Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Hav­ing served in Afghanistan, the navy vet­er­an lead­ing Cal­i­for­nia-based Epi­cen­tRx wants to leave no pa­tient be­hind with his ar­se­nal of an­ti-can­cer drugs. On Thurs­day, the com­pa­ny was giv­en a $35 mil­lion boost to fur­ther its mis­sion.

The in­jec­tion of funds will be used to shep­herd its late-stage CD47 drug, RRx-001, to the FDA for mar­ket­ing, and its on­colyt­ic virus pro­gram in­to the clin­ic.

RRx-001, en­gi­neered as an agent that makes tu­mor cells more sen­si­tive to ther­a­py, is in a Phase III tri­al in com­bi­na­tion with chemother­a­py for use in third-line and be­yond small cell lung can­cer (SCLC). The drug has been grant­ed or­phan drug des­ig­na­tion from FDA for SCLC, neu­roen­docrine can­cer and glioblas­toma.

In a 26-pa­tient open-la­bel mid-stage study pre­ced­ing the piv­otal SCLC study, treat­ment with the RRx-001/chemother­a­py com­bo helped pa­tients live longer (over­all sur­vival) by 8.6 months and kept their can­cer at bay (pro­gres­sion-free sur­vival) for 7.5 months. In con­trast, the OS and PFS for third-line line SCLC are re­port­ed in the lit­er­a­ture as 4.7 months and less than two months, re­spec­tive­ly, the com­pa­ny said.

Bryan Oron­sky Epi­cen­tRx

Hit­ting the “don’t eat me” CD47 re­cep­tor tar­get has gal­va­nized an army of drug de­vel­op­ers who want to make in­roads in the bur­geon­ing field of can­cer im­munother­a­py by off­set­ting im­muno­sup­pres­sion. A pletho­ra of drug de­vel­op­ers in­clud­ing Alexo Ther­a­peu­tics, Arch On­col­o­gy, Au­ri­gene, BliNK Bio­med­ical, Cel­gene, Forty Sev­en, Novim­mune, OSE Im­munother­a­peu­tics, Sor­ren­to, Syn­thon Hold­ing and Tril­li­um Ther­a­peu­tics, are de­vel­op­ing CD47 an­tag­o­nists in the hope of scram­bling the “don’t eat me” sig­nal that can­cer cells are de­pen­dent on to evade macrophages.

Epi­cen­tRx’s drug is de­rived from a com­pound used in rock­et fu­el. Its de­vel­op­ment was an­chored in faith that it was non-tox­ic, even when its ben­e­fits were un­known — giv­en that mil­i­tary agen­cies in the US have con­duct­ed risk as­sess­ments to eval­u­ate the po­ten­tial threat of det­o­nat­ing ni­troge­nous com­bustibles in the at­mos­phere to the health of hu­mans, live­stock, wildlife, and ecosys­tems, the com­pa­ny’s chief med­ical of­fi­cer Bryan Oron­sky not­ed in a study pub­lished in 2016.

Tony Reid Epi­cen­tRx

The com­pa­ny’s on­colyt­ic virus plat­form was in-li­censed via its Chief Sci­en­tif­ic Of­fi­cer and UCSD pro­fes­sor of med­i­cine Tony Reid.

Virus­es are a pesky pathogen that have been im­pli­cat­ed in the de­vel­op­ment of liv­er, cer­vi­cal and head and neck can­cer — but mod­i­fied ver­sions of the par­a­site can be used to at­tack tu­mors. These on­colyt­ic virus­es work by spot­light­ing tu­mor cells as tar­gets. Once in­ject­ed, they prop­a­gate pri­mar­i­ly through can­cer cells elic­it­ing the body’s nat­ur­al im­mune re­sponse to snuff the virus, and their home, the can­cer cells.

In 2015, the FDA ap­proved its first on­colyt­ic virus ther­a­py, Am­gen’s Im­ly­g­ic for melanoma pa­tients. In re­cent years, big phar­ma has been in­tox­i­cat­ed with the po­ten­tial of this class of ther­a­pies, with As­traZeneca, Mer­ck, Boehringer In­gel­heim, Bris­tol-My­ers Squibb, and J&J all sign­ing pacts to de­vel­op on­colyt­ic virus drugs.

Corey Carter Epi­cen­tRx

En­hanced with var­i­ous bits of ther­a­peu­tic DNA or trans­genes, Epi­cen­tRx’s first on­colyt­ic virus pro­gram is de­signed to prime the ef­fi­ca­cy of ex­ist­ing im­munother­a­pies. Its sec­ond pro­gram, per­son­al­ized can­cer vac­cines equipped with pa­tient-spe­cif­ic neoanti­gens, is set for the clin­ic in 2020.

Launched in 2002, the La Jol­la-based com­pa­ny has so far raised rough­ly $77 mil­lion in ven­ture cap­i­tal. The lat­est round of Se­ries D fi­nanc­ing was fur­nished by undis­closed Eu­ro­pean pri­vate fi­nanc­ing sources.

“This fi­nanc­ing val­i­dates the po­ten­tial and unique­ness of our two com­ple­men­tary an­ti­cancer plat­forms, which re­pro­gram both arms of the im­mune sys­tem, in­nate and adap­tive, to seek out and de­stroy can­cer cells,” chief Corey Carter said in a state­ment.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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