Sumant Ramachandra, ImmPACT Bio CEO

Next-gen CAR-T play­er steps on the gas with a $111M boost and a pos­i­tive glimpse at ear­ly da­ta

Though Imm­PACT Bio was tech­ni­cal­ly found­ed in Is­rael back in 2017, in­com­ing CEO Sumant Ra­machan­dra says the com­pa­ny was re­born last year when it merged with UCLA spin­off Kalthera. Now, with $111 mil­lion more to work with, the new chief ex­ec­u­tive is step­ping on the gas.

Imm­PACT Bio un­veiled a mas­sive Se­ries B round ear­ly Thurs­day morn­ing, along with a C-suite shake­up and a first glimpse at some Phase I da­ta. Sev­en of eight pa­tients with re­lapsed or re­frac­to­ry B cell non-Hodgkin’s lym­phoma giv­en the com­pa­ny’s lead can­di­date — a CD19/CD20 bis­pe­cif­ic CAR-T — achieved com­plete re­mis­sion af­ter a me­di­an fol­low-up of 12 months, Ra­machan­dra said.

Sheila Gu­jrathi

Ex­ecs are al­ready plot­ting a piv­otal Phase II launch some­time in 2023. Ra­machan­dra is lead­ing the charge as Imm­PACT’s fresh­ly tapped CEO, while for­mer CEO Rick Kendall moves over to the CSO spot. And Sheila Gu­jrathi — Or­biMed ven­ture ad­vi­sor and for­mer Gos­samer Bio CEO  —  is the new board chair.

“Dur­ing my PhD I worked on B cell, chron­ic lym­pho­cyt­ic leukemia, so this was a bit like com­ing home,” Ra­machan­dra said.

Be­fore this, he was chief sci­ence, tech­nol­o­gy, and med­ical of­fi­cer at Bax­ter In­ter­na­tion­al. Part of what drew him to Imm­PACT was the com­pa­ny’s bis­pe­cif­ic CAR-T, which showed signs of ef­fi­ca­cy ear­ly on.

“You’re see­ing the per­sis­tence of these CAR-T cells, you are see­ing a per­sis­tence in CR, so for me, this was un­usu­al. But what was even more un­usu­al oth­er than ef­fi­ca­cy and dura­bil­i­ty was the tol­er­a­bil­i­ty da­ta was very dif­fer­ent than any oth­er ther­a­py out there in the CAR-T space,” Ra­machan­dra said.

So far, the can­di­date has shown a fa­vor­able tol­er­a­bil­i­ty pro­file, with no treat­ment-emer­gent neu­ro­tox­i­c­i­ty and no cy­tokine re­lease syn­drome cas­es high­er than Grade 1.

The im­mune sys­tem rec­og­nizes for­eign sub­stances in the body by search­ing for pro­teins called anti­gens on the sur­face of cells. T cell re­cep­tors at­tach to the for­eign anti­gens, trig­ger­ing an im­mune re­sponse to de­stroy the for­eign sub­stance. CAR-Ts are de­signed to help T cells bet­ter iden­ti­fy spe­cif­ic can­cer anti­gens, such as CD19 or CD20. But ac­cord­ing to Ra­machan­dra, a ma­jor cause of re­lapse is CD19 anti­gen loss af­ter treat­ment with CAR-T ther­a­py.

Imm­PACT Bio is look­ing to get around that with a dual-tar­get­ed CAR-T that rec­og­nizes both CD19 and CD20, two anti­gens present on B cell lym­phoma. This isn’t the first time re­searchers have con­sid­ered the use of a dual CAR — but Ra­machan­dra thinks his can­di­date’s dura­bil­i­ty and tol­er­a­bil­i­ty are where it will stand out.

Right be­hind it are two pre­clin­i­cal can­di­dates — an ac­ti­va­tor/in­hibitor CAR pro­gram and a TGF-β CAR pro­gram — that are ex­pect­ed to hit the clin­ic in 2023 and 2024, though Ra­machan­dra says the com­pa­ny isn’t yet sure which will come first.

Imm­PACT’s roots trace back to the Fu­tuRx in­cu­ba­tor in Ness Ziona, Is­rael, and Mi­gal Re­search In­sti­tute pro­fes­sor Gideon Gross, who was set on de­vel­op­ing new strate­gies for tar­get­ing sol­id tu­mors. The com­pa­ny even­tu­al­ly moved to the US, and this past Ju­ly merged with Kalthera, a UCLA spin­off found­ed by Yvonne Chen, An­toni Ribas, Cristi­na Puig Saus and Jim John­ston.

In­clud­ing the Se­ries B, Imm­PACT has raised around $145 mil­lion so far, a ma­jor­i­ty of which will be used to fund the on­go­ing clin­i­cal tri­al and to set up a man­u­fac­tur­ing fa­cil­i­ty in West Hills, Los An­ge­les. Ra­machan­dra al­so wants to grow the rough­ly 25-per­son team to 80 by the end of the year.

Ven­Bio Part­ners led the round, along with co-leads Fore­site Cap­i­tal and Decheng Cap­i­tal. Sur­vey­or Cap­i­tal, Or­biMed, the No­var­tis Ven­ture Fund, RM Glob­al Part­ners (RMGP), and Buk­wang Phar­ma­ceu­ti­cal al­so chipped in.

When asked if a pub­lic de­but is in the near fu­ture, Ra­machan­dra said the team is con­sid­er­ing a po­ten­tial win­dow late this year or ear­ly next year.

“If the mar­kets are re­cep­tive, that is one av­enue,” he said. “If that win­dow is open and we have suf­fi­cient da­ta and mo­men­tum to go in­to pub­lic space, we will do that.”

What hap­pens if the win­dow isn’t open? “We could po­ten­tial­ly go for an­oth­er pri­vate round,” Ra­machan­dra said. “We prob­a­bly will start hav­ing those types of dis­cus­sions to­ward the lat­er part of this year.”

Up­date: Imm­PACT’s two pre­clin­i­cal can­di­dates should be ready for the clin­ic in 2023 and 2024, ac­cord­ing to the com­pa­ny, which has raised $145 mil­lion so far. 

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.

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.

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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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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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.

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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