IMV Inc. Presents New Positive Data from Phase 2 Monotherapy Arm of Its Decide1 Trial in Advanced Ovarian Cancer and Continued Duration of Clinical Benefits to Patients with Progression Free Survival
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Tumor regressions demonstrate potential for DPX-Survivac
immunotherapy in hard-to-treat solid tumors
Data correlations of survivin specific T cell levels and durable
clinical benefit continue to link novel mechanism of action of
DPX-Survivac with anti-cancer activity
DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology
corporation, today announced that investigators shared new positive data
for its DeCidE1 (DPX-Survivac with low dose Cyclophosphamide and
Epacadostat) clinical trial at the 2019
American Society for Clinical Oncology (ASCO) Annual Meeting.
These new data are from the ongoing Phase 1b/2 trial evaluating the
safety and efficacy of IMV’s lead candidate DPX-Survivac and
intermittent low-dose cyclophosphamide (CPA), with and without Incyte’s
IDO1 enzyme inhibitor epacadostat, in patients with advanced recurrent
ovarian cancer. New data from evaluable patients from the phase 2
monotherapy arm of the trial indicated the potential for DPX-Survivac to
impact solid tumor growth in hard to treat ovarian cancer patients.
Longer-term follow-up from the phase 1b portion of the trial continued
to demonstrate that the levels of survivin-specific T cells in the blood
of patients – a measure of DPX-Survivac’s novel mechanism of action
(MOA) – correlated with durable clinical benefits.
Updated Clinical Data for DeCidE1
In a poster
presentation, Janos L. Tanyi, M.D., Ph.D., Assistant Professor of
Obstetrics and Gynecology at the Hospital of the University of
Pennsylvania, provided an update on the clinical results from the first
patients enrolled in the phase 2 monotherapy cohort. Researchers
have enrolled 19 of 28 participants to date:
-
Of seven patients evaluable at data cut-off in the monotherapy arm,
five showed signs of treatment benefits, including reduction of target
lesions in two patients, while two patients progressed. -
Within the group of four patients with low tumor burden – a potential
predictor of response – three showed stable diseases including two
reductions in tumor burden continuing the positive trend seen in
earlier results. -
All subjects evaluable for T cell responses (five of five) showed
survivin specific T cell activation in the blood, four of five showed
a robust response. IHC analysis for tumor infiltration is ongoing - Treatments have been well tolerated.
“We believe that immunotherapy can and should be an integral part of
treatment options for hard-to-treat cancers, including solid tumor
indications like ovarian cancer in which patients continue to maintain
an urgent need for better outcomes,” said Frederic Ors, Chief Executive
Officer, IMV Inc. “We continue to accumulate evidence of DPX-Survivac’s
clinical activity in these patients and are encouraged by the multiple
tumor shrinkages and long-lasting responses we have seen to date.”
The data also highlighted long-lasting responders from the phase 1b
portion of the study with key takeaways as follows:
-
Prolonged duration of clinical benefits reaching up to more than two
years, surpassing the progression-free survival to previous
treatments, including platinum-based chemotherapy. -
Long-lasting clinical benefits and high levels of survivin specific T
cells are associated with long-term treatment;-
One subject has received DPX-Survivac for more than 21 months so
far. This finding is the longest duration of treatment for
DPX-Survivac on record to date. -
It is supportive of DPX Survivac’s ability to maintain high levels
of survivin-specific T cells in the blood over a prolonged period
of time.
-
One subject has received DPX-Survivac for more than 21 months so
About the DeCidE1 Phase 1b/2 Trial
The DeCidE1 study is an open label, uncontrolled phase 1b/2 trial to
assess the safety and efficacy of DPX-Survivac and cyclophosphamide with
and without epacadostat in individuals with advanced, platinum-sensitive
and resistant ovarian cancer. IMV completed enrollment of 53 subjects in
the phase 1b cohort in December 2018. Following positive top line data,
IMV amended the phase 2 protocol to stop enrollment in the combination
arm with epacadostat and evaluate DPX-Survivac monotherapy with CPA in
patients with lower tumor burden. As of the May 27, 2019 data cut-off
date, 12 subjects have been enrolled in the phase 2 randomized portion
of the trial and 7 subjects have been enrolled so far in the monotherapy
population with lower baseline tumour burden.
