Thomas Willemsen, Tessa Therapeutics CEO

Flush with $126M raise, Tes­sa Ther­a­peu­tics woos new CEO from Take­da

Af­ter some repo­si­tion­ing — and a $126 mil­lion fi­nanc­ing round to take it down that di­rec­tion — Sin­ga­pore’s Tes­sa Ther­a­peu­tics has found a new cap­tain to steer the ship.

Thomas Willem­sen is jump­ing from Take­da, where he was most re­cent­ly SVP, Asia-Pa­cif­ic, to spear­head Tes­sa’s dri­ve to de­vel­op new CAR-T ther­a­pies, in­clud­ing both au­tol­o­gous and off-the-shelf ones.

As pres­i­dent and CEO, Willem­sen will be in charge of “cor­po­rate, busi­ness and de­vel­op­ment strat­e­gy,” the com­pa­ny added.

John Ng

John Ng, who served as in­ter­im CEO, will now re­turn to his po­si­tion as chief tech­ni­cal of­fi­cer.

Found­ed in 2012 with roots that ex­tend all the way to Bay­lor Col­lege of Med­i­cine, Tes­sa was orig­i­nal­ly bank­ing on the idea that it can cre­ate a new class of T cell ther­a­pies against can­cer by adapt­ing virus-spe­cif­ic T cells to tar­get vi­ral­ly-as­so­ci­at­ed tu­mors like cer­vi­cal and head and neck can­cer — open­ing up new ground in sol­id tu­mors.

Tes­sa took that idea all the way to Phase III with a lead pro­gram, TT10, that was ul­ti­mate­ly side­lined by less-than-stel­lar re­sults. Along the way, the biotech has al­ready ro­tat­ed through a cou­ple CEOs — with Jeff Buchal­ter re­plac­ing co-founder An­drew Khoo be­fore Ng was tapped for the job.

John Con­nol­ly was once Tes­sa’s lead sci­en­tist, but he left to be­come the CSO at the Park­er In­sti­tute, which, per­haps not so co­in­ci­den­tal­ly, had backed Tes­sa a few years ago.

The fo­cus has now shift­ed to a make-or-break study of its au­tol­o­gous CD30-CAR-T ther­a­py called TT11, a drug for clas­si­cal Hodgkin lym­phoma. The goal, Ng pre­vi­ous­ly told End­points News, is to reach in­ter­im analy­sis for a piv­otal tri­al around 2024.

But the work on virus-spe­cif­ic T cells isn’t over. There’s al­so an al­lo­gene­ic CD30.CAR EBVST ther­a­py — TT11X — that us­es virus-spe­cif­ic T cells aug­ment­ed with CD30-CAR.

For sol­id tu­mors the com­pa­ny has TT16, a com­bi­na­tion of virus-spe­cif­ic T cells and an on­colyt­ic virus that is tar­get­ing HER2.

In ad­di­tion to the hard-earned ex­pe­ri­ence, Tes­sa can al­so boast of its own be­spoke man­u­fac­tur­ing op­er­a­tions, a big fea­ture at a num­ber of the cell ther­a­py com­pa­nies out there.

“Tes­sa is at the fore­front of de­vel­op­ing the next gen­er­a­tion of CAR-T ther­a­pies, in­clud­ing our al­lo­gene­ic ‘off-the-shelf’ EBVST tech­nol­o­gy, which has demon­strat­ed very en­cour­ag­ing safe­ty and ef­fi­ca­cy da­ta in the on­go­ing Phase 1/2 clin­i­cal tri­al in CD30 pos­i­tive lym­phomas,” Willem­sen said in a state­ment.

Willem­sen has spent much of his ca­reer build­ing up what’s usu­al­ly known as “rest of world” for Big Phar­ma. Be­fore Take­da, he was VP of on­col­o­gy for GSK’s in­ter­con­ti­nen­tal & emerg­ing mar­kets busi­ness, and pri­or to that he was chair­man and gen­er­al man­ag­er for GSK in Chi­na. But it was Mer­ck KGaA that first brought him to Asia, paving the way for the com­mer­cial theme that’s dom­i­nat­ed his work since then.

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.

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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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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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.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

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.

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.”