Covid-19 roundup: US buys more of the on­ly an­ti­body that works against Omi­cron; BioN­Tech taps AI to de­tect new vari­ants faster

Glax­o­SmithK­line and Vir’s mon­o­clon­al an­ti­body sotro­vimab is still the on­ly mAb treat­ment that works against the Omi­cron vari­ant, and the US on Tues­day boost­ed its sup­ply again.

This lat­est deal, the fi­nan­cial de­tails of which were not im­me­di­ate­ly dis­closed, will bring 600,000 ad­di­tion­al dos­es to the US, ready for dis­tri­b­u­tion this quar­ter. GSK and Vir pre­vi­ous­ly land­ed two pri­or pro­cure­ment deals that amount­ed to about $1 bil­lion in sotro­vimab sold. GSK said it’s now signed agree­ments for ship­ping 1.7 mil­lion dos­es of sotro­vimab world­wide.

So far, the US has dis­trib­uted about 385,000 dos­es of sotro­vimab, which is less than half of the num­ber of dos­es of Re­gen­eron and Eli Lil­ly mAbs dis­trib­uted so far. And while the US has paused and then restart­ed its dis­tri­b­u­tion of the Re­gen­eron and Lil­ly prod­ucts, nei­ther of those work against Omi­cron.

BioN­Tech part­ners with Lon­don AI de­vel­op­er to hunt Covid vari­ants

BioN­Tech said Tues­day it’s work­ing with Lon­don-based AI de­vel­op­er In­staDeep to come up with a new com­pu­ta­tion­al method that an­a­lyzes se­quenc­ing da­ta and pre­dicts high-risk vari­ants of SARS-CoV-2.

The ear­ly warn­ing sys­tem com­bines struc­tur­al mod­el­ing of the SARS-CoV-2 spike pro­tein and AI al­go­rithms to flag po­ten­tial­ly high-risk vari­ants en­tered in­to SARS-CoV-2 se­quence da­ta repos­i­to­ries “with­in less than a day,” based on met­rics scor­ing their fit­ness (e.g. ACE2 and vari­ant Spike pro­tein in­ter­ac­tion) as well as their im­mune es­cape prop­er­ties, the com­pa­nies said.

Dur­ing a tri­al pe­ri­od of the sys­tem, it iden­ti­fied >90% of WHO-des­ig­nat­ed vari­ants two months faster than oth­er in­ter­na­tion­al ex­perts, the part­ners claimed.

“More than 10,000 nov­el vari­ant se­quences are cur­rent­ly dis­cov­ered every week and hu­man ex­perts sim­ply can­not cope with com­plex da­ta at this scale,” Karim Be­guir, co-founder and CEO of In­staDeep, said in a state­ment.

Mod­er­na vac­cine per­forms bet­ter than Pfiz­er against in­fec­tion, hos­pi­tal­iza­tion, new VA re­al-world da­ta study shows

A new re­al-world study fund­ed by the De­part­ment of Vet­er­ans Af­fairs re­veals that com­pared to those who re­ceived Pfiz­er’s Covid-19 vac­cine, Mod­er­na vac­cine re­cip­i­ents had a sig­nif­i­cant­ly low­er risk of SARS-CoV-2 in­fec­tion and re­lat­ed hos­pi­tal­iza­tions across all age groups, co­mor­bid­i­ty-bur­den cat­e­gories and race.

Au­thors of the study, pub­lished as a pre-print last week, not­ed dif­fer­ences be­tween Mod­er­na’s mR­NA-1273 vac­cine and Pfiz­er’s BNT162b2 “in risk of in­fec­tion or hos­pi­tal­iza­tion were pro­gres­sive­ly greater when the fol­low-up pe­ri­od was longer.”

The study eval­u­at­ed more than 900,000 vac­cine re­cip­i­ents, fol­lowed for a mean of 192 days, dur­ing which there were al­most 17,000 in­fec­tions, more than 3,500 hos­pi­tal­iza­tions and 381 deaths.

While few­er pa­tients who re­ceived Mod­er­na’s vac­cine died com­pared with Pfiz­er (168 ver­sus 213), the re­searchers said this dif­fer­ence was not sta­tis­ti­cal­ly sig­nif­i­cant (aHR 0.808, 95% CI 0.592-1.103).

Pfiz­er preps to launch Omi­cron-tar­get­ed vac­cine in March

Pfiz­er CEO Al­bert Bourla told CN­BC yes­ter­day his com­pa­ny is ready­ing the launch of an Omi­cron-spe­cif­ic vac­cine in March, and ramp­ing up man­u­fac­tur­ing now.

“The hope is that we will achieve some­thing that will have way, way bet­ter pro­tec­tion par­tic­u­lar­ly against in­fec­tions, be­cause the pro­tec­tion against the hos­pi­tal­iza­tions and the se­vere dis­ease — it is rea­son­able right now, with the cur­rent vac­cines as long as you are hav­ing let’s say the third dose,” Bourla said.

In ad­di­tion, the com­pa­ny is plan­ning for hu­man tri­als of the Omi­cron-tar­get­ed vac­cine to be­gin by the end of the month, ac­cord­ing to Busi­ness In­sid­er.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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