An­oth­er one of Bob Langer's MIT post­docs scores a biotech deal, auc­tion­ing his start­up for up to $415M

An­oth­er one of Bob Langer’s for­mer post­docs has scored a win in the biotech field.

Bryan Laulicht has struck a deal to sell a lit­tle biotech he built up to AM­AG Phar­ma­ceu­ti­cals, which likes the late-stage an­ti­co­ag­u­lant re­ver­sal agent he has been de­vel­op­ing with the team at Per­os­phere Phar­ma­ceu­ti­cals.

AM­AG is pay­ing $50 mil­lion in cash to buy the com­pa­ny while as­sum­ing $18.2 mil­lion in debt and li­a­bil­i­ties. There’s $140 mil­lion in reg­u­la­to­ry mile­stones on the ta­ble, with a lump sum pay­out for an FDA ap­proval with­out a black box warn­ing as well as $40 mil­lion for an EMA OK. An­oth­er $225 mil­lion is built in for sales goals.

In ex­change, AM­AG is get­ting cira­paran­tag, which Per­os­phere says is a “next gen” agent that can swift­ly at­tach to and re­verse the big an­ti­co­ag­u­lants on the mar­ket in an emer­gency room set­ting as physi­cians work to pre­vent po­ten­tial­ly lethal bleed­ing events.

AM­AG chief William Hei­den says he’s hap­py to nab the late-stage treat­ment, which he be­lieves will be a good fit for the hema­tol­ogy team mar­ket­ing Fer­a­heme.

The small mol­e­cule agent is de­signed to work with an­ti­co­ag­u­lants like Xarel­to, Eliquis, Savaysa and Lovenox.

Julie Krop

MIT Pro­fes­sor Bob Langer has been a pro­lif­ic en­tre­pre­neur in and around the Cam­bridge, MA area, help­ing launch more than 30 biotechs. He has a sig­nif­i­cant piece of the eq­ui­ty in Mod­er­na and a long line­up of his for­mer stu­dents — like Bryan Laulicht — have been in­spired to start com­pa­nies of their own while work­ing in his lab.

“Bryan is a re­al­ly bright, cre­ative guy,” Langer tells me via email.

“We look for­ward to work­ing with the FDA to con­firm the de­sign of our Phase 3 pro­gram, which is ex­pect­ed to in­clude a Phase 3a tri­al in healthy vol­un­teers fol­lowed by a Phase 3b/4 tri­al in pa­tients,” said Julie Krop, chief med­ical of­fi­cer and ex­ec­u­tive vice pres­i­dent of de­vel­op­ment at AM­AG.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

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Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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