Compared To Synthetic Controls, INT230-6 Alone
Extended Survival In Refractory Soft Tissue Sarcoma Subjects by
Nearly 450 Days With Favorable Safety
INT230-6, a Locally Delivered Cytotoxic
Treatment Leading to a Systemic Immune Response in Hot or Cold
Tumors, Is A New Way To Treat Sarcoma
Results to be Presented Today, June 3, at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting
WESTPORT, Conn., June 3, 2023
/PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity"), a
clinical-stage biotechnology company focused on the discovery
and development of proprietary, novel immune-based intratumoral
(IT) cancer therapies designed to kill tumors and increase immune
system recognition of cancers, today announced that data from its
ongoing phase 1/2 clinical trial demonstrating the efficacy and
tolerability of INT230-6, either as monotherapy or in combination
with ipilimumab in patients with relapsed, refractory and
metastatic sarcomas, will be presented this afternoon at the 2023
American Society of Clinical Oncology (ASCO) Annual Meeting being
held in Chicago and virtually from
June 2-6, 2023.
Abstract Title: Intratumoral INT230-6 (Cisplatin,
Vinblastine, SHAO) alone or with ipilimumab (IPI) prolonged
survival with favorable safety in adults with refractory sarcomas
[Intensity IT-01; BMS#CA184-592].
Presenter/First
Author: Christian F. Meyer, MD, Johns
Hopkins Sydney Kimmel Cancer
Center
Session Title:
Sarcoma
Poster Session Date and
Time: Saturday, June 3,
2023, 1:15 PM – 4:15 PM EDT
Location:
Exhibit Hall
Abstract Number:
11568
Poster number: 502
Copies of the presentation materials are available on
Intensity's website on the publications, papers and posters
page.
Sarcoma remains a very challenging cancer to treat and has
historically proven resistant to checkpoint blockade. Novel
approaches are needed for this patient population, and Intensity's
data indicate that sarcoma is an attractive target for intratumoral
injection. Christian Frederick
Meyer, M.D., Ph.D., M.S. Assistant Professor of Oncology at
the Sidney Kimmel Cancer Center at Johns
Hopkins University is an investigator for Intensity's phase
1/2 clinical trial and the presenter of the data at ASCO. Dr. Meyer
has placed a number of his sarcoma patients into the study.
INT230-6 has demonstrated significant survival prolongation and
continues to be of great interest to a sarcoma oncologists, such as
Dr. Meyer, especially given the data on immune ignition, as sarcoma
is considered non-immunogenic and therefore largely unresponsive to
immunotherapies.
"The prolonged survival of nearly 450 days compared to what
would be expected in such a severe sarcoma patient population is a
testament to the strength of our novel drug's potency," stated
Lewis H. Bender, President and Chief
Executive Officer of Intensity. "Causing significant tumor
necrosis, immune infiltrates, uninjected tumor shrinkage and
prolonged survival provides strong proof-of-concept evidence of our
drug's mechanism of action and underscores the potential of
INT230-6 to help metastatic sarcoma patients. As recent data
readouts demonstrate, there remains a high unmet need for new
therapeutic approaches to treat metastatic cancers in general. With
that in mind, we have discussed our next steps with the U.S. Food
and Drug Administration, drafted a protocol and look forward to
advancing INT230-6 into a phase 3 trial for sarcoma patients."
Efficacy in subjects administered INT230-6, with or without
ipilimumab, were compared to a synthetic control. The poster
reports the median overall survival (mOS) and disease control rate
(DCR equals the cases of stable disease, partial response and
complete response divided by number of subjects) per the Response
Evaluation Criteria in Solid Tumors (RECIST). Abscopal responses
for INT230-6 alone were observed primarily in subjects dosed ≥ 40%
of their total tumor burden (TTB). The DCR for the all-treated
population (those who received at least one dose of INT230-6) was
93% for monotherapy and 86% for the ipilimumab combination. For the
combination arm, one subject had yet to reach the first timepoint
for SD at the time of data cut-off.
