On May 3, 2021 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: BVAXF) ("BioVaxys" or "Company") reported that it has signed the definitive exclusive bioproduction agreement ("Agreement") with BioElpida S.A.S. ("BioElpida") of Lyon, France, to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys’ vaccine candidate for Stage III/Stage IV ovarian cancer (Press release, BioVaxys Technology, MAY 3, 2021, View Source [SID1234579031]). BioVaxys and BioElpida executed a Term Sheet in February outlining the commercial relationship, with todays definitive Agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill. BioVaxys expects to be able to prepare its regulatory submission for a EU Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of this year, with vaccine supply for the planned clinical study available early May 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!

BioElpida is a biotechnology contract development and manufacturing company ("CDMO") which applies single-use bioprocessing for development and manufacturing of biological and cell-based products. BioElpida’s expertise extends from R&D to pharmaceutical manufacturing and release of clinical batches, and intermediate steps such as process development, feasibility studies, analytical method validation, as well as aseptic fill & finish and other bioproduction services. BioElpida’s facility is certified for clinical bioproduction by France’s National Security Agency of Medicines and Health Products (ANSM).

"Early on we made the decision to seek a bioproduction partner with the ability to quickly move from smaller-yield GMP-grade clinical study supplies to large-scale manufacturing if our clinical trials prove successful and EU regulatory approval is granted," said Kenneth Kovan, Co-Founder, President and Chief Operating Officer of BioVaxys. "BioElpida’s technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those suffering from advanced ovarian cancer."

BioVaxys is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia S.A.S., which plans to submit a Clinical Trial Application ("CTA") for BVX-0918A to the European Medicines Agency ("EMEA") later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer. ProCare Health will have marketing rights to BVX-0918A in the EU and UK, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World.

Globally, there remain significant unmet therapeutic needs for ovarian cancer treatment. Worldwide, over 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer the leading cause of death from gynecologic malignancy in the United States (American Cancer Society Facts & Figures 2020). An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths (National Cancer Institute, Surveillance and Epidemiology Program, 2020). The majority of women with Stage III or Stage IV cancer will ultimately have recurrent disease resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have limited life expectancy even with multiple salvage regimens. This large group of non-responders to first line therapy, or those who relapse after first line therapy, are the initial target market for BioVaxys.

The global ovarian cancer drugs market was valued US$1.2B in 2017 and is expected to reach US$4.6B by 2026, at a CAGR of 18.29 % (www.medgadget.com/2020/11/ovarian-cancer-drugs-2020-global-market-to-reach-us-4-6-bn-and-growing-at-cagr-of-18-29-by-2026.html).

On May 3, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the Company will release its first quarter 2021 financial results on Thursday, May 13, 2021 before the U.S. financial markets open (Press release, Compugen, MAY 3, 2021, View Source [SID1234579028]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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!

To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S.,
or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On May 3, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in two upcoming virtual conferences (Press release, BioMarin, MAY 3, 2021, View Source [SID1234579027]). An audio webcast of the presentations will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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!

On March 3, 2021 Kiromic BioPharma, Inc. (Nasdaq: KRBP), an immuno-oncology target discovery and gene-editing company, with a proprietary artificial intelligence neural network platform (Diamond AI) to develop novel oncology therapeutics, reported its technology showcases at the recent American Association of Cancer Research ("AACR") 2021 meeting (Press release, Kiromic, MAY 3, 2021, View Source [SID1234579026]).

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!

Kiromic BioPharma is using cutting-edge artificial intelligence (AI) technology to select biomarkers to develop CAR-T therapy for solid tumors.

The Company believes that the use of AI will enable it to compress development timelines in ways which are not achievable by its peers who are not equipped with AI technology.

The American Association of Cancer Research recognized Kiromic’s innovation with its acceptance of 6 poster presentations at the recent conference on April 9-14, 2021.

Kiromic’s 6 posters showcased the company’s following technology platforms and advances:

CancerDiff, a deep data mining engine that harmonizes billions of data points across disease types and states, data types, data structures and data platforms and Diamond AI, a proprietary system which combs through billions of transcription data points across public and private RNA databases to present the best immunogenic peptide candidates for CAR-T;
CancerSplice, the Company’s 3D, isoform prediction engine, which examines billions of data points to select the best targets;
Validation of the Company’s AI technology in identifying NY-ESO-1, which is a very well-known target and served as an excellent validation of the Company’s engine’s accuracy;
Our company also demonstrated that our chPD1 receptor is effective on solid tumors in both in vitro and in vivo models with minimal toxicities;
We showed that our non-viral gene edit technology could have the same target specificity of Cas9 without the DNA destruction common to HIV integrase;
Finally we investigated NK as a potential adoptive cell therapy platform for CAR-T.
Dr. Maurizio Chiriva, PhD stated that, "Our mission is to become the leader in allogenic, off-the-shelf CAR-T in solid tumors. Our cutting-edge AI engine for biomarker identification and selection will support our development pathway going forward. We believe that our ability to deliver allogenic, off-the-shelf CAR-T for solid tumors is within reach and that our therapy will offer patients higher efficacy at lower costs. We expect to make this therapy a reality this year."

