Cell­tri­on teams up with an­oth­er Ko­re­an bio­phar­ma in an­ti­body dis­cov­ery deal

Two Ko­re­an com­pa­nies have signed a joint R&D dis­cov­ery agree­ment, with the po­ten­tial to earn in the nine-fig­ures.

Clin­i­cal-stage bio­phar­ma Genuv has part­nered up with Cell­tri­on to dis­cov­er an­ti­bod­ies us­ing the for­mer’s Shine Mouse plat­form, which they hope could po­ten­tial­ly open up more R&D projects to­geth­er in the fu­ture. There’s no up­front cash, but Genuv will re­ceive mile­stone pay­ments of up to $25 mil­lion if Cell­tri­on de­cides to op­tion a pro­gram in­to the clin­ic, and up to $680 mil­lion in mile­stones per pro­gram if its sales sur­pass $7.5 bil­lion.

Genuv, which is fo­cused on on­col­o­gy and neu­rode­gen­er­a­tive dis­eases, al­ready has sev­er­al an­ti­bod­ies in its pipeline: GNUV205, a tu­mor-spe­cif­ic IL-2-based im­muno­cy­tokine an­ti­cancer drug and an­oth­er an­ti-PD-1 drug can­di­date GNUV201.

Ac­cord­ing to Genuv, the com­pa­ny’s plat­form “gen­er­ates an­ti­bod­ies with greater di­ver­si­ty com­pared to those de­vel­oped with con­ven­tion­al mice.” Genuv has a sec­ond plat­form, Nu­voFc, which en­ables the de­sign and de­vel­ops new bi-/mul­ti-specifics. Genuv is al­so near­ing the com­ple­tion of a third plat­form, Nu­voMab,which di­rect­ly dis­cov­ers hu­man an­ti­bod­ies.

Sung­ho Han

“We are ex­cit­ed to em­bark on our mouse plat­form busi­ness with Cell­tri­on as our first part­ner,” Sung­ho Han, Genuv founder and CEO, said in a state­ment. “We be­lieve Cell­tri­on’s in-depth knowl­edge and ex­pe­ri­ences in an­ti­body de­vel­op­ment and pro­duc­tion and Genuv’s ex­per­tise in nov­el an­ti­body dis­cov­ery with our SHINE MOUSE plat­form could gen­er­ate great syn­er­gies in pro­vid­ing in­no­v­a­tive an­ti­body ther­a­peu­tics.”

Genuv lists sev­en to­tal can­di­dates in its pipeline, in­clud­ing SNR1611, a MEK1/2 in­hibitor in Phase II tri­als for ALS and in the IND-en­abling phase for Alzheimer’s.

Cell­tri­on has been on the ex­pan­sion path over the last sev­er­al years, with an in­vest­ment of $453 mil­lion in 2020 in­to build­ing a new re­search cen­ter and man­u­fac­tur­ing fa­cil­i­ty in its home city of In­cheon, Ko­rea. In 2019, the com­pa­ny blue­print­ed a $514 mil­lion bi­o­log­ics plant in Chi­na.

In 2020, hon­orary chair­man Jung Jin Seo laid out his vi­sion for the com­pa­ny over the next decade with a goal of launch­ing one biosim­i­lar prod­uct every year, reach­ing a to­tal num­ber of 18 prod­ucts by 2030. It ap­pears to be on its way to Seo’s goal with sev­en biosim­i­lars de­scribed on its web­site so far.

In Sep­tem­ber of last year, reg­u­la­tors ap­proved Cell­tri­on’s biosim­i­lar Veg­zel­ma in six can­cer types, the com­pa­ny’s third can­cer biosim­i­lar ap­proved in the US.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.