Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the
Company”), a biotechnology company developing novel LAG-3 related
immunotherapy treatments for cancer and autoimmune diseases,
provides an update on the ongoing development of its product
candidates, eftilagimod alpha (efti) and IMP761 for its fiscal
fourth quarter ended 30 June 2023 (Q4 FY23).
EFTI DEVELOPMENT PROGRAM FOR
CANCER
TACTI-002 (KEYNOTE-PN798) Phase II
clinical trial evaluating
efti + KEYTRUDA®
(pembrolizumab):
- 1st
line
Non-Small
Cell
Lung
Cancer (1L NSCLC)
Meaningful long-term survival was reported in
from Immutep’s TACTI-002 (Two
ACTive
Immunotherapies) trial in May. An initial median
Overall Survival (mOS) of 25 months was achieved in 1L NSCLC
patients with >1% PD-L1 TPS (Tumour Proportion Score), a key
area of focus for future clinical development with FDA Fast Track
designation granted for efti and pembrolizumab in this patient
population. Encouragingly, the initial mOS of 25.0 months for this
chemo-free combination exceeds the reported rates for patients with
the same PD-L1 TPS of >1% from registration trials of anti-PD-1
monotherapy (16.4-month mOS) and combinations of anti-PD-1 with
chemotherapy (15.8-to-23.3-month mOS) or with anti-CTLA-4
(17.1-month mOS).
Based on the robust initial results, the trial’s
Data Monitoring Committee recommended extending OS follow-up data
collection to show mature 3-year and potentially 5-year rates. More
mature OS data and additional efficacy and safety results will be
presented at a major medical conference in H2 CY2023.
-
2nd Line
Head and
Neck
Squamous
Cell
Carcinoma (2L HNSCC)
Immutep reported positive final TACTI-002 data
in 2L HNSCC patients in a poster presentation at the ASCO 2023
Annual Meeting in June. Deep and durable responses were seen from
efti plus pembrolizumab regardless of patients’ PD-L1 expression
levels (measured by Combined Positive Score or CPS). Encouragingly,
median Duration of Response had not been reached (meaning the
response is still ongoing) despite a long median follow up of 39
months, providing continued evidence of the durable responses efti
helps drive. Notably, one long-lasting Complete Response occurred
in a patient with negative PD-L1 expression, who wouldn’t typically
be expected to respond to PD-L1 monotherapy.
Efti plus pembrolizumab led to an encouraging
overall response rate (ORR) of 29.7% and Complete Response (CR)
rate of 13.5% in 2L HNSCC patients. Responses were seen across all
PD-L1 subgroups. A promising ORR of 38.5% & 60%, median Overall
Survival (mOS) of 12.6 & 15.5 months, and 12-month Overall
Survival (OS) rate of 52.0% & 66.7%, were seen in patients with
a PD-L1 CPS of ≥1 and a PD-L1 CPS ≥20, respectively. The results
from the chemo-free IO-IO combination of efti plus pembrolizumab in
2L HNSCC patients with a PD-L1 CPS ≥1 compare favourably to
reported results from a registrational trial of anti-PD-1
monotherapy in the same patient population, which showed a 17.3%
ORR, mOS of 8.7 months, 12-month OS rate of 40%, a CR rate of 2%,
and mDoR of 18.4 months.1
TACTI-003 – Phase IIb clinical trial in
1st line HNSCCImmutep’s ongoing TACTI-003 trial is
evaluating efti in combination with pembrolizumab in the 1st line
setting in HNSCC. The trial has reached ~91% patient recruitment,
and Immutep is on track to report top-line results from TACTI-003
in H2 of CY2023.
TACTI-004
Phase III registrational
trial in 1st line NSCLC
In May, Immutep received positive feedback from the US Food and
Drug Administration (FDA), which is supportive of a registrational
trial to evaluate efti in combination with an anti-PD-1 for the
treatment of 1L NSCLC. Among the items discussed at the meeting
were the toxicological package and general aspects of the trial
design, including statistics and potential patient population with
a focus on 1st line NSCLC patients with a Tumor Proportion Score
(TPS) PD-L1 of >1% for which efti plus pembrolizumab has
already received Fast Track designation. The Company is
advancing its preparations for the trial.
