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.

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.

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.

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.

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 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.