Colorized scanning electron micrographs of natural killer cells from a human donor (Images: NIH / Graphics: Shehla Shakoor, Endpoints News)

Kiadis aban­dons lead PhI­II pro­gram, shifts fo­cus to nat­ur­al killer cells

Kiadis Phar­ma an­nounced that it is shift­ing fo­cus to nat­ur­al killer cells — and is it­self killing off the long-run­ning but deeply trou­bled Phase III ATIR pro­gram that has large­ly de­fined the com­pa­ny. It will cut ap­prox­i­mate­ly half of its work­force.

Kiadis ac­quired Cy­toSen Ther­a­peu­tics and its nat­ur­al killer (NK) tech­nol­o­gy in April. The Nether­lands-based Kiadis had been de­vel­op­ing a T cell ther­a­py called ATIR101 that was then in Phase III for blood can­cer pa­tients, name­ly acute myeloid leukemia. At the time, it seemed that the Dutch biotech would pair its T cell ther­a­py with the US-based NKs in an in­ter­con­ti­nen­tal, mul­ti-cel­lu­lar ef­fort with im­pli­ca­tions for trans­plants and on­col­o­gy.

Arthur Lahr

“The ATIR T-cell and CS­DT002-NK-cell pro­grams each have the po­ten­tial to make trans­plants safer and more ef­fec­tive,” Kiadis CEO Arthur Lahr said at the time. “In com­bi­na­tion, they have the po­ten­tial to rev­o­lu­tion­ize HSCT, mak­ing it suit­able for an even wider group of pa­tients.”

The big red flag came at the end of Oc­to­ber, when Kiadis warned in­vestors it was ex­pect­ing a re­jec­tion from the EMA for ATIR101, which would set it back un­til at least the next in­ter­im analy­sis in 2021. To­day, Kiadis is end­ing that tri­al al­to­geth­er and re­tir­ing the com­pound. Lahr said the de­ci­sion was “tak­en in the best in­ter­est of pa­tients.”

Jef­feries an­a­lyst Philip­pa Gard­ner was sur­prised and unim­pressed by the news.

“This now shifts the fo­cus to the ear­ly-stage NK-cell plat­form ac­quired April, to which we do not cur­rent­ly as­cribe any val­ue,” she wrote. “An ex­pert event on Fri­day is now crit­i­cal for un­der­stand­ing its po­ten­tial. The re­struc­tur­ing should ex­tend the cash run­way, but a lack of cat­a­lysts and dent to man­age­ment cred­i­bil­i­ty re­main over­hangs.”

Kiadis is now left with two main com­pounds it ac­quired from Cy­tosen. K-NK003 al­so tar­gets AML. It is head­ed in­to the clin­ic next year, based on ear­ly proof-of-con­cept da­ta from 25 pa­tients.  Those pa­tients showed a 69% com­plete re­sponse rate, Kiadis said.

The oth­er drug is K-NK0002, a sup­ple­men­tal treat­ment to the stan­dard of care for cer­tain stem cell trans­plants: name­ly hap­loiden­ti­cal hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) with post-trans­plant cy­clophos­phamide. A Phase I/II tri­al on 63 pa­tients will be­gin next year based on proof-of-con­cept da­ta from 25 pa­tients. The drug re­duced long-term re­lapse rates from 45% to 8% in those pa­tients, Kiadis said.

The Cy­tosen-ac­quired plat­form is based on re­search from the Uni­ver­si­ty of Cen­tral Flori­da that showed how nanopar­ti­cles from anti­gen-pre­sent­ing cells could be used to stim­u­late NK cell pro­lif­er­a­tion.

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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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.

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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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.

Ali Tehrani, Zymeworks CEO

Zymeworks squares up with Her­ceptin af­ter HER2 bis­pe­cif­ic aces mid-stage test in esophageal can­cer

Roche’s Herceptin has long stood as standard of care across multiple advanced cancers, but a suite of next-gen players are looking to beat the aging giant at its own game. In HER2-expressing esophageal cancer, BeiGene partner Zymeworks thinks its bispecific antibody could have the juice to get it done.

Zymeworks’ bispecific antibody zanidatamab, combined with one of two chemotherapy regimens, posted an overall response rate of 75% in patients with advanced gastroesophageal adenocarcinoma (GEA) who had not previously received a HER2-targeted cancer therapy, the Vancouver-based biotech said Thursday.

UP­DAT­ED: Gilead keeps push­ing trove of Trodelvy da­ta as it seeks to be­come new stan­dard of care in TNBC

Gilead is continuing to churn out results for its newly approved drug Trodelvy, and #ESMO21 is the latest stop on the data train.

The biopharma put out new quality of life data in second-line patients with metastatic triple-negative breast cancer, saying that a sub-analysis from their Phase III study showed significant and clinically meaningful improvements in health-related quality of life over standard of care.