Apollon Papadimitriou, iOmx CEO

iOmx re­fu­els with $75M+ on its search for im­mune check­point tar­gets on tu­mor cells

While a big chunk of on­col­o­gy re­search is fo­cused on tar­get­ing T-cell reg­u­la­tors to stamp out can­cer, iOmx Ther­a­peu­tics is hom­ing in on im­mune check­point tar­gets on tu­mor cells — and it’s just re­ceived an­oth­er $75.3 mil­lion to fu­el their push to­ward the clin­ic.

iOmx un­veiled the €65 mil­lion Se­ries B round on Tues­day morn­ing, rough­ly five years af­ter emerg­ing from stealth. The new cash will help the start­up put its first can­di­date, an SIK3 ki­nase in­hibitor called IMT-07, in the clin­ic late next year for sol­id tu­mors.

Right be­hind that pro­gram is an IGSF11-tar­get­ing an­ti­body to treat PD-1/PD-L1-re­sis­tant tu­mors, which is al­so in the lead op­ti­miza­tion stage, ac­cord­ing to iOmx’s web­site.

“Us­ing our iO­Targ plat­form, we have pre­vi­ous­ly iden­ti­fied two nov­el im­mune-check­point mol­e­cules ex­pressed by can­cer cells, SIK3 and IGSF11, and shown that block­ing these tar­gets with our pro­pri­etary drug can­di­dates has an­ti-tu­mor ef­fects and the po­ten­tial to treat tu­mors that can­not oth­er­wise be ad­dressed by ex­ist­ing im­mune ther­a­pies,” CEO Apol­lon Pa­padim­itri­ou said in a state­ment.

Pa­padim­itri­ou was tapped as CEO back in 2019, tak­ing the reins from Se­bas­t­ian Meier-Ew­ert, who gave up his job as a man­ag­ing part­ner at MPM Cap­i­tal to take the lead at iOmx. Meier-Ew­ert is now at Roscue Ther­a­peu­tics, ac­cord­ing to his LinkedIn. Be­fore tak­ing the helm, Pa­padim­itri­ou was iOmx’s chief de­vel­op­ment of­fi­cer for two years.

The biotech isn’t say­ing much about its pro­grams for now. But ac­cord­ing to its web­site, there’s al­so a third can­di­date (an undis­closed mon­o­clon­al an­ti­body) in the works.

iOmx co-founder Philipp Beck­hove did much of the com­pa­ny’s foun­da­tion re­search while work­ing at the Ger­man Can­cer Re­search Cen­ter in Hei­del­berg and is now at the RCI Re­gens­burg Cen­ter for In­ter­ven­tion­al Im­munol­o­gy. The com­pa­ny’s screen­ing plat­form was de­vel­oped by co-founder Nisit Khan­del­w­al, SVP of re­search. Al­so among the com­pa­ny’s co-founders are Patrick Baeuer­le, who’s laud­ed as a pi­o­neer in the bis­pe­cif­ic space; and El­mar Maier, cur­rent CEO at EM Biotech.

“In the vi­tal world of can­cer im­munother­a­py, iOmx’s plat­form tech­nol­o­gy stands out be­cause it screens for nov­el drug­gable im­mune check­point tar­gets on tu­mor cells in­stead of T cells, there­by al­low­ing the de­vel­op­ment of drugs that can pre­vent tu­mor im­mune eva­sion,” said Matthias Kro­may­er, man­ag­ing part­ner at MIG Cap­i­tal, which co-led the Se­ries B round.

Athos Ser­vice (the Strüng­mann fam­i­ly of­fice) al­so helped lead the round, and Welling­ton Part­ners, Sofinno­va Part­ners and M Ven­tures chipped in.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Saqib Islam, SpringWorks CEO

Pfiz­er spin­out Spring­Works will ship its first drug to the FDA be­fore year’s end with PhI­II win

SpringWorks Therapeutics thinks it has cemented the backbone for its first “pipeline-in-a-product” oncology treatment and will send it to the FDA before the clock strikes 2023 with a Phase III win on Tuesday.

The oral gamma secretase inhibitor, dubbed nirogacestat, beat placebo on the primary goal of progression-free survival in adults with progressing desmoid tumors.

The soft-tissue tumors can lead to long-lasting pain, disfigurement and amputation, and there are currently no approved meds for the rare oncology indication. The tumors typically impact patients aged 20 to 44 years old and disproportionately affect women at rates 2 to 3 times higher, with up to a total of 1,650 new cases diagnosed in the US annually, according to SpringWorks.

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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