Mike Sherman, Chimerix CEO

Chimerix places its bets on On­co­ceu­tic­s' dopamine an­tag­o­nist for rare brain can­cer in quest to sal­vage its im­age

In the clin­i­cal waste­land of ag­gres­sive brain can­cers, Philly’s On­co­ceu­tics has churned out promis­ing da­ta with a Phase II can­di­date on the verge of an FDA fil­ing. Chimerix, look­ing to turn around its rep­u­ta­tion — and share price — has jumped on board, putting half-a-bil­lion-dol­lar hopes in On­co­ceu­tics’ drug.

Chimerix will ac­quire pri­vate biotech On­co­ceu­tics and lead can­di­date ONC-201, an oral small mol­e­cule dopamine re­cep­tor D2 an­tag­o­nist and ca­seinolyt­ic pro­tease ag­o­nist cur­rent­ly be­ing test­ed in a Phase II tri­al against re­cur­rent glioma, a form of brain can­cer with a par­tic­u­lar­ly poor prog­no­sis, the com­pa­nies said Fri­day.

On­co­ceu­tics ex­pects piv­otal da­ta on the ONC-201 pro­gram some time this year for glioma pa­tients with the H3 K27M mu­ta­tion, a con­di­tion that comes with a four-month over­all sur­vival prog­no­sis. Along­side ONC-201, On­co­ceu­tics will bring an­oth­er four on­col­o­gy pro­grams in­to the fold for Chimerix, which is ad­vanc­ing its own can­di­date, a gly­cosamino­gly­can com­pound de­rived from porcine he­parin dubbed DSTAT, through a Phase III tri­al in acute myeloid leukemia.

A win with ONC-201 could open a $500 mil­lion mar­ket op­por­tu­ni­ty in re­cur­rent glioma, Chimerix said.

As part of the deal, Chimerix will pay out $78 mil­lion to On­co­ceu­tics in­vestors — half in stock and half in cash — with a po­ten­tial $360 mil­lion in de­vel­op­ment, reg­u­la­to­ry and sales mile­stones down the road. In terms of the $39 mil­lion in cash on the ta­ble, Chimerix will pay out $25 mil­lion at clos­ing and the re­main­ing $14 mil­lion on the first an­niver­sary of clos­ing.

In ad­di­tion, share­hold­ers will be due 15% roy­al­ties on com­bined sales of ONC-201 and an­oth­er pro­gram, ONC206, of up to $750 mil­lion per year and 20% roy­al­ties above $750 mil­lion in an­nu­al rev­enue.

ONC-201 has earned the FDA’s fast track des­ig­na­tion based on da­ta from three tri­als show­ing promis­ing re­sponse rates. The drug’s Phase II study is test­ing the mol­e­cule in 50 pa­tients above the age of 2 who have re­ceived ra­di­a­tion at least 90 days pri­or to en­roll­ment and dis­played ev­i­dence of pro­gres­sive dis­ease, and cer­tain oth­er cri­te­ria, Chimerix said.

The re­sults from that study are planned for a Blind­ed In­de­pen­dent Cen­tral Re­view com­mit­tee’s analy­sis some­time this year, which could form the ba­sis for a reg­u­la­to­ry fil­ing down the road, Chimerix said. Re­sults from the first 30 pa­tients in that study were al­ready re­viewed in a sep­a­rate BI­CR held in No­vem­ber. So far, in over 350 pa­tients treat­ed, ONC-201 has shown a “gen­er­al­ly well tol­er­at­ed” safe­ty pro­file with most com­mon side ef­fects of nau­sea/vom­it­ing, fa­tigue and de­creased lym­pho­cytes.

Ac­quir­ing a promis­ing can­di­date in ag­gres­sive brain can­cers could help turn around the North Car­oli­na biotech with a sketchy past. In mid-2020, Chimerix laid off half its staff af­ter piv­ot­ing work on its oral an­tivi­ral brin­cid­o­fovir to small­pox fol­low­ing a string of clin­i­cal fail­ures. Now, that small­pox ap­pli­ca­tion for brin­cid­o­fovir is up for a PDU­FA date April 7 in what could be the biotech’s first ap­proval. Shares of Chimerix ($CM­RX) were trad­ing up 16% be­fore the bell Fri­day at $5.79.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.