Michael Heffernan, Avenge Bio CEO

Tak­ing notes from MD An­der­son and Rice Uni­ver­si­ty, Avenge Bio un­cloaks with $45M and a slate of im­munother­a­pies

Omid Veiseh

Michael Hef­fer­nan was al­ready the head of a biotech com­pa­ny fo­cused on chron­ic pain, called Col­legium Phar­ma­ceu­ti­cal, which he suc­cess­ful­ly brought pub­lic in 2015. But when his wife was di­ag­nosed with ovar­i­an can­cer, he knew that was his next mis­sion.

Hef­fer­nan’s wife is do­ing well — but un­for­tu­nate­ly, that isn’t the case for most pa­tients, he said. In 2018, he stepped down from Col­legium to look for a bet­ter op­tion for women with re­cur­rent re­frac­to­ry ovar­i­an can­cer. That’s when he met Rice Uni­ver­si­ty’s Omid Veiseh, who was work­ing on an im­munother­a­py plat­form with a physi­cian over at The Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter.

On Wednes­day, Hef­fer­nan, Veiseh and their col­league Paul Wot­ton (who’s al­so CEO of Ob­sid­i­an Ther­a­peu­tics) un­veiled a new com­pa­ny around the tech­nol­o­gy called Avenge Bio, equipped with $45 mil­lion in Se­ries A cash and a lead can­di­date ready for the clin­ic.

Paul Wot­ton

“The rea­son I got in­ter­est­ed in this is there were some da­ta in the lit­er­a­ture that was ex­plained to me by the folks at MD An­der­son and Omid from back in the 90s, out of the Uni­ver­si­ty of Pitts­burgh,” said Hef­fer­nan, who has tak­en the helm at Avenge.

A few decades ago, pro­fes­sor Robert Ed­wards used re­com­bi­nant Pro­leukin IL-2, and in­fused it in­to the peri­toneal cav­i­ties of women with re­frac­to­ry re­cur­rent ovar­i­an can­cer us­ing an in­dwelling catheter over 16 weeks.

“It was a very cum­ber­some process, not a very user-friend­ly process, but he got some re­al­ly dra­mat­ic re­sults,” Hef­fer­nan said. “It nev­er be­came stan­dard of care be­cause of how dif­fi­cult it is to do that type of a pro­ce­dure.”

Avenge Bio’s lead can­di­date, AVB-001, takes a slight­ly dif­fer­ent ap­proach. The plat­form, dubbed LO­CO­cyte, be­gins with an al­lo­gene­ic hu­man cell line re-en­gi­neered to pro­duce im­munomod­u­la­tors. AVB-001, for in­stance, pro­duces IL-2.

“We ac­tu­al­ly are able to, through a hu­man cell line, cre­ate hu­man na­tive IL-2,” Hef­fer­nan said. “We en­cap­su­late these cells, and then we im­plant them in prox­im­i­ty to the tu­mor.”

In the case of ovar­i­an can­cer pa­tients, that’s in the peri­toneal cav­i­ty. While the im­plant­ed cells are pro­tect­ed by the en­cap­su­la­tion, they be­come fac­to­ries, pro­duc­ing high lev­els of IL-2 for 15 to 30 days in the peri­toneal cav­i­ty.

“The IL-2 is not in the sys­temic cir­cu­la­tion where a lot of the tox­i­c­i­ty oc­curs,” he added, not­ing that you get a cor­re­spond­ing sys­temic im­mune re­sponse, while avoid­ing the tox­i­c­i­ties as­so­ci­at­ed with sys­temic ex­po­sure.

AVB-001 should be in the clin­ic in mid-2022, ac­cord­ing to Hef­fer­nan. They’re al­so ex­plor­ing a pipeline of can­di­dates be­hind IL-2 (in­clud­ing an IL-12 and an IL-15), all based on the tech­nol­o­gy ex­clu­sive­ly li­censed from Rice. In the fu­ture, they may ex­pand AVB-001 to tar­get lung can­cers, in­clud­ing mesothe­lioma. AVB-002, the IL-12, will ad­dress oth­er peri­toneal can­cers, in­clud­ing pan­cre­at­ic can­cer.

One of the Holy Grails in im­muno-on­col­o­gy over the last few years has been find­ing an IL-2 drug that can be used safe­ly and ef­fec­tive­ly to com­bat can­cer, sans the tox­i­c­i­ty that large­ly side­lined the orig­i­nal IL-2 Pro­leukin. Anaveon raked in $119 mil­lion just last month to see its own can­di­date in­to a se­ries of Phase II tri­als — and it’s not the on­ly IL-2-fo­cused com­pa­ny to swing a megaround in the last year or so.

Ovar­i­an can­cer of­ten goes un­de­tect­ed un­til it has spread with­in the pelvis and bel­ly, at which time it’s more dif­fi­cult to treat. Women who are di­ag­nosed ear­li­er have much high­er five-year sur­vival rates, but on­ly about 15% of pa­tients are di­ag­nosed ear­ly, ac­cord­ing to the Ovar­i­an Can­cer Re­search Al­liance.

The Se­ries A round — co-led by Per­cep­tive Xon­toge­ny and CAM Cap­i­tal, with par­tic­i­pa­tion from seed in­vestor Lon­gi­tude Cap­i­tal and new in­vestors Rock Springs Cap­i­tal and Pap­pas Cap­i­tal — should fund the en­tire Phase I study for AVB-001, and al­low the roughy eight- to 10-per­son team in Nat­ick, MA to grow the pipeline.

As for the name Avenge Bio? It re­flects the “per­son­al na­ture of the mis­sion,” Hef­fer­nan said: “To treat hard-to-treat sol­id tu­mors.”

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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