Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Pfiz­er or­dered to dis­close FBI com­mu­ni­ca­tions in trade se­crets case

A federal judge has ordered Pfizer to hand over its communications with the FBI in a trade secrets case it brought against the founders of Regor Therapeutics last year.

Pfizer filed suit last February against two former employees, Xiayang Qiu and Min Zhong, who quit their Big Pharma jobs in 2018 to launch the Eli Lilly-partnered startup Regor. About five months after leaving Pfizer, Qiu and Zhong applied for patents on a set of compounds that plaintiffs allege “appear strikingly similar to . . . compounds that Pfizer had developed,” according to court documents.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Chat­G­PT and gen­er­a­tive AI land in phar­ma mar­ket­ing with sense of awe — and plen­ty of cau­tion

A professionally dressed woman stands in front of an office background and introduces herself to talk about the use of artificial intelligence in pharma marketing.

Except she’s not a real person. “She” is an AI-generated avatar in a video created in less than a minute using the generative AI application Synthesia along with a typed script from a real person — in this case, a healthcare agency executive showing an example of how a generative AI avatar can work.

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Mar­ket­ingRx roundup: Pfiz­er plans mar­ket­ing spend bump for 2023; Am­gen, Mer­ck join ‘Pro­ject Black’ eq­ui­ty fund­ing

Pfizer debuted its first brand campaign for its Covid-19 treatment Paxlovid and mentioned in an Endpoints News Grammy Awards story yesterday, but it’s worth noting again. Until now, Pfizer has been encouraging people to go to a healthcare provider quickly — to the tune of more than $108 million in NFL TV ad placements alone, according to real-time TV ad tracker iSpot.tv.

There’s also no reason to expect the advertising will stop. Not only are Paxlovid treatments underused, but also Pfizer has earmarked funds for spending. It reported last week that it plans to spend an extra $1.3 billion in 2023 “to support anticipated new launches, acquired assets and commercial launch of COVID-19 products” for a total expected selling, informational and administrative (SI&A) tab of $13.8 billion to $14.8 billion for 2023. The spending bump follows a 17% SI&A increase in the fourth quarter of 2022.

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Dhvanit Shah, Garuda Therapeutics CEO

Blood stem cell ther­a­py mak­er Garu­da nabs $62M

Garuda Therapeutics brought in $62 million via a Series B to take its off-the-shelf cell therapies into the clinic next year.

The Boston-area biotech wants to rid the need for blood stem cell transplants and instead give patients self-renewing blood stem cells. The proceeds, which add to a $72 million Series A from September 2021, will bankroll two lead programs in hematological and oncology indications, Garuda said Tuesday morning.

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Alessandro Maselli, Catalent CEO, at Endpoints #JPM23 (Adrien Villez for Endpoints News)

As ac­qui­si­tion ru­mors sur­face, Catal­ent re­mains mum on deal

Contract manufacturer Catalent became the subject of acquisition rumors over the weekend, but execs were quick to put the kibosh on any questions about the deal in a Q&A with investors.

CEO Alessandro Maselli started Catalent’s Q2 earnings call Tuesday addressing a Saturday report from Bloomberg, which said that Danaher Corporation may be interested in acquiring the New Jersey-based CDMO. However, Maselli told those on the call that “as a matter of policy,” Catalent does not comment on “market rumors.”

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Levi Garraway, Roche CMO and EVP of global product development (Genentech)

Roche says its C5 in­hibitor aced PhI­II head-to-head tri­als with As­traZeneca’s Soliris

One of the new drugs Roche is banking on for a 2023 launch has cleared two Phase III trials, the company reported.

Roche’s Genentech tested crovalimab, a C5 inhibitor, in two different groups of patients with the rare blood disorder paroxysmal nocturnal hemoglobinuria and reached two conclusions: Firstly, its drug works just as well as AstraZeneca’s blockbuster Soliris, a current standard of care, among patients who have not been treated with complement inhibitors; and secondly, it’s safe for patients to switch from currently approved C5 inhibitors to crovalimab.

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Akseli Hemminki. TILT Biotherapeutics CEO

On­colyt­ic virus start­up TILT rais­es €22M to ad­vance can­cer ther­a­pies

Finland-based TILT Biotherapeutics announced today it raised €22 million in the final close of a second round of financing to push its oncolytic virus pipeline into Phase II trials. The company raised €10 million in the first round in June of last year.

A chunk of the second round, €5.9 million, comes from the European Innovation Council Fund with another €2.1 million grant from EIC’s Accelerator program.