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.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Most of the gene therapy world centers around viral vectors, but a few biotechs have sprung up in recent years to try and avoid the safety issues that can come with adeno-associated viruses.

A new biotech has emerged to straddle somewhere “close to the middle,” in the words of Alex Mayweg, Versant managing director and board member of the incubator’s latest startup, Vector BioPharma.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”