The disease control rate for subjects in the
monotherapy was 93% for patients who received at least one dose of
INT230-6
INT230-6 extended survival in refractory soft
tissue sarcoma subjects by nearly 15 months when compared to a
synthetic control group
In the study, INT230-6 was found to have a
favorable safety profile and be well tolerated, with approximately
90% adverse events being grade 1 or 2
WESTPORT, Conn., Nov. 2, 2023
/PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), a
clinical-stage biotechnology company focused on the discovery and
development of proprietary, novel immune-based intratumoral cancer
therapies designed to kill tumors and increase immune system
recognition of cancers, today announced that safety, tolerability
and efficacy data from IT-01, the company's ongoing Phase 1/2
clinical trial of INT230-6, either as a monotherapy or in
combination with ipilimumab in patients with relapsed, refractory
and metastatic sarcomas, was presented at the Connective Tissue
Oncology Society 2023 Annual Meeting being held in Dublin, Ireland from November 1-4, 2023. The poster will be displayed
for the duration of the Annual Meeting.
Abstract Title: INTRATUMORAL INT230-6 (CISPLATIN,
VINBLASTINE, SHAO) ALONE OR WITH IPILIMUMAB PROLONGED SURVIVAL WITH
FAVORABLE SAFETY AND IMMUNE ACTIVATION IN ADULTS WITH REFRACTORY
SARCOMAS (NCT 03058289)
Presenter: Christian F.
Meyer, M.D., Ph.D., M.S., Johns Hopkins Sydney Kimmel Cancer
Center
Abstract Number: 1574238
Copies of the presentation materials are available on
Intensity's website on the publications, papers and posters
page.
Christian Frederick Meyer, M.D.,
Ph.D., M.S., is an Assistant Professor of Oncology at the Sidney
Kimmel Cancer Center at Johns Hopkins
University. Dr. Meyer is an investigator for Intensity's
Phase 1/2 clinical trial of INT230-6 and the presenter of the data
at CTOS. Dr. Meyer has placed a number of his sarcoma patients into
the study due to the demonstrated significant survival prolongation
effects of INT230-6.
"The data presented at CTOS highlights the true potential of
INT230-6 as both a monotherapy or in combination with ipilimumab.
INT230-6 showed an extensive increase in overall survival in
metastatic patients over expected results for the heavily
pretreated and diverse sarcoma population with an increase of
nearly 15 months compared to a synthetic control. Approval of
INT230-6, a locally delivered therapy, could be a paradigm-changing
treatment for metastatic cancers," said Lewis H. Bender, President and Chief Executive
Officer of Intensity. "INT230-6 can fully saturate a tumor with
cytotoxic agents to begin apoptosis and cause necrosis when
delivered intratumorally, resulting in immune activation consisting
of dendritic and T-cell influx to the tumor all while maintaining a
favorable safety profile. We have begun the preparations for a
Phase 3 study of INT230-6 as a monotherapy and look forward to
providing updates on the trial in the future."
IT-01, now complete, was an open-label Phase 1/2 study of
INT230-6 in adults with locally advanced, unresectable or
metastatic solid tumors, including sarcoma. INT230-6 dose was
determined by a target injected tumor's diameter or volume and
administered intratumorally once every two weeks for up to 5 doses
with regular maintenance treatment either alone or in combination
with ipilimumab at 3 mg/kg every three weeks for 4 doses. The
primary endpoint was safety and approximately 90% of subjects had
low grade adverse events.
Efficacy Data:
When compared to synthetic controls, INT230-6 alone extended
survival in refractory soft tissue sarcoma subjects by
approximately 14.9 months. Dosing higher amounts of INT230-6
relative to a patient's presenting total tumor burden showed
increased survival when compared to the synthetic control. An
INT230-6 dose relative to the presenting tumor burden of ≥ 40%
further improved overall survival and the addition
of ipilimumab may improve survival further.
- Median overall survival of INT230-6 was ~14.9 months longer
than a synthetic control that was developed to predict survival of
the enrolled sarcoma population.
- Median survival of synthetic control was about 6.8 months.
- The INT230-6 Disease Control Rate was 93% in subjects who
received at least one dose of INT230-6 as monotherapy.
Safety Data:
Data to date indicate that INT230-6 has a favorable safety
profile and is well tolerated.
- The majority of treatment-emergent adverse events (TEAEs) were
grade 1 or 2 primarily localized pain, fatigue, and nausea.
- Two monotherapy and one combination subject experienced a grade
3 adverse event (AE)
- There were no reported grade 4 or 5 AEs.
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 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. The Company's lead product candidate, INT230-6, is in
development for the treatment of patients with solid tumors, such
as sarcoma and breast cancer. Intensity has a clinical
collaboration agreement with Merck Sharpe & Dohme (Merck) to
evaluate INT230-6 with pembrolizumab. In addition, the Company 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. Intensity has also executed
agreements with the Ottawa Hospital Research Institute (OHRI) and
the Ontario Institute of Cancer Research (OICR) to study INT230-6
in a randomized controlled neoadjuvant phase 2 study in women with
early stage breast cancer (the INVINCIBLE study) (NCT04781725).
Additionally, 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
Certain statements in this press release may constitute
"forward-looking statements" within the meaning of the United
States Private Securities Litigation Reform Act of 1995, as amended
to date. These statements include, but are not limited to,
statements relating to the expected future plans, development
activities, projected milestones, business activities or results.
We have based these forward-looking statements on our current
expectations and projections about future events, nevertheless,
actual results or events could differ materially from the plans,
intentions and expectations disclosed in, or implied by, the
forward-looking statements we make. These risks and uncertainties,
many of which are beyond our control, include: the risk that the
anticipated milestones may be delayed or not occur or be changed,
as well as other risks described in the section entitled "Risk
Factors" in the Company's SEC filings, which can be obtained on the
SEC website at www.sec.gov. Readers are cautioned not to place
undue reliance on the forward-looking statements, which speak only
as of the date on which they are made and reflect management's
current estimates, projections, expectations and beliefs. The
Company does not plan to update any such forward-looking statements
and expressly disclaims any duty to update the information
contained in this press release except as required by law.
Investor Relations Contact:
Argot Partners
Jonathan Nugent
Intensity@argotpartners.com
Media Contact:
Argot Partners
David Rosen
david.rosen@argotpartners.com
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