Cannabics Concludes a Pre-Clinical Study on Human Biopsies in Preparation for FDA pre-IND Meeting Request on Colorectal Cancer Drug Candidate RCC-33

On November 9, 2020 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, reported that it has completed a pre-clinical study using its proprietary and novel RCC-33 formulation on human biopsies, obtained under a Helsinki Committee approved protocol (Press release, Cannabics Pharmaceuticals, NOV 9, 2020, View Source [SID1234570658]). The results show an antitumor synergistic effect of the active compounds, thus confirming the company’ previously obtained data on the antitumor properties of the drug candidate when screened on colorectal cell lines.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Eyal Ballan, Cannabics Pharmaceuticals’ CTO said: "the study results brings us one step closer in preparing our submission to the U.S. Food and Drug Administration for a pre-IND meeting. Our next step will be launching a study on mice to try and demonstrate the same synergistic effect and see tumor growth attenuation in-vivo."

Leap Therapeutics Presents DKN-01 Monotherapy Data at AACR Virtual Special Endometrial Cancer Conference

On November 9, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the presentation of clinical data from its Phase 2 clinical trial of DKN-01 in patients with recurrent epithelial endometrial cancers (EEC) at the AACR (Free AACR Whitepaper) Virtual Special Conference on Endometrial Cancer: New Biology Driving Research and Treatment being held November 9-10, 2020 (Press release, Leap Therapeutics, NOV 9, 2020, View Source [SID1234570657]). DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DKN-01 demonstrated single agent activity in the EEC patients treated in the study, particularly in biomarker-selected subgroups relating to DKK1 biology. Patients with a Wnt signaling alteration had a higher overall response rate (ORR), greater objective disease control rate (ODCR), and longer median overall survival (OS) compared to patients without a Wnt signaling alteration. Patients with Wnt activating mutations, a subgroup of the Wnt signaling alterations, had the longest progression-free survival (PFS) and OS of the subgroups evaluated. Wnt activating mutations are associated with higher tumoral DKK1 expression, and DKK1-high patients treated with DKN-01 monotherapy experienced a higher ORR and ODCR and longer PFS compared to DKK1-low patients.

"Pathways modulated by DKK1, such as the Wnt/Beta-catenin and PI3kinase/AKT pathways, are frequently mutated in patients with endometrial cancer, and high levels of DKK1 can both promote tumor growth and create an immunosuppressive tumor microenvironment. The DKN-01 results in endometrial cancer patients with Wnt activating mutations and high tumoral DKK1 expression continue to suggest that treatment with DKN-01 could provide clinically meaningful benefit to patients with advanced disease and few treatment options," said Rebecca Arend, M.D., Associate Professor, Gynecologic Oncology Division, University of Alabama at Birmingham, and Associate Scientist, O’Neal Comprehensive Cancer Center.

"These DKN-01 monotherapy efficacy results are achieved with a favorable safety profile and warrant further study of DKN-01 either as a monotherapy or in combination in endometrial cancer patients with Wnt activating mutations or high levels of tumor DKK1 expression," added Dr. Arend.

The P204 Study in Gynecologic Cancers

The P204 study is a Phase 2 basket study evaluating DKN-01 as a monotherapy or in combination with paclitaxel in patients with advanced gynecologic malignancies, including EEC, epithelial ovarian cancer (EOC), and carcinosarcoma. Data being presented at the AACR (Free AACR Whitepaper) Virtual Special Endometrial Cancer Conference pertain to DKN-01 as monotherapy in EEC patients. The primary endpoint of the P204 study is ORR, and secondary endpoints include ODCR, PFS, and OS in patients with recurrent EEC, EOC, or carcinosarcoma. Tumoral DKK1 expression was determined retrospectively by RNAscope chromogenic in situ hybridization and correlated with clinical outcomes.

