Schrödinger teams up with MD An­der­son on WEE1 in­hibitor pro­gram; Amid JAK safe­ty con­cerns, Ab­b­Vie touts new da­ta for Rin­voq 

Physics-based dis­cov­ery out­fit Schrödinger and the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter an­nounced to­day a two-year re­search col­lab­o­ra­tion — fo­cused on ac­cel­er­at­ing and op­ti­miz­ing de­vel­op­ment of Schrödinger’s in­ves­ti­ga­tion­al WEE1 in­hibitor.

The team, made up of Schrödinger em­ploy­ees and re­searchers with  MD An­der­son’s Trans­la­tion­al Re­search to Ad­vance Ther­a­peu­tics and In­no­va­tion in On­col­o­gy (TRAC­TION) plat­form, will seek to pri­or­i­tize clin­i­cal stud­ies of a WEE1 in­hibitor as a sin­gle agent in cer­tain can­cer in­di­ca­tions and in com­bi­na­tions for de­fined clin­i­cal sub­pop­u­la­tions, ac­cord­ing to a com­pa­ny state­ment.

“Through our col­lab­o­ra­tion with Schrödinger, we aim to iden­ti­fy clin­i­cal­ly rel­e­vant pa­tient pop­u­la­tions that may ben­e­fit from WEE1 in­hi­bi­tion and to ad­vance in­no­v­a­tive tar­get­ed ther­a­pies that can im­prove their lives,” said TRAC­TION ex­ec­u­tive di­rec­tor Tim­o­thy Hef­fer­nan.

MD An­der­son and Schrödinger will joint­ly pur­sue trans­la­tion­al stud­ies, and Schrödinger will pro­vide re­search sup­port fund­ing.

And as part of the arrange­ment, MD An­der­son can re­ceive undis­closed pay­ments based on fu­ture de­vel­op­ment and com­mer­cial­iza­tion mile­stones for the mol­e­cule. Schrödinger will have sole re­spon­si­bil­i­ty for the de­vel­op­ment, man­u­fac­ture and com­mer­cial­iza­tion of all com­pounds and prod­ucts, and ex­clu­sive rights to all new in­tel­lec­tu­al prop­er­ty from the col­lab­o­ra­tion. — Paul Schloess­er

Amid JAK safe­ty con­cerns, Ab­b­Vie touts new da­ta for Rin­voq 

Ab­b­Vie took a hit last month when its JAK in­hibitor Rin­voq was looped in­to new class-wide FDA warn­ings, which in­clude risks of se­ri­ous heart-re­lat­ed events, can­cer, blood clots and death. Now it’s look­ing to make a come­back, tout­ing topline re­sults in two sub­sets of a chron­ic in­flam­ma­to­ry dis­ease that af­fects the spine.

The first study, part of the Phase III SE­LECT-AX­IS 2 tri­al, looked at anky­los­ing spondyli­tis (AS), a con­di­tion in which pa­tients have struc­tur­al dam­age of their sacroil­i­ac joints vis­i­ble on x-rays. The study en­rolled 420 pa­tients who had an in­ad­e­quate re­sponse to bi­o­log­ic DMARD ther­a­py.

At week 14, 45% of pa­tients on Rin­voq achieved an As­sess­ment in Spondy­loArthri­tis In­ter­na­tion­al So­ci­ety (ASAS) 40 re­sponse, com­pared to just 18% of those who took a place­bo (p<0.0001). Pa­tients treat­ed with the drug saw sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in signs and symp­toms, in­clud­ing back pain and in­flam­ma­tion, as well as im­prove­ments in phys­i­cal func­tion and dis­ease ac­tiv­i­ty, Ab­b­Vie said.

In the sec­ond study, 45% of pa­tients with non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis (nr-axS­pA) achieved ASAS 40, com­pared to just 23% of pa­tients on place­bo (p<0.0001), ac­cord­ing to Ab­b­Vie. Nr-axS­pA is de­fined by the ab­sence of de­fin­i­tive x-ray ev­i­dence of struc­tur­al dam­age to the sacroil­i­ac (SI) joint.

“Peo­ple liv­ing with ac­tive non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis suf­fer from chron­ic in­flam­ma­to­ry back pain and lim­it­ed phys­i­cal func­tion that can be very de­bil­i­tat­ing,” Michael Sev­eri­no, vice chair­man and pres­i­dent of Ab­b­Vie, said in a state­ment.

No new safe­ty risks were iden­ti­fied in the stud­ies, Ab­b­Vie said. And no ad­ju­di­cat­ed ma­jor ad­verse car­dio­vas­cu­lar events, ve­nous throm­boem­bol­ic events or deaths were re­port­ed in ei­ther group through week 14. — Nicole De­Feud­is 

ALX ac­quires ScalmiBio in pipeline ex­pan­sion

On­col­o­gy biotech ALX an­nounced to­day that it bought biotech ScalmiBio in an ex­pan­sion of their im­muno-on­col­o­gy pipeline.

ScalmiBio de­vel­oped a tech­nol­o­gy called SHIELD — which is sup­posed to min­i­mize in­ter­ac­tion be­tween an­ti­body ther­a­peu­tics and nor­mal tis­sue, work­ing in­stead to in­crease tar­get bind­ing abil­i­ty with­in a tu­mor en­vi­ron­ment, ac­cord­ing to ALX.

