James Sabry adds an­oth­er weapon to Roche-Genen­tech ar­se­nal; Dai­ichi Sankyo adds ADC #6

James Sabry and Aviv Regev at Roche and Genen­tech have been rack­ing up ear­ly stage part­ner­ships, ty­ing up with ear­ly stage biotechs de­vel­op­ing every­thing from new AI en­gines to new ways of de­liv­er­ing gene ther­a­py. Now, they’ve signed on with an old­er play­er, join­ing a small mol­e­cule biotech that’s al­ready col­lab­o­rat­ed with many of the biggest names in drug de­vel­op­ment.

Genen­tech and X-Chem, a biotech that spe­cial­izes in DNA-en­cod­ed li­braries, have signed an agree­ment that will al­low the big biotech to both use their tech­nol­o­gy to find new mol­e­cules and give them an ex­clu­sive li­cense on a pre-ex­ist­ing pro­gram. De­tails for that pro­gram were undis­closed, as were up­front pay­ment and mile­stones.

One of the first biotechs to spe­cial­ize in mas­sive DNA-en­cod­ed li­braries — huge sets of mol­e­cules that can be rapid­ly screened for var­i­ous prop­er­ties be­cause they’re tagged with DNA iden­ti­fiers — X-Chem has racked up part­ner­ships with over a dozen ma­jor drug de­vel­op­ers. That in­cludes Servi­er, Ot­su­ka, Bris­tol My­ers Squibb, Ver­tex, Ab­b­Vie, As­traZeneca, Alex­ion, Astel­las, Bay­er, Gilead, J&J, Pfiz­er, Roche, and Sanofi.

Found­ed a decade ago by Glax­o­SmithK­line’s head of dis­cov­ery chem­istry, Matt Clark, X-Chem was bought out last year for an undis­closed sum by the British firm GHO Cap­i­tal. — Ja­son Mast

Dai­ichi Sankyo finds a sixth ADC to love — hit­ting a first-in-class tar­get

Dai­ichi Sankyo’s pro­lif­ic an­ti­body-drug con­ju­gate plat­form has spawned a sixth clin­i­cal can­di­date, with the first pa­tient dosed in a Phase I tri­al tar­get­ing ad­vanced re­nal cell car­ci­no­ma and ovar­i­an can­cer that pro­gressed fol­low­ing stan­dard treat­ment.

DS-6000 is di­rect­ed against CDH6, a cad­herin fam­i­ly pro­tein over­ex­pressed in sev­er­al can­cers.

Five-year sur­vival rates for re­nal cell car­ci­no­ma and ovar­i­an can­cer, Dai­ichi said, re­main low de­spite ad­vances in tar­get­ed treat­ment.

There aren’t cur­rent­ly any mar­ket­ed drugs hit­ting CDH6, mak­ing theirs a po­ten­tial first-in-class play — right along­side the pro­grams against known tar­gets that As­traZeneca has bet big mon­ey to part­ner with Dai­ichi on, in­clud­ing HER2 and TROP2.

This new drug is the third de­vel­oped in col­lab­o­ra­tion with Sarah Can­non Re­search In­sti­tute in Nashville, TN, Dai­ichi added. — Am­ber Tong

Jun­shi hands Co­herus back a few dol­lars

Here’s an un­usu­al way to spend cash from a col­lab­o­ra­tion an­nounce­ment: hand­ing it back to your col­lab­o­ra­tor.

A day af­ter the biosim­i­lar com­pa­ny Co­herus an­nounced they would pay Jun­shi Bio­sciences $150 mil­lion for the PD-1 an­ti­body tori­pal­imab, Jun­shi an­nounced they would in­vest $50 mil­lion in­to Co­herus. Al­though the stag­gered na­ture of the move was un­usu­al, Jun­shi CEO Ning Li said it was all part of a co­gent plan.

“We view our col­lab­o­ra­tion with Co­herus as a strate­gic long-term part­ner­ship for the de­vel­op­ment and com­mer­cial­iza­tion of tori­pal­imab and promis­ing PD-1 com­bi­na­tion can­di­dates,” Li said in a state­ment. “We want­ed to in­vest in Co­herus so we could share our fu­ture growth to­geth­er and mu­tu­al suc­cess with these pro­grams.”

The Jun­shi deal rep­re­sent­ed a shift for Co­herus, which has fo­cused ex­clu­sive­ly on copy­cat drugs to date. Al­though de­vel­op­ing a PD-1 is hard­ly nov­el — six are al­ready ap­proved in the US — the biotech said this would be the be­gin­ning of a push in­to new can­cer drug R&D.  — Ja­son Mast

Nan Fung-backed En­grail nabs a buy­out

En­grail Ther­a­peu­tics has on­ly been out of stealth for 7 months but they’ve al­ready se­cured a buy­out, scoop­ing up Neu­ro­Cy­cle Ther­a­peu­tics and their GA­BA-A mol­e­cules for an undis­closed sum Tues­day morn­ing.

The deal is the first pub­lic step in En­grail’s larg­er strat­e­gy of iden­ti­fy­ing and li­cens­ing in promis­ing mol­e­cules for brain dis­or­ders. Found­ed in 2017 by Glax­o­SmithK­line vet Matthew Toczko and  ETH Zurich sci­en­tist Jed Hubbs, Neu­ro­Cy­cle had been de­vel­op­ing a small mol­e­cule drug for the seizure dis­or­der Dravet syn­drome and oth­er dis­eases, and had large­ly re­lied on grant mon­ey.  — Ja­son Mast

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Philip Mor­ris gets share­hold­er back­ing in Vec­tura saga; Tarve­da strikes ex­clu­sive li­cens­ing agree­ment with Sci­Clone

Tobacco giant Philip Morris now has crossed the 50% threshold it needs for shareholder backing for its controversial, $1.5 billion takeover of asthma inhaler maker Vectura.

Investors have accepted a $2.28-per-share offer from the company behind Marlboro cigarettes, according to Sky News — and those investors represent nearly 75% of the company’s shares.

Acquiring the British inhaler maker is only a part of Philip Morris’ long term plan to develop “smoke-free” products, with a desire to ultimately become a “broader healthcare and wellness” company.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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