Hint­ing at an IPO and big things ahead for syn­thet­ic lethal­i­ty, pre­clin­i­cal Ideaya touts a $94M round

Big botech ven­ture rounds are com­ing fast and fu­ri­ous in Q1, and much of the mon­ey is be­ing fun­neled in­to pre­clin­i­cal out­fits like Ideaya Bio­sciences — abun­dant­ly hope­ful on promise in a hot can­cer R&D field but skimpy with de­tails.

Yu­jiro Ha­ta

The South San Fran­cis­co-based biotech has all the key fea­tures that’s made biotech such a trendy in­vest­ment for packed syn­di­cates. And to­day it’s tak­ing the wraps off a whop­ping $94 mil­lion B round.

There’s some tech hype: It promis­es to go well be­yond the first gen­er­a­tion of PARP in­hibitors and show what can be done with syn­thet­ic lethal­i­ty, a ge­net­i­cal­ly tar­get­ed ap­proach at trig­ger­ing the de­struc­tion of can­cer cells. Pipeline plans al­so call for mul­ti­ple projects on im­muno-on­col­o­gy.

There’s no da­ta, but there are a few hints at where it’s head­ed: In this case PARG, where the com­pa­ny just an­nounced a deal to work with CRUK in Lon­don on small mol­e­cule drugs. PARG is a cel­lu­lar en­zyme that breaks down Poly(ADP-ri­bose), aim­ing at a pro­tein func­tion re­quired for DNA re­pair — the very essence of syn­thet­ic lethal­i­ty.

An A-list of mar­quee in­vestors: Roche and Cel­gene are both jump­ing in here, along­side No­var­tis, which came to the ta­ble dur­ing the $46 mil­lion A round. The full mix on the crossover round in­clude new in­vestors BVF Part­ners, Per­cep­tive Ad­vi­sors LLC, Nex­tech In­vest Ltd, GV (you’ll call them Google Ven­tures), Roche Ven­ture Fund, 6 Di­men­sions Cap­i­tal, Box­er Cap­i­tal of the Tavi­s­tock Group, and Driehaus Cap­i­tal Man­age­ment. Cel­gene came back with 5AM Ven­tures, Canaan Part­ners, WuXi Health­care Ven­tures and Alexan­dria Ven­ture In­vest­ments.

Eye­ing an IPO? Yes, but there’s no time­line. In fact, there are no time­lines about any­thing.

“I would say where we are dif­fer­en­ti­at­ed,” says CEO Yu­jiro Ha­ta, “we’re prob­a­bly the fur­thest ahead with the most di­verse port­fo­lio.”

No, he’s not de­tail­ing the port­fo­lio. This ear­ly in the game, not many would, par­tic­u­lar­ly with sev­er­al oth­er ven­ture-backed ri­vals in the field.

Ha­ta al­so has the ad­van­tage of be­ing an ex­pe­ri­enced play­er in biotech. He was the COO at Flexus, which was bought out by Bris­tol-My­ers for $1.25 bil­lion. His for­mer boss Ter­ry Rosen just com­plet­ed a $120 mil­lion IPO. And these days ex­pe­ri­enced teams with close ties to the ven­ture crowd can raise hun­dreds of mil­lions of dol­lars be­fore see­ing any hu­man da­ta.

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.

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.

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.

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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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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