Endocyte Presents Data on Two Lead Clinical Programs at European Society for Medical Oncology (ESMO) 2016 Congress
October 10 2016 - 8:00AM
Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small
molecule drug conjugates (SMDCs) and companion imaging agents for
personalized therapy, presented poster updates on its two lead
clinical programs at the European Society for Medical Oncology
(ESMO) 2016 Congress, being held in Copenhagen, Denmark October
7-11, 2016.
“We are pleased that both EC1456 and EC1169 have shown
anti-tumor activity during the dose escalation phase of their
respective trials, even in patients not specifically identified as
positive for the drug targets,” said Mike Sherman, president and
CEO at Endocyte. “The activity we’ve seen to date with EC1169 in
prostate cancer patients is particularly exciting, with our first
confirmed radiologic partial response (PR). This quarter we expect
to move the 6.5 mg/m2 dose into the expansion phase of the study
where we will evaluate EC1169 in patients selected as prostate
specific membrane antigen (PSMA)-positive using our companion
imaging agent, EC0652. We have also moved on to the expansion phase
of the EC1456 trial, using our companion imaging agent etarfolatide
to select folate receptor (FR)-positive non-small cell lung cancer
(NSCLC) patients.”
“Despite the current therapy options available for prostate
cancer patients, there remains a need for safe and effective
alternatives for these patients following treatment with hormone
therapies,” stated Michael J. Morris, M.D., Associate Professor,
Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New
York. “The disease is more challenging to treat at this stage, so
the safety data, and at least the preliminary efficacy data, which
we’re seeing with Endocyte’s PSMA-targeted agent is encouraging. I
look forward to further exploring this novel drug in patients with
metastatic prostate cancer.”
EC1169 Poster #731P - Phase 1 Study of the
PSMA-Targeted Tubulysin Small-Molecule Drug Conjugate EC1169 in
Patients with Metastatic Castrate-Resistant Prostate Cancer
(mCRPC): Study Update
Data presented in this poster showed that total target tumor
burden reduction was observed in 4 of the 6 patients with
measurable soft tissue disease treated at doses of 3.8 mg/m2 and
higher. One of these patients demonstrated the first
confirmed radiologic partial tumor response (PR) as measured by
RECIST 1.1 criteria. Two patients also demonstrated confirmed
prostate specific antigen (PSA) reductions of greater than 50%, one
of whom went on to demonstrate the PR. After observing toxicity at
8.5 mg/m2, the company is in the process of confirming 6.5 mg/m2 as
the highest clinical dose. EC1169 was well tolerated without
causing dose-limiting hematologic toxicity frequently associated
with traditional chemotherapy. Primary toxicities included fatigue
and gastrointestinal (GI) toxicity; predominantly grade 1 and 2,
reversible and responsive to simple medication.
EC1456 Poster #395P - Dose Escalation Phase 1,
Safety and Pharmacokinetic Study of the Folate Receptor-Targeted
Drug Conjugate EC1456 in Advanced Cancer Patients: Study Update
A dose of 6.0 mg/m2 was established as the maximum twice per
week dose, administered 2 weeks out of a 3 week cycle, which is
being used in the expansion phase of the trial in FR-positive NSCLC
patients. EC1456 was well tolerated, with primary toxicities
including fatigue, GI toxicity, and electrolyte disturbance;
predominantly grade 1 and 2, reversible and responsive to simple
medication. In spite of the inclusion of patients who were not
selected as positive for the targeted FR, most patients
demonstrated stable disease as best response and several patients
demonstrated a reduction in target tumor volume.
About EC1169 and EC0652
EC1169 is an investigational therapeutic SMDC constructed of a
high affinity PSMA-targeting ligand conjugated through a releasable
linker system to a potent cytotoxic microtubule inhibitor,
tubulysin B hydrazide (TubBH). The high affinity of EC1169
for PSMA allows for the active and specific delivery of TubBH to
PSMA-expressing cancer cells, while minimizing exposure to normal
cells. PSMA is known to be highly expressed on the majority
of prostate cancers with limited expression on normal
tissues.
The PSMA-targeted companion imaging agent EC0652 is being
co-developed to characterize whole body PSMA expression in real
time, to identify patients most likely to benefit from EC1169
therapy. EC1169 and EC0652 are currently being evaluated in a
phase 1 study in patients with metastatic, castration-resistant
prostate cancer (mCRPC) (ClinicalTrials.gov Identifier:
NCT02202447).
About EC1456 and etarfolatide
EC1456 is an investigational therapeutic SMDC constructed of
folic acid conjugated through a spacer and releasable linker system
to a potent cytotoxic microtubule inhibitor, TubBH. The high
affinity of the folic acid ligand for the FR allows for the active
and specific targeting of EC1456 to FR-expressing cancer
cells. The FR is highly expressed in several epithelial
cancers (e.g. ovarian, NSCLC) but is expressed at low levels in
most normal tissues.
Etarfolatide is an FR-targeted companion imaging agent being
co-developed to characterize whole body FR expression in real time,
to identify patients most likely to benefit from EC1456
therapy. EC1456 and etarfolatide are currently being
evaluated in a phase 1 study in patients with advanced solid tumors
(ClinicalTrials.gov Identifier: NCT01999738).
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing
personalized therapy for cancer and other serious diseases through
targeted SMDCs and companion imaging agents. The company's
SMDCs actively deliver highly potent payloads into targeted cells
via cell surface receptors that have been identified in patients
using companion imaging agents. This approach allows
for selected treatment to those patients that may be the most
likely to benefit from targeted therapy. EC1169, EC0652, EC1456,
and etarfolatide are wholly owned by Endocyte. For more
information, visit http://www.endocyte.com.
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those relating to the company’s development
programs and upcoming milestones. Actual results or developments
may differ materially from those projected or implied in these
forward-looking statements. Factors that may cause such a
difference include risks that the company may experience delays in
the completion of its clinical trials (whether caused by
competition, adverse events, patient enrollment rates, shortage of
clinical trial materials, regulatory issues or other factors);
risks that data from its clinical trials may not be indicative of
subsequent clinical trial results; risks related to the safety and
efficacy of the company’s product candidates; risks that early
stage preclinical data may not be indicative of subsequent data
when expanded to additional preclinical models or to subsequent
clinical data; risks that evolving competitive activity and
intellectual property landscape may impair the company's ability to
capture value for the technology; estimates of the potential
markets for its product candidates; estimates of the capacity of
manufacturing and other facilities required to support its product
candidates; projected cash needs; and expected future revenues,
operations, expenditures and cash position. More information about
the risks and uncertainties faced by Endocyte, Inc. is contained in
the company’s periodic reports filed with the Securities and
Exchange Commission. Endocyte, Inc. disclaims any intention or
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Contacts:
Michael Schaffzin, Stern Investor Relations, Inc., (212) 362-1200, michael@sternir.com
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