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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.