The amended phase 2 cohort of the DECIDE1 trial is targeting enrollment
of at least 16 subjects in the population with a lower baseline tumor
burden. Enrollment is ongoing at multiple sites in the U.S. and Canada.
About DPX-Survivac
DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies
that programs targeted T cells in vivo. It has demonstrated the
potential for industry-leading targeted, persistent, and durable T cell
activation. IMV believes this mechanism of action (MOA) is key to
generating durable solid tumor regressions. DPX-Survivac consists of
survivin-based peptides formulated in IMV’s proprietary DPX drug
delivery platform. DPX-Survivac is designed to work by eliciting a
cytotoxic T cell immune response against cancer cells presenting
survivin peptides on their surface.
Survivin, recognized by the National Cancer Institute (NCI) as a
promising tumor-associated antigen, is broadly over-expressed in most
cancer types, and plays an essential role in antagonizing cell death,
supporting tumor-associated angiogenesis, and promoting resistance to
anti-cancer therapies. IMV has identified over 15 cancer indications in
which the over-expression of survivin can be targeted by DPX-Survivac.
DPX-Survivac has received Fast Track designation from the U.S. Food and
Drug Administration (FDA) as maintenance therapy in advanced ovarian
cancer, as well as orphan drug designation status from the U.S. FDA and
the European Medicines Agency (EMA) in the ovarian cancer indication. It
is currently being evaluated in multiple Phase 1b/2 clinical trials.
About IMV
IMV Inc. is a clinical stage biopharmaceutical company dedicated to
making immunotherapy more effective, more broadly applicable, and more
widely available to people facing cancer and other serious diseases. IMV
is pioneering a new class of immunotherapies based on the Company’s
proprietary drug delivery platform. This patented technology leverages a
novel mechanism of action that enables the programming of immune cells in
vivo, which are aimed at generating powerful new synthetic
therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T
cell-activating immunotherapy that combines the utility of the platform
with a target: survivin. IMV is currently assessing DPX-Survivac as a
monotherapy in advanced ovarian cancer, as well as a combination therapy
in multiple clinical studies with Merck. Connect at www.imv-inc.com.
IMV Forward-Looking Statements
This press release contains forward-looking information under
applicable securities law. All information that addresses activities or
developments that we expect to occur in the future is forward-looking
information. Forward-looking statements are based on the estimates and
opinions of management on the date the statements are made. However,
they should not be regarded as a representation that any of the plans
will be achieved. Actual results may differ materially from those set
forth in this press release due to risks affecting the Corporation,
including access to capital, the successful completion of clinical
trials and receipt of all regulatory approvals. IMV Inc. assumes no
responsibility to update forward-looking statements in this press
release except as required by law. These forward-looking statements
involve known and unknown risks and uncertainties and those risks and
uncertainties include, but are not limited to, our ability to access
capital, the successful and timely completion of clinical trials, the
receipt of all regulatory approvals and other risks detailed from time
to time in our ongoing quarterly filings and annual information form.
Investors are cautioned not to rely on these forward-looking statements
and are encouraged to read IMV’s continuous disclosure documents,
including its current annual information form, as well as its audited
annual consolidated financial statements which are available on SEDAR at www.sedar.com and
on EDGAR at www.sec.gov/edgar.
Contacts
Media:
Andrea Cohen, Sam Brown Inc.
O: (917)
209-7163
E: [email protected]
Investor
Relations:
Marc Jasmin, IMV Senior Director, Investor Relations
and Communications
O: (902) 492-1819 ext :1042
M: (514)
617-9481
E: [email protected]
Indivior
Indivior Provides Update on Aelis Farma’s Clinical Phase 2B Study Results with AEF0117 in Participants with Cannabis Use Disorder
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) 596/2014 (AS IT FORMS PART OF DOMESTIC LAW IN THE UK BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018).
