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.

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.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Stephen Squinto, Gennao Bio chairman

Scoop: Stephen Squin­to’s Yale spin­out is rais­ing a Se­ries B for ge­net­ic med­i­cines

The nucleic acid therapeutics at Stephen Squinto’s Yale-originated biotech are en route to a $40 million R&D payday.

After a Series A of that size in the spring of 2021, Hopewell, NJ-based Gennao Bio is closing on a round of the same amount, Endpoints News has learned. A Series B is in the works, according to an investor’s post on LinkedIn and as confirmed by a spokesperson. An SEC filing on Thursday outlines $15 million in equity sold thus far in the round.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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