Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer.

Start Date05 Aug 2022

Sponsor / Collaborator

Immunovaccine Technologies, Inc.

NCT04920617 / RecruitingPhase 2

A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

Start Date18 Jun 2021

Sponsor / Collaborator

IMV, Inc.

[+1]

EUCTR2013-005387-25-IT / Unknown statusPhase 2IIT

Phase 2a Study of an Immunotherapeutic Vaccine, DPX-Survivac, Alone or with Low dose Cyclophosphamide in Primary Glioblastoma Patients Receiving Standard of Care Therapy

Start Date05 May 2016

Sponsor / Collaborator

Sapienza University of Rome

100 Clinical Results associated with EMD-640744

100 Translational Medicine associated with EMD-640744

100 Patents (Medical) associated with EMD-640744

Literatures (Medical) associated with EMD-640744

01 Aug 2023·European journal of haematology

PD‐L1 expression predicts efficacy in the phase II SPiReL trial with MVP‐S, pembrolizumab, and low‐dose CPA in R/R DLBCL

Article

Author: Berinstein, Neil L ; Roos, Kim ; Bence-Bruckler, Isabelle ; Tomlinson, George ; Forward, Nicholas ; Klein, Gail ; Mangel, Joy ; Amitai, Irina ; Jiang, Yidi ; Mangoff, Kathryn ; Stewart, Douglas ; Laneuville, Pierre ; Rashedi, Iran

Abstract:

Background:

Patients with relapsed/refractory diffuse large B‐cell lymphoma (R/R DLBCL) have limited treatment options.

Methods:

R/R DLBCL patients, who were mostly ineligible for ASCT due to age or comorbidities, were treated with maveropepimut‐S (MVP‐S, previously DPX‐Survivac) a survivin directed T cell educating therapy, pembrolizumab, and intermittent low‐dose cyclophosphamide.

Findings:

We identified, using univariate analysis, a subset of patients with enhanced ORR, PFS and DOR. Patients with baseline CD20+/PD‐L1 expression had an ORR of 46% (6/13) and the disease control rate was 10/13 (77%). The PFS and OS of the positive CD20+/PD‐L1 patients were 7.1 months and 17.4 months, whereas in the intent‐to‐treat (ITT) population of 25 enrolled patients, the ORR was 28% (7/25), median PFS and OS were 4.2 months and 10.1 months respectively. A total of 6/7 clinical responders occurred in CD20+/PD‐L1 patients. The regimen was well‐tolerated, requiring only minor dose modifications and one discontinuation. Grade 1 or 2 injection site reactions occurred in 14/25, (56%). Statistically significant associations were also seen between PFS and; injection site reactions; and ELISpot response to survivin peptides, both identifying the mechanistic importance of specific immune responses to survivin.

Interpretation:

This immunotherapy combination was found to be active and safe in this clinically challenging patient population.

01 Aug 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Maveropepimut-S, a DPX-Based Immune-Educating Therapy, Shows Promising and Durable Clinical Benefit in Patients with Recurrent Ovarian Cancer, a Phase II Trial.

Article

Author: Ebrahimizadeh, Walead ; Ghatage, Prafull ; Provencher, Diane ; Torrey, Heather ; Villella, Jeannine ; Bramhecha, Yogesh ; Ghamande, Sharad ; Pejovic, Tanja ; Oza, Amit M ; Kaliaperumal, Valarmathy ; Fiset, Stephan ; MacDonald, Lisa D ; Dorigo, Oliver ; Hirsch, Heather A

PURPOSE:

Patients with platinum-resistant ovarian cancer respond poorly to existing therapies. Hence there is a need for more effective treatments.

PATIENTS AND METHODS:

The DeCidE1 trial is a multicenter, randomized, open-label, single-arm phase II study to evaluate the safety and effectiveness of maveropepimut-S with cyclophosphamide in patients with recurrent ovarian cancer. Median follow-up for evaluable subjects was 4.4 months. Data were collected from March 2019 to June 2021. Subjects received two injections of 0.25 mL maveropepimut-S 3 weeks apart, followed by one 0.1-mL doses, every 8 weeks up to progression. Oral cyclophosphamide, 50 mg twice daily, was administered in repeating weekly on and off cycles.