Key Findings from the P204 Study

Twenty-nine EEC patients were enrolled in the DKN-01 monotherapy group, over 75% of whom had experienced three or more prior lines of therapy. Of those patients, 26 were evaluable for response. Three important biomarker-selected subgroups were the focus of the data presentation:

Patients with Wnt Signaling Alterations: In the group of 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response (PR), eight patients (40%) had a best response of stable disease (SD), and 10 patients (50%) had progressive disease (PD), representing an ORR of 10% and a ODCR of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.7%) had a best response of SD and five patients (83.3%) had PD. The patients with a Wnt signaling alteration experienced PFS of 1.9 months and OS of 15.1 months, compared to the patients without a Wnt signaling alteration who experienced PFS of 1.8 months and OS of 8.4 months.
Patients with Wnt Activating Mutations: The nine patients with a Wnt activating mutation experienced PFS of 5.5 months and had not reached a median OS, compared to the 20 patients without a Wnt activating mutation who experienced PFS of 1.8 months and OS of 12.2 months.
Patients expressing high tumor levels of DKK1: Tumoral DKK1 expression data was available for 19 EEC patients treated with DKN-01 monotherapy. In the group of seven patients with DKK1-high tumors, one patient (14.3%) had a PR, three patients (42.9%) had SD, and 3 patients (42.9%) had PD, representing an ORR of 14.3% and a ODCR of 57.1%. In the group of 12 patients with DKK1-low tumors, one patient (8.3%) had SD and 11 patients (91.7%) had PD. The DKK1-high patients experienced PFS of 3.0 months, compared to the DKK1-low patients who experienced PFS of 1.8 months.
About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK ligands on tumor cells. The U.S. Food and Drug Administration has granted Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.

Amphivena Presents Clinical Update and Translational Data of AMV564 in Solid Tumor Patients at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 9, 2020 Amphivena Therapeutics, a clinical-stage oncology company focused on developing immunotherapeutics that restore anti-cancer immunity in patients, reported updated clinical and translational data for the lead clinical candidate, AMV564, from the Amphivena ReSTORETM (Relieve Suppression of T cells in Oncology and Reinvigorate Effectors) platform of bivalent T-cell engagers, in two poster presentations at the SITC (Free SITC Whitepaper) Annual Meeting being held virtually from November 9-14, 2020 (Press release, Amphivena Therapeutics, NOV 9, 2020, View Source [SID1234570656]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1 dose escalation study (NCT04128423) enrolled 16 advanced solid tumor patients into the monotherapy cohort at the time of data cut off. The majority (62.5%) of patients received 3 or more lines of prior therapy while 31% of patients received prior checkpoint-inhibitor therapy. AMV564 continues to be well tolerated with no dose-limiting toxicities reported. Based on the safety, PK profile and clinical activity including a confirmed RECIST complete response in an ovarian cancer patient, AMV564 will be further explored in selected solid tumor indications.

Assessment of the pharmacodynamic effects in solid tumor patients using patient blood samples demonstrates that AMV564 potently depletes immunosuppressive MDSC and increases both effector CD8+ and CD4+ Th1 T cells in patients. Correlative to increases in effector CD8+ T cells, expansion of the T cell repertoire was apparent with ≥1 cycle of AMV564 treatment. Consistent with findings from patients, in vitro analyses confirm that AMV564 is highly selective for MDSC and does not target differentiated monocytes or neutrophils. AMV564 can also elicit T-cell mediated killing of MDSC utilizing different T cell subsets (CD4+, CD8+ and naïve CD8).

Details of the Presentations:

Poster Title:

Single-agent anti-tumor activity in relapsed/refractory solid tumors: interim data from the Phase
1 solid tumor trial of AMV564, a novel T-cell engager

Presenter:

Sarina Piha-Paul M.D.

Poster Number:

372

Poster Q&A:

Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST

Poster Title:

AMV564, a clinically active T cell engager, induces a target-dependent adaptive immune
response

Presenter:

Sterling C. Eckard, Ph.D.

Poster Number:

692

Poster Q&A:

Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST

The full abstracts and posters will be available on the SITC (Free SITC Whitepaper) conference and Amphivena websites as of 8:00AM ET on Monday, November 9th.

About AMV564

AMV564 relieves immune suppression via targeted depletion of immunosuppressive MDSC and drives T cell activation and polarization to restore anti-cancer immunity. To date, over 95 patients have received AMV564 across three Phase 1 clinical trials for patients with solid tumors, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS).

