Evelo touts PhII win for in­flam­ma­tion pro­gram; In­novent, An­Heart claim in­ter­im PhII suc­cess in NSCLC

Flag­ship’s Evelo Bio­sciences is tout­ing a win Mon­day in a Phase II study ex­am­in­ing an oral treat­ment for in­flam­ma­to­ry dis­eases.

Re­searchers saw a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion for the ex­per­i­men­tal drug EDP1815 in the Pso­ri­a­sis Area and Sever­i­ty In­dex (PASI) score com­pared to place­bo af­ter 16 weeks, Evelo an­nounced Mon­day. The pro­gram is in clin­i­cal de­vel­op­ment for a wide range of in­flam­ma­to­ry dis­eases such as pso­ri­a­sis, atopic der­mati­tis and Covid-19.

“These clin­i­cal re­sults rep­re­sent a sig­nif­i­cant ad­vance­ment for those who live with in­flam­ma­to­ry dis­ease,” CEO Sim­ba Gill said in a state­ment. “This is the first Phase II study to demon­strate that we can har­ness the small in­testi­nal ax­is to make a clin­i­cal im­pact on pa­tients with an oral prod­uct can­di­date.”

With the da­ta in hand, Evelo in­tends to ad­vance the can­di­date in­to a reg­is­tra­tional study in pso­ri­a­sis, but the tim­ing re­mains un­clear. Across three co­horts in Mon­day’s re­sults, 25% to 32% of pa­tients achieved a PASI score of at least 50% re­duc­tion at week 16 com­pared to 12% on place­bo, good for a p-val­ue of p=0.027.

Evelo not­ed that the pro­gram reached sta­tis­ti­cal sig­nif­i­cance for Co­hort 1 and Co­hort 2, but failed to hit the p<0.05 mark in Co­hort 3.

In­novent and An­Heart claim in­ter­im PhII win in NSCLC

In­novent and New York-based part­ner An­Heart Ther­a­peu­tics are trum­pet­ing a new in­ter­im read­out from a Phase II study.

The com­pa­nies said Mon­day that their ex­per­i­men­tal ty­ro­sine ki­nase in­hibitor known as tale­trec­tinib in­duced ob­jec­tive re­spons­es in 19 of 21 treat­ment-naïve pa­tients as of a June 16 da­ta cut­off. Among 16 pre­vi­ous­ly pre-treat­ed pa­tients, re­spons­es were ob­served in sev­en pa­tients and dis­ease con­trol was ob­served in 12.

All pa­tients had been di­ag­nosed with non-small cell lung can­cer dri­ven by mu­ta­tions in the ROS1 gene.

“Our team is fo­cused on com­plet­ing pa­tient en­roll­ment for our Phase Ⅱ TRUST tri­al,” said An­Heart CMO Bing Yan in a state­ment. “The in­ter­im da­ta pre­sent­ed builds a strong foun­da­tion for our on­go­ing glob­al piv­otal tale­trec­tinib clin­i­cal pro­gram.”

Tale­trec­tinib is be­ing de­vel­oped as a TKI that tar­gets ROS1 and NTRK fu­sion mu­ta­tions, de­signed to treat first-time and pre­vi­ous­ly treat­ed pa­tients.

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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