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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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