Charles Riv­er bags an­ti­body dis­cov­ery-fo­cused Dis­tri­b­u­tion Bio for $104M, sig­nal­ing re­turn to pre-pan­dem­ic buy­out spree

Charles Riv­er Labs, one of the biggest CROs that spe­cial­izes in pre­clin­i­cal re­search pro­grams, has inked a new dis­cov­ery pact as part of a string of deals over the last few years. And af­ter the Covid-19 pan­dem­ic proved less of a fi­nan­cial bur­den than ex­pect­ed, the com­pa­ny could be ready to make even more moves.

Charles Riv­er $CRL pur­chased an­ti­body dis­cov­ery com­pa­ny Dis­trib­uted Bio for up to $104 mil­lion, the com­pa­nies an­nounced Mon­day, a fig­ure that in­cludes $83 mil­lion in up­front cash. The oth­er $21 mil­lion in the deal is re­served for fu­ture “per­for­mance” pay­ments.

With the ac­qui­si­tion, Charles Riv­er hopes to “meet our goal of elim­i­nat­ing an ad­di­tion­al year from our clients’ ear­ly-stage de­vel­op­ment time­lines,” Charles Riv­er CEO James Fos­ter said in a state­ment. Shares ticked up­ward rough­ly 1% in ear­ly Mon­day trad­ing.

The goal of the deal is to give more clients ac­cess to Dis­tri­b­u­tion Bio’s pro­pri­etary plat­form, which is called Su­per­Hu­man. By com­bin­ing an­ti­body li­braries and data­bas­es with a ma­chine learn­ing de­sign, the plat­form can cut the dis­cov­ery process by sev­er­al months, the com­pa­nies said.

Mon­day’s deal al­so marks the for­mal­iza­tion of an ex­clu­sive part­ner­ship the two com­pa­nies struck in Oc­to­ber 2018. Back then, the com­pa­nies had aimed to cre­ate a new plat­form for an­ti­body dis­cov­ery, mar­ry­ing Charles Riv­er’s re­sources with Su­per­Hu­man.

Charles Riv­er has been on an ac­qui­si­tion spree in re­cent years, drop­ping $800 mil­lion for ri­val CRO MPI Re­search in Feb­ru­ary 2018, one of its biggest com­peti­tors in the pre­clin­i­cal sphere. The fol­low­ing Feb­ru­ary, the com­pa­ny paid north of half a bil­lion dol­lars to buy out Citoxlab and its slate of non-clin­i­cal ex­perts, beef­ing up tox­i­col­o­gy, dis­cov­ery, ge­nomics and med­ical de­vice test­ing ser­vices while ex­pand­ing its foot­print in Eu­rope.

The CRO had al­so been part­ner­ing with Ei­sai for years in pre­clin­i­cal work, ex­tend­ing a two-year col­lab­o­ra­tion in 2017 for an­oth­er year to work on pre­clin­i­cal med­i­cines for malar­ia.

But the Covid-19 pan­dem­ic halt­ed much of Charles Riv­er’s mo­men­tum, as well as the mo­men­tum of the en­tire CRO in­dus­try, when it forced more than 1,000 clin­i­cal tri­als to hit the pause but­ton in the ear­ly stages of the out­break. Back in May, the CRO re­port­ed that it need­ed to adopt a va­ri­ety of cost-cut­ting mea­sures due to the pan­dem­ic, and ex­pect­ed to chop away $55 mil­lion to $90 mil­lion in 2020 costs.

In sec­ond quar­ter and third quar­ter earn­ings re­ports, how­ev­er, Fos­ter not­ed that the Covid-19 head­winds end­ed up be­ing more mod­er­ate than they’d orig­i­nal­ly an­tic­i­pat­ed. For 2020’s third quar­ter, the com­pa­ny’s rev­enue was up 11.3% over the same time pe­ri­od in 2019.

Charles Riv­er op­er­ates more than 90 fa­cil­i­ties in at least 20 coun­tries and notes it sup­port­ed de­vel­op­ment for about 85% of FDA ap­proved drugs in 2019.

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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Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

No­vo Nordisk Foun­da­tion tees up $47.5M to ex­plore the dri­vers of ge­net­ic dis­ease with the Broad In­sti­tute

The Broad Institute of Harvard and MIT played a significant role in mapping out genes as part of the Human Genome Project about two decades ago. Now, it’s joining forces with one of the industry’s largest research foundations in an effort to translate those maps.

The Novo Nordisk Foundation, which operates independently from the biotech Novo Nordisk, is teeing up $47.5 million to work with the Broad on mining genetic data in the hopes of better understanding how variants drive disease.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.