Shreds of Tregs: French biotech wins Medicxi back­ing to kill the rogue im­muno­sup­pres­sive agent to fight can­cer

Ex­ist­ing CD25 drugs tend to thwart IL-2 sig­nal­ing, which is im­per­a­tive to shap­ing the body’s im­mune re­sponse. But a French drug de­vel­op­er thinks it has found a way to snuff out reg­u­la­to­ry T cells (known to con­tribute to the ear­ly es­tab­lish­ment and pro­gres­sion of tu­mors) by tar­get­ing CD25 with­out dis­turb­ing IL-2, and now has €18.5 mil­lion in its cof­fers to prove it.

Ar­naud Fous­sat

The Parisian com­pa­ny, Alder­aan Biotech­nol­o­gy, is still very ear­ly in its jour­ney. The Se­ries A round of fund­ing from Ad­vent France Biotech­nol­o­gy (AFB) and Medicxi will be used to com­plete the pre­clin­i­cal de­vel­op­ment of its reg­u­la­to­ry T cell (Tregs) de­plet­ing CD25-spe­cif­ic an­ti­body and take it in­to the clin­ic by 2022.

An un­shack­led im­mune sys­tem can be as dan­ger­ous as a weak one. Tregs are de­signed to po­lice the im­mune sys­tem in­to work­ing as need­ed, but on the flip side, in the tu­mor mi­croen­vi­ron­ment, they con­tribute to dis­ease pro­gres­sion by sup­press­ing the body’s im­mune re­sponse. CD25 is not on­ly a mark­er for Tregs but is al­so key for the main­te­nance and func­tion of these cells. Mean­while, along with CD122 and CD132, CD25 forms the high-affin­i­ty re­cep­tor for in­ter­leukin(IL)-2, which is a growth fac­tor for T cells.

“What we’re do­ing with our an­ti­body is that we tar­get CD25 in a way that can kill reg­u­la­to­ry T cells in the tu­mor, so there is an elim­i­na­tion of those Tregs that are known to be im­muno­sup­pres­sive — but since our an­ti­bod­ies have the speci­fici­ty to spare the IL-2 re­cep­tor, it does not block IL-2 sig­nal­ing,” chief Ar­naud Fous­sat ex­plained in an in­ter­view with End­points News.

“This is crit­i­cal be­cause the old CD25 an­ti­bod­ies (such as Roche’s da­clizum­ab and No­var­tis’ Simulect) that have been de­vel­oped — they are block­ing IL-2, which means they are an­ti-in­flam­ma­to­ry by na­ture, and this is not good for on­col­o­gy.”

The ap­proach sounds a lot like the one tak­en by the British biotech, Tusk Ther­a­peu­tics, which was swal­lowed by Roche in 2018.

Alder­aan, which al­so has an even ear­li­er stage as­set de­signed to boost nat­ur­al killer (NK) cell cy­to­tox­ic ac­tiv­i­ty in can­cer, was found­ed in 2017. That year, it re­ceived €1.5 mil­lion in seed fund­ing in a round led by AFB.

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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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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