Tun­ing in: In­ten­si­ty's im­mune-based chemo de­liv­ery tech at­tracts back­ing of British bil­lion­aire Jim Mel­lon

In can­cer treat­ment, chemother­a­py and im­munother­a­py are of­ten seen as com­plete­ly sep­a­rate, if com­ple­men­tary, cat­e­gories of treat­ments. A tiny biotech out of West­port, CT now wants to shake up that par­a­digm — and has just raised $6.5 mil­lion to do so with back­ing from British bil­lion­aire Jim Mel­lon, crowd­fund­ing in­vestor V Cap­i­tal, Bat­ter­son Ven­ture Cap­i­tal and sev­er­al fam­i­ly of­fices.

Lew Ben­der

What In­ten­si­ty Ther­a­peu­tics’ drug de­liv­ery tech al­lows them to do, CEO Lew Ben­der tells me, is to in­ject po­tent drugs di­rect­ly in­to the tu­mor, where they dif­fuse and dis­perse, es­sen­tial­ly at­ten­u­at­ing the can­cer with­out de­stroy­ing the cell sur­face. That makes the can­cer cells “much more rec­og­niz­able and there­fore more anti­genic for recog­ni­tion by the im­mune sys­tem,” un­leash­ing an at­tack not just on the in­ject­ed tu­mor but al­so on non-in­ject­ed ones, he says.

It’s a “physics ap­proach” that can the­o­ret­i­cal­ly tar­get all sorts of sol­id tu­mors, ac­cord­ing to Ben­der, a chem­i­cal en­gi­neer by train­ing who spent the bet­ter part of the last two decades at a drug de­liv­ery com­pa­ny. But it was while he was at the helm of In­ter­leukin Ge­net­ics that he came up with the idea to start his own biotech ven­ture in 2012.

“If you go to ge­nomics con­fer­ences, it’s all about try­ing to get a ge­nom­ic pro­file so you can match a drug, so that you can get a bet­ter re­cep­tor up­take for that drug in­to the tu­mors,” he says, “and I thought, well, if get­ting drugs in­to tu­mors or get­ting drugs in­to can­cer cells is re­al­ly the prob­lem, I know how to do that.”

In­ten­si­ty is start­ing out with INT230-6, a for­mu­la­tion com­bin­ing its “cell pen­e­tra­tion en­hancer mol­e­cule” with the chemo drugs cis­platin and vin­blas­tine.

While Ben­der ini­tial­ly thought his tech could on­ly be used in com­bi­na­tion with check­point in­hibitors, mice ex­per­i­ments sug­gest­ed that the drug alone pro­vid­ed enough stim­u­la­tion to trig­ger an im­mune re­sponse. The monother­a­py is now in Phase I/II; if all goes well with ear­ly read­outs on some of the more re­frac­to­ry tu­mors like pan­cre­at­ic, liv­er and breast can­cer, In­ten­si­ty ex­pects to launch a Phase II with­in a year.

The biotech is still keen to get its hands on a PD-1 — some­thing that Ben­der an­tic­i­pates in the next six to nine months.

“PD-1 is ba­si­cal­ly like a vol­ume di­al on a ra­dio,” he says. “Turn­ing up the di­al, which is what I/O does, doesn’t solve the prob­lem of tun­ing in. We are the tuner of the ra­dio to al­low the im­mune sys­tem to rec­og­nize the can­cer and go af­ter it in a much more ef­fi­cient way with­out as much tox­i­c­i­ty.”

With a “tiny burn rate” — around $3 mil­lion last year — and just three full time em­ploy­ees in­clud­ing him­self, Ben­der says the Se­ries B he’s just raised will fund all that, and then some, all the way through to 2020.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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