Jacek Olczak, Philip Morris CEO (Yen Meng Jiin/Singapore Press via AP Images)

UK busi­ness sec­re­tary look­ing in­to Philip Mor­ris' pro­posed deal to ac­quire Vec­tura — re­port

Philip Mor­ris’ pro­posed $1.5 bil­lion deal to ac­quire the UK-based in­haled ther­a­peu­tics com­pa­ny Vec­tura has an­ti-smok­ing groups up in arms — and now, the British gov­ern­ment is re­port­ed­ly look­ing in­to the deal.

The UK’s busi­ness sec­re­tary Kwasi Kwarteng has re­port­ed­ly asked of­fi­cials to mon­i­tor Philip Mor­ris’ pro­posed takeover of Vec­tura, which spun out of the Uni­ver­si­ty of Bath back in 1997, ac­cord­ing to the Lon­don Times.

Kwarteng is tak­ing a fur­ther look at the pro­posed deal along with un­named of­fi­cials, af­ter the coun­try’s shad­ow health sec­re­tary Jon Ash­worth and shad­ow busi­ness sec­re­tary Ed Miliband wrote a let­ter urg­ing the gov­ern­ment to in­ter­vene, the Times re­port­ed. The UK’s Shad­ow Cab­i­net con­sists of a team of se­nior spokes­peo­ple ap­point­ed to ques­tion and chal­lenge their coun­ter­parts and pro­pose al­ter­na­tive poli­cies.

“Vec­tura must be pro­tect­ed. Its work in de­vel­op­ing drugs for res­pi­ra­to­ry con­di­tions makes it an im­por­tant firm in help­ing to tack­le the Covid-19 pan­dem­ic, and on this ba­sis there are clear grounds to block this deal,” the shad­ow sec­re­taries wrote, per the Times.

Char­i­ties and an­ti-smok­ing groups have lam­bast­ed the deal, in­clud­ing Lon­don-based Can­cer Re­search UK, which took to Twit­ter on Tues­day to dis­cuss the is­sue.

“It’s iron­ic that a to­bac­co com­pa­ny wants to in­vest in the lung health in­dus­try when their prod­ucts are the biggest pre­ventable cause of can­cer, in­clud­ing lung can­cer,” CEO Michelle Mitchell wrote in a state­ment. “If PMI re­al­ly want­ed to help, they could stop sell­ing and ag­gres­sive­ly pro­mot­ing their prod­ucts al­to­geth­er.”

Deb­o­rah Arnott, chief ex­ec­u­tive of the health char­i­ty Ac­tion on Smok­ing and Health (ASH), told the Evening Stan­dard: “I can’t imag­ine the sci­en­tists work­ing for Vec­tura, a re­spectable com­pa­ny mak­ing prod­ucts that treat lung can­cer, are go­ing to be at all hap­py wak­ing up to find they’re go­ing to be work­ing for Big To­bac­co.”

Philip Mor­ris — the man­u­fac­tur­er of Marl­boro cig­a­rettes — took the wraps off a pro­posed deal on Fri­day to ac­quire Vec­tura and the ser­vices of some 200 sci­en­tists work­ing on build­ing their new pipeline. CEO Jacek Ol­czak says the move is in line with the com­pa­ny’s “be­yond nico­tine” strat­e­gy an­nounced ear­li­er this year. He hopes to gen­er­ate more than 50% of the com­pa­ny’s rev­enue from smoke-free prod­ucts by 2025, and at least $1 bil­lion from non-nico­tine prod­ucts.

Med­ica­go, which is par­tial­ly owned by Philip Mor­ris In­ter­na­tion­al, en­tered the race for a Covid-19 vac­cine last sum­mer, with an ap­proach that us­es to­bac­co leaves to pro­duce an S-spike pro­tein. But af­ter get­ting off to a late start, the com­pa­ny quick­ly fell be­hind oth­er drug­mak­ers, in­clud­ing Pfiz­er/BioN­Tech and Mod­er­na who snagged the first two US au­tho­riza­tions in De­cem­ber.

This May, Med­ica­go re­port­ed pos­i­tive Phase II re­sults from its can­di­date pro­duced in col­lab­o­ra­tion with Glax­o­SmithK­line, claim­ing that near­ly 10 times the amount of an­ti­bod­ies were found in pa­tients dosed with the vac­cine than a pan­el of pa­tients re­cov­er­ing from the virus.

Vec­tura re­cent­ly re­or­ga­nized in­to a CD­MO, at­tract­ing top in­dus­try clients like No­var­tis to make their in­haled drugs.

“The mar­ket for in­haled ther­a­peu­tics is large and grow­ing rapid­ly, with sig­nif­i­cant po­ten­tial for ex­pan­sion in­to new ap­pli­ca­tion ar­eas,” Ol­czak said. “PMI has the com­mit­ment to sci­ence and the fi­nan­cial re­sources to em­pow­er Vec­tura’s skilled team to ex­e­cute on an am­bi­tious long-term vi­sion.”

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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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.

Carl Hansen, AbCellera CEO

Look­ing for the next mR­NA break­through, Mod­er­na taps Ab­Cellera in mys­te­ri­ous an­ti­body dis­cov­ery deal

Moderna’s success with its Covid-19 vaccine has busted the dam open on a range of potential mRNA therapeutics — and now the biotech is pushing to keep the cutting edge in-house. A new partnership with standout antibody discovery outfit AbCellera could help keep the ball in the competition’s court.

Moderna will partner with antibody player AbCellera on up to six undisclosed targets for a range of mRNA-encoded drugs harvested from AbCellera’s bustling discovery platform, the companies said Wednesday.

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.