Ox­ford Bio­med­ica sees new in­vest­ment for man­u­fac­tur­ing; Twist gets a part­ner to help build out dis­cov­ery li­braries 

Ox­ford Bio­med­ica has land­ed some new cash.

The British gene and cell ther­a­py biotech an­nounced Wednes­day it has se­cured an in­vest­ment “just over” £50 mil­lion from the Serum In­sti­tute of In­dia’s in­vest­ment arm. Funds are ex­pect­ed to help Ox­ford Bio­med­ica build out its 84,000-square-foot man­u­fac­tur­ing fa­cil­i­ty and bring on­line sev­er­al in­de­pen­dent suites by mid-2023.

John Daw­son

“Serum In­sti­tute of In­dia has played a big part in the fight against COVID-19, as have we, and we look for­ward to a strong and col­lab­o­ra­tive re­la­tion­ship,” CEO John Daw­son said in a state­ment. “This in­vest­ment will al­low us to ex­pand ca­pac­i­ty at Oxbox at a time when our busi­ness de­vel­op­ment pipeline has nev­er looked stronger.”

Daw­son added that he ex­pects the fund­ing will cre­ate up to 120 new jobs.

Ox­ford Bio­med­ica’s fa­cil­i­ty was orig­i­nal­ly built in 2019 and com­prised 45,000 square feet, as well as four cGMP suites, two fill-and-fin­ish suites and sup­port­ing ar­eas such as ware­house, cold-chain fa­cil­i­ties and QC lab­o­ra­to­ries. The com­pa­ny hopes the new ex­pan­sion area can prove “flex­i­ble,” it said in the re­lease.

Twist gets new part­ner to help build out li­braries 

In its quest to de­vel­op prod­ucts based on syn­thet­ic DNA, Twist Bio­science now has a new part­ner to do so.

Emi­ly Lep­roust

The South San Fran­cis­co com­pa­ny an­nounced Thurs­day a col­lab­o­ra­tion with deep­C­DR Bi­o­log­ics, a Swiss firm with a pro­pri­etary mam­malian dis­play plat­form that aims to screen and iden­ti­fy an­ti­body can­di­dates through deep learn­ing. Fi­nan­cial terms of the deal were not dis­closed.

“[D]eep­C­DR of­fers a unique ap­proach en­abled by deep learn­ing to gen­er­ate large pan­els of ful­ly hu­man an­ti­body se­quences,” Twist CEO Emi­ly Lep­roust said in a state­ment. “Uti­liz­ing these se­quences, we’ve built mul­ti­ple ful­ly hu­man naïve syn­thet­ic an­ti­body li­braries.”

Specif­i­cal­ly, Twist has been able to build an AI Hy­per­mu­tat­ed sin­gle-chain frag­ment vari­ables li­brary and a new coro­n­avirus spe­cif­ic scFv li­brary, Lep­roust added.

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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