Art Krieg, Checkmate CSO

IPO bound? Five years in, Art Krieg and the Check­mate crew col­lect $85M to back up their 1-drug pipeline

Five years af­ter Art Krieg picked up a drug to make a bid in the fever­ish im­muno-on­col­o­gy space with a start­up called Check­mate Phar­ma­ceu­ti­cals, he and the team are still locked in to their sin­gle path­way ap­proach. And they just scored $85 mil­lion and a cou­ple of new mar­quee in­vest­ments to make some im­por­tant mid-stage moves on the R&D board.

The drug is CMP-001, which con­tains a CpG-A oligonu­cleotide that ac­ti­vates the TLR9 path­way to kick up an in­nate im­mune re­sponse to can­cer — one of the most pop­u­lar re­search strate­gies in the on­col­o­gy hand­book these days. And Check­mate says they are still the on­ly play­er in biotech to go af­ter this par­tic­u­lar path­way.

That’s not nec­es­sar­i­ly a val­i­da­tion of the ap­proach. Hot can­cer tar­gets like TIG­IT at­tract swarms of com­peti­tors, but it would leave Check­mate well ahead of any ri­val that might ap­pear.

Krieg, an oli­go ex­pert who moved from CEO to the CSO spot as the biotech moved in­to the clin­ic, has pas­sion­ate­ly be­lieved the ther­a­py can be dou­bled up with a PD-1 to amp up the im­pact for can­cer pa­tients. And they tied up with Keytru­da and Op­di­vo, the gold stan­dard in PD-1 check­points, to prove the point.

The goal here is to make a pipeline out of a prod­uct.

A key cat­a­lyst for the pri­vate play­er ar­rived last fall at SITC, when the biotech post­ed da­ta in­di­cat­ing a 25% over­all re­sponse rate for their Keytru­da-com­bo melanoma pa­tients who had al­ready proven to be re­sis­tant to an­ti-PD-(L)1 drugs. And that ev­i­dent­ly in­spired Lon­gi­tude Cap­i­tal and No­vo Hold­ings to lead the new round — al­most dou­bling the amount raised so far.

Oth­er new in­vestors in­clude Medix­ci (which puts a high pre­mi­um on fo­cus), Omega Funds, Clough Cap­i­tal Part­ners, Sec­toral As­set Man­age­ment and Bright­Edge, the ven­ture in­vest­ment fund of the Amer­i­can Can­cer So­ci­ety. Check­mate’s ex­ist­ing in­vestors Sofinno­va In­vest­ments, ven­Bio Part­ners, F-Prime Cap­i­tal and Decheng Cap­i­tal al­so stepped in.

These days, that kind of raise for a biotech in the clin­ic begs the ques­tion of whether Check­mate plans to pitch an IPO soon.

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.

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.

Wen Wang, IASO CEO

Chi­nese CAR-T play­er books a megaround to dri­ve bustling cell ther­a­py port­fo­lio through the clin­ic

China has quickly emerged as a major driver of oncology R&D in recent years, particularly in cell therapies where the potential for cheaper development has investors drooling. Now, one player, with a handful of early data, is swimming in a new round of investor cash.

IASO Bio has closed a $108 million Series C that the Chinese and California-based biotech said it will use to advance its slate of cell therapy lead programs, while also propping up a roster of next-gen allogeneic cell therapies for the future, according to a release.

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.