­troe­sophageal junc­tion (GEJ) ade­no­car­ci­no­ma. The biotech was al­so test­ing the drug in com­bi­na­tion with Seagen’s Tukysa in pa­tients with a HER2 low ver­sion of the gas­tric can­cer.

Back in May, Jef­feries an­a­lysts not­ed the drug met en­roll­ment chal­lenges in the HER2 low co­hort, cit­ing “more ed­u­ca­tion and sites,” and changed the ex­pect­ed da­ta read­out from this year to 2023. HER2 high da­ta were al­so ex­pect­ed next year.

“Since the PRS-060/AZD1402 phase 2 study will take more time to en­roll than orig­i­nal­ly planned, we have made the dif­fi­cult but nec­es­sary de­ci­sion to dis­con­tin­ue cin­re­ba­fusp al­fa (PRS-343), de­spite show­ing clear sin­gle-agent ac­tiv­i­ty in phase 1 and mean­ing­ful clin­i­cal ben­e­fit in the on­go­ing phase 2 study in HER2-ex­press­ing gas­tric can­cer pa­tients,” CEO and pres­i­dent Stephen Yo­der said in a state­ment. The duo re­cent­ly ex­pand­ed their re­search terms around two dis­cov­ery stage pro­grams.

On that As­traZeneca-part­nered pro­gram, Pieris says its Big Phar­ma peer did a “re­fore­cast” of the study to ac­count for “glob­al chal­lenges” in re­cruit­ing pa­tients be­cause of Covid-19’s im­pact on clin­i­cal tri­als of res­pi­ra­to­ry drugs. The com­pa­nies are loos­en­ing the en­roll­ment cri­te­ria and fo­cus­ing on the 3 mg co­hort for the ef­fi­ca­cy read­out, Pieris said in its quar­ter­ly earn­ings Thurs­day. Topline re­sults are slat­ed for the third quar­ter of next year af­ter orig­i­nal­ly ex­pect­ing the da­ta this year.

Af­ter those re­sults come in, Pieris can ex­er­cise a co-de­vel­op­ment op­tion and could co-com­mer­cial­ize the drug in the US.

Pieris will con­tin­ue test­ing a 4-1BB drug, its Servi­er-part­nered PD-L1 bis­pe­cif­ic. Known as PRS-344 and S095012, the drug is be­ing stud­ied in pa­tients with sol­id tu­mors in a Phase I/II tri­al that is ex­pect­ed to col­lect fi­nal pri­ma­ry out­come da­ta in No­vem­ber 2024.

The com­pa­ny had $80.9 mil­lion at the end of June, which it an­tic­i­pates will keep op­er­a­tions go­ing in­to the sec­ond quar­ter of 2024, tak­ing in­to ac­count the culling of cin­re­ba­fusp al­fa Phase II tri­als and the “ex­pec­ta­tion of mod­est near-term de­vel­op­ment mile­stones.”

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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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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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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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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(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.

Al Sandrock, Voyager Therapeutics CEO

Al San­drock prunes his post-Bio­gen voy­age with sim­i­lar fo­cus on ALS

Al Sandrock is narrowing the focus of Voyager Therapeutics, concentrating on CNS diseases that were the hallmark of his time leading R&D at Biogen, including an emphasis on a familial form of ALS for which his former employer is getting a speedy review at the FDA.

Less than six months into his journey as CEO at Voyager, Sandrock is focusing the preclinical pipeline on Alzheimer’s disease, GBA1 Parkinson’s disease and SOD1 amyotrophic lateral sclerosis, the rare form of ALS for which the FDA will decide whether to approve Biogen’s tofersen by Jan. 25, 2023.

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Pfiz­er ter­mi­nates PhI­II study of rare car­dio­vas­cu­lar drug picked up in $11.4B Ar­ray ac­qui­si­tion

While Pfizer’s $11.4 billion acquisition of Array BioPharma in the summer of 2019 was mainly focused on oncology, namely Braftovi and Mektovi, there were a few non-cancer assets, including a Phase III drug being tested in a rare cardiovascular disease.

The late-stage trial is now being axed, alongside any further development of the oral small molecule, the pharma giant disclosed after the closing bell on Wednesday. Based on an interim futility analysis of the global Phase III REALM-DCM trial, Pfizer determined a path forward was not in its best interest. Pfizer no longer expected the study would meet its primary goal.

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