ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very be­gin­ning at SciNeu­ro, CEO Min Li has en­vi­sioned a mix of li­cens­ing deals and sci­en­tif­ic ef­forts to repli­cate the break­out suc­cess of Chi­na’s on­col­o­gy com­pa­nies in neu­ro­science.

The Glax­o­SmithK­line vet has now inked a deal that some­what strad­dles the line be­tween the two strate­gies.

Team­ing up with Maby­lon out of Zurich, SciNeu­ro is now look­ing to test the hy­poth­e­sis that the hu­man im­mune sys­tem can play a role in fight­ing neu­rode­gen­er­a­tive dis­eases by dis­cov­er­ing and de­vel­op­ing hu­man au­toan­ti­bod­ies against neu­ro­log­i­cal “tar­gets of mu­tu­al in­ter­ests.” The new part­ners of­fered TAR DNA bind­ing pro­tein-43 (TDP-43) and apolipopro­tein E (APOE), which are linked to ALS and Alzheimer’s, as ex­am­ples.

For every 10,000 pa­tients screened, there are usu­al­ly one to 10 spe­cif­ic hits on an­ti­body re­ac­tiv­i­ty against pro­teins present in the hu­man body, ac­cord­ing to Maby­lon. By screen­ing large co­horts of blood sam­ples — on the mag­ni­tude of more than 100,000 in­di­vid­u­als per year — it boasts of a pow­er­ful tech­nol­o­gy for the de­tec­tion of au­toan­ti­bod­ies.

Shang­hai-based SciNeu­ro, which gets a big say in how stud­ies will be run up to proof of con­cept, will have rights to de­vel­op and com­mer­cial­ize re­sult­ing prod­ucts in Chi­na, with an op­tion to grab glob­al rights down the road.

Backed by top-tier life sci­ences in­vestors in­clud­ing ARCH, Lil­ly Asia Ven­tures and Boyu, SciNeu­ro has care­ful­ly cu­rat­ed a slate of in-house R&D projects as well as some com­pounds li­censed from Eli Lil­ly.

“Na­tive hu­man an­ti­body-based ap­proach­es have proven suc­cess­ful for the treat­ment of in­fec­tious dis­eases in­clud­ing COVID-19,” Li said in a state­ment. “Dis­cov­ery of au­to-an­ti­bod­ies to treat oth­er dis­eases has been more chal­leng­ing, due in part to the avail­abil­i­ty of suf­fi­cient­ly large and high-qual­i­ty sam­ple col­lec­tions.” — Am­ber Tong

Mer­ck, Gilead kick off PhII tri­al for HIV com­bo

Just yes­ter­day, Mer­ck’s an­nounced its ex­per­i­men­tal an­ti-HIV drug is­la­travir got a Phase III com­bo win.

De­vel­op­ing the mol­e­cule with oth­er Mer­ck drugs is just one part of the com­pa­ny’s strat­e­gy, though. It is al­so part an on­go­ing part­ner­ship be­tween Mer­ck and Gilead to chal­lenge GSK on long-act­ing HIV meds by com­bin­ing is­la­travir with a drug from Gilead (lenaca­pavir) that had shown po­ten­tial.

Now, that part­ner­ship got a new up­date — in the form of a new Phase II clin­i­cal tri­al. The two biotechs said in a state­ment this morn­ing that the tri­al will use their drugs in a com­bi­na­tion treat­ment to be tak­en once week­ly by par­tic­i­pants.

“The ini­ti­a­tion of this study is key to fur­ther un­der­stand­ing the po­ten­tial of is­la­travir and lenaca­pavir in com­bi­na­tion for the treat­ment of HIV-1,” said Mer­ck’s vice pres­i­dent of glob­al clin­i­cal de­vel­op­ment for in­fec­tious dis­eases Joan But­ter­ton. — Paul Schloess­er

My­ovant pur­sues oth­er part­ner­ships af­ter Pfiz­er opts out of in­ter­na­tion­al re­l­u­golix rights

Pfiz­er has cho­sen to de­cline its op­tion to ex­er­cise its right to com­mer­cial­ize re­l­u­golix out­side of the US and Cana­da, My­ovant re­vealed in its 2021 Q2 cor­po­rate up­date call Tues­day.

In De­cem­ber 2020, the Swiss biotech that was for­mer­ly a part of the Vivek Ra­maswamy fam­i­ly of Vants won FDA ap­proval for the drug for the treat­ment of ad­vance prostate can­cer. It’s the first oral hor­mone ther­a­py ap­proved for in­di­ca­tion.