- Primary and Secondary End Points of the Study were Not Met
- Indivior Does Not Currently Expect to Exercise AEF0117 Option
SLOUGH, United Kingdom and RICHMOND, Va., Sept. 4, 2024 /PRNewswire/ — Indivior PLC (Nasdaq/LSE: INDV) is today providing an update following Aelis Farma’s announcement of the results from its clinical Phase 2B trial with AEF01171, evaluating the efficacy and safety in treatment-seeking participants with moderate to severe Cannabis Use Disorder (CUD). The purpose of this trial was twofold: (1) to show that AEF0117 (0.1, 0.3, 1 mg once a day for 12 weeks) lowers cannabis use and (2) to determine the endpoints and optimal dosage of AEF0117 for use in future studies. In this phase 2B study, patients were treatment-seeking participants, 84% of whom had severe CUD.
The results of the study demonstrated that the primary endpoint, the proportion of participants who reduced their cannabis use to ≤1 day per week, as well as secondary endpoints measuring the proportion of participants reaching either complete abstinence or who used ≤2 day per week, were not met. Although these results are disappointing, they indicate that significant work remains to be done to understand subpopulations of patients with CUD, specifically those with severe CUD.
This clinical Phase 2B study is part of the strategic collaboration between Aelis Farma and Indivior, which includes an exclusive option for Indivior to license the global rights to AEF0117. Given the lack of separation from placebo on primary and secondary endpoints and before seeing further additional favorable clinical data, Indivior does not currently expect to exercise its option.
Important Cautionary Note Regarding Forward-Looking Statements
This news release contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding whether: we will be able to ultimately demonstrate the safety and efficacy of AEF0117, which is a prerequisite to filing any New Drug Application; we might ever exercise our option for AEF0117 and, if so, when; and other statements containing the words “believe,” “anticipate,” “plan,” “expect,” “intend,” “estimate,” “forecast,” “strategy,” “target,” “guidance,” “outlook,” “potential,” “project,” “priority,” “may,” “will,” “should,” “would,” “could,” “can,” “outlook,” “guidance,” the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future.
Actual results may differ materially from those because they relate to future events. Various factors may cause differences between Indivior’s expectations and actual results, including, among others, the risks described in our most recent annual report on Form 20-F beginning on page 9 as filed with the U.S. SEC and in subsequent releases; legal and market restrictions that may limit how quickly we can repurchaser our shares; the substantial litigation and ongoing investigations to which we are or may become a party; our reliance on third parties to manufacture commercial supplies of most of our products, conduct our clinical trials and at times to collaborate on products in our pipeline; our ability to comply with legal and regulatory settlements, healthcare laws and regulations, requirements imposed by regulatory agencies and payment and reporting obligations under government pricing programs; risks related to the manufacture and distribution of our products, most of which contain controlled substances; market acceptance of our products as well as our ability to commercialize our products and compete with other market participants; competition; the uncertainties related to the development of new products, including through acquisitions, and the related regulatory approval process; our dependence on third-party payors for the reimbursement of our products and the increasing focus on pricing and competition in our industry; unintended side effects caused by the clinical study or commercial use of our products; our ability to successfully execute acquisitions, partnerships, joint ventures, dispositions or other strategic acquisitions; our ability to protect our intellectual property rights and the substantial cost of litigation or other proceedings related to intellectual property rights; the risks related to product liability claims or product recalls; the significant amount of laws and regulations that we are subject to, including due to the international nature of our business; macroeconomic trends and other global developments such as armed conflicts and pandemics; the terms of our debt instruments, changes in our credit ratings and our ability to service our indebtedness and other obligations as they come due; changes in applicable tax rate or tax rules, regulations or interpretations and our ability to realize our deferred tax assets; and volatility in our share price due to factors unrelated to our operating performance or that may result from the potential move of our primary listing to the U.S.
Forward-looking statements speak only as of the date that they are made and should be regarded solely as our current plans, estimates and beliefs. Except as required by law, we do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events.
This release is being made by Kathryn Hudson, Company Secretary Indivior PLC.
About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD), overdose and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease.
Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
References:
- National Library of Medicine (U.S.) (2022, April). Effect of AEF0117 on treatment-seeking patients with cannabis use disorder (CUD) (SICA2). Identifier
NCT05322941 https://www.clinicaltrials.gov/study/NCT05322941
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HERZLIYA, Israel and CALGARY, Alberta, Aug. 29, 2024 /PRNewswire/ — Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (“Innocan” or the “Company”), a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that it has completed its previously announced non-brokered private placement offering of 5,025,725 units of the Company (the “Units”) at a price of C$0.22 per Unit for gross proceeds of C$1,105,659.50 (the “Offering”).