INOVIO Reports Third Quarter 2020 Financial Results

On November 9, 2020 INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, reported financial results for the quarter ended September 30, 2020 (Press release, Inovio, NOV 9, 2020, View Source [SID1234570654]). INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Standard Time today to discuss financial results and provide a general business update, including near-term expectations for its COVID-19 DNA vaccine development program and a clinical program update for its DNA medicines portfolio. The live webcast and a replay may be accessed by visiting INOVIO’s website at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

INOVIO Third Quarter 2020 Highlights

INOVIO has responded to the United States Food & Drug Administration (FDA) to address the questions related to the partial clinical hold on INOVIO’s Investigational New Drug Application (IND) for the Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800
Recent publication of preclinical data in npj Vaccines demonstrated INO-4800’s ability to neutralize multiple newly prevalent mutant strains of the SARS-CoV-2 virus
INOVIO added Thermo Fisher Scientific to its global manufacturing consortium to manufacture COVID-19 vaccine candidate INO-4800
INO-5401 glioblastoma (GBM) overall survival at 18 months (OS18) data selected for late-breaking presentation at the Society for Neuro-Oncology 2020 Annual Meeting on November 20, 2020
Completion of double-blind Phase 3 REVEAL 1 data collection for VGX-3100 has been impacted by the recent pandemic surge; data readout for primary CIN Phase 3 trial is expected in the first half of 2021
INO-3107, a DNA medicine candidate for treatment of recurrent respiratory papillomatosis (RRP), a rare, debilitating disease caused by human papillomavirus (HPV) infection, was granted Orphan Drug designation by the FDA
Dr. J. Joseph Kim, INOVIO’s President and CEO, said, "INOVIO continues to focus on the development of our COVID-19 vaccine, INO-4800, as well as advancing our other core DNA medicine programs. We are committed to following the science – on a critically important mission to safely and diligently develop medicines to address the impact of COVID-19 and other infectious diseases, as well as unmet medical needs in GBM and HPV. While the partial clinical hold for INO-4800 has resulted in delays to our originally anticipated development timeline, the company remains well-capitalized and focused as both clinical trials and manufacturing efforts continue."

Dr. Kim continued, "As a reminder, the FDA’s partial clinical hold is not related to the occurrence of adverse events nor does it impact the completion of our ongoing, expanded Phase 1 clinical trial for INO-4800 or the development timelines for any of our other product candidates. INOVIO provided responses to address the FDA’s questions in October and anticipates a response from the FDA this month as to whether the planned Phase 2/3 clinical trial of INO-4800 can proceed. We remain encouraged by the safety and tolerability data we have observed thus far, as well as its excellent thermostability profile – making it possible to manufacture at scale and transport vaccine without frozen cold chain requirements. INO-4800 also maintains the ability to be safely readministered and is differentiated by its ability to stimulate CD8 T cell responses. As we await a response from the FDA, we are continuing with our partners to plan and prepare for the next stages of development. INOVIO looks forward to advancing our efforts to provide a safe and effective vaccine to combat COVID-19."

INOVIO Third Quarter 2020 Program Updates

DNA Vaccine Candidate

INO-4800: COVID-19

In October, npj Vaccines published an article titled "Experimental and in silico evidence suggests vaccines are unlikely to be affected by D614G mutation in SARS-CoV-2 spike protein." Researchers at the Commonwealth Scientific and Industrial Research Organization (CSIRO), Australia’s national science research agency, and INOVIO reported that INO-4800 vaccination in a preclinical model was able to neutralize SARS-CoV-2 viruses with ‘D614G’ mutation (Aspartate-to-Glycine change at position 614) of the spike protein, which has become the dominant variant in the global COVID-19 pandemic. This latest publication builds off INOVIO’s previous non-human primate (NHP) data which demonstrated vaccine-generated memory immune responses protected NHPs for more than 3 months (13 weeks) from the last vaccination of INO-4800.

In September, INOVIO signed a letter of intent with Thermo Fisher Scientific to manufacture INO-4800. Thermo Fisher joins other contract development and manufacturing organizations in INOVIO’s global manufacturing consortium. Thermo Fisher plans to manufacture INO-4800 drug substance as well as perform fill and finish of INO-4800 drug product at its commercial facilities in the United States. Thermo Fisher projects that it could produce at least 100 million doses of INO-4800 annually if the candidate is approved by regulatory authorities.

