Ver­sant-backed pre­ci­sion on­col­o­gy start­up Re­pare Ther­a­peu­tics scores $82M+ in lat­est round

More than two years af­ter emerg­ing out of stealth mode with $68 mil­lion and Ver­sant as a found­ing in­vestor, pre­ci­sion on­col­o­gy drug de­vel­op­er Re­pare Ther­a­peu­tics has scored an­oth­er $82.5 mil­lion to take its lead prod­uct — carved out of the biotech’s syn­thet­ic lethal­i­ty plat­form — in­to the clin­ic.

Syn­thet­ic lethal­i­ty is a con­cept that re­lies on the idea that while tu­mors can tol­er­ate in­di­vid­ual de­fects in DNA, com­bi­na­tions of de­fects cre­ate dis­tinct vul­ner­a­bil­i­ties in can­cer cells which, when iso­lat­ed, present op­por­tu­ni­ties for pre­ci­sion ther­a­peu­tics. For in­stance, PARP in­hibitors — such as Clo­vis’ Rubra­ca, As­traZeneca’s $AZN Lyn­parza and GSK’s $GSK Ze­ju­la — were de­vel­oped to treat can­cers with mu­ta­tions in BR­CA1 or BR­CA2 genes.

Jer­el Davis

“This is a field we know and our con­vic­tion is that PARP is the tip of the ice­berg,” Ver­sant man­ag­ing di­rec­tor Jer­el Davis told End­points News in 2017.

Re­pare has har­nessed CRISPR gene edit­ing tech­nol­o­gy as an in­ter­ro­ga­tion tool to iden­ti­fy new tar­gets for small mol­e­cule drug dis­cov­ery. Its lead drug is en­gi­neered to in­hib­it atax­ia telang­iec­ta­sia and rad3-re­lat­ed (ATR) ki­nase — which is found on a va­ri­ety of can­cer cell types and plays a key role in DNA re­pair, cell cy­cle pro­gres­sion, and sur­vival. With this fresh round of fund­ing, the drug — RP-3500 — is set to en­ter the clin­ic next year.

The com­pa­ny — which ear­li­er this year found an Asian part­ner for its in­hibitor of Polθ, a DNA poly­merase es­sen­tial to re­pair­ing DNA breaks — will al­so use the cap­i­tal in­jec­tion to ad­vance its ‘Man­ches­ter’ pro­gram, a tar­get­ed ther­a­py tar­get­ing the CC­NE1 gene, in the com­ing quar­ters.

The lat­est round of fi­nanc­ing was led by Cowen Health­care In­vest­ments, and in­clud­ed the par­tic­i­pa­tion of new in­vestors such as Or­biMed, Red­mile, BVF Part­ners and Lo­gos Cap­i­tal, as well as ex­ist­ing in­vestors: Ver­sant Ven­tures, MPM Cap­i­tal, Fonds de sol­i­dar­ité FTQ, and BDC Cap­i­tal.

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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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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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.

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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