FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has an­oth­er ad­comm com­ing down the pipeline — this time on Covid-19 oral an­tivi­ral mol­nupi­ravir.

The fed­er­al agency’s ad­vi­so­ry com­mit­tee will meet on No­vem­ber 30th to go over Mer­ck and Ridge­back’s EUA re­quest for their in­ves­ti­ga­tion­al an­tivi­ral drug, and dis­cuss the avail­able da­ta sup­port­ing its use in Covid-19 pa­tients.

This comes two weeks af­ter Mer­ck claimed that their an­tivi­ral pill re­duced the chance that new­ly di­ag­nosed Covid-19 pa­tients would be hos­pi­tal­ized or die by 50%. The phar­ma made the an­nounce­ment af­ter in­ter­im da­ta on 775 pa­tients in their clin­i­cal tri­al showed the an­tivi­ral’s po­ten­tial.

Mer­ck said it can make 10 mil­lion dos­es of the drug this year, in­clud­ing a deal with the US for 1.7 mil­lion cours­es of the drug it signed back in June. It al­so inked deals with dif­fer­ent gener­ic man­u­fac­tur­ers to pro­duce the drug for low and mid­dle in­come coun­ties.

Re­searchers fin­ish at­las for small cell lung can­cer — re­veal­ing new tar­get 

Af­ter sev­er­al years of re­search, a can­cer “at­las” for small cell lung can­cer is ready.

Re­vealed by in­ves­ti­ga­tors at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter in the jour­nal Can­cer Cell yes­ter­day, a team of sci­en­tists used sin­gle cell RNA se­quenc­ing to find a small group­ing of cells in small cell lung can­cer tu­mors.

“The most ex­cit­ing thing we found is a rare pop­u­la­tion of stem-like cells with­in these tu­mors that is close­ly cor­re­lat­ed with pa­tient out­comes,” ex­plained Charles Rudin, who co-led the lung can­cer project to Eu­rekAlert. “The more en­riched they are in the tu­mor, the worse the prog­no­sis.”

The sin­gle cell tech­nique al­so al­lowed the in­ves­ti­ga­tors to dive even deep­er. With­in the cells mak­ing up this tiny pop­u­la­tion, one gene stood out: PLCG2. This gene makes a pro­tein that acts as a mes­sen­ger of sorts — re­lay­ing sig­nals from one pro­tein to an­oth­er.

Ac­cord­ing to some of the in­ves­ti­ga­tors, the gene is most ex­pressed in this stem cell-like pop­u­la­tion. And when they ex­per­i­men­tal­ly in­creased or low­ered its ac­tiv­i­ty in can­cer cell lines, it al­tered the abil­i­ty of the can­cer cells to metas­ta­size.

The re­searchers think that PLCG2-high cells could be part of the ex­pla­na­tion for SCLC’s ag­gres­sive­ness. If so, it could open up new treat­ment pos­si­bil­i­ties.

“If we can de­vel­op strate­gies to se­lec­tive­ly tar­get this cell pop­u­la­tion, we might be able to sup­press metas­ta­sis and ul­ti­mate­ly im­prove out­comes for pa­tients with small cell lung can­cer,” Rudin said.

Shang­hai’s Han­soh inks de­vel­op­ment deal with UK biotech

For the sec­ond time this week, Chi­nese biotech Han­soh made a deal. This time, the $1 bil­lion+ deal is with the Lon­don-based  siR­NA firm Si­lence Ther­a­peu­tics.

The two com­pa­nies an­nounced a col­lab­o­ra­tion to­day to de­vel­op siR­NAs for three undis­closed tar­gets, lever­ag­ing Si­lence’s mR­NAi plat­form. Han­soh will pay Si­lence $16 mil­lion up­front, with a po­ten­tial $1.3 bil­lion more in ad­di­tion­al mile­stones plus roy­al­ties on net prod­uct sales.

Han­soh will have the ex­clu­sive op­tion to li­cense rights to the first two tar­gets in Chi­na, Hong Kong, Macau and Tai­wan fol­low­ing the com­ple­tion of Phase I stud­ies. Si­lence will re­tain ex­clu­sive rights for those two tar­gets in all oth­er mar­kets, main­tain­ing re­spon­si­bil­i­ty for all ac­tiv­i­ties un­til Han­soh ex­er­cis­es its op­tion.

Si­lence will al­so re­tain re­spon­si­bil­i­ty for de­vel­op­ment out­side those Asian mar­kets af­ter the Phase I stud­ies are com­plete.

Han­soh will al­so have the ex­clu­sive op­tion to li­cense glob­al rights for a third tar­get at the point of IND fil­ing, main­tain­ing re­spon­si­bil­i­ty for all de­vel­op­ment ac­tiv­i­ties af­ter ex­er­cis­ing that op­tion.

“We are ex­cit­ed to part­ner with Si­lence, a pi­o­neer in siR­NA ther­a­peu­tic de­vel­op­ment with decades of sci­en­tif­ic and tech­ni­cal ex­pe­ri­ence,” said ex­ec­u­tive di­rec­tor of Han­soh’s board Eliza Sun in a state­ment.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges


Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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vTv Ther­a­peu­tics cuts 65% of em­ploy­ees in shake­up; Freenome bags $300M in Se­ries D to ex­pand mul­ti­omics plat­form

vTv Therapeutics has decided to chop down its workforce by almost two-thirds.

The High Point, NC biotech announced Monday that it would pivot and now prioritize its lead program, the oral glucokinase activator TTP399, as it gears up for Phase III pivotal trials.

The drug was granted breakthrough therapy designation after showing a 40% reduction in hypoglycemic episodes compared to placebo, and back in October vTv announced positive results in a study showing no increased risk for ketoacidosis, a severe complication of diabetes.

Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.