June 13, 2022 06:49 AM EDTUpdated 07:00 AM
R&D
Coronavirus

Sanofi, GSK keep the ball rolling with da­ta on sec­ond-gen Covid vac­cine can­di­date

Amber Tong

Senior Editor

Sanofi and GSK are keep­ing the R&D en­gine churn­ing for Covid-19 vac­cines.

The part­ners, which have yet to get their first shot on the mar­ket, re­port­ed that their next-gen­er­a­tion boost­er — mod­elled on the Be­ta vari­ant of the SARS-CoV-2 virus and in­cor­po­rat­ing GSK’s ad­ju­vant — kicked up a stronger im­mune re­sponse to adults who re­ceived mR­NA jabs than both its own first-gen­er­a­tion shot and Pfiz­er/BioN­Tech’s Comir­naty.

Cit­ing da­ta from two tri­als, Sanofi first not­ed that in the Phase III COV­I­BOOST VAT02 Co­hort 2 study, the next-gen can­di­date “gen­er­at­ed dou­ble the num­ber of neu­tral­iz­ing an­ti­bod­ies against Omi­cron BA.1 and BA.2 com­pared to the D614-based (orig­i­nal par­ent virus) boost­er.”

Then from the much small­er COV­I­BOOST VAT013 study, which was con­duct­ed by a hos­pi­tal in Paris, in­ves­ti­ga­tors al­so ob­served high­er neu­tral­iz­ing an­ti­body titers — with 76.1% of all par­tic­i­pants see­ing at least a “10-fold in­crease for the wild-type strain.” By com­par­i­son, 63.2% of those who got the Pfiz­er/BioN­Tech boost­er reached that thresh­old, and 55.3% of those who got the first-gen Sanofi/GSK boost­er did.

Sanofi, GSK prep reg­u­la­to­ry fil­in­gs for Covid-19 vac­cine af­ter post­ing PhI­II, boost­er da­ta — but who will use it?

“Covid-19 keeps evolv­ing and the com­bi­na­tion of emer­gence of vari­ants and wan­ing im­mu­ni­ty is like­ly to lead to the need for ad­di­tion­al boost­er shots, at least in some pop­u­la­tions,” said Thomas Tri­om­phe, ex­ec­u­tive VP, Sanofi vac­cines.

The first-gen­er­a­tion can­di­date is now un­der reg­u­la­to­ry re­views, the com­pa­nies said.

AUTHOR

Amber Tong

Senior Editor

amber@endpointsnews.com @AmberTongPW
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December 5, 2022 06:00 AM EST

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

Allucent

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.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)
December 6, 2022 07:15 AM ESTUpdated 10:52 AM
Bioregnum
R&D

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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December 7, 2022 07:00 AM ESTUpdated 03:57 PM
Special

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

ENDPOINTS

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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Mark McKenna, Prometheus Biosciences chairman & CEO
December 7, 2022 11:22 AM ESTUpdated 11:39 AM
R&D

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

Kyle LaHucik

Associate Editor

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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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)
December 6, 2022 12:30 PM ESTUpdated 03:44 PM
Pharma
Marketing

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

Beth Snyder Bulik

Senior Editor

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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Graphic: Shutterstock
December 7, 2022 05:18 PM EST
Financing

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

Kyle LaHucik

Associate Editor

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
December 7, 2022 02:47 PM ESTUpdated 04:19 PM
Manufacturing

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

Tyler Patchen

News Reporter

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.

December 7, 2022 01:48 PM ESTUpdated 04:56 PM
Pharma
Marketing

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

Beth Snyder Bulik

Senior Editor

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)
December 7, 2022 11:28 AM EST
FDA+

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

Max Gelman

Senior Editor

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.

Endpoints News

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Sanofi, GSK keep the ball rolling with da­ta on sec­ond-gen Covid vac­cine can­di­date

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

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

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

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

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

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

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

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

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