William Bonificio, ValenzaBio chief strategy officer (ValenzaBio)

Valen­z­aBio's on­col­o­gy is­land of mis­fit toys snares $70M af­ter toil­ing be­hind the scenes for months

David Maizen­berg’s imag­i­na­tion sparked when he came across a mon­o­clon­al an­ti­body from Can­cer Re­search UK’s re­ject pile.

The CD19-tar­get­ing mAb, orig­i­nal­ly dis­cov­ered by Mer­ck Serono, didn’t per­form as well as the or­ga­ni­za­tion hoped against B cell ma­lig­nan­cies. But it could have val­ue, Maizen­berg hy­poth­e­sized, in au­toim­mune dis­ease.

The life sci­ences con­sul­tant and mar­keter en­tered talks with Can­cer Re­search UK in the sum­mer of 2019 about li­cens­ing the can­di­date — and in De­cem­ber, he and Patrick Crutch­er (a for­mer as­so­ciate of Mar­tin Shkre­li) launched Valen­z­aBio to “find a bet­ter home” for for­mer on­col­o­gy can­di­dates in au­toim­mune and in­flam­ma­to­ry in­di­ca­tions.

The com­pa­ny kept qui­et for the most part, un­til burst­ing on­to the scene on Thurs­day with a hefty $70 mil­lion Se­ries A round and plans to take their lead can­di­date — now called VB119 — in­to the clin­ic this quar­ter.

The com­pa­ny is pur­su­ing an OK in mem­bra­nous nephropa­thy, a dis­or­der where the body’s im­mune sys­tem at­tacks the fil­ter­ing mem­branes in the kid­ney. Valen­z­aBio plans on ini­ti­at­ing an open-la­bel Phase Ib/IIa study this quar­ter, as well as sub­mit­ting a clin­i­cal tri­al ap­pli­ca­tion in the UK.

“MN can lead to dis­abling and, in some cas­es, life-threat­en­ing com­pli­ca­tions for pa­tients; and giv­en the lack of any FDA-ap­proved ther­a­pies to­day, VB119 has an op­por­tu­ni­ty to im­pact the lives of pa­tients with this rare dis­ease,” CSO Stephen Thomas said in a state­ment.

Valen­z­aBio’s sec­ond can­di­date, VB421, which it li­censed from Pierre Fab­re in March, is a mAb di­rect­ed to in­sulin-like growth fac­tor 1 re­cep­tor (IGF-1R) in de­vel­op­ment for thy­roid eye dis­ease. It’s de­signed to bind to IGF-1R, which when over­ex­pressed or ac­ti­vat­ed with­in or­bital fi­brob­lasts is be­lieved to have a hand in the pro­gres­sion of TED. That one’s head­ed to the clin­ic in the first half of 2022, Maizen­berg said.

The com­pa­ny de­clined to re­lease the fi­nan­cial terms of ei­ther li­cens­ing deal.

“The com­pa­ny has al­ways been dri­ven by oth­er as­sets,” chief strat­e­gy of­fi­cer William Bonifi­cio said, adding that they’re con­stant­ly look­ing for new things. “We’re drug hunters at our core.”

The Se­ries A was led by Fi­deli­ty Man­age­ment & Re­search Com­pa­ny and Ikar­i­an Cap­i­tal, with help from Sur­vey­or Cap­i­tal, Janus Hen­der­son In­vestors and Opal­eye Man­age­ment. Pierre Fab­re will al­so take an eq­ui­ty stake in the com­pa­ny as part its re­cent li­cense agree­ment.

Cor­rec­tion: The round was led by Fi­deli­ty and Ikar­i­an. 

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.

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.

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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.

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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.

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.

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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.

UK gov­ern­ment, pri­vate in­vestors dole out $340M+ to drug, di­ag­nos­tic man­u­fac­tur­ers

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.

Kourosh Davarpanah, Inato CEO

Big Phar­ma-part­nered clin­i­cal tri­al match­mak­er se­cures $20M to im­prove plat­form

A company with public links to Sanofi and Moderna has raised more money to expand its mission of improving diversity and enrollment in clinical trials.

Inato put the word out on Wednesday that it raised $20 million via an A2 round to advance its matching platform between pharma companies and potential clinical trial sites.

Inato CEO Kourosh Davarpanah told Endpoints News that with the $20 million in hand, it will pursue improvements to its diversity offerings, its focus on oncology and data collection.

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.”