Philip Mor­ris nabs over 20% of Vec­tura's shares; On­copep­tides drug may be head­ed for ad­comm, CEO says

About a week af­ter Vec­tura’s board of di­rec­tors said they would unan­i­mous­ly back a Philip Mor­ris takeover, the to­bac­co gi­ant now has con­trol of more than a fifth of the res­pi­ra­to­ry drug­mak­er’s shares.

Share­hold­ers with 22.61% of Vec­tura’s shares have ten­dered their stock to Philip Mor­ris, Reuters re­port­ed on Wednes­day. The move is part of the cig­a­rette com­pa­ny’s $1.5 bil­lion bid to buy Vec­tura. Philip Mor­ris, best known for its Marl­boro prod­ucts, of­fered 165 pence per share, beat­ing out a 155 pence per share of­fer by the pri­vate eq­ui­ty firm The Car­lyle Group.

Though the deal has drawn skep­ti­cism from con­sumer ad­vo­cates, char­i­ties, an­ti-smok­ing groups and the UK’s busi­ness sec­re­tary, Vec­tura’s board is­sued a state­ment last week that it con­sid­ers Philip Mor­ris’ of­fer “fair and rea­son­able.”

“To­bac­co com­pa­nies should not prof­it from the ill­ness­es their prod­ucts cause,” a group of rep­re­sen­ta­tives from more than 20 an­ti-smok­ing and lung health or­ga­ni­za­tions wrote to Vec­tura’s board.

CEO Jacek Ol­czak says the deal is in line with his “be­yond nico­tine” strat­e­gy, which would po­si­tion the com­pa­ny to gen­er­ate more than half its rev­enue from smoke-free prod­ucts by 2025. — Nicole De­Feud­is 

On­copep­tides drug may be head­ed for ad­comm, CEO says

Fol­low­ing the FDA plac­ing a par­tial hold on its con­fir­ma­to­ry tri­al for Pepax­to, On­copep­tides said Thurs­day that the agency may call for an ad­comm to dis­cuss the study.

In its sec­ond quar­ter re­port, CEO Mar­ty Du­vall wrote in a let­ter to in­vestors that reg­u­la­tors “in­di­cat­ed that a pub­lic meet­ing may be held lat­er this year to dis­cuss the safe­ty find­ings and the con­tin­ued mar­ket­ing of the drug in the US.” The FDA placed the hold on all tri­als in­volv­ing Pepax­to on Ju­ly 8 af­ter the drug flopped the over­all sur­vival mea­sure.

Three weeks lat­er, the agency alert­ed pa­tients and health­care providers with more spe­cif­ic in­for­ma­tion, ex­plic­it­ly not­ing the drug re­sult­ed in an in­creased risk of death. Some cost-cut­ting “mea­sures” may be tak­en due to all the un­cer­tain­ty sur­round­ing the drug, Du­vall added in this let­ter.

Pepax­to won ac­cel­er­at­ed ap­proval in Feb­ru­ary, com­par­ing the drug in com­bi­na­tion with dex­am­etha­sone to a Bris­tol My­ers Squibb/steroid com­bo in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. — Max Gel­man

Bris­tol My­ers nets EU ap­proval for Abec­ma

About five months af­ter get­ting FDA ap­proval for its BC­MA CAR-T ther­a­py Abec­ma, Bris­tol My­ers Squibb has now won an OK in Eu­rope.

The Eu­ro­pean Com­mis­sion ap­proved the drug for adults with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma who had pre­vi­ous­ly failed at least three ear­li­er lines of ther­a­py, Bris­tol My­ers an­nounced Thurs­day. The pri­or ther­a­py lines must have in­clud­ed an im­munomod­u­la­to­ry agent, a pro­tea­some in­hibitor and an an­ti-CD38 an­ti­body, and pa­tients had to have demon­strat­ed dis­ease pro­gres­sion on the last ther­a­py, the drug­mak­er added.

“The EC ap­proval of Abec­ma is an im­por­tant mile­stone for the treat­ment of mul­ti­ple myelo­ma, and moves us clos­er to of­fer­ing a first-in-class, per­son­al­ized ther­a­py to pa­tients in Eu­rope bat­tling this in­cur­able dis­ease af­ter ex­haust­ing pri­or treat­ment op­tions with the three stan­dards of care,” CMO Samit Hi­rawat said in a state­ment.

Bris­tol My­ers has been push­ing Abec­ma for mul­ti­ple myelo­ma along­side an­oth­er drug, Breyanzi, which was ap­proved for third-line dif­fuse large B cell lym­phoma back in Feb­ru­ary. — Max Gel­man

Third time, like the first and sec­ond, is the charm for Ada­gene, Mer­ck

Ada­gene ap­par­ent­ly loves work­ing with Mer­ck so much they’re go­ing back for thirds.

The San Fran­cis­co biotech an­nounced its third clin­i­cal tri­al col­lab­o­ra­tion on Thurs­day, aim­ing to pair its ex­per­i­men­tal an­ti-CD137 can­di­date with Mer­ck’s Keytru­da in ad­vanced or metasta­t­ic sol­id and/or hema­to­log­i­cal ma­lig­nan­cies. The new clin­i­cal study will build on monother­a­py and com­bi­na­tion ther­a­py da­ta from a Phase I tri­al of the can­di­date, called ADG106.

“While PD-1 drugs have ad­vanced the can­cer treat­ment par­a­digm, there are still a sub­stan­tial num­ber of pa­tients with ad­vanced metasta­t­ic sol­id and hema­to­log­i­cal ma­lig­nan­cies who ei­ther re­lapse or are un­re­spon­sive, high­light­ing the need for new ap­proach­es,” Ada­gene CEO Pe­ter Luo said in a state­ment.

ADG106 is an ag­o­nis­tic an­ti-CD137 IgG4 mon­o­clon­al an­ti­body be­ing eval­u­at­ed in a Phase Ib/II com­bi­na­tion study in ad­vanced sol­id tu­mors and re­lapsed/re­frac­to­ry non-Hodgkin lym­phoma. Ada­gene’s Phase I tri­als have been com­plet­ed with en­roll­ment of near­ly 100 pa­tients in both the US and Chi­na, the biotech said. — Max Gel­man

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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