AskBio CEO Sheila Mikhail

Bay­er-owned AskBio will shift fo­cus to­ward its dog­gy­bone DNA in re­struc­ture with Touch­light

The year was 2018, and AskBio CEO Sheila Mikhail want­ed 100% con­trol­ling in­ter­est in a joint ven­ture with Touch­light. The com­pa­ny was in ne­go­ti­a­tion with an un­named Big Phar­ma for a col­lab­o­ra­tion that would have pro­vid­ed it with enough cash to make that a re­al­i­ty. Af­ter 18 months of ne­go­ti­a­tions and agree­ments in place, the Big Phar­ma deal fell through, and so did Mikhail’s Touch­light am­bi­tions.

Run­ning a biotech is no dif­fer­ent than man­ag­ing a fam­i­ly’s fi­nances, she said. You have to stick to a bud­get.

But now, a re­vised arrange­ment has giv­en both AskBio and Touch­light co-ex­clu­sive rights to its dog­gy­bone DNA tech­nol­o­gy through their re­spec­tive CD­MOs. AskBio will shift its fo­cus away from plas­mid DNA en­tire­ly to the man­u­fac­tur­ing of dbD­NA, a move that Mikhail in par­tic­u­lar be­lieves the in­dus­try will latch on to.

“Now that we have 100% con­trol, we can make the in­vest­ments we want to build up the busi­ness,” she said in a call to End­points News Wednes­day. “Like any­thing, you’re sub­ject to 50-50 de­ci­sion mak­ing in a joint ven­ture.”

AskBio will now com­plete­ly own its San Se­bas­t­ian man­u­fac­tur­ing site for the re­search, clin­i­cal and com­mer­cial AAV dbD­NA. Mean­while, Touch­light AAV will re­brand to TAAV, re­tain the right to make AAV dbD­NA both for AskBio’s in­ter­nal prod­uct de­vel­op­ment pipeline as well as third par­ties. It al­so re­gains rights to man­u­fac­ture its dbD­NA for AAV pro­duc­tion.

The San Se­bas­t­ian site is a part of a small gene man­u­fac­tur­ing eco­cen­ter in the mid­dle of Eu­rope, with a Vi­ral­gen — a CD­MO born out of a joint ven­ture with Colum­bus Ven­ture — build­ing down the street in Spain. The sites em­ploy a more-than-typ­i­cal amount of young women in their 20s and 30s, some­thing Mikhail said can be at­trib­uted to the women in lead­er­ship at those fa­cil­i­ties.

dbD­NA is a lin­ear, dou­ble-strand­ed, co­va­lent­ly closed mol­e­cule that is made dur­ing the en­zy­mat­ic man­u­fac­tur­ing process. It can en­able faster and safer DNA pro­duc­tion with­out con­t­a­m­i­nat­ing the plas­mid DNA back­ground. It can take just weeks to pro­duce, as op­posed to months, and is man­u­fac­tured in a small­er set­ting, mean­ing it can be quick­ly scaled up and is high­ly trans­portable.

AskBio was ac­quired by Bay­er for $4 bil­lion in Oc­to­ber 2020. That marked the start of a push in­to cell and gene ther­a­pies, just two years af­ter it cut 900 R&D jobs af­ter a re­struc­tur­ing move. Bay­er was in­trigued by the ex­per­tise in build­ing a bet­ter AAV vec­tor, some­thing that had stumped many across gene ther­a­py. Its pipeline fea­tures can­di­dates for con­ges­tive heart fail­ure, mul­ti­ple sys­tem at­ro­phy, LGMD 2i, Parkin­son’s dis­ease and Pompe dis­ease.

Mean­while, Touch­light made noise with its $60 mil­lion fi­nanc­ing round last March, when it sug­gest­ed that it could triple the pro­duc­tion of dbD­NA and sup­ply up to 1 bil­lion Covid-19 shots per month. It lat­er land­ed a $65 mil­lion round in Sep­tem­ber, at a time when de­mand for syn­thet­ic DNA has reached an all-time high. It near­ly dou­bled its team from about 65 to 125 em­ploy­ees at the end of 2021.

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.

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.

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.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

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.