Each Unit is comprised of: (i) one (1) common share in the capital of the Company (each a “Common Share”); and (ii) one (1) common share purchase warrant (each a “Warrant”). Each Warrant will entitle the holder thereof to purchase one Common Share at a price of C$0.32 for a period of four (4) years from the date of issuance.
Innocan intends to use the proceeds of the Offering for working capital and general corporate purposes.
The securities issued to Canadian subscribers in connection with the Offering are subject to a hold period of four months and one day from the date of issuance, in accordance with applicable Canadian securities laws.
Iris Bincovich, Chief Executive Officer of the Company, stated “we are very pleased with our successful offering. I would like to extend my sincere gratitude to our investors for their unwavering support. We see this as a strong vote of confidence by both existing and new investors which demonstrates investor support of our vision and strategic direction. These new funds will provide us with additional working capital to enable us to capitalize on new opportunities and allow us to advance strongly on our growth plans.”
The Company is also pleased to announce that it has granted an aggregate of 300,000 stock options (each an “Option“) to certain consultants of the Company pursuant to the Company’s stock option plan (the “Plan“). Each Option may be exercised for one (1) common share in the capital of the Company (each, a “Share“) at a price of $0.25 per Share. The Options expire on August 27, 2029.
All Options granted vest in accordance with the following vesting schedule: (i) 1/3rd of the Options vested immediately at grant; (ii) 1/3rd of the Options will vest on February 28, 2025; and (iii) 1/3rd will vest on August 27, 2025; all subject to the terms and conditions of the Plan.
About Innocan Pharma:
Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies comprises with cannabinoids science, to treat various conditions to improve patients’ quality of life. This segment involves two drug delivery technologies: (i) LPT CBD-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for two indications: Epilepsy and Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment Innocan has established a Joint Venture by the name of BI Sky Global Ltd. that focuses developing on advanced targeted online sales. https://innocanpharma.com/
Contact Information:
For Innocan Pharma Corporation:
Iris Bincovich, CEO
+1 5162104025
+972-54-3012842
+442037699377
[email protected]
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
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Cannabis
Europe Medical Cannabis Market Forecast 2024-2032: Tilray, Aurora Cannabis, and GW Pharmaceuticals Dominate the Market Landscape
Dublin, Aug. 29, 2024 (GLOBE NEWSWIRE) — The “Europe Medical Cannabis Oil Market Size, Industry Dynamics, Opportunity Analysis and Forecast 2024-2032.” report has been added to ResearchAndMarkets.com’s offering.
The Europe Medical Cannabis Oil market is poised for significant growth, projected to escalate from US$ 0.91 billion in 2023 to US$ 2.40 billion by 2032, advancing at a CAGR of 12.08%. In this comprehensive research report, the market is analyzed by:
- Derivatives;
- Source;
- Application;
- Route of Administration;
- End-user;
- Distribution Channel; and
- Country.
Market Highlights Identified in the Report
- Progressive legalization across Europe is creating a favorable regulatory environment, enhancing market expansion for medical cannabis oil products.
- Germany leads the market with a robust infrastructure and supportive regulations, while other countries like the UK, Italy, and Spain show significant growth potential based on evolving regulatory landscapes and market dynamics.
- Key players such as Tilray, Aurora Cannabis Inc., and GW Pharmaceuticals dominate the market, emphasizing research, strategic partnerships, and innovation to maintain competitive edge amidst evolving industry dynamics.
The medical cannabis oil market has experienced substantial growth as legalization and acceptance of cannabis-based treatments expand globally. Cannabis oil, derived from the cannabis plant through extraction methods, contains cannabinoids such as THC and CBD, known for their therapeutic properties. Increasing recognition of cannabis oil’s potential in alleviating symptoms of various medical conditions, including chronic pain, epilepsy, and anxiety disorders, has driven its adoption in medical settings.
