RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based start­up Gen­tiBio land­ed a $20 mil­lion seed fund from three in­vestors to dive in­to en­gi­neered reg­u­la­to­ry T cell (En­gTreg) de­vel­op­ment.

Mar­quee in­vestors Or­biMed, No­var­tis Ven­ture Fund and RA Cap­i­tal Man­age­ment have backed Gen­tiBio’s mis­sion to de­vel­op En­gTregs for the treat­ment of au­toim­mune, al­loim­mune, au­toin­flam­ma­to­ry, and al­ler­gic dis­eases. Un­like oth­er com­pa­nies study­ing treat­ments us­ing a pa­tient’s own Tregs, Gen­tiBio plans to make use of CD4+ im­mune cells, found in the blood.

Gen­tiBio’s co-founders hail from the  Seat­tle Chil­dren’s Re­search In­sti­tute, Be­naroya Re­search In­sti­tute at Vir­ginia Ma­son (BRI), and MI­GAL Galilee Re­search In­sti­tute (MI­GAL). All three com­pa­nies are now part­ners, and Seat­tle Chil­dren’s has agreed to li­cense its tech­nol­o­gy ex­clu­sive­ly to Gen­tiBio.

Many com­pa­nies have eyed Treg cell ther­a­pies in the last decade, but the rar­i­ty and plas­tic­i­ty of en­doge­nous Treg cells pose a sig­nif­i­cant chal­lenge.

David Rawl­ings

“Tregs are rare cells with­in the im­mune sys­tem and cur­rent ther­a­pies that source Tregs cells from the blood stream can be cost­ly and cum­ber­some. In con­trast, Seat­tle Chil­dren’s unique tech­nol­o­gy en­ables the gen­er­a­tion of en­gi­neered reg­u­la­to­ry T cells, or En­gTregs, from the more abun­dant CD4+ cell pop­u­la­tion, ad­dress­ing a crit­i­cal man­u­fac­tur­ing short­com­ing for this nov­el treat­ment,” David Rawl­ings, Gen­tiBio co-founder and se­nior sci­en­tif­ic ad­vi­sor and di­rec­tor of the Cen­ter for Im­mu­ni­ty and Im­munother­a­pies at Seat­tle Chil­dren’s Re­search In­sti­tute, said in a state­ment.

Adel Na­da

Gen­tiBio co-founder and CEO Adel Na­da added in a state­ment: “Gen­tiBio is fo­cused on ad­dress­ing the tech­ni­cal bot­tle­necks that have throt­tled Treg ther­a­peu­tics, and we are thrilled to ex­clu­sive­ly in-li­cense a port­fo­lio of un­prece­dent­ed breadth from Seat­tle Chil­dren’s and Be­naroya Re­search In­sti­tute in the U.S. and MI­GAL Galilee Re­search In­sti­tute in Is­rael,””The tech­nolo­gies li­censed from these pre­mier re­search in­sti­tu­tions are ma­ture and well-dif­fer­en­ti­at­ed, and will be fur­ther op­ti­mized in spon­sored re­search col­lab­o­ra­tions with the sci­en­tif­ic teams that dis­cov­ered them to ad­vance nov­el and po­tent ther­a­peu­tics with the po­ten­tial to treat and cure se­ri­ous au­toim­mune and in­flam­ma­to­ry dis­eases.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.