At­las cre­ates sec­ond op­por­tu­ni­ty fund with $300M; BioN­Tech's col­orec­tal can­cer vac­cine starts PhII tri­al

Life sci­ence VC At­las Ven­ture closed its sec­ond Op­por­tu­ni­ty Fund with $300 mil­lion. Known as AVOF II, the fund will en­able At­las to con­tin­ue back­ing its port­fo­lio com­pa­nies, ac­cord­ing to a com­pa­ny state­ment.

“We are de­light­ed to re­ceive sup­port from both our long­stand­ing LP base and new in­vestors in AVOF II, for our mis­sion of build­ing and scal­ing biotech com­pa­nies that can bring nov­el med­i­cines to pa­tients,” said At­las part­ner David Grayzel in a state­ment.

At­las has in­cu­bat­ed or fund­ed a se­ries of dif­fer­ent biotechs across sev­er­al new fields since its last fund closed, in­clud­ing the rare blood dis­or­der start­up Disc Med­i­cine, the obe­si­ty start­up Ver­sa­nis and the RNA start­up Remix.

BioN­Tech starts treat­ing pa­tients with can­cer vac­cine in Phase II tri­al

The first col­orec­tal can­cer pa­tient has been treat­ed with BioN­Tech’s in­di­vid­u­al­ized mR­NA can­cer vac­cine in a Phase II clin­i­cal tri­al, BioN­Tech an­nounced to­day.

The tri­al — which plans to en­roll about 200 pa­tients in to­tal across the Unit­ed States, Ger­many, Spain and Bel­gium — will be look­ing at pre­vent­ing re­cur­rence of Stage II/III col­orec­tal can­cer tu­mors af­ter pa­tients have com­plet­ed both surgery and chemo.

A pro­por­tion of these pa­tients are ex­pect­ed to have a re­cur­rence with­in 2-3 years af­ter surgery, ac­cord­ing to a BioN­Tech state­ment. Pa­tients deemed high risk for re­cur­rence will be iden­ti­fied ear­ly with a ctD­NA blood test.

“This tri­al is an im­por­tant mile­stone in our ef­forts to bring­ing in­di­vid­u­al­ized im­munother­a­pies to pa­tients,” said BioN­Tech co-founder and CMO Özlem Türe­ci.

BioN­Tech is one of a cou­ple mR­NA com­pa­nies work­ing on per­son­al­ized can­cer vac­cines. Fel­low Covid-19 vac­cine mak­er Mod­er­na re­leased da­ta late last year on their per­son­al­ized can­cer vac­cine in con­junc­tion with PD-1 drug Keytru­da.

Take­da and JCR to col­lab­o­rate on Hunter syn­drome treat­ment

Take­da joined forces with JCR Phar­ma­ceu­ti­cals to com­mer­cial­ize JCR’s in­ves­ti­ga­tion­al fu­sion pro­tein treat­ment JR-141, Take­da an­nounced yes­ter­day.

The drug tar­gets the iduronate-2-sul­fa­tase (IDS) en­zyme for the treat­ment of Hunter syn­drome, a ge­net­ic dis­or­der caused by a de­fi­cien­cy of IDS in the body, ren­der­ing the body un­able to break down cer­tain com­plex sug­ars. This re­sults in buildup of these mol­e­cules in all tis­sues, and can al­so re­sult in stunt­ed growth and heart valve is­sues.

Un­der the terms of the ex­clu­sive col­lab­o­ra­tion and li­cense agree­ment, Take­da will ex­clu­sive­ly com­mer­cial­ize JR-141 out­side of the Unit­ed States, in­clud­ing Cana­da and Eu­rope, among oth­ers (ex­clud­ing Japan and spe­cif­ic undis­closed Asia-Pa­cif­ic coun­tries, ac­cord­ing to Take­da’s state­ment).

JCR will re­ceive an up­front pay­ment for an undis­closed amount, with po­ten­tial for de­vel­op­ment and com­mer­cial mile­stone mile­stones as well as tiered roy­al­ties on po­ten­tial sales.

Un­der a sep­a­rate agree­ment, Take­da re­ceives an op­tion to ac­quire an ex­clu­sive li­cense to com­mer­cial­ize JR-141 in the US up­on com­ple­tion of a Phase III clin­i­cal tri­al, which will be run by JCR.

“JCR is pleased to have reached an agree­ment with Take­da who is well placed to achieve our com­mon goal of max­i­miz­ing the im­pact of JR-141,” said JCR pres­i­dent and chair­man Shin Ashi­da in a state­ment.

PhRMA sues state of Arkansas over 340B law

Lob­by­ing firm PhRMA sued Arkansas’ in­sur­ance de­part­ment com­mis­sion­er Alan Mc­Clain and at­tor­ney gen­er­al Leslie Rut­ledge on Wednes­day to stop the state from re­quir­ing drug­mak­ers to pro­vide drugs dis­count­ed un­der the 340B pro­gram to con­tract phar­ma­cies.

The law­suit filed Wednes­day in the US Dis­trict Court for the East­ern Dis­trict of Arkansas is part of a grow­ing fight be­tween bio­phar­ma com­pa­nies and hos­pi­tals over the pro­gram.

In the fed­er­al 340B pro­gram, drug­mak­ers agree to of­fer cer­tain dis­counts to cer­tain providers in ex­change for par­tic­i­pa­tion in Medicare and Med­ic­aid. These types of providers can in­clude hos­pi­tals and com­mu­ni­ty health cen­ters but Arkansas’ law seeks to add con­tract phar­ma­cies as an­oth­er cov­ered en­ti­ty.

PhRMA con­tends in the law­suit that the law vi­o­lates the con­sti­tu­tion’s Com­merce Clause, which gov­erns com­merce among states.

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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