Intensity Therapeutics Presents Positive Preliminary Phase 1/2 Results for Intratumoral Injection of INT230-6 at ASCO 2019

• INT230-6 well tolerated at all doses given
• Durable clinical benefit seen in multiple patients
• Increases in circulating and intratumoral CD4 and CD8 T-cells along
  with abscopal responses in non-injected tumors indicate immune
  activation

WESTPORT, Conn.–(BUSINESS WIRE)–Intensity
Therapeutics, Inc., a clinical-stage
biotechnology company pioneering a novel, immune-based approach to treat
solid tumor cancers through direct injection of its proprietary
therapeutic agents, today announced positive preliminary results from
the company’s ongoing Phase 1/2 clinical trial of its lead product
candidate, INT230-6, in a poster at the American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago.

The poster highlights the results of 34 patients with 15 different types
of advanced or metastatic solid tumors that have failed all or are not
candidates for approved, available therapies.

INT230-6 was well tolerated in doses up to 120 mL, including
intratumoral dosing into more than 100 tumors deep in the body. The 120
mL dose of INT230-6 contains amounts of the cytotoxic agents greater
than a typical intravenous (IV) dose. Based on comparisons to historical
IV data of the active agents comprising INT230-6, the observed
pharmacokinetic profiles indicate that drug remains mostly in the tumor
following INT230-6 dosing. While the trial is aimed at assessing safety,
several patients have shown tumor shrinkage and prolonged disease
control after completing INT230-6 treatment. The results show greater
benefit in patients who have received higher doses, and who have had
multiple tumors injected. Dose escalation is ongoing.

Additionally, the immune activation data observed was consistent with
nonclinical data, as local delivery of INT230-6 into tumors induced an
immune response with increases of CD4+ and CD8+ T-cells in the blood and
in the tumor microenvironment without any immune-related adverse events.
Several patients have had shrinkage of non-injected tumors indicating an
abscopal response.

“We are excited and encouraged by the positive preliminary results of
our Phase 1/2 trial,” said Lewis
H. Bender, President and Chief Executive Officer of Intensity
Therapeutics. “It is our aim to improve cancer treatment, reduce the
side effects associated with systemic therapies and improve patient
outcomes using intratumorally dosed INT230-6.”

“The patients in our trial have a tremendous need for a new therapy.
They have failed a median of three prior treatments with a number of
patients having progressed following seven or more drug therapies,” said Ian
B. Walters, MD, Chief Medical Officer of Intensity Therapeutics.
“Thus far, the data indicate that direct intratumoral injection of our
product minimizes systemic side effects while promoting an augmented
natural immune response that can fight a patient’s cancer for several
months following completion of our treatment.”

Details of the poster presentation are as follows:

Title: Safety profile of INT230-6, a novel intratumoral (IT)
formulation, during injections into a variety of refractory deep and
superficial tumors with evidence of tumor regression and immune
activation

Abstract Number: 2602

Date/Time: Saturday, June 1, 2019, 8-11 a.m. CDT

Poster Session: Developmental Immunotherapy and Tumor
Immunobiology

Presenter: Anthony El-Khoueiry, MD, Associate Professor of
Clinical Medicine and Director of the Phase I Drug Development Clinical
Program, University of Southern California

About INT230-6

INT230-6,
Intensity’s lead proprietary product candidate, is designed for direct
intratumoral injection. The drug is comprised of two proven, potent
anti-cancer agents and a penetration enhancer molecule that helps
disperse the drugs throughout tumors and diffuse into cancer cells.
INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289)
in patients with various advanced solid tumors. In preclinical studies,
INT230-6 eradicated tumors by a combination of direct tumor kill and
recruitment of dendritic cells to the tumor micro-environment that
induced anti-cancer T-cell activation. Treatment with INT230-6 in in
vivo models of severe cancer resulted in substantial improvement in
overall survival compared to standard therapies. Further, INT230-6
provided complete responder animals with long-term, durable protection
from multiple re-inoculations of the initial cancer and resistance to
other cancers. In mouse models, INT230-6 has shown strong synergy with
checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies.
INT230-6 was discovered from Intensity’s DfuseRx^SM platform.

About Intensity Therapeutics

Intensity Therapeutics, Inc. is a clinical-stage biotechnology company
pioneering a new immune-based approach to treat solid tumor cancers.
Intensity leverages its DfuseRx^SM technology platform to
create new, proprietary drug formulations that, following direct
injection, rapidly disperse throughout a tumor and diffuse therapeutic
agents into cancer cells. Intensity’s product candidates have the
potential to induce an adaptive immune response that not only attacks
the injected tumor, but also non-injected tumors. INT230-6, Intensity’s
lead product candidate, is being evaluated in a Phase 1/2 clinical study
in patients with various advanced solid tumors. For more information,
please visit www.intensitytherapeutics.com
and follow us on Twitter @IntensityInc.

Forward Looking Statements

This press release contains forward-looking statements regarding
Intensity Therapeutics’ plans, future operations and objectives. Such
statements involve known and unknown risks, uncertainties and other
factors that may cause actual performance or achievements to be
materially different from those currently anticipated. These
forward-looking statements include, among other things, statements about
the initiation and timing of future clinical trials.

Contacts

Investors:
Kerry Conlin
Stern
Investor Relations
212-698-8685
[email protected]

Media:
Claire LaCagnina
6 Degrees
PR
(315) 765-1462
[email protected]