Governments in several countries are progressively legalizing medical cannabis, creating a conducive regulatory environment for market expansion. Additionally, growing consumer awareness about alternative and natural therapies has fueled the demand for cannabis oil products. The market is characterized by diverse product offerings, including full-spectrum and CBD-isolate oils, catering to different therapeutic needs and preferences.
Despite regulatory challenges and stigma associated with cannabis, the medical cannabis oil market continues to evolve, driven by ongoing research, favorable legislative changes, and shifting attitudes toward cannabis-based therapies in healthcare.
Regional Insights
Germany is likely to maintain its leadership position in the European medical cannabis oil market due to its established infrastructure, supportive regulations, and strong healthcare system. Germany legalized medical cannabis in 2017, giving the market a head start compared to many other European countries. This established infrastructure and experience position Germany as a leader in the field. As awareness and acceptance of medical cannabis increase, the number of patients seeking treatment in Germany is steadily rising. This fuels market growth and incentivizes further investment in research and development.
Germany’s regulatory framework for medical cannabis is considered relatively patient-friendly compared to some other European countries. This facilitates access for patients with qualifying conditions. The UK legalized medical cannabis in 2018 and is experiencing an increase in patient access programs. This, coupled with ongoing research, could lead to significant market growth. Italy legalized medical cannabis in 2006 but has faced challenges with availability. As regulations become more streamlined and patient access expands, the Italian market holds significant growth potential. Spain has a well-established medical cannabis industry with a focus on domestic production. As regulations evolve and export opportunities increase, the Spanish market could see a boost.
Competitive Landscape
The Medical Cannabis Oil market is characterized by a vigorous competitive landscape, with prominent entities like Tilray, Aurora Cannabis Inc., GW Pharmaceuticals, Almiral, Bedrocan, and others at the forefront, collectively accounting for approximately 41 % of the overall market share. This competitive milieu is fueled by their intensive efforts in research and development as well as strategic partnerships and collaborations, underscoring their commitment to solidifying market presence and diversifying their offerings.
The primary competitive factors include pricing, product caliber, and technological innovation. As the Medical Cannabis Oil industry continues to expand, the competitive fervor among these key players is anticipated to intensify. The impetus for ongoing innovation and alignment with evolving customer preferences and stringent regulations is high. The industry’s fluidity anticipates an uptick in novel innovations and strategic growth tactics from these leading corporations, which in turn propels the sector’s comprehensive growth and transformation.
Key Topics Covered
Chapter 1. Research Framework
Chapter 2. Research Methodology
Chapter 3. Executive Summary: Europe Medical Cannabis Oil Market
Chapter 4. Europe Medical Cannabis Oil Market Overview
Chapter 5. Europe Medical Cannabis Oil Market Analysis, by Derivatives
Chapter 6. Europe Medical Cannabis Oil Market Analysis, by Source
Chapter 7. Europe Medical Cannabis Oil Market Analysis, by Application
Chapter 8. Europe Medical Cannabis Oil Market Analysis, by Route of Administration
Chapter 9. Europe Medical Cannabis Oil Market Analysis, by End-user
Chapter 10. Europe Medical Cannabis Oil Market Analysis, by Distribution Channel
Chapter 11. Europe Medical Cannabis Oil Market Analysis, by Country
Chapter 12. The UK Medical Cannabis Oil Market Analysis
Chapter 13. Germany Medical Cannabis Oil Market Analysis
Chapter 14. The Netherlands Medical Cannabis Oil Market Analysis
Chapter 15. Italy Medical Cannabis Oil Market Analysis
Chapter 16. Spain Medical Cannabis Oil Market Analysis
Chapter 17. Poland Medical Cannabis Oil Market Analysis
Chapter 18. Rest of Europe Medical Cannabis Oil Market Analysis
Chapter 19. Company Profiles (Company Overview, Financial Matrix, Key Product Landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)
A selection of companies mentioned in this report includes, but is not limited to:
- Aurora Cannabis Inc.
- Bedrocan
- Biocann
- BIOTA Biosciences LLC
- Cannamedical
- Mary Jane CBD
- Sanity Group GmbH
- Tilray
- Valcon Medical
For more information about this report visit https://www.researchandmarkets.com/r/dh7q46
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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