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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.