RESULTS:

Twenty-two patients were enrolled. Median age was 58 years (38-78 years). Among the evaluable population, the objective response rate (ORR) was 21% [90% confidence interval (CI), 7.5%-41.9%], with a disease control rate (DCR) of 63% (90% CI, 41.8%-81.3%), including 4 (21%) patients with partial responses, 8 (42%) stable disease, and 7 (37%) progressive disease. The ORRs were consistent across subgroups based on platinum sensitivity, and DCR was higher in the platinum-resistant subpopulation. Four SD patients maintained clinical benefit up to 25 months. Most treatment-related adverse events (TRAE) were grade 1 and 2 (87% of unique events). Most common AEs were injection site reactions. Eight subjects reported grade 3 and no grade 4 AEs. Survivin-specific T-cell responses were observed in treated patients with clinical benefit.

CONCLUSIONS:

Maveropepimut-S with intermittent low-dose cyclophosphamide is well-tolerated, with clinical benefit for patients with recurrent ovarian cancer. Observed responses are irrespective of the platinum status.

22 Oct 2019·ACS nanoQ1 · MATERIALS SCIENCE

Multilamellar Vaccine Particle Elicits Potent Immune Activation with Protein Antigens and Protects Mice against Ebola Virus Infection

Q1 · MATERIALS SCIENCE

Article

Author: van Tongeren, Sean A. ; Cooper, Christopher L. ; Erwin, Amanda ; Fan, Yuchen ; Moon, James J. ; Stronsky, Sabrina M. ; Steffens, Jesse T. ; Xu, Yao

Recent outbreaks of emerging infectious diseases, such as Ebola virus disease (EVD), highlight the urgent need to develop effective countermeasures, including prophylactic vaccines. Subunit proteins derived from pathogens provide a safe source of antigens for vaccination, but they are often limited by their low immunogenicity. We have developed a multilamellar vaccine particle (MVP) system composed of lipid-hyaluronic acid multi-cross-linked hybrid nanoparticles for vaccination with protein antigens and demonstrate their efficacy against Ebola virus (EBOV) exposure. MVPs efficiently accumulated in dendritic cells and promote antigen processing. Mice immunized with MVPs elicited robust and long-lasting antigen-specific CD8⁺ and CD4⁺ T cell immune responses as well as humoral immunity. A single-dose vaccination with MVPs delivering EBOV glycoprotein achieved an 80% protection rate against lethal EBOV infection. These results suggest that MVPs offer a promising platform for improving recombinant protein-based vaccine approaches.

News (Medical) associated with EMD-640744

10 May 2024

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BioVaxys Technology Corp. Closes SECOND Tranche of Private Placement

// THIS PRESS RELEASE IS NOT INTENDED FOR RELEASE OR DISSEMINATION IN THE UNITED STATES // VANCOUVER, BC, May 10, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (the " Company") is pleased to announce that it has closed the second tranche (the " Second Tranche") of its previously announced non-brokered private placement (the " Private Placement") with the issuance of 4,301,923 units (the " Units") of the Company at a price of $0.065 per Unit for aggregate gross proceeds of $279,625.00. Each Unit consists of one common share in the capital of the Company (each, a " Share") and one whole common share purchase warrant (each, a " Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until May 10, 2026, being the date that is 24 months from the date of issue. The Company intends to use the net proceeds of the Private Placement for general working capital purposes, including, enabling the Company to fund and advance its business plans in regard to its successful recent acquisition on February 16, 2024, of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX™ immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA. All securities issued pursuant to the Second Tranche are subject to a statutory hold period under applicable Canadian securities laws expiring September 11, 2024, being the date that is four months and one day from the date of closing of the Second Tranche. This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities offered have not been and will not be registered under the United States Securities Act of 1933, as amended (the " U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws, unless an exemption from such registration is available. About BioVaxys Technology Corp. BioVaxys Technology Corp. (), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it's HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company's clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© 'neoantigen' tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +1 646 452 7054 Cautionary Statements Regarding Forward Looking Information This news release contains certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable securities legislation. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or" should" occur or be achieved. All statements, other than statements of historical fact, included herein, without limitation, statements relating to the use of proceeds, the benefits of the Private Placement, and the receipt of regulatory approvals are forward-looking statements. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation, the ability to obtain necessary approvals, the Company's ability to advance its business plans and the results thereof, continued availability of capital, and changes in general economic, market and business conditions. Readers should not place undue reliance on the forward-looking statements and information contained in this news release concerning these items. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by applicable securities laws. Logo - SOURCE BioVaxys Technology Corp.

