Helix BioPharma Corp. (TSX, FSE: “HBP”), an immuno-oncology company
developing drug candidates for the prevention and treatment of
cancer, provides a strategic update of its L-DOS47 clinical
program.
Helix’s L-DOS47 strategic development plan has
two parts. The first part is to ensure L-DOS47 will be used in a
well-established treatment setting, while being ready to be applied
in novel therapies. For this reason, L-DOS47 clinical programs will
focus primarily in a combination setting. In this plan L-DOS47 will
be studied with well-established chemotherapeutics and in
combination with novel immunotherapy. The Company is well advanced
in carrying out the study of L-DOS47 with chemotherapy in lung
cancer. The planning for combining with immunotherapies in this
indication is also in progress.
In the second part of the strategic development
plan, the Company will focus on expanding the utility of L-DOS47 to
indications other than lung cancer. In choosing a new indication
for L-DOS47, the company has considered available preclinical and
clinical L-DOS47 data, consulted with key opinion leaders and
considered the best strategic application of limited financial
resources. To this end, the Company has recently announced the
start of a new pancreatic cancer program.
As of today, the Company has completed a
monotherapy study of L-DOS47 in lung cancer, with two combination
studies in the same indication that are actively recruiting
patients. The Company is also working diligently to prepare for
regulatory filing of a new pancreatic cancer study with the United
Sates Food and Drug Administration (“FDA”).
The following is a status update of active
studies currently taking place.
LDOS001
LDOS001 is a Phase I dose escalation study of
L-DOS47 with pemetrexed and carboplatin for the first line
treatment in recurrent or metastatic non-squamous non-small cell
lung cancer. A total of seven (7) cohorts comprising of L-DOS47
doses at 0.59, 0.78, 1.5, 3.0, 6.0, 9.0 and 12.0 ug/kg were
approved. To date, five (5) cohorts have been completed and a total
of 12 patients were dosed. No dose limiting toxicity was observed.
In cohort 1, one patient had a partial response (36% tumor
regression). In cohort 2, three other patients had partial response
(40%, 44% and 91% tumor regression) and one additional patient
experienced stable disease for 13.3 months. In cohort 4, one
patient had a partial response (69% tumor regression). The company
expects to enroll six more patients to complete recruitment for
study dosing cohorts if no dose limiting toxicity is observed.
LDOS003
LDOS003 is a phase II, open-Label, randomized
study of immunoconjugate L-DOS47 in combination with vinorelbine
and cisplatin versus vinorelbine and cisplatin alone in patients
with lung adenocarcinoma. Regulatory and Ethics approvals to dose
patients were first received from Ukraine in March and from Poland
in April. While the company had planned to enroll patient shortly
thereafter, the program was delayed due to financial constraints.
The company has recently reprioritized its resources and expects to
enroll patients in this study immediately.
LDOS006
The Company recently announced the launch of a
U.S. Phase I/II study of L-DOS47 in combination with doxorubicin
for the treatment of metastatic pancreatic cancer. The study will
be led by Dr. Daniel Von Hoff and his team. The Company is
currently completing the study protocol and related documents
necessary for an investigational new drug (“IND”) application to
the FDA.
About Helix BioPharma Corp.
Helix BioPharma Corp. is an immuno-oncology
company specializing in the field of cancer therapy. The company is
actively developing innovative products for the prevention and
treatment of cancer based on its proprietary technologies. Helix’s
product development initiatives include its novel L-DOS47 new drug
candidate and Chimeric Antigen Receptor (“CAR”) based cell
therapies. Helix is currently listed on the TSX and FSE under the
symbol “HBP”.
Investor Relations
Helix BioPharma Corp.9120 Leslie Street, Suite
205Richmond Hill, Ontario, L4B 3J9Tel: 905-841-2300Email:
ir@helixbiopharma.com
Cautionary Statements
This news release may contain forward-looking
statements and information (collectively, "forward-looking
statements") within the meaning of applicable Canadian securities
laws. Forward-looking statements are statements and information
that are not historical facts but instead include financial
projections and estimates; statements regarding plans, goals,
objectives, intentions and expectations with respect to Helix’s
future business, operations, research and development, including
Helix’s activities relating to its drug development program, the
anticipated timelines for the commencement or completion of certain
activities, including enrolment of patients, the expansion of the
DOS47 platform into other compounds and indications and other
information in future periods. Forward-looking statements, which
may be identified by words including, without limitation,
“encouraging”, “may”, “improve”, “planned”, “possible”,
“postulated”, “enhances”, “potential”, “development”, “unique”,
“expects”, “plans”, “will”, “intends”, “pending”, “objective”,
“exploring”, “projected”, and other similar expressions, are
intended to provide information about management’s current plans
and expectations regarding future operations.
Although Helix believes that the expectations
reflected in such forward-looking statements are reasonable, such
statements involve risks and uncertainties that may cause actual
results or events to differ materially from those anticipated and
no assurance can be given that these expectations will be realized,
and undue reliance should not be placed on such statements. Risk
factors that could cause actual results or events to differ
materially from the forward-looking statements include, without
limitation: (i) Helix’s ability to operate as a going concern being
dependent mainly on securing sufficient additional financing in
order to fund its ongoing research and development and other
operating activities; (ii) the generally inherent uncertainty
involved in scientific research and drug development and those
specific to Helix’s pre-clinical and clinical development programs
(DOS47, L-DOS47, V-DOS47 and CAR-T); (iii) difficulties in
predicting accurate timelines for the commencement or completion of
certain activities including those in support of ongoing clinical
trials; (iv) positive preliminary results from early-stage clinical
trials may not be indicative of the final results from the trial or
be indicative of favorable outcomes in later-stage clinical trials;
(v) delays or inability to complete clinical trials successfully
and the long lead-times and high costs associated with obtaining
regulatory approval to market any product which may result from
successful completion of such trials; (vi) clinical data may not
demonstrate adequate efficacy and safety to result in regulatory
approval to market any of Helix’s product candidates in any
jurisdiction; (vii) economic and market conditions may become worse
and market shifts may require a change in strategic focus; and
(viii) those risks and uncertainties affecting Helix as more fully
described in Helix’s most recent Annual Information Form, including
under the headings “Forward-Looking Statements” and “Risk Factors”,
filed under Helix’s profile on SEDAR at
www.sedar.com (together, the “Helix Risk Factors”). Certain
material factors and assumptions are applied in making the
forward-looking statements, including, without limitation, that
sufficient financing will be obtained in a timely manner to allow
Helix to continue operations and implement its clinical trials in
the manner and on the timelines anticipated and that the Helix Risk
Factors will not cause Helix’s actual results or events to differ
materially from the forward-looking statements. These cautionary
statements qualify all such forward-looking statements.
Forward-looking statements and information are
based on the beliefs, assumptions, opinions, plans and expectations
of Helix’s management on the date of this news release, and the
Company does not assume any obligation to update any
forward-looking statement or information should those beliefs,
assumptions, opinions, plans or expectations, or other
circumstances change, except as required by law.
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