Se­nior Ab­b­Vie li­ai­son quits job to launch neu­ro start­up, with sights set on ALS

About a year ago, Howard Berman was sit­ting in a wait­ing room at Hous­ton Methodist Hos­pi­tal with his fa­ther, who was show­ing cog­ni­tive loss. They were there to see Joseph Mas­deu, one of the lead­ing neu­rol­o­gists in the area.

Howard Berman

“You know what?” Berman re­calls Mas­deu say­ing. “Why don’t you meet with Dr. Stan Ap­pel, he’s work­ing on some very in­no­v­a­tive work in the field of neu­rode­gen­er­a­tive dis­ease.”

And so last spring, Berman found him­self in a pri­vate meet­ing with Ap­pel, the 86-year-old co-di­rec­tor of Hous­ton Methodist’s Neu­rol­o­gy In­sti­tute, who was don­ning his icon­ic bow tie.

Ap­pel pre­sent­ed on his reg­u­la­to­ry T cell (Treg) re­search — and by the third slide, Berman was hooked. Not long af­ter, he quit his job at Ab­b­Vie and launched Coya Ther­a­peu­tics — named af­ter an is­land off Cos­ta Ri­ca — to de­vel­op Ap­pel’s Treg ap­proach for ALS.

On Wednes­day, Coya un­veiled a $10 mil­lion Se­ries A to ad­vance that pro­gram and build out a pipeline.

“We want to do for ALS what peo­ple did for HIV and AIDS,” Berman said: ex­tend pa­tients’ lives. ALS pa­tients typ­i­cal­ly live an av­er­age of three years af­ter di­ag­no­sis, he added.

Stan­ley Ap­pel

Ap­pel and his team ob­served that many ALS pa­tients have low lev­els of Treg cells, or ones that don’t func­tion prop­er­ly. Im­prov­ing the num­ber and func­tion of the Treg cells, they hy­poth­e­sized, just might slow the pro­gres­sion of dis­ease.

Many com­pa­nies have eyed Treg cell ther­a­pies in the last decade, but the rar­i­ty and plas­tic­i­ty of en­doge­nous Treg cells pose a sig­nif­i­cant chal­lenge.

Coya’s process be­gins with leuka­phere­sis, or draw­ing a pa­tient’s blood and iso­lat­ing the Treg cells. Then sci­en­tists add cer­tain types of agents — like ra­pamycin or IL-2 — de­signed to sta­bi­lize the Tregs and help them grow and func­tion prop­er­ly. Coya then ex­pands the cells, con­vert­ing them from mil­lions to bil­lions of Tregs, which are frozen for fu­ture use.

“What we found out is you can in­fuse the cells, (and) it stops pro­gres­sion for about a month… dur­ing the course of in­fu­sion. But when you stop the in­fu­sions, what hap­pens is the pa­tients start to de­cline again,” Berman said. “It’s not a one-shot deal. You need to be able to give it month­ly,” he added lat­er.

Their longest cry­op­re­served cells have been frozen for a year and a half. And so far, they’re still vi­able, ac­cord­ing to Berman.

Coya has al­ready con­duct­ed a Phase I tri­al, which “suc­cess­ful­ly demon­strat­ed… the safe­ty and tol­er­a­bil­i­ty of au­tol­o­gous in­fu­sions of ex­pand­ed Tregs in ALS pa­tients, with the po­ten­tial of slow­ing or halt­ing dis­ease pro­gres­sion,” Ap­pel said in a state­ment.

An on­go­ing Phase II tri­al with eight pa­tients should pro­duce da­ta this June or Ju­ly, Berman added.

“We will be work­ing with the FDA to de­sign an­oth­er tri­al that will re­al­ly pro­vide, hope­ful­ly, com­pelling da­ta to bring us in­to an ap­proval process,” he said.

The com­pa­ny is al­so go­ing af­ter Parkin­son’s, Alzheimer’s, fron­totem­po­ral de­men­tia and oth­er au­toim­mune dis­eases, as well as non-cell based ex­o­somes and small mol­e­cules.

“We’re not just a cell ther­a­py com­pa­ny per sé,” Berman said.

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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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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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.

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.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.