Rallybio founders (L-R): Jeff Fryer, Martin Mackay and Steve Uden

As Sanofi prunes pipeline, ex-Alex­ion crew at Rally­bio picks up ane­mia drug

More than a year af­ter it bought Kymab for $1.5 bil­lion, Sanofi is get­ting rid of a pre­clin­i­cal pro­gram that came with the deal.

Sanofi has out-li­censed its KY1066 an­ti­body to New Haven, CT-based Rally­bio who has re­dubbed it RLYB331. The deal saw Rally­bio make an up­front cash pay­ment of $3 mil­lion to Sanofi in ad­di­tion to promis­ing de­vel­op­ment and com­mer­cial mile­stones and mid to high sin­gle-dig­it roy­al­ties on net sales.

Rally­bio, which was formed by old Alex­ion ex­ecs, is a clin­i­cal-stage biotech fo­cused on de­vel­op­ing ther­a­pies for pa­tients with se­vere and rare dis­eases. Tues­day’s deal is fair­ly stan­dard for the biotech, as its mod­el is to scout rare dis­ease drugs in acad­e­mia and phar­ma and form a pipeline of drugs to ex­e­cute a quick piv­ot to reg­u­la­tors.

This deal al­so comes as Sanofi re­shapes it­self through di­vest­ments, pipeline prun­ing and launch­ing spin-offs as CEO Paul Hud­son at­tempts to rein­vig­o­rate the com­pa­ny. By the end of this year, the com­pa­ny is look­ing to re­duce its ap­proved drug port­fo­lio to about 125 fran­chis­es, ei­ther by di­vest­ing or dis­con­tin­u­ing pro­grams.

CEO Mar­tin Mack­ay tells End­points News that this an­ti­body has been on Rally­bio’s radar for quite a while. Ac­cord­ing to Mack­ay, RLYB331 can ad­dress se­vere ane­mia with in­ef­fec­tive ery­thro­poiesis and iron over­load, with ap­pli­ca­tions in a range of dis­eases like be­ta-tha­lassemia and a sub­set of myelodys­plas­tic syn­dromes, among oth­ers.

RLYB331 it­self is a mon­o­clon­al an­ti­body that in­hibits Ma­trip­tase-2 (MTP-2), which can in­crease lev­els of an iron-reg­u­lat­ing pep­tide hor­mone. The stan­dard of care for many such hema­to­log­i­cal dis­or­ders leaves some pa­tients with iron over­load-as­so­ci­at­ed ane­mias, which can re­sult in com­pli­ca­tions and even death.

“We see re­al­ly big po­ten­tial here. We’ve worked in rare dis­eases for many years now. And the key thing about work­ing in rare dis­eases is mak­ing sure that the ben­e­fit is tru­ly trans­for­ma­tive,” Mack­ay said. “And we’re not look­ing for an in­cre­men­tal step ben­e­fit here.”

In terms of a time­line to­ward de­vel­op­ment, Mack­ay said that the ob­jec­tive now is just for Rally­bio to ful­ly un­der­stand the an­ti­body, but it does plan to move quick­ly once that is achieved.

Tues­day’s deal comes af­ter Rally­bio brought in sig­nif­i­cant fund­ing over the past sev­er­al years, cul­mi­nat­ing with a $145 mil­lion Se­ries B in 2020.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Tim Miller, Forge Biologics CEO

CNS-fo­cused gene ther­a­py biotech forges man­u­fac­tur­ing deal for hear­ing loss drug

A growing gene therapy company is teaming up with one of the largest gene therapy manufacturers to get its drug into patients in clinical trials.

Myrtelle announced on Monday that it inked a deal with Forge Biologics to make Myr-201, a gene therapy indicated for monogenic hearing loss. The target patient population, Myrtelle said, is people with a type of hearing loss called DFNB8, or autosomal recessive deafness 8.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

Leo Tarkovsky, Fingerpaint Group's new chief commercial officer

Fin­ger­paint Group taps for­mer WPP and Mc­Cann Health ex­ec for new com­mer­cial role

Healthcare agency veteran Leo Tarkovsky has joined Fingerpaint Group as chief commercial officer to oversee its growing portfolio of pharma and healthcare agencies and communications companies.

Tarkovsky came to Fingerpaint from WPP where he was EVP for global healthcare growth over the past year. Before that served at McCann Health for seven years including as president overseeing the New York agencies with pharma clients including AstraZeneca, Bristol Myers Squibb, Eli Lilly and Johnson & Johnson’s Janssen.

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