AIPAC-003 –
Integrated Phase II/III trial in
Metastatic Breast
Cancer Immutep enrolled and safely dosed the first patient
in its integrated Phase II/III AIPAC-003 trial in May. Recruitment
has continued with 12 clinical sites now actively recruiting
patients, and the trial currently has 3 patients enrolled in the
open-label lead-in portion of the trial. This lead-in portion of 6
to 12 patients dosed at 90mg efti will be followed by a randomized
(1:1) portion of the Phase II consisting of up to 58 evaluable
patients who will receive 30mg efti or 90mg efti to determine the
optimal biological dose in combination with paclitaxel.
INSIGHT-003 – Phase I in 1st line
NSCLCImmutep reported new encouraging clinical data in 1L
NSCLC patients in May from the INSIGHT-003 trial, an
investigator-initiated Phase I trial conducted by the Frankfurt
Institute of Clinical Cancer Research IKF as part of the
investigator-initiated INSIGHT platform of studies. The new data
showed the therapy is well tolerated and promising initial efficacy
signals were observed including a 67% response rate and 91% disease
control rate in metastatic 1st line non-small cell lung cancer
patients, despite 81% of patients having low or negative PD-L1
expression.
INSIGHT-005 – Phase
I trial in
Urothelial
CarcinomaRegulatory approval was
received from the Paul-Ehrlich-Institut (“PEI”), German Federal
Institute for Vaccines and Biomedicines, to initiate INSIGHT-005 in
May. This study is an investigator-initiated trial, open-label
Phase I trial evaluating the safety and efficacy of efti in
combination with BAVENCIO® (avelumab) in up to 30 patients with
metastatic urothelial carcinoma which is being conducted by
Frankfurt Institute of Clinical Cancer Research IKF as part of the
investigator-initiated INSIGHT platform.
EFTISARC-NEO -
Phase II Trial in Soft Tissue
Sarcoma The investigator-initiated study, EFTISARC-NEO,
was initiated by the Maria Skłodowska-Curie National Research
Institute of Oncology in April. The study is an open-label Phase II
trial evaluating efti in combination with radiotherapy and
pembrolizumab in up to 40 soft tissue sarcoma (STS) patients in the
neoadjuvant (prior to surgery) setting and is the first time efti
will be studied in neoadjuvant, non-metastatic cancer setting. The
first patient has been enrolled and safely dosed in July 2023.
IMP761 DEVELOPMENT PROGRAM FOR
AUTOIMMUNE DISEASEIn May, Immutep appointed a clinical
research organisation to conduct its GLP toxicology study
evaluating the safety and toxicity of IMP761, Immutep's proprietary
preclinical candidate and the world’s first LAG-3 agonist for
autoimmune diseases. This study is a key step before the
commencement of first-in-human trials to treat the underlying cause
of multiple autoimmune diseases.
INTELLECTUAL PROPERTYImmutep
was granted three patents during the quarter. A new patent was
granted by the US Patent Office protecting Immutep’s intellectual
property for treating cancer by administering efti and a PD-1
pathway inhibitor, specifically BMS-936559, durvalumab,
atezolizumab or avelumab.
The US Patent Office also granted a new patent
for composition-of-matter claims covering Immutep’s pre-clinical
immunosuppressive product candidate, IMP761, which is designed to
target the root cause of autoimmune diseases by directly silencing
self-antigen-specific effector T cells.
Finally, the Japan Patent Office granted a new
patent protecting Immutep’s intellectual property for a potency
assay for release testing of efti which is used in the
commercial-scale (2,000L) manufacturing process for efti. This new
Japanese patent follows the grant of a similar patents in Australia
and South Korea in 2023 and 2022 respectively.
CORPORATE OVERVIEW
Financing
CompletedDuring the quarter, Immutep completed a
fully underwritten pro rata accelerated non-renounceable
entitlement offer (Entitlement Offer) and a placement to
institutional investors (Placement) to raise a total amount of A$80
million. The funds raised extends Immutep’s cash runway to early
CY2026 and will support its registrational and late-stage trials of
efti and ongoing expansion of its clinical pipeline including
potentially a first-in-human trial for IMP761. Immutep was pleased
to have very strong support from its existing shareholders and
welcomed new healthcare-focussed and specialist funds to its
register.
