From left: Cara CEO Derek Chalmers and board member Christopher Posner

Weeks in­to first ap­proval, Cara waves good­bye to found­ing CEO in fa­vor of board mem­ber

A biotech’s first drug ap­proval is a process of­ten years in the mak­ing and a crown­ing achieve­ment for founder-CEOs who have run the race from the be­gin­ning. Af­ter 17 years watch­ing Cara Ther­a­peu­tics grow to a com­mer­cial brand, this biotech’s found­ing CEO is now ready to move on to his next phase.

Cara has ap­point­ed Christo­pher Pos­ner, a cur­rent board mem­ber and for­mer CEO of Leo Phar­ma’s US branch, as its next leader, re­plac­ing found­ing CEO Derek Chalmers, the com­pa­ny said Wednes­day. Chalmers will move over in­to a se­nior ad­vi­so­ry role, with Pos­ner set to take on the man­tle Nov. 9.

Chalmers found­ed Cara way back in 2004 and has served as CEO ever since, watch­ing the biotech cross the FDA fin­ish line for the first time in Au­gust with Ko­r­su­va (dife­like­falin), a nov­el kap­pa opi­oid re­cep­tor ag­o­nist in­jec­tion to treat se­vere-to-mod­er­ate pru­ri­tus, or itch­ing, in pa­tients with chron­ic kid­ney dis­ease un­der­go­ing dial­y­sis.

Pri­or to Cara, Chalmers co-found­ed Are­na Phar­ma­ceu­ti­cals and served as its VP and ex­ec­u­tive di­rec­tor from June 1997 un­til May 2004. Pre­vi­ous­ly, he was a group leader at Neu­ro­crine Bio­sciences. Chalmers had this to say about his de­par­ture:

As Ko­r­su­va in­jec­tion moves to­ward com­mer­cial launch, now is the right time to make this tran­si­tion. Hav­ing worked close­ly with Chris since he joined Cara as a board mem­ber, I am con­fi­dent in his abil­i­ty to suc­cess­ful­ly lead the Com­pa­ny through its next phase of de­vel­op­ment and look for­ward to work­ing with Chris and the Cara lead­er­ship to en­sure a smooth tran­si­tion.

Mean­while, Pos­ner most re­cent­ly served as pres­i­dent and CEO of Leo Phar­ma, the US af­fil­i­ate of Leo Phar­ma A/S, and pre­vi­ous­ly was head of world­wide com­mer­cial op­er­a­tions at R-Phar­ma-US, a spe­cial­ty phar­ma in the on­col­o­gy and chron­ic im­mune dis­or­der space. Be­fore that, Pos­ner held se­nior man­age­ment roles in com­mer­cial and mar­ket­ing op­er­a­tions at Bris­tol-My­ers Squibb, Pfiz­er, Wyeth Phar­ma­ceu­ti­cals and En­do.

Pos­ner will take the helm as Cara and part­ner Vi­for Phar­ma prep a Q1 launch for Ko­r­su­va. As part of the part­ners’ com­mer­cial­iza­tion agree­ment in the US, Cara and Vi­for will split prof­its 60-40 in dial­y­sis clin­ics not owned by Fre­se­nius Med­ical Care, the clin­i­cal care arm of the larg­er Vi­for Fre­se­nius Med­ical Care Re­nal Phar­ma busi­ness. Mean­while, in Fre­se­nius clin­ics, the com­pa­nies will split prof­its 50-50. In a con­ver­sa­tion with End­points News in April 2020, Chalmers in­di­cat­ed Fre­se­nius clin­ics rep­re­sent­ed around 38% of the mar­ket.

The agency based its re­view on two Phase III tri­als, KALM-1 and KALM-2, with the lat­ter study show­ing 54% of pa­tients dosed with Ko­r­su­va post­ed a 3-point or greater im­prove­ment from base­line in the week­ly mean of the 24-hour Worst Itch In­ten­si­ty Nu­mer­ic Rat­ing Scale (WI-NRS) score com­pared with 42% on place­bo. The drug’s da­ta pack­age in­clud­ed re­sults from an ad­di­tion­al 32 tri­als.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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