Ali Ansary, Ozette Technologies CEO

A new AI start­up, launched with a trio of Fred Hutch vets, wants to give a 'zoomed-in' view of can­cer cells

Ali Ansary, a trained physi­cian, had re­al­ized by 2018 that can­cers would no longer be treat­ed just with tra­di­tion­al chemother­a­py and ra­di­a­tions. Im­munother­a­py was be­com­ing big, and yet there was no way for doc­tors to get a com­plete pic­ture of how im­mune cells worked at the cel­lu­lar lev­el when used for can­cer ther­a­py, he says.

“How do we get to know more in­for­ma­tion about this sys­tem that is more than in­flam­ma­to­ry mark­ers?” he won­dered.

Then, through a Seat­tle ven­ture cap­i­tal com­mu­ni­ty, he met three Fred Hutch re­searchers in Greg Fi­nak, Raphael Got­tar­do and Evan Green. Af­ter sev­er­al con­ver­sa­tions about the prob­lems they saw in the space, Ozette Tech­nolo­gies was born the next year.

This Seat­tle-based start­up wants to au­to­mate analy­sis of da­ta col­lect­ed from a sin­gle cell and do away with the tra­di­tion­al way of do­ing it man­u­al­ly, join­ing the cadre of AI biotechs jump­ing in­to the space re­cent­ly. It re­ceived a $26 mil­lion Se­ries A fund­ing, the com­pa­ny an­nounced Thurs­day.

“The (cel­lu­lar) da­ta is so com­plex that we miss a lot of in­for­ma­tion when done man­u­al­ly,” says Ansary, Ozette’s CEO. “In fact, 90% of the da­ta is sit­ting on the ta­ble and a lot of peo­ple say we do not even know how to look at this kind of da­ta. It is so com­plex.”

Re­sults from cel­lu­lar ex­per­i­ments are typ­i­cal­ly an­a­lyzed man­u­al­ly, he says, with a process look­ing some­thing like com­pu­ta­tion­al bi­ol­o­gists go­ing over the da­ta be­fore send­ing it to da­ta sci­en­tists, who would in turn send it to sta­tis­ti­cians and so forth. But Ozette claims it has de­vised a ma­chine learn­ing-based plat­form that com­pletes months of analy­sis in a mat­ter of days.

“We are us­ing ma­chine learn­ing to un­cov­er all the dif­fer­ent parts of the da­ta that comes out of ex­per­i­ments,” he said.

The com­pa­ny saw one of its ini­tial suc­cess­es when it an­a­lyzed the tu­mor cells of skin can­cer pa­tients tak­ing PD-1 in­hibitors, Ansary said. The Ozette re­search team was able to give a zoomed-in pic­ture of the tu­mor en­vi­ron­ment and pub­lished their find­ings in the jour­nal Pat­terns. The re­search showed that some as­pects of the tu­mors were repli­cat­ed in the blood­stream, which led to the dis­cov­ery of nov­el bio­mark­ers spe­cif­ic to pa­tients who re­spond to the treat­ment, Ansary said.

“Imag­ine all the peo­ple in the world who have a tu­mor,” Ansary said. “You can­not go and al­ways do biop­sies on the tu­mor. In that case, you can ex­tract valu­able in­for­ma­tion around what the im­mune sys­tem is do­ing in that tu­mor, by just look­ing at the blood.”

The fund­ing was led by Madrona Ven­tures with oth­er par­tic­i­pat­ing in­vestors such as Cer­cano Man­age­ment (for­mer­ly Vul­can Cap­i­tal), M12, Mi­crosoft’s ven­ture fund, Alexan­dria Ven­ture In­vest­ments, OCV Part­ners and Duke Uni­ver­si­ty. The new fund­ing will go to­wards ex­pand­ing the lab space that the com­pa­ny re­cent­ly launched and hir­ing more da­ta sci­en­tists and web lab sci­en­tists.

“The mar­ket is still at an ear­ly stage, be­cause it is on­ly in that last hand­ful of years, we have been able to get down to the sin­gle-cell lev­el and dis­tin­guish a par­tic­u­lar cell from an­oth­er cell,” said Matt McIl­wain, man­ag­ing di­rec­tor at Madrona Ven­tures, which had al­so poured in $6 mil­lion in seed fund­ing in 2020.

“Ul­ti­mate­ly,” Ansary says, “whether some­one is healthy or sick, we want Ozette to be a key part in giv­ing in­sights in­to what’s hap­pen­ing.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.