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.”

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.