Can­cer biotech up­start grabs $18M round, sets out to mas­ter re­lapsed prostate can­cer

Jay Lichter

UC San Fran­cis­co re­searcher Bin Liu has spent years in the lab study­ing how to tack­le prostate can­cer cells. Re­cent­ly, he’s been mak­ing progress on a new re­cep­tor tar­get that he be­lieves can come in­to play as pa­tients start to be­come re­sis­tant to the new ther­a­pies that have hit the mar­ket. And now, Jay Lichter and his crew at Aval­on Ven­tures in San Diego are adding a start­up to the port­fo­lio that will set out to make it a new drug for the field.

The new biotech has been named For­tis Ther­a­peu­tics and it now has an $18 mil­lion start­up round to get in­to busi­ness de­vel­op­ing an­ti­body drug con­ju­gates. Lichter will take the reins on For­tis, run­ning it un­der an um­brel­la or­ga­ni­za­tion that has birthed a wide va­ri­ety of up­start drug de­vel­op­ers over the years.

While Liu has pub­lished sev­er­al stud­ies on his work, in­clud­ing an ex­am­i­na­tion of AR-V7 as a po­ten­tial tar­get for drug re­sis­tant pa­tients, Lichter says that’s not the tar­get they’ll be work­ing with. Liu is about to pub­lish a pa­per on his new tar­get, and they’re keep­ing it un­der wraps un­til it’s out.

The mar­ket op­por­tu­ni­ty is well de­fined. Cas­trate-re­sis­tant prostate can­cer treat­ment has been rev­o­lu­tion­ized over the last few years with the ar­rival of J&J’s Zyti­ga and Medi­va­tion’s — now Pfiz­er’s — ri­val Xtan­di. But they aren’t cures. Pa­tients be­come re­sis­tant to them, and that’s where a new drug like this can step in.

This is well ad­vanced work. UCSF pro­vid­ed a drug can­di­date ready for the clin­ic, and Lichter tells me that the biotech is ramp­ing up pro­grams for prostate can­cer as well as mul­ti­ple myelo­ma, where they see some added promise. There’s al­so mouse da­ta in hand for oth­er can­cers as well.

The plan now is to start with a small dose-es­ca­la­tion study and then ex­pand that, look­ing for some signs of ear­ly ef­fi­ca­cy as they work out dosage and safe­ty is­sues. Lichter runs his own shop, so he can af­ford to be blunt about what he’d like to see hap­pen with For­tis fair­ly ear­ly on.

“The best out­come is some­body buys us for a ton of mon­ey,” says the ven­ture chief.

Bar­ring a sweet deal, he’s al­so open to rais­ing more cash from the syn­di­cate — which now al­so in­cludes Bregua Cor­po­ra­tion, Lil­ly Asia Ven­tures, Os­age Uni­ver­si­ty Part­ners, and Vi­vo Cap­i­tal — and go­ing af­ter a piv­otal tri­al, should the da­ta war­rant it. In the mean­time, he’s gath­er­ing a small team of a half dozen or so ex­ecs to run the com­pa­ny, which will be plugged in­to Aval­on’s net­work of con­trac­tors who car­ry out much of the day-to-day work in­volved in study­ing a new drug.

UCSF’s Er­ic Small, who’s been study­ing the way re­sis­tance to the new drugs de­vel­ops, is step­ping in as head of the sci­en­tif­ic ad­vi­so­ry board.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.