Brian Wong. RAPT

RAPT signs on with strug­gling Han­mi for Asian en­trance of can­cer ther­a­py aimed at 'charged tu­mors'

In the ear­ly 60s, two British vi­rol­o­gists an­a­lyz­ing tu­mor cells from Ugan­da made a land­mark sci­en­tif­ic dis­cov­ery that would lead to a land­mark sci­en­tif­ic er­ror.

They dis­cov­ered the first can­cer-caus­ing virus, lat­er epony­mous­ly named Ep­stein-Barr, and Amer­i­ca — fresh off the po­lio vac­cine’s un­prece­dent­ed suc­cess — was ready to be­lieve that most can­cers were caused by virus­es and thus could be cured by vac­cines. The prob­lem was sim­ple: Most can­cers weren’t, and the ones caused by Ep­stein-Barr most­ly af­flict­ed peo­ple oceans away from Wash­ing­ton DC, where the Na­tion­al Can­cer In­sti­tute be­gan spend­ing mil­lions on the sub­field.

So as RAPT Ther­a­peu­tics watched the ear­ly Phase I re­sults roll in last year on a treat­ment aimed large­ly at virus-fu­eled tu­mors, they be­gan plan­ning to cross the Pa­cif­ic. To­day they an­nounced a col­lab­o­ra­tion with South Ko­rea’s Han­mi Phar­ma­ceu­ti­cals worth $10 mil­lion up­front and up to $108 mil­lion in po­ten­tial de­vel­op­ment and sales mile­stones.

“It pro­vides ad­di­tion­al shots on goal and more proof-of-con­cept da­ta,” RAPT CEO Bri­an Wong told End­points News. “The sec­ond thing it does is pro­vide a piv­ot to Asia.”

The deal came af­ter sev­er­al months of ne­go­ti­a­tions with a va­ri­ety of Asian play­ers in mul­ti­ple coun­tries, Wong said. It will give Han­mi an ex­clu­sive li­cense to de­vel­op and com­mer­cial­ize RAPT’s lead prod­uct, FLX475, for can­cer in South Ko­rea, Chi­na, Hong Kong and Tai­wan. Han­mi will aug­ment an ex­ist­ing Phase I/II and be­gin their own Phase II in par­al­lel with a forth­com­ing US Phase II.

Formed from spare parts left­over af­ter Bris­tol-My­ers Squibb bought Flexus in 2015, RAPT – known as FLX Bio un­til this past May – tar­gets what they call “charged tu­mors.” These are tu­mors that have all the com­po­nents to be hit by the body’s im­mune re­sponse but sur­vive by har­ness­ing reg­u­la­to­ry T cells.

These T cells are meant to sup­press the im­mune sys­tem and stop the body from at­tack­ing healthy cells, but a tu­mor can al­so some­times use them to sur­vive. FLX475 blocks a path­way on those cells called CCR4, and RAPT thinks that will pre­vent them from en­ter­ing the tu­mor and turn­ing down the im­mune re­sponse.

And these charged tu­mors hap­pen to in­clude many virus-as­so­ci­at­ed can­cers and oth­ers, such as gas­tric can­cer, that are more preva­lent in Asia.

“We are run­ning our own glob­al tri­als but we re­al­ly we couldn’t ac­cess all of the charged tu­mors,” Wong said. “This is what the col­lab­o­ra­tion al­lows us to do.”

For RAPT, the part­ner­ship comes af­ter its hopes of a $70-mil­lion-plus IPO got cold-shoul­dered by an oth­er­wise pop­ping sum­mer biotech mar­ket. Ul­ti­mate­ly, they set­tled for rais­ing $36 mil­lion on 3 mil­lion shares.

For Han­mi, the small biotech deal comes af­ter it’s been spurned by its old deep-pock­et­ed part­ners. J&J and Eli Lil­ly dumped two deals with the com­pa­ny this year worth a com­bined $1.5 bil­lion, and of course, in 2016 Boehringer In­gel­heim abrupt­ly walked out of a $730 mil­lion part­ner­ship af­ter Han­mi failed to re­port pa­tient deaths in a tri­al.

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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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 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.

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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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.

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.

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.