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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

David Coman, Science 37

Amid vir­tu­al tri­al craze, Sci­ence 37 earns uni­corn sta­tus and a trip to Nas­daq on the back of SPAC deal

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As the Covid-19 pandemic made conventional trials impossible for some drugmakers, more and more companies moved to decentralize their clinical studies, accelerating business for tech developers like Science 37. Leveraging that boost, the company is on the verge of a SPAC merger, landing unicorn status and its very own stock ticker.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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