DNA Immunotherapies: HPV-related Diseases and Immuno-Oncology

HPV-related Diseases

VGX-3100: Cervical, vulvar, and anal Precancerous Dysplasia or HSIL

The global COVID-19 pandemic has impacted the timeline for data collection for INOVIO’s VGX-3100 program. Since the last update in August, an increasing number of study participants are either not able or do not feel safe going into healthcare facilities – which is a normal and necessary component of the collection and completion of data samples for this double-blind trial. These concerns are magnified by rising COVID-19 infection rates, surges in cases globally, and a return to lockdowns in parts of Europe. As a result, it is taking longer to complete the data collection process. INOVIO remains committed to ensuring the safety of study participants, employees, principal investigators and partners involved in the process, and the company expects to read out data from VGX-3100 Phase 3 clinical trial REVEAL 1 in the first half of 2021. INOVIO plans to report the data from anal intraepithelial neoplasia (AIN) and vulvar intraepithelial neoplasia (VIN) Phase 2 clinical trials in the fourth quarter of 2020. Additionally, for VIN/AIN, the company expects to apply for rare and orphan disease designation in the first half of 2021.

INO-3107: Recurrent Respiratory Papillomatosis (RRP)

In July, INOVIO received Orphan Drug designation from the FDA for INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP), a rare, debilitating, and potentially life-threatening disease currently treated by invasive and recurrent surgeries. Recruitment recently began in the Phase 1/2 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of INO-3107 in 63 participants with HPV-6 and/or HPV-11 associated RRP. For more information on the clinical trial please visit clinicaltrials.gov (Identifier: NCT04398433).

Immuno-oncology

INO-5401: Newly Diagnosed Glioblastoma Multiforme (GBM)

INOVIO’s abstract, titled "INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma," was accepted as a late-breaking presentation at the 24th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO). The virtual presentation, scheduled for November 20, will include INO-5401 overall survival at 18 months (OS18) data and preliminary analysis on T cell immune responses to tumor antigens in both methylation status groups.

Third Quarter 2020 Financial Results

Total revenue was $236,000 for the three months ended September 30, 2020, compared to $867,000 for the same period in 2019. Total operating expenses were $36.6 million compared to $24.8 million for the same period in 2019.

INOVIO’s net income for the quarter ended September 30, 2020 was $19.2 million, or $0.12 per basic and $0.11 per diluted share, compared to net loss of $23.1 million, or $0.23 per basic and $0.25 per diluted share, for the quarter ended September 30, 2019. The net income for the 2020 quarter was primarily due to the $35.3 million change in fair value of the derivative liability related to the embedded conversion feature in our August 2019 Convertible Bonds, which was revalued at each reporting period and then immediately prior to the full conversion of these bonds into shares of the Company’s common stock in August 2020. The Company also recorded a gain on investment in affiliated entities of $27.0 million during the quarter, primarily related to the sale of its equity interest in GeneOne, which is no longer an affiliated entity. Without the non-cash gain on derivative liability and the gain on investment in affiliated entities, the Company’s net loss for the quarter would have been $43.1 million and basic net loss per share would have been $0.26.

Operating Expenses

Research and development (R&D) expenses for the three months ended September 30, 2020, were $26.5 million compared to $19.1 million for the same period in 2019. The increase in R&D expenses was primarily related to an increase in drug manufacturing expenses related to INO-4800, VGX-3100 and other clinical trials, an increase in engineering services related to our CELLECTRA 3PSP device, higher employee and contractor compensation, an increase in consulting services related to COVID-19, higher device inventory expense and higher employee stock-based compensation expense. These increases were offset by an increase in contra-research and development expense recorded from grant agreements of $10.1 million, among other variances.

General and administrative (G&A) expenses were $10.1 million for the three months ended September 30, 2020, versus $5.7 million for the same period in 2019. The increase in G&A expenses was primarily related to an increase in legal expenses and employee and consultant compensation, including non-cash stock-based compensation, among other variances.

Capital Resources

As of September 30, 2020, cash and cash equivalents and short-term investments were $337.2 million compared to $89.5 million as of December 31, 2019. As of September 30, 2020, the Company had 167.5 million common shares outstanding and 192.1 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended September 30, 2020, which can be accessed at: View Source

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss INOVIO’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting INOVIO’s website at View Source

About INOVIO’s Global Coalition Advancing INO-4800

INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and the Laval University. INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including Thermo Fisher Scientific, Richter-Helm BioLogics and Ology Biosciences to produce INO-4800 and seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy the urgent global demand for a safe and effective vaccine. To date, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the U.S. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.