ImmunotherapyPhase 2VaccineAcquisition

03 May 2024

·www.prnewswire.com

BioVaxys Technology Corp. Closes First Tranche of Private Placement

// THIS PRESS RELEASE IS NOT INTENDED FOR RELEASE OR DISSEMINATION IN THE UNITED STATES // VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (the " Company") is pleased to announce that it has closed the first tranche (the " First Tranche") of its previously announced non-brokered private placement (the " Private Placement") with the issuance of 5,126,574 units (the " Units") of the Company at a price of $0.065 per Unit for aggregate gross proceeds of $333,227.31. Each Unit consists of one common share in the capital of the Company (each, a " Share") and one whole common share purchase warrant (each, a " Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until May 3, 2026, being the date that is 24 months from the date of issue. In connection with the closing of the First Tranche of the Private Placement, the Company paid cash finder's fees in the aggregate of $6,500 and issued a total of 60,000 finder's warrants (each, a " Finder's Warrant"). Each Finder's Warrant is also convertible into an additional Share at an exercise price of $0.15 until May 3, 2026. The Company intends to use the net proceeds of the First Tranche for general working capital purposes, including, enabling the Company to fund and advance its business plans in regard to its successful recent acquisition on February 16, 2024, of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX™ immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA. All securities issued pursuant to the First Tranche are subject to a statutory hold period under applicable Canadian securities laws expiring September 4, 2024, being the date that is four months and one day from the date of closing of the First Tranche. The Company anticipates closing the second and final tranche (the " Final Tranche") of the Private Placement within the next two weeks. Closing of the Final Tranche is subject to the receipt of all necessary regulatory approvals, including approval of the Canadian Securities Exchange. This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities offered have not been and will not be registered under the United States Securities Act of 1933, as amended (the " U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws, unless an exemption from such registration is available. About BioVaxys Technology Corp. BioVaxys Technology Corp. (), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it's HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company's clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© 'neoantigen' tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +1 646 452 7054 Cautionary Statements Regarding Forward Looking Information This news release contains certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable securities legislation. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or" should" occur or be achieved. All statements, other than statements of historical fact, included herein, without limitation, statements relating to the use of proceeds, the benefits of the Private Placement, and the receipt of regulatory approvals are forward-looking statements. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation, the ability to obtain necessary approvals, the Company's ability to advance its business plans and the results thereof, continued availability of capital, and changes in general economic, market and business conditions. Readers should not place undue reliance on the forward-looking statements and information contained in this news release concerning these items. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by applicable securities laws. Logo - SOURCE BioVaxys Technology Corp.

