BioN­Tech part­ners with Bill and Melin­da Gates Foun­da­tion, scor­ing $55M eq­ui­ty in­vest­ment; BeiGene brush­es off short at­tack

→ Less than two months af­ter Ger­man biotech BioN­Tech raised a her­culean $325 mil­lion in an up­sized round of fi­nanc­ing — the Bill and Melin­da Gates Foun­da­tion have signed a pact with the com­pa­ny, mak­ing an ini­tial eq­ui­ty in­vest­ment of $55 mil­lion to de­vel­op vac­cine and im­munother­a­py can­di­dates to pre­vent HIV and tu­ber­cu­lo­sis. To­tal fund­ing un­der the deal could hit $100 mil­lion, via po­ten­tial grant fund­ing from the foun­da­tion, BioN­Tech said on Wednes­day.

→ BeiGene, a pi­o­neer and dar­ling of the grow­ing US-Chi­na biotech crowd, was the sub­ject of a fe­ro­cious short re­port pub­lished by J Cap­i­tal on Thurs­day. Shares fell rough­ly 9% on both the Nas­daq $BGNE and the Hong Kong stock ex­change (06160) on al­le­ga­tions that the com­pa­ny faked sales of the Cel­gene drugs it’s in charge of mar­ket­ing in Chi­na, in­vest­ed in bo­gus man­u­fac­tur­ing sites, and over­spent on wages for R&D staff. Tim Mur­ray, au­thor of the re­port, fur­ther ac­cused ex­ecs of “pump­ing and dump­ing,” talk­ing up BeiGene’s stand­ing with Chi­nese drug reg­u­la­tors and po­ten­tial for its drugs while covert­ly sell­ing off their own stock.

In a state­ment to the HKEX, BeiGene called the al­le­ga­tions “in­ac­cu­rate, un­found­ed and mis­lead­ing” as well as “bla­tant­ly false.”

“From its in­cep­tion, BeiGene has op­er­at­ed with an un­wa­ver­ing com­mit­ment to com­pli­ance, ethics, and in­tegri­ty,” it wrote. “BeiGene re­mains fo­cused on its mis­sion to build a bio­phar­ma­ceu­ti­cal com­pa­ny that will pro­vide the high­est qual­i­ty ther­a­pies to the great­est num­ber of pa­tients around the world.”

No­var­tis $NVS is palm­ing off a Chi­na-based unit for $790 mil­lion yuan (about $110.5 mil­lion), ac­cord­ing to a Wednes­day re­port by Dow Jones. The plant, which was opened a decade ago, was sold to Chi­na’s Zhe­jiang Ji­uzhou, ex­clud­ing the Swiss drug­mak­er’s tech­nol­o­gy and drug-de­vel­op­ment as­sets. The ac­qui­si­tion will help Zhe­jiang Ji­uzhou ce­ment its po­si­tion as a strate­gic sup­pli­er to No­var­tis, not­ed the re­port.

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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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Philip Mor­ris gets share­hold­er back­ing in Vec­tura saga; Tarve­da strikes ex­clu­sive li­cens­ing agree­ment with Sci­Clone

Tobacco giant Philip Morris now has crossed the 50% threshold it needs for shareholder backing for its controversial, $1.5 billion takeover of asthma inhaler maker Vectura.

Investors have accepted a $2.28-per-share offer from the company behind Marlboro cigarettes, according to Sky News — and those investors represent nearly 75% of the company’s shares.

Acquiring the British inhaler maker is only a part of Philip Morris’ long term plan to develop “smoke-free” products, with a desire to ultimately become a “broader healthcare and wellness” company.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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