Keytru­da gets ac­cel­er­at­ed OK in HER2-pos­i­tive gas­tric can­cer; Twin­Strand gets $50M to hunt for 'nee­dles in a haystack'

King Keytru­da keeps rack­ing up ap­provals, earn­ing a new ac­cel­er­at­ed OK from the FDA on Wednes­day.

Reg­u­la­tors hand­ed down the ap­proval for HER2-pos­i­tive gas­tric can­cer in the first-line set­ting, in com­bi­na­tion with trastuzum­ab, flu­o­ropy­rim­i­dine- and plat­inum-based chemo. It’s yet an­oth­er thumbs-up for one of the best-sell­ing drugs in the world.

Wednes­day’s OK came on the ba­sis of a 264-pa­tient study with in­di­vid­u­als who had not pre­vi­ous­ly re­ceived treat­ment for their dis­ease. Pa­tients were ran­dom­ized 1-to-1 to re­ceive Keytru­da or place­bo every three weeks in ad­di­tion to the chemother­a­py reg­i­men.

The drug arm reg­is­tered an over­all re­sponse rate of 74% com­pared to 52% tak­ing the con­trol, good for a p-val­ue of p<0.0001. Re­searchers al­so saw a me­di­an du­ra­tion of re­sponse of 10.6 months with Keytru­da ver­sus 9.5 months in the con­trol arm.

With the ap­proval, reg­u­la­tors gave pa­tients the op­tion of tak­ing 200 mg of Keytru­da every three weeks or 400 mg every six weeks. Both are rec­om­mend­ed for use by the FDA in oth­er in­di­ca­tions. The full in­di­ca­tion is for lo­cal­ly ad­vanced un­re­sectable or metasta­t­ic HER2-pos­i­tive gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma. — Max Gel­man

Twin­Strand gets $50M to hunt for ge­net­ic ‘nee­dles in a haystack’

A cou­ple months af­ter wran­gling a $16 mil­lion Se­ries A round, Twin­Strand Bio­sciences has re­turned to the ven­ture well, this time near­ly dou­bling its last raise to fund the de­vel­op­ment of tech­nol­o­gy used to find ge­net­ic “nee­dles in a haystack.”

Twin­Strand un­veiled a $50 mil­lion Se­ries B round on Thurs­day, led by Sec­tion 32, with par­tic­i­pa­tion from Soleus Cap­i­tal, Janus Hen­der­son In­vestors, Madrona Ven­ture Group, Ridge­back Cap­i­tal, Alexan­dria Ven­ture In­vest­ments and oth­ers.

Jesse Salk

The com­pa­ny’s DNA se­quenc­ing tech de­liv­ers “a new lev­el of sen­si­tiv­i­ty, clar­i­ty, and ac­cu­ra­cy to the ex­plo­ration of ge­nom­ic vari­a­tion,” Sec­tion 32’s Michael Pelli­ni said in a state­ment. Twin­Strand says it can iden­ti­fy ul­tra-low fre­quen­cy DNA mu­ta­tions with a res­o­lu­tion 10,000-fold greater than oth­er tools on the mar­ket.

“In ad­di­tion to the com­mer­cial launch of our first prod­ucts, and the build out of our clin­i­cal lab, 2020 marked an im­por­tant mile­stone in the val­i­da­tion of our ex­pand­ing in­tel­lec­tu­al prop­er­ty port­fo­lio as we closed a ma­jor deal in liq­uid biop­sy to kick off our out-li­cens­ing pro­gram,” CEO and CSO Jesse Salk said in a state­ment. — Nicole De­Feud­is 

Val­ne­va makes Nas­daq de­but two weeks af­ter launch­ing PhI­II Covid-19 vac­cine tri­al

The lat­est over­seas biotech de­vel­op­ing Covid-19 vac­cines has hit the Nas­daq in France-based Val­ne­va. The com­pa­ny raised $94 mil­lion and priced Thurs­day at $26.41, the mid­point of its pro­posed range.

Val­ne­va made news re­cent­ly when it an­nounced in late April that it would be giv­ing up vac­cine sup­ply dis­cus­sions with the EU and in­stead deal­ing with mem­ber states di­rect­ly. It had been wary of the trade ten­sions be­tween the UK and rest of the con­ti­nent since Brex­it, not­ing in its S-1 that ex­port re­stric­tions may af­fect its abil­i­ty to de­liv­er those shots promised to the UK.

Val­ne­va has com­mit­ments to de­liv­er 100 mil­lion vac­cines to Britain by 2022, with the UK own­ing ad­di­tion­al op­tions for an­oth­er 90 mil­lion in sup­ply be­tween 2023 and 2025.

In a Phase I/II tri­al, more than 90% of all study par­tic­i­pants de­vel­oped sig­nif­i­cant lev­els of an­ti­bod­ies to the SARS-CoV-2 virus spike pro­tein across all dose groups test­ed. They launched their Phase III tri­al on April 21, look­ing to en­roll 4,000 in a study pit­ting its own vac­cine head-to-head against the As­traZeneca/Ox­ford Uni­ver­si­ty shot. — Max Gel­man

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.