Study IT-01 was without a randomized control group; however,
published clinical phase 1/2 basket trials in sarcoma report mOS
ranging from 7.6 to 9.6 months (Jones et. al., Cancer Chemotherapy
Pharmacology (2011) 68:423–429; Cassier et. al., Annals of Oncology
25: 1222–1228, 201; vi. Subbiah et. al., Scientific Reports |
6:35448 2016). Using the Subbiah study data and the Royal Marsden
Hospital scoring system to predict survival for the sarcoma
subjects from the IT-01 study, a synthetic Kaplan Meier (KM) control curve was generated.
The overall survival of the control, all INT230-6 patients in
sarcoma, including those receiving a cumulative dose of greater
than 40% of their TTB, are shown in the below table.
Phase 1/2
studies
|
Control
(Subbiah)
|
INT230-6
all
|
INT230-6 >40%
TTB
|
INT230-6 +
IPI
|
Median OS
|
205 days
|
649 days
|
Not yet
reached
|
Not yet
reached
|
Confidence
Interval
|
-
|
(146, NR)
|
|
|
Sample size
|
56
|
15
|
11
|
14
|
About INT230-6
INT230-6, Intensity's lead
proprietary investigational product candidate, is designed for
direct intratumoral injection. INT230-6 was discovered
using Intensity's proprietary DfuseRx℠ technology
platform. The drug is composed of two proven, potent anti-cancer
agents, cisplatin and vinblastine, and a
penetration enhancer molecule (SHAO) that
helps disperse potent cytotoxic drugs throughout
tumors for diffusion into cancer cells. These agents remain in the
tumor resulting in a favorable safety profile. In addition to local
disease control, direct killing of the tumor by INT230-6 releases a
bolus of neoantigens specific to the patient's
malignancy, leading to engagement of the immune system and systemic
anti-tumor effects. Importantly, these effects are mediated without
the immunosuppression of concomitant systemic
chemotherapy.
About Intensity Therapeutics' Clinical
Studies
INT230-6 has completed enrollment of over 200
patients in two phase 2 and phase 1 dose escalation clinical trials
(NCT03058289 and NCT04781725) with
various advanced solid tumors; IT-01 in metastatic disease, and
IT-02 the INVINCIBLE study, in presurgical breast
cancer. The Company has a clinical collaboration agreement with
Merck Sharpe & Dohme (Merck) to
evaluate the combination of INT230-6, Intensity's lead product
candidate, and KEYTRUDA®
(pembrolizumab), Merck's anti-PD-1 (programmed death
receptor-1) therapy, in patients with advanced pancreatic,
colon, squamous cell and bile duct malignancies. The
Company also has a clinical collaboration agreement with
Bristol-Myers Squibb to evaluate the combination INT230-6
with Bristol-Myers Squibb's anti-CTLA-4
antibody, ipilimumab, in patients with advanced liver,
breast and sarcoma cancers. Intensity is managing the individual
combination arms separately with each respective partner via a
joint development committee. The Company also executed agreements
with the Ottawa Hospital Research Institute (OHRI) and
the Ontario Institute of Cancer Research (OICR) to
study INT230-6 in the INVINCIBLE study, a randomized
controlled neoadjuvant phase 2 study in women with
early stage breast cancer.
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℠ 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. In addition to the clinical collaborations, the Company
executed a Cooperative Research and Development Agreement
(CRADA) with the National Cancer Institute's (NCI)
Vaccine Branch. For more information, please
visit www.intensitytherapeutics.com and
follow the Company 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.
Contact Information
Investor Relations Contact:
Rx Communications
Group
Michael
Miller
917-633-6086
mmiller@rxir.com
US Media Contact:
KOGS
Communication
Edna
Kaplan
781-639-1910
kaplan@kogspr.com
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SOURCE Intensity Therapeutics, Inc.