On January 26, 2022 Servier, an independent international pharmaceutical company, reported that it has partnered with French start-up Epigene Labs to develop an artificial intelligence-based application that prioritizes new cancer drug targets to determine the best therapeutic pathway to treat cancer patients (Press release, Servier, JAN 26, 2022, View Source;utm_medium=rss&utm_campaign=oncology-servier-collaborates-to-create-innovative-application-for-researchers [SID1234607399]). The application will be deployed within Servier R&D in the first quarter of 2022.

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!

Founded in January 2019, French startup Epigene Labs has developed the mCUBE platform with augmented intelligence for aggregating and analyzing genomic data in oncology to derive biomarkers and prioritize new cancer drug targets.

Based on Epigene Labs’ mCUBE platform, the application is perfectly suited for oncology projects and Servier R&D users. The mCUBE platform allows users to cross-analyze clinical and molecular data (omics data) through a suite of dynamic dashboards, accelerating the decision-making process in the early phases of oncology projects.

Epigene Labs has developed this application based on specifications provided by Servier’s teams from several fields of expertise (Bioinformatics, IT/data, oncology, Digital Information and Data System – DIDS). The mCUBE platform is widely deployed among Servier R&D users. In order to ensure continuous improvement, users will regularly share their feedback with Epigene Labs teams.

According to Céline Lefebvre, Ph.D., who leads the computational medicine team at Servier R&D and who is in charge of this project: "Epigene Labs has delivered a solution that is perfectly adapted to Servier’s projects in the field of oncology and that is in line with Servier’s Data&IA R&D strategy. The mCUBE platform will accelerate our decision making. It is a great lever for improving our working methods for the benefit of cancer patients.

Akpéli Nordor, Pharm.D., Ph.D., co-founder and CEO of Epigene Labs, added, "Epigene Labs is pleased to work with Servier to demonstrate the utility of its tools. As oncologists, we have a unique understanding of the tools other oncologists need to accelerate data-driven drug discovery, biomarker identification and patient selection. We look forward to continuing our collaboration with Servier to rapidly deliver the best treatments to cancer patients."

The partnership with Epigene Labs illustrates Servier’s open and collaborative innovation dynamic, which aims to surround itself with a network of diversified partners to accelerate therapeutic innovation and offer patients innovative and personalized treatments.

Céline Triquel, Open Innovation Project Manager at Servier, concludes: "This project called for collaborative work methods, agility, courage and perseverance, with the objective of developing innovations for the patient. I would like to thank all the contributors to this project, which illustrates our willingness and ability to access and integrate cutting-edge technologies, driven by open innovation and supported by the startup@servier program. "*

* The startup@servier program aims to create value for the startup and Servier with the objective of accelerating therapeutic innovation for the benefit of patients. A first phase of joint work allows the startup to conduct a key study or pilot application of a technology, before entering into a classic collaboration.

On January 26, 2022 Sysmex Inostics, a global leader in the liquid biopsy revolution for oncology, reported the use of their HPV-SEQ test in the prospective University of Chicago clinical trial,1 "Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer (Press release, Sysmex Inostics, JAN 26, 2022, View Source [SID1234607397])."

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 ability to reliably detect HPV-DNA in plasma at such low frequency shows HPV-SEQ could be a promising non-invasive biomarker test for effectively assessing treatment response, appropriately de-intensifying treatment using real-time dynamic HPV quantification, and monitoring HPV-positive OPC patients’ post-treatment," said Dr. Nishant Agrawal, Professor of Surgery at the University of Chicago. "Therefore, the HPV-SEQ test has the potential to be an important tool for oncologists in treating patients with HPV-associated head and neck cancer," he concluded.

Current standard therapy used to treat OPC patients is associated with acute and long-term toxicities from chemotherapy, radiation, and surgery.2 In the trial, Dr. Agrawal and team will dynamically assess the level of cfHPV-DNA in patients’ blood and use this information to de-intensify treatment which would improve therapeutic outcome while minimizing treatment-associated toxicity.

Sysmex Inostics senior director of medical affairs, Fred Jones, noted, "The University of Chicago trial is a strong step forward in showing the clinical utility of HPV-SEQ test as a tool in treating patients with HPV-associated head and neck cancer. We look forward to the results of the trial."