VaccineImmunotherapyPhase 2Acquisition

18 Apr 2024

·www.prnewswire.com

BioVaxys Technology Corp. Provides Bi-Weekly MCTO Status Update

VANCOUVER, BC, April 18, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (the " Company") is providing this bi-weekly update on the status of the management cease trade order granted on February 29, 2024 (the " MCTO"), by its principal regulator, the Ontario Securities Commission (the " OSC"), under National Policy 12-203 - Management Cease Trade Orders (" NP 12-203"), following the Company's announcement on February 21, 2024 (the " Default Announcement"), that it was unable to file its audited annual financial statements for the year ended October 31, 2023, its management's discussion and analysis of financial statements for the year ended October 31, 2023, its annual information form for the year ended October 31, 2023, and related filings (collectively, the " Required Annual Filings"). Under National Instrument 51-102, the Required Annual Filings were required to be made no later than February 28, 2024. As a result of the delay in filing the Required Annual Filings, the Company was unable to file its interim financial statements for the three months ended January 31, 2024, its management's discussion and analysis of financial statements for the three months ended January 31, 2024, and related filings (collectively, the " Required Interim Filings"). Under National Instrument 51-102, the Required Interim Filings were required to be made no later than April 1, 2024. The Company had anticipated filing the Required Annual Filings and the Required Interim Filings by April 30, 2024; however, the auditor of the Company has advised that it will not be in a position to complete the audit by April 30, 2024, and has advised that it requires additional time to complete the audit. As a result, the Company requested approval from the Ontario Securities Commission for an extension of the MCTO and such extension was granted by the OSC until May 13, 2024. As previously disclosed, the auditor of the Company requires additional time to complete its audit of the Company, including the Company's recent acquisition of all intellectual property, immunotherapeutics platform Technology, and clinical stage assets of the former IMV Inc. that closed on February 16, 2024. The Company is working with its auditor in order to file the Required Annual Filings and with its accountants in order to file the Required Interim Filings, all of which is expected to be filed on or before May 13, 2024. Except as herein disclosed, there are no material changes to the information contained in the Default Announcement. In addition, (i) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi-weekly default status reports for so long as the delay in filing the Required Annual Filings and/or Required Interim Filings is continuing, each of which will be issued in the form of a press release; (ii) the Company does not have any information at this time regarding any anticipated specified default subsequent to the default in filing the Required Annual Filings and Required Interim Filings; (iii) the Company is not subject to any insolvency proceedings; and (iv) there is no material information concerning the affairs of the Company that has not been generally disclosed. About BioVaxys Technology Corp. BioVaxys Technology Corp. (), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it's HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company's clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© 'neoantigen' tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +1 646 452 7054 Logo: SOURCE BioVaxys Technology Corp.

VaccinePhase 2Immunotherapy

100 Deals associated with EMD-640744

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Epithelial Ovarian Carcinoma	Phase 2	US	Immunovaccine Technologies, Inc.	05 Aug 2022
Platinum-Resistant Epithelial Ovarian Carcinoma	Phase 2	CA	Immunovaccine Technologies, Inc.	05 Aug 2022
Platinum-Resistant Epithelial Ovarian Carcinoma	Phase 2	PR	Immunovaccine Technologies, Inc.	05 Aug 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	US	Immunovaccine Technologies, Inc.	05 Aug 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	CA	Immunovaccine Technologies, Inc.	05 Aug 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	PR	Immunovaccine Technologies, Inc.	05 Aug 2022
Diffuse large B-cell lymphoma recurrent	Phase 2	US	IMV, Inc.	18 Jun 2021
Diffuse large B-cell lymphoma recurrent	Phase 2	AU	IMV, Inc.	18 Jun 2021
Diffuse large B-cell lymphoma recurrent	Phase 2	CA	IMV, Inc.	18 Jun 2021
Diffuse large B-cell lymphoma recurrent	Phase 2	FR	IMV, Inc.	18 Jun 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2022 Manual	Not Applicable	Metastatic Neoplasm to the Bladder	17	Cyclophosphamide+Pembrolizumab+EMD 640744	vffcykftle(wytdjggspt) = The combination was well-tolerated, with majority of AEs being grade 1 or grade 2. xaxedxuacd (whmogtbndw )	Positive	15 Jun 2022
NCT02785250 (DeCidE1, ASCO2019) Manual	Phase 1	Recurrent ovarian cancer	65	cyclophosphamide+±Epacadostat+epacadost	lhrcmrfnmg(svixigpoly) = ytnjabract wvfvbozqyz (juatgquqbn )	Positive	01 Jun 2019
NCT02323230 (ASCO2016) Manual	Phase 2	Diffuse large B-cell lymphoma recurrent	24	cyclophosphamide+DPX-Survivac	zdtqogvyaj(uukhywphip) = 2 pts on day 100 and 162 uzfeaosgkg (oohcwvmzcr )	Positive	03 Jun 2016

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