Pfiz­er and My­ovant land­ed a key ap­proval to open up the women’s health side of the re­l­u­golix fran­chise in late May when the FDA cleared a three-in-one pill dubbed Myfem­bree to treat heavy men­stru­al bleed­ing as­so­ci­at­ed with uter­ine fi­broids.

The com­pa­ny’s to­tal Q2 rev­enue of $77.9 mil­lion in­clud­ed $18.7 mil­lion from the sales of re­l­u­golix, al­so known as Or­govyx. That drug ac­count­ed for 78% of the com­pa­ny’s se­quen­tial growth. — Josh Sul­li­van

Genen­tech and Bi­cy­cle un­veil new ex­pan­sion in im­muno-on­col­o­gy dis­cov­ery and com­mer­cial­iza­tion deal

Genen­tech will ini­ti­ate a new pro­gram with Bi­cy­cle Ther­a­peu­tics un­der an ex­clu­sive, strate­gic col­lab­o­ra­tion agree­ment, Bi­cy­cle an­nounced to­day.

The new pro­gram ex­pands Genen­tech’s stand­ing agree­ment with the British on­col­o­gy biotech to com­mer­cial­ize im­mune-on­col­o­gy ther­a­pies dis­cov­ered and de­vel­oped on Bi­cy­cle’s name­sake plat­form.

Bi­cy­cle and Genen­tech are col­lab­o­rat­ing on the dis­cov­ery and pre-clin­i­cal de­vel­op­ment of dif­fer­ent im­munother­a­pies against mul­ti­ple tar­gets, as part of a deal the com­pa­nies made back in Feb­ru­ary 2020.

As part of the agree­ment, Genen­tech ex­er­cised an op­tion to in­clude a new pro­gram un­der the agree­ment, thus pay­ing Bi­cy­cle $10 mil­lion.

This deal takes place just a few months af­ter Io­n­is en­list­ed Bi­cy­cle’s plat­form for $45 mil­lion up­front for drugs that can pass through the blood brain bar­ri­er.

“We are pleased both with the progress achieved so far in our on­go­ing work with Genen­tech and that Genen­tech has elect­ed to ex­er­cise an op­tion to add a new pro­gram un­der the col­lab­o­ra­tion,” said Bi­cy­cle CEO Kevin Lee in a state­ment. “We look for­ward to con­tin­u­ing to work close­ly with the pre­em­i­nent im­muno-on­col­o­gy team at Genen­tech to de­vel­op po­ten­tial new can­cer treat­ments.” — Paul Schloess­er

Se­lec­ta inks $85M+ deal for Gink­go’s en­zyme dis­cov­ery plat­form

Ear­li­er this month, Se­lec­ta was on the re­ceiv­ing end of a $1 bil­lion-plus deal for its so­lu­tion to gene ther­a­py’s de­liv­ery prob­lem. Now, the com­pa­ny is dish­ing out some se­ri­ous cash to pair that plat­form with Gink­go’s high-through­put en­zyme dis­cov­ery tech­nol­o­gy.

Se­lec­ta and Gink­go un­veiled an R&D pact on Tues­day that adds up to $85 mil­lion in clin­i­cal mile­stones, in ad­di­tion to an undis­closed amount up­front, pay­ments in the form of Se­lec­ta’s stock, and sales roy­al­ties. In re­turn, Gink­go will de­sign en­zymes to pair with Se­lec­ta’s Imm­TOR plat­form, which is de­signed to be giv­en in con­junc­tion with gene ther­a­pies to in­duce anti­gen-spe­cif­ic im­mune tol­er­ance.

“We are ex­cit­ed to part­ner with Gink­go and ex­pect that our Imm­TOR tech­nol­o­gy, in com­bi­na­tion with Gink­go’s high through­put en­zyme dis­cov­ery, de­sign, and screen­ing ca­pa­bil­i­ties will bring us one step clos­er to im­prov­ing the sus­tained ef­fi­ca­cy of nov­el bi­o­log­ic ther­a­peu­tics,” Se­lec­ta CEO Carsten Brunn said in a state­ment.

At the be­gin­ning of the month, Take­da shelled out an undis­closed amount up­front and more than $1.1 bil­lion in biobucks to li­cense Se­lec­ta’s Imm­TOR plat­form for its two undis­closed gene ther­a­pies for lyso­so­mal stor­age dis­or­ders. While it isn’t clear which tar­gets Se­lec­ta and Gink­go are pur­su­ing, the com­pa­nies said they’re look­ing at or­phan and rare dis­eases. — Nicole De­Feud­is 

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

KEY POINTS

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.