Rongkuan Frank Hu, Starna Therapeutics CEO

Star­na Ther­a­peu­tics emerges with fi­nanc­ing for mR­NA vac­cine and ther­a­pies

Star­na Ther­a­peu­tics has emerged with 150 mil­lion Yuan, or about $24 mil­lion, in Se­ries A fi­nanc­ing to take on two dif­fi­cult ar­eas in biotech R&D: RSV and id­io­path­ic pul­monary fi­bro­sis.

The Suzhou, Chi­na-based biotech se­cured the funds to move an mR­NA vac­cine for RSV in­to the clin­ic next year and a ther­a­peu­tic for IPF some­time af­ter that, CEO Rongkuan Frank Hu told End­points News. Hu was pre­vi­ous­ly a gen­er­al man­ag­er at RNA tech and ser­vices biotech GenePhar­ma and, be­fore that, a post­doc at UT South­west­ern Med­ical Cen­ter. His co-founder is Qiang Cheng, a PI at Peking Uni­ver­si­ty, he said.

The fi­nanc­ing will sup­port pre­clin­i­cal work to se­cure the biotech’s first IND for the RSV tri­al, like­ly to take place in Chi­na, Hu said. The com­pa­ny was found­ed in Au­gust 2021 based on the tech from Cheng, the CEO said.

The 34-em­ploy­ee com­pa­ny will al­so open a site in Shang­hai in the com­ing months, the CEO said. Much of the city has been closed be­cause of Covid-19 in re­cent weeks.

Star­na will eye its next round of fi­nanc­ing in 2023 and could ink col­lab­o­ra­tions with biotechs in the US to li­cense out the US rights to its as­sets, Hu said. The biotech will look at on­col­o­gy as an area, as well.

RSV is a hot space among Big Phar­ma right now, with Pfiz­er bet­ting $525 mil­lion on RSV biotech Re­Vi­ral af­ter hav­ing racked up back-to-back break­through ther­a­py nods for its own RSV vac­cine. Mean­while, Sanofi and As­traZeneca tout­ed new da­ta on their at­tempt ear­li­er this month and GSK ran in­to three tri­al paus­es in Feb­ru­ary for its ma­ter­nal RSV vac­cine.

Clos­er to home, Star­na will have to catch up to RSV vac­cine ri­val Nu­ance Phar­ma. The Shang­hai-based biotech li­censed Bavar­i­an Nordic’s poxvirus-based vac­cine in March to study the jab in a Phase III study in Chi­nese main­land, Hong Kong, Macau, Tai­wan, South Ko­rea and cer­tain South­east Asian coun­tries.

Mean­while, in IPF, Star­na is en­ter­ing a dif­fi­cult R&D land­scape. The dis­ease leads to scar­ring of tis­sue that sup­ports the lung’s air sacs, im­ped­ing a per­son’s breath­ing. The drug de­vel­op­ment in­dus­try has yield­ed on­ly two ap­proved drugs: Roche’s Es­bri­et and Boehringer In­gel­heim’s Ofev, both green­lit in 2014. Roche has lawyered up against gener­ics mak­ers.

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.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

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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