Board ChangesIn April, Immutep
was pleased to appoint highly experienced corporate lawyer, Lis
Boyce to its Board as Non-Executive Director. Ms Boyce is currently
a partner at Piper Alderman. She has extensive involvement in the
Life Sciences and Healthcare sectors and is currently deputy chair
of AusBiotech’s AusMedtech Advisory Group and a member of
AusBiotech’s NSW Leadership Committee. Ms Boyce replaces Lucy
Turnbull who resigned from the Board at the same time.
Senior LeadershipThe Company
appointed Florian D. Vogl, M.D., Ph.D., MSc, as Chief Medical
Officer (CMO) in May. Dr Vogl brings over a decade of experience in
the biopharmaceutical industry to the role, with extensive clinical
development expertise in the field of oncology. Prior to Immutep,
Dr. Vogl held senior management roles in Europe and the United
States, including CMO of Cellestia Biotech, Head of Clinical
Development Europe at Rainier Therapeutics, Senior Global Medical
Leader, Oncology Development at Novartis, and Early Development
Leader, Oncology Pipeline at Amgen. He assumed the CMO role from
Frédéric Triebel, M.D., Ph.D., who is now primarily focused on his
responsibilities as CSO and as a member of Immutep’s Board of
Directors.
FINANCIAL SUMMARYImmutep’s
financial performance over the final quarter (Q4 FY23) continues to
reflect prudent cash management as well as investment into its
clinical trial program for efti, as aligned with its strategy.
Following its financing completed in June, Immutep is fully funded
for its current and expanded clinical program through to early
CY2026.
Cash receipts from customers Q4 FY23 were $16k,
compared to $30k in Q3 FY23. The net cash used in G&A
activities in the quarter was $1.61 million, compared to $1.12
million in Q3 FY23. The increase is mainly due to the prepayment of
certain G&A expenses, including insurance premiums.
Payments to Related Parties, for the quarter
includes $282k in payment of Non-Executive Director’s fees and
Executive Director’s remuneration.
The net cash used in R&D activities in the
quarter was $5.41 million, compared to $11.52 million in Q3 FY23.
The decrease in cash used for the quarter was mainly due to reduced
manufacturing activities in the current quarter and the prepayment
of clinical trial expenses in the previous quarter.
Total net cash outflows used in operating
activities in the quarter was $8.35 million compared to $14.17
million in Q3 FY23.
The company completed a capital raising of $80m
in June 2023, which consisted of a placement and institutional
component of the Entitlement Offer of approximately $68m and a
retail Entitlement Offer component of approximately $12m. Net cash
inflow from financing activities for the quarter was $76.2m.
Immutep’s cash and cash equivalent balance as at
30 June 2023 was approximately $123.4 million. Immutep will
continue to manage its strong cash balance carefully as it pursues
its overall development strategy for efti and IMP761.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
- Ezra E W Cohen
et al., Pembrolizumab versus methotrexate, docetaxel, or cetuximab
for recurrent or metastatic head-and-neck squamous cell carcinoma
(KEYNOTE-040): a randomised, open-label, phase 3 study; The Lancet
2019. http://dx.doi.org/10.1016/S0140-6736(18)31999-8
About ImmutepImmutep is a
clinical-stage biotechnology company developing novel LAG-3
immunotherapy for cancer and autoimmune disease. We are pioneers in
the understanding and advancement of therapeutics related to
Lymphocyte Activation Gene-3 (LAG-3), and our diversified product
portfolio harnesses its unique ability to stimulate or suppress the
immune response. Immutep is dedicated to leveraging its expertise
to bring innovative treatment options to market for patients in
need and to maximise value for shareholders. For more information,
please visit www.immutep.com.
Australian
Investors/Media:Catherine Strong, Citadel-MAGNUS+61 (0)406
759 268; cstrong@citadelmagnus.com
U.S.
Investors/Media:Chris Basta, VP,
Investor Relations and Corporate Communications+1 (631) 318 4000;
chris.basta@immutep.com
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