Paul Peter Tak (Candel)

Af­ter build­ing pipelines from Glax­o­SmithK­line to Flag­ship, Paul Pe­ter Tak takes the helm at an un­der-the-radar on­colyt­ic virus play­er

Paul Pe­ter Tak has done it all: From a pro­fes­sor­ship in his na­tive Nether­lands to the head of im­munoin­flam­ma­tion R&D at Glax­o­SmithK­line, from lead­ing small biotechs to more re­cent­ly join­ing the ven­ture world as a Flag­ship part­ner, he’s of­ten found him­self in roles he wouldn’t have imag­ined him­self.

His lat­est ap­point­ment as CEO of on­colyt­ic virus com­pa­ny Can­del Ther­a­peu­tics is one of them.

The pan­dem­ic might have ac­cel­er­at­ed the move, he ad­mit­ted. Hav­ing com­mut­ed be­tween the two Cam­bridges across the At­lantic dur­ing the last cou­ple years, Tak gave up his apart­ment in Mass­a­chu­setts back in March and start­ed tun­ing in re­mote­ly to meet­ings at Kin­tai Ther­a­peu­tics, the Flag­ship start­up where he was chief ex­ec­u­tive. Then he was asked to hop on Zoom to talk about Can­del — a biotech he’s nev­er heard of but works in on­colyt­ic virus­es, an in­stant­ly rec­og­niz­able modal­i­ty.

“There’s a lot of ex­cite­ment in the field and I think it’s one of the next big things in med­i­cine,” he said.

Es­tu­ar­do Aguilar-Cor­do­va

Sev­er­al months of due dili­gence lat­er, he was hooked. Pre­vi­ous­ly known as Ad­van­ta­gene, the com­pa­ny was found­ed by Es­tu­ar­do Aguilar-Cor­do­va in 2002 based on years of re­search in the gene ther­a­py space. Lever­ag­ing a non-repli­cat­ing ade­n­ovirus as a shell, he can de­liv­er an en­zyme that con­verts a com­pan­ion small mol­e­cule pro­drug in­to a can­cer killing metabo­lite.

With $65 mil­lion in ven­ture fund­ing so far, the plat­form spawned four clin­i­cal pro­grams in prostate can­cer, glioblas­toma, non-small cell lung can­cer and pan­cre­at­ic can­cer, now in mid-to-late-stage tri­als.

“I don’t know many com­pa­nies that are al­ready Phase II and Phase III but in im­munother­a­py in can­cer that has dosed more than 700 pa­tients that ba­si­cal­ly come more or less out of stealth mode,” he said.

While the first gen­er­a­tion of on­colyt­ic virus­es failed to live up to ex­pec­ta­tions — even Am­gen’s ap­proved T-Vec post­ed mod­est sales — Tak be­lieves a smarter way of go­ing about de­vel­op­ment and ap­pro­pri­ate com­bi­na­tions will re­sult in bet­ter da­ta and adop­tion.

In­tra­tu­moral ad­min­is­tra­tion, he posits, might have been a big hur­dle, and it mat­ters who’s ad­min­is­ter­ing the treat­ment. In­stead of med­ical on­col­o­gists, who may not be used to in­ject­ing tu­mors, Can­del is go­ing af­ter in­di­ca­tions where the on­colyt­ic virus would be de­liv­ered by sur­geons. In the case of prostate can­cer, it’d be urol­o­gists who are fa­mil­iar with biop­sies and sim­i­lar pro­ce­dures.

Can­del is al­so col­lab­o­rat­ing with Bris­tol My­ers Sqi­ubb to test its on­colyt­ic virus­es in com­bi­na­tion with Op­di­vo.

The first Phase III tri­al in prostate can­cer is un­der­way, and he plans to start an­oth­er for glioblas­toma in 2021.

Aguilar-Cor­do­va will now step in­to the CSO post, work­ing with a new C-suite that Tak has re­cruit­ed since start­ing in Sep­tem­ber. Nathan Caf­fo is jump­ing from ALX On­col­o­gy to be­come the chief busi­ness of­fi­cer; Fre­quen­cy alum John Canepa will be chief fi­nan­cial of­fi­cer; while Su­san Stew­art is tak­ing up the new role of chief reg­u­la­to­ry of­fi­cer.

In­ter­est­ing­ly enough, the role with Can­del will even­tu­al­ly bring Tak to Need­ham, MA, where the com­pa­ny is head­quar­tered and plot­ting a man­u­fac­tur­ing site. He is al­so in the process of set­ting up a new dis­cov­ery plat­form built on a her­pes sim­plex vi­ral vec­tor.

“We can do this again and again,” he said.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Who are the women break­ing bar­ri­ers in drug de­vel­op­ment? Nom­i­nate them for End­points' an­nu­al re­port

Today, we’re opening nominations for our fifth annual Women in Biopharma R&D special report.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. We’re looking for big thinkers, scientists, executives and other enterprising women who are breaking barriers in drug development and inspiring the next generation of leaders.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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