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. 

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.