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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist partnered with Novartis, the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).

Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”