ALX has plans to de­vel­op new an­ti-can­cer drug can­di­dates based on ScalmiBio’s plat­form — with the in­ten­tion to ad­dress cer­tain can­cer pa­tient needs as both stand-alone drugs or in tan­dem with ALX’s CD47 block­er evor­pacept, ac­cord­ing to a com­pa­ny state­ment.

“ALX On­col­o­gy was found­ed to ad­dress lim­i­ta­tions of CD47 block­ade through pro­tein en­gi­neer­ing,” said ALX pres­i­dent, founder and CEO Jaume Pons. “ScalmiBio’s uni­ver­sal SHIELD tech­nol­o­gy al­lows us to ex­pand our pipeline and bring more treat­ment op­tions to pa­tients.

ALX On­col­o­gy paid ScalmiBio share­hold­ers close to $4.5 mil­lion in cash on Mon­day af­ter close, and will pay an ad­di­tion­al $2 mil­lion cash in one year, along­side mile­stone pay­ments and roy­al­ties. — Paul Schloess­er

Re­lief files law­suit in NY against Neu­roRx + CEO over breach of con­tract

Swiss biotech Re­lief Ther­a­peu­tics filed a law­suit against Neu­roRx and CEO Jonathan Javitt, the com­pa­ny an­nounced to­day.

The law­suit, filed in the Supreme Court of the State of New York in Man­hat­tan, al­leges that Neu­roRx and Javitt com­mit­ted mul­ti­ple breach­es of the col­lab­o­ra­tion agree­ment be­tween Re­lief and Neu­roRx, re­lat­ed to de­vel­op­ing and com­mer­cial­iz­ing the once shot-down Covid treat­ment avip­tadil.

These in­clud­ed, ac­cord­ing to the suit, fail­ing to pro­vide Re­lief with all the re­quired da­ta from a re­cent­ly-com­plet­ed Phase IIb/III clin­i­cal tri­al eval­u­at­ing the drug for acute res­pi­ra­to­ry fail­ure due to Covid-19; along with fail­ing to al­low a fi­nan­cial au­dit on where Neu­roRx spent the mon­ey that Re­lief gave them, among oth­er breach­es.

“We are dis­ap­point­ed that Neu­roRx has con­tin­ued to refuse to ame­lio­rate their breach­es of the Col­lab­o­ra­tion Agree­ment,” stat­ed Re­lief CFO and trea­sur­er Jack We­in­stein in a state­ment. “While we con­tin­ue to hope to set­tle these mat­ters with Neu­roRx, we are com­pelled to bring this ac­tion to pre­serve our rights un­der the Col­lab­o­ra­tion Agree­ment and to al­low us to con­tin­ue to de­vel­op avip­tadil in a time­ly man­ner.” — Paul Schloess­er

Am­gen’s Lumakras com­bi­na­tions post dis­ap­point­ing re­spons­es

A few months af­ter cross­ing the fin­ish line with the first FDA-ap­proved KRAS in­hibitor, Am­gen is now look­ing to see if it can bump up Lumakras’ ef­fi­ca­cy with new drug com­bos. How­ev­er, two re­cent stud­ies didn’t turn up the re­sults the com­pa­ny had been hop­ing for.

In one of the stud­ies, Am­gen com­bined Lumakras with Mekin­ist, a mi­to­gen-ac­ti­vat­ed pro­tein ki­nase in­hibitor (ME­Ki), in pa­tients with non-small cell lung can­cer (NSCLC), col­orec­tal can­cer (CRC) and oth­er sol­id tu­mors.

Just two of 18 pa­tients with CRC achieved a par­tial re­sponse, one of whom had al­ready been treat­ed with Lumakras as a monother­a­py, ac­cord­ing to Am­gen. In NSCLC, five of 18 pa­tients achieved a par­tial re­sponse, two of whom had pre­vi­ous­ly re­ceived Lumakras.

The most com­mon side ef­fects were di­ar­rhea, rash, der­mati­tis ac­neiform, nau­sea and vom­it­ing, with no new safe­ty con­cerns iden­ti­fied, Am­gen said.

In the oth­er study, Am­gen paired Lumakras with Gilotrif, a pan-ErbB ty­ro­sine ki­nase in­hibitor. That one en­rolled 33 heav­i­ly-pre­treat­ed pa­tients with KRAS G12C-mu­tat­ed NSCLC, in­clud­ing five who had been treat­ed with Lumakras as a monother­a­py. Pa­tients were ran­dom­ized to re­ceive one of two dose reg­i­mens:  20 mg of afa­tinib/960 mg of Lumakras; or 30 mg of afa­tinib/960 mg of Lumakras.

The co­horts post­ed ob­jec­tive re­sponse rates of 20% and 35% re­spec­tive­ly, ac­cord­ing to Am­gen. In a sep­a­rate study, Lumakras alone re­port­ed a 37.1% over­all re­sponse rate among 126 pa­tients with ad­vanced NSCLC. — Nicole De­Feud­is 

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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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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