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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Bat­tle-test­ed biotech ex­ecs turn to an ex­pe­ri­enced in­dus­try god­fa­ther for some board­room guid­ance

Little Sling Therapeutics out of Ann Arbor, MI may be just a few days out of the starting gate from the announcement of its $35 million launch round, but execs are positioning themselves within clear sight of a key clinical finish line. And they’re revving up with an experienced player to help guide them on the way.

The biotech is putting out word this morning that Faheem Hasnain has agreed to godfather the drug developer as chairman of the board, adding a measured dash of seasoning at a point when most biotechs are still struggling with the embryo stage.

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