Howard Berman, Coya Therapeutics CEO

Tiny IPO clos­es out Nas­daq's bar­ren biotech year

Nas­daq added one more biotech to its 2022 ros­ter in the fi­nal days of the year, clos­ing out a qui­et chap­ter in its his­to­ry with a tiny IPO.

Coya Ther­a­peu­tics raised $15.25 mil­lion by sell­ing a mix of stock and war­rants, with shares priced at $5 apiece and each war­rant grant­i­ng pur­chasers the right to buy Coya stock at $7.50 per share.

Based out of Hous­ton, Coya spe­cial­izes in lever­ag­ing reg­u­la­to­ry T cells for neu­rode­gen­er­a­tive, au­toim­mune and meta­bol­ic dis­eases. At the time it filed its S-1 — in late No­vem­ber — the biotech com­prised on­ly six full-time em­ploy­ees.

Its one clin­i­cal can­di­date is an au­tol­o­gous Treg ther­a­py for ALS. The ther­a­py, dubbed COYA 101, is made out of a pa­tient’s own T cells that are en­gi­neered to re­duce neu­roin­flam­ma­tion as­so­ci­at­ed with ALS, aim­ing to slow the break­down of mo­tor neu­rons.

COYA 101 has been grant­ed or­phan drug des­ig­na­tion by the FDA. While it’s been through Phase I and Phase IIa stud­ies ini­ti­at­ed by in­ves­ti­ga­tors, Coya said it’s look­ing to fund Phase IIb stud­ies through non-di­lu­tive gov­ern­ment grants or a phar­ma part­ner­ship rather than in­ter­nal in­vest­ments.

The com­pa­ny planned to use IPO pro­ceeds to ad­vance its oth­er, pre­clin­i­cal can­di­dates, in­clud­ing bi­o­log­ics that mod­i­fy Tregs and off-the-shelf Treg-de­rived ex­o­somes.

As biotechs floun­dered on the pub­lic mar­kets, many pri­vate star­tups were hes­i­tant to make the leap to Wall Street, turn­ing in­stead to fa­mil­iar in­vestors for new cash — or tak­ing out the bud­get axe and reshuf­fling op­er­a­tions. Coya joins a small club led by Prime Med­i­cine and Third Har­mon­ic that is brav­ing the head­winds as ob­servers hope for a re­bound in 2023.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

UK gov­ern­ment, pri­vate in­vestors dole out $340M+ to drug, di­ag­nos­tic man­u­fac­tur­ers

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.

Kourosh Davarpanah, Inato CEO

Big Phar­ma-part­nered clin­i­cal tri­al match­mak­er se­cures $20M to im­prove plat­form

A company with public links to Sanofi and Moderna has raised more money to expand its mission of improving diversity and enrollment in clinical trials.

Inato put the word out on Wednesday that it raised $20 million via an A2 round to advance its matching platform between pharma companies and potential clinical trial sites.

Inato CEO Kourosh Davarpanah told Endpoints News that with the $20 million in hand, it will pursue improvements to its diversity offerings, its focus on oncology and data collection.