Andy Scharenberg, Michael Jensen

MPM, DCVC Bio back $53M round for a bold con­cept: Let pa­tients make their own CAR-T in vi­vo

The oner­ous process of mak­ing a per­son­al­ized CAR-T — one that in­volves ex­tract­ing cells from pa­tients, en­gi­neer­ing and then in­ject­ing them back — is one of the defin­ing fea­tures of the first gen­er­a­tion of en­gi­neered cell ther­a­pies. It’s part­ly why the treat­ments are so ex­pen­sive; it’s al­so an in­spi­ra­tion for new al­lo­gene­ic ap­proach­es that promise to be faster and cheap­er.

But a biotech start­up in Seat­tle wants to go fur­ther.

Umo­ja Bio­phar­ma is start­ing out with $53 mil­lion in Se­ries A cash to test whether a lentivi­ral vec­tor de­liv­ered di­rect­ly in vi­vo can gen­er­ate a pop­u­la­tion of T cells that ex­pand and fight can­cer just as well as the ex­ter­nal­ly man­u­fac­tured ones do.

“So we don’t ac­tu­al­ly have to man­u­fac­ture the cells,” co-founder and CEO Andy Scharen­berg told End­points News. “We’re gonna be ef­fec­tive­ly mak­ing a com­plex bi­o­log­ic.”

Scharen­berg, who’s ex­plored mul­ti­ple ways to do gene trans­fer through the years at places like Cel­lec­tis and Gen­er­a­tion Bio, high­light­ed the “in­cred­i­ble safe­ty record” of lentivi­ral vec­tors and their abil­i­ty to not just trans­duce but al­so in­te­grate the ge­nom­ic pay­load in­to daugh­ter cells. Be­cause the re­sult­ing CAR-T would ex­pand in a way that repli­cates a nat­ur­al im­mune re­sponse, he al­so fore­sees few of the side ef­fects, such as cy­tokine re­lease syn­drome, that pa­tients ex­pe­ri­ence with Kym­ri­ah and Yescar­ta.

A sec­ond tech­nol­o­gy uti­lizes small mol­e­cules to con­trol and tune these self-gen­er­at­ed CAR-T cells fol­low­ing a sin­gle ad­min­is­tra­tion. And Umo­ja has lined up an ad­di­tion­al tech plat­form to push it in­to sol­id tu­mors by tag­ging can­cer cells for recog­ni­tion by T cells.

Bring­ing all three ap­proach­es and the re­spec­tive ex­perts un­der the same roof is a key idea be­hind Umo­ja — a Swahili word for “uni­ty.”

“In many ways the sci­en­tif­ic con­cept un­der­ly­ing the com­pa­ny is a lit­tle bit sum­ma­rized in that word,” Scharen­berg said. “In or­der to have a re­al­ly im­pact­ful ap­proach to ad­vanc­ing im­munother­a­pies, you need to in­te­grate mul­ti­ple tech­nol­o­gy plat­forms.”

Philip Low

With Michael Jensen of Seat­tle Chil­dren’s and Philip Low of Pur­due Uni­ver­si­ty on board as co-founders, Umo­ja plans to pur­sue par­al­lel de­vel­op­ment paths for the in vi­vo gene de­liv­ery and tu­mor tag tech­nolo­gies, which the CEO de­scribes as two sides of the same coin. Jensen will lead a col­lab­o­ra­tion to eval­u­ate the tu­mor tag ap­proach among chil­dren with os­teosar­co­ma in the com­ing year. Mean­while, Umo­ja will get ready to put its ini­tial CAR-T hit­ting a fa­mil­iar tar­get — CD19 — in the clin­ic.

If “things go re­al­ly well,” Scharen­berg sees the com­pa­ny stack­ing the two ap­proach­es for a more po­tent ef­fect in the 2023, 2024 time frame.

MPM Cap­i­tal and DCVC Bio seed­ed the com­pa­ny, with Qim­ing Ven­ture Part­ners USA join­ing to co-lead the Se­ries A.

As cel­lu­lar im­munother­a­pies grad­u­al­ly move from their cur­rent ap­pli­ca­tions to­ward the front­line — some­thing Scharen­berg en­vi­sions — he sees the scale and ac­ces­si­bil­i­ty be­ing his com­pa­ny’s key mantra.

“When we think about what Umo­ja as­pires to be as an or­ga­ni­za­tion, it’s not on­ly to ad­vance and make im­munother­a­pies that are more ef­fec­tive against all tu­mors,” he said, “but al­so to make them ac­ces­si­ble and to al­le­vi­ate some of the eco­nom­ic tox­i­c­i­ties that are as­so­ci­at­ed with the cost of some of the cur­rent ther­a­pies as well.”

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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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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