J&J dives deep­er in­to bis­pecifics; Spring­Works an­nounces re­search deal over Stan­ford pro­fes­sor's work

Mass­a­chu­setts biotech F-Star en­tered a li­cens­ing and col­lab­o­ra­tion agree­ment with J&J in a deal po­ten­tial­ly worth $1.35 bil­lion in mile­stones.

In ex­change for $17.5 mil­lion up­front, F-Star an­nounced this morn­ing that the biotech is giv­ing J&J world­wide, ex­clu­sive and roy­al­ty-bear­ing li­cense to do R&D and com­mer­cial­ize up to five new bis­pe­cif­ic an­ti­bod­ies for J&J ther­a­peu­tic tar­gets us­ing F-star’s re­search plat­forms. J&J will take on all re­spon­si­bil­i­ties for R&D and com­mer­cial­iza­tion un­der the agree­ment.

The deal was fa­cil­i­tat­ed by J&J com­pa­ny John­son & John­son In­no­va­tion, the Big Phar­ma said.

“We are pleased to col­lab­o­rate with Janssen and lever­age the sci­ence of F-star’s pro­pri­etary tetrava­lent bis­pe­cif­ic tech­nol­o­gy,” said F-Star CSO Neil Brewis.

Spring­Works bonds clos­er with Dana Far­ber on EGFR

Three months af­ter Spring­Works Ther­a­peu­tics an­nounced a part­ner­ship with Dana-Far­ber Can­cer In­sti­tute to in­ves­ti­gate one of its can­cer mol­e­cules, the biotech has an­nounced an­oth­er part­ner­ship — a world­wide li­cense agree­ment to ad­vance a port­fo­lio of small mol­e­cule EGFR in­hibitors.

Spring­Works al­so un­veiled a spon­sored re­search agree­ment with Stan­ford Med­i­cine for that port­fo­lio. De­vel­oped in the lab­o­ra­to­ry of Stan­ford Med­i­cine and Dana-Far­ber pro­fes­sor Nathanael Gray, it was de­signed to po­ten­tial­ly treat EGFR-mu­tant lung can­cers.

The port­fo­lio is de­signed to ad­dress both de no­vo onco­genic dri­vers and emerg­ing re­sis­tance mu­ta­tions to ex­ist­ing EGFR in­hibitors, ac­cord­ing to a com­pa­ny state­ment — and the most ad­vanced as­set in the port­fo­lio is cur­rent­ly in lead op­ti­miza­tion.

Spring­Works will pay Dana-Far­ber an undis­closed amount up­front, along with mile­stone pay­ments and roy­al­ties based on any fu­ture net sales. On top of the world­wide li­cense, the Spring­Works deal will fund con­tin­u­ing R&D in Gray’s lab and col­lab­o­rat­ing labs at Dana-Far­ber. The agree­ment is in­tend­ed to sup­port lead op­ti­miza­tion and trans­la­tion­al bi­ol­o­gy ef­forts as the port­fo­lio moves to­wards nom­i­nat­ing a drug can­di­date, ac­cord­ing to a Spring­Works state­ment.

Wash­ing­ton DC’s Chase Ther­a­peu­tics com­pletes mile­stone-based $20M se­ries B

Wash­ing­ton DC-based Chase Ther­a­peu­tics re­vealed the com­ple­tion of a mile­stone-based $20M Se­ries B fi­nanc­ing, led by Hong Kong in­vestor Chi­nalink Asia Hold­ings.

The funds will sup­port Phase III piv­otal tri­als for Chase’s ma­jor de­pres­sive dis­or­der (MDD) can­di­date CTC-501 and Parkin­son’s dis­ease can­di­date CTC-413, as well as com­plet­ing de­vel­op­ment and val­i­da­tion of a Parkin­son’s di­ag­nos­tic prod­uct.

Chase al­so an­nounced that Javier Romero, Chair­man and CEO of Chi­nalink, will join the Board of Di­rec­tors.

“Javier Romero brings decades of in­ter­na­tion­al busi­ness ex­pe­ri­ence to the Board of CTC,” said Chase Ther­a­peu­tics co-founder and board chair Kath­leen Clarence-Smith. “We look for­ward to work­ing with Javier as we ad­vance our pro­grams in ma­jor de­pres­sive dis­or­der and Parkin­son’s dis­ease.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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