HPV-associated OPC has increased dramatically over the last decade. In the United States HPV is thought to cause 70% of oropharyngeal cancers, back of the throat, including the base of the tongue and tonsils.3

Approximately 10 percent of men and 3.6 percent of women in the U.S. have HPV in their mouths and HPV infection is more commonly found with older age. While most people clear the infections on their own within a year or two, in some people HPV infection persists.4 Patients with HPV-driven disease respond better to treatment and demonstrate a more favorable prognosis, compared to patients with HPV negative head and neck cancer.

HPV-SEQ, Sysmex Inostics ultra-sensitive quantitative, CLIA-validated, blood test for the detection of cell-free HPV 16/18 DNA (cfHPV-DNA), will be used in the trial to monitor personalized treatment and de-escalation of HPV positive oropharyngeal cancer (OPC) patients. HPV-SEQ, which can detect as few as 5 HPV 16/18 molecules in a background of 20,000 wild-type molecules (0.025% allele frequency), empowers this ground-breaking trial. The protocol was published in the recent BMC Cancer paper,5 "Prospective study evaluating dynamic changes of cell-free HPV-DNA in locoregional viral-associated oropharyngeal cancer treated with induction chemotherapy and response-adaptive treatment."

The trial is a follow-on to the poster6 presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in which Dr. Agrawal described how HPV-SEQ exhibits robust quantitative detection of cfHPV-DNA across a broad dynamic range, thus enabling high-resolution monitoring for patients with HPV positive OPC.

HPV-SEQ is available as a testing service provided by the Sysmex Inostics CLIA lab in Baltimore. MD.

On January 26, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported the initiation of the company’s global Phase 2 clinical trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, which is referred to as the ASPIRE trial (Press release, Panbela Therapeutics, JAN 26, 2022, View Source [SID1234607396]).

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!

Arvind Chaudhry MD, PhD, Principal Investigator at Summit Cancer Centers in Spokane, Washington was the first clinical site activated, with approximately 60 additional sites expected to be activated in 2022. Panbela has commenced screening for eligible patients, with enrollment expected to complete in approximately 12 months.

The ASPIRE trial is designed as a randomized double-blind placebo-controlled trial, with a primary endpoint of overall survival. The design includes a futility analysis after 104 progression-free survival events. Panbela is seeking to conduct the trial at leading cancer centers in the United States, Europe, and the Asia-Pacific region.

"Pancreatic cancer is one of the most common causes of cancer deaths in the United States and represents a significant unmet medical need, as is underscored by SBP-101’s Fast Track and Orphan Drug designations," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "We are enthusiastic about having initiated the ASPIRE global randomized Phase 2 trial. Given the rigor of the trial design, we expect the resulting data to support our registration effort."

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown potential signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, if SPB-101 receives approval in the US. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events observed in the Company’s recently completed Phase 1a/1b clinical trial have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On January 26, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that David E. Anderson, Ph.D, VBI’s Chief Scientific Officer, will present an overview of VBI-1901, the Company’s cancer immunotherapeutic for the treatment of glioblastoma (GBM), at B. Riley’s Oncology Investor Conference (Press release, VBI Vaccines, JAN 26, 2022, View Source [SID1234607395]). During his presentation, Dr. Anderson will highlight data from the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients.

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!

Presentation Details

Event: B. Riley Securities 2022 Oncology Investor Conference
Date: Friday, January 28, 2022
Time: 1:30-2:00 PM ET
Webcast: View Source
A live webcast of the presentation will also be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

On January 26, 2022 Vaccinex, Inc. (Nasdaq: VCNX, Vaccinex, the Company), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of semaphorin 4D (SEMA4D), reported positive interim response data in the Phase Ib segment of the KEYNOTE-B84 study of Vaccinex’s pepinemab in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (Press release, Vaccinex, JAN 26, 2022, View Source [SID1234607394]).

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!

Among the three patients enrolled in the Phase1b safety segment of the study, two patients have been observed to experience a complete response (CR), as per RECIST v.1.1. Biomarker analysis revealed that tumors in both responders expressed low levels of PD-L1 biomarker (CPS<20), a subset of HNSCC patients who have historically low response rates to anti-PD-1/L1 antibodies administered as single agents.