About INO-4800

INO-4800 is INOVIO’s DNA vaccine candidate intended to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INOVIO has extensive experience working with coronaviruses and is the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not need to be frozen in transport of storage, which are important factors when implementing mass immunizations.

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response. INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

Quest Announces that OncoQuest Pharmaceuticals Inc. Doses First Patient in Phase 3 Clinical Trial, FLORA-5, of Company’s Lead Investigational Drug, Oregovomab, in Frontline Ovarian Cancer and appoints Dr. Sunil Gupta as Chief Medical Officer

On November 9, 2020 Quest PharmaTech Inc. (TSXV: QPT) reported that OncoQuest Pharmaceuticals, Inc., Seoul, South Korea (078590.KQ) ("OQP") has begun dosing patients in the USA for the Phase 3 clinical trial of its immunotherapeutic drug candidate oregovomab (Press release, Quest PharmaTech, NOV 9, 2020, View Source [SID1234570653]). This global pivotal trial is expected to enroll 602 patients from 140 clinical sites in 17 countries.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 3 clinical trial called FLORA-5/GOG-3035, is a double-blind, placebo-controlled, multicenter clinical study to compare the safety and efficacy of oregovomab versus placebo when administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin) for the treatment of newly diagnosed patients with advanced epithelial ovarian, fallopian tube or peritoneal carcinoma, in conjunction with optimal debulking surgical resection. The primary and secondary endpoints, for both the adjuvant and neoadjuvant cohorts of this trial, are progression free survival and overall survival, respectively.

The FLORA-5 trial is being conducted in collaboration with the Gynecologic Oncology Group Foundation in the US and IQVIA (a clinical research organization). Greater China area clinical trials are conducted in collaboration with OncoVent, a Shenzhen Hepalink Pharmaceuticals Group Company in China, which is also the commercialization license holder of oregovomab for China. "OncoVent is glad to enter into a Clinical Trial Collaboration Agreement with OncoQuest Pharmaceuticals and participate in this global Phase 3 clinical trial" said Dr. Yuenian Eric Shi, CEO of OncoVent.

Information on the clinical trial can be found on www.clinicaltrials.gov with the identifier: NCT04498117.

OQP also announces the appointment of Dr. Sunil Gupta as Chief Medical Officer. Dr. Gupta, MBBS, FRCPC has over 30 years of senior leadership experience in clinical development, medical and regulatory affairs focussed on oncology drug development.

Prior to joining OQP, Dr. Gupta was with Agenus Inc. for 2 years as Vice President of Regulatory and Pharmacovigilance. Prior to joining Agenus, Dr. Gupta was with Sanofi and legacy company Rhone-Poulenc Rorer for 22 years. Dr. Gupta has led several clinical trial programs in oncology that led to regulatory approvals with FDA, EMA and other agencies worldwide during his pharmaceutical industry career. In a leadership role he has secured registration of 2 molecules, Eloxatin (oxaliplatin) for colorectal cancer and Jevtana (cabozitaxel) for advanced prostate cancer, with successful FDA, EMA, and other health agency interactions worldwide. Dr. Gupta obtained his medical education in India followed by an internal medicine residency and oncology fellowship at the Ottawa University Hospitals, Ottawa, Canada. He completed an additional year of advanced fellowship at the Indiana University Purdue University Medical Center at Indianapolis.

"We are pleased to welcome Dr. Gupta to our clinical development team and to have started the Phase 3 trial" said Dr. Madi Madiyalakan, Chairman of OncoQuest Pharmaceuticals, Inc. and CEO of Quest PharmaTech Inc. "We are grateful to so many individuals who have helped us get to this milestone, including Dr. Eliel Bayever, our former Chief Medical Officer who recently left OQP to pursue other opportunities".

A summary of the company’s work to date on Ovarian Cancer can be found at www.oncoquestinc.com

About Oregovomab.

Oregovomab is a murine IgG monoclonal antibody against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in a recently completed randomized Phase 2 clinical trial of 97 patients. In this Phase 2 clinical trial, treatment with oregovomab demonstrated a highly clinically significant outcome for both progression-free survival and overall survival favoring the addition of oregovomab to a standard of care chemotherapy combination of paclitaxel and carboplatin. The risk of progression and of death was reduced by more than 50% when compared to placebo, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecology Oncology 2020 156:523-529) and Cancer Immunology and Immunotherapy 2020 69: 383-397, respectively.