KEYNOTE-B84 Study (NCT04815720)

The Phase 1b safety observation segment of KEYNOTE-B84 enrolled 3 patients to assess potential Dose Limiting Toxicity (DLT) for pepinemab, Vaccinex’s monoclonal antibody inhibitor of SEMA4D, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (pembrolizumab), in R/M HNSCC. The trial’s Data Safety Monitoring Boarddetermined that the recommended phase 2 dose of pepinemab (20 mg/kg Q3W), in combination with KEYTRUDA (200 mg Q3W), appeared to be well-tolerated. Treatment was continued following the 28-day Safety Observation Period, and, as per protocol, an on-treatment biopsy of a target lesion was obtained at week 5, and scans for tumor response assessments were performed week 9 and every 6-weeks thereafter. Two of these initial three patients have been observed to experience a complete response (CR), as per RECIST v.1.1.

Case Study: #1, Complete Response (Confirmed)

Oropharyngeal cancer
Adverse Events: none of notable severity
Target lesions: metastatic lung lesions (Left 11mm, Right 15mm)
Biopsy at Week 5: left lung target lesion: "no evidence of malignancy. Fibrous and chronic inflammation"
Week 9 scan: Stable Disease, 19% decrease in target lesion size
Week 15 scan: Complete Response, 100% decrease
Week 21 scan: Confirmed, Complete Response
Biomarkers: PD-L1: Combined Positive Score (CPS) <20 and HPV status: negative
Case Study: #2. Complete Response (pending confirmation by repeat scan)

Larynx cancer with direct invasion into thyroid and neck
Adverse Events: Grade 1 rash
Target lesion: neck mass (37mm)
Biopsy at Week 5: "no evidence of malignancy"
Week 9 scan: Complete Response, 100% decrease
Week 15 scan: Confirmation pending, expected early March 2022
Biomarkers: PD-L1: CPS <1 and HPV status: negative
The third patient in this group who had cancer of the tongue was deemed by investigator to have clinical progression and withdrew from the study at Week 6, which was prior to the first radiologic tumor response assessment at Week 9, and was, therefore, non-evaluable for tumor response. Patient also suffered serious adverse events (SAE) including dehydration and hyperglycemia that were attributed to a pre-existing co-morbidity (diabetes and other complications) unrelated to treatment.

Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex, remarked, "We believe there is a strong rationale for continued development of pepinemab in combination with KEYTRUDA in HNSCC because these tumors are known to express high levels of SEMA4D and preclinical studies by Vaccinex and others have indicated that SEMA4D induces increased numbers and activity of myeloid suppressor cells that inhibit immune responses. Notably, pepinemab in combination with KEYTRUDA does not include administration of chemotherapy. The KEYNOTE-B84 study is accruing patients in the now open expansion phase which will enroll up to an additional 62 patients in approximately equal groups of patients with CPS <20 and CPS ≥20 across 18 U.S. trial sites. We look forward to sharing further results at a medical conference as the study progresses, with interim analysis around the midpoint of enrollment (2H 2022)."

Vaccinex has global commercial and development rights to pepinemab, and is sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov link.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates chronic inflammation in the tumor microenvironment. Preclinical and clinical data show that pepinemab promotes infiltration/activation of dendritic cells/ CD8+ T-cells and reverses immunosuppression within the tumor.

Results of a Phase 1b/2 study to evaluate the combination of pepinemab with checkpoint inhibitor, BAVENCIO, avelumab (Merck KGaA) were presented at ASCO (Free ASCO Whitepaper) 2020 and were highlighted in the July 2021 publication of Clinical Cancer Research. Vaccinex reported that results of this Phase 1b/2 CLASSICAL-Lung trial showed a 25-33% Overall Response Rate (ORR) for patients with difficult to treat PD-L1 low/negative tumors treated with the combination. The study report also indicated that pepinemab did not increase immune-related toxicities of BAVENCIO but increased penetration of cytotoxic T cells. The publication is available electronically at: Clinical Cancer Research.