Mr. Gianluca Rotino, the Company’s Chief Strategy and Innovation Officer, noted that, "We are proud to have set a new record for the number of posters accepted for a single company by the prestigious American Association of Cancer Research (AACR 2021), who accepted 6 of our posters. These poster presentations also broke ground for the number of new technologies that Kiromic is bringing to the world of live-cell therapy (CAR-T).

"We believe that we are disrupting the industry with our innovative approach as summarized in the following table:

Kiromic’s approach

Industry standard

Targeting

AI driven and machine learning bio-informatics for targeting

Classic chemistry

Live Cell Type

Gamma Delta T cells for CAR-T

Peers’ NK, or Mesenchymal (stem cells)

Donor Tissue Type

Allogenic gamma delta T cells from healthy donors

Marketed therapies’ autologous T-cells from frail patients

Gene Editing

Non-viral, non-destructive to DNA

Industry standard CRISPR Cas9

GMP Manuf.

In-house Vivarium and GMP manufacturing for our clinical trials

Industry standard of using external Contract Manufacturers

"With these innovations, we believe that we are poised to lead the future for CAR-T in solid tumors. We expect to build on this lead with planned in-human dosing in the third quarter of 2021."

ABOUT KIROMIC POSTERS AT AACR (Free AACR Whitepaper) 2021

Session

Focus

Poster

Link to Poster at AACR (Free AACR Whitepaper)

BSB01.05

New Software for Data Analysis

247

Identification of an ovarian cancer selective splice variant of mesothelin utilizing the Kiromic proprietary search engine CancerDiff

CancerDiff:

Our deep data-mining engine which harmonizes billions of data points across:

— disease types and states

— data types,

— data structures, and

— data platforms.

Diamond AI:

Our system which combs through billions of transcription data points across public and private RNA databases to present the best immunogenic peptide candidates for CAR-T.

PO.IM02.01

Adoptive Cell Therapy

1534

Mesothelin isoform 2 is a novel target for allogenic CARγδT cell therapy in solid tumors

CancerSplice:

Our 3D, isoform prediction engine which examines billions of data points to select the best targets.

BSB01.04

New Algorithms

243

Identification of novel epitopes of NY-ESO-1 for solid malignancies by Kiromic proprietary search engine Diamond

NY-ESO-1:

How we got to NY-ESO-1 using our AI target selection engine. NY-EOS-1 is a very well-known target and served as an excellent validation of our engine’s accuracy.

PO.ET08.01

Gene and Vector-Based Therapy

1154

Site-specific gene editing with ABBIE for T-cell therapy

ABBIE:

We showed that our non-viral gene edit technology could have the same target specificity of Cas9 without the DNA destruction common to HIV integrase.

PO.IM02.01

Adoptive Cell Therapy

LB148

Gamma delta T cells engineered with a chimeric PD-1 receptor effectively control PD-L1 positive tumors in vitro and in vivo with minimal toxicities.

chPD1:

We demonstrated that our chPD1 receptor was effective on solid tumors in both in vitro and in vivo models with minimal toxicities.

PO.IM02.01

Adoptive Cell Therapy

1535

Allogenic CAR iNKT as a cell therapy platform targeting tumor antigen Isomesothelin

iNKT:

We investigated NK as a potential adoptive cell therapy platform for CAR-T.

About AACR (Free AACR Whitepaper) (American Association of Cancer Research)

On May 3, 2021 EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence (AI) solutions to Find, Fight and Follow serious medical conditions, reported that it has received CE Mark clearance for aPROMISE in Europe (Press release, EXINI Diagnostics, MAY 3, 2021, View Source [SID1234579025]).

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!

aPROMISE is artificial intelligence-based, deep learning-enabled, medical device software that allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen (PSMA) PET/CT in oncology. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context.1,2 The AI tool provides enhanced consistency in quantitative analysis and is intended to increase efficiency, accuracy and reproducibility of PSMA PET/CT image assessments.

In a prospectively planned independent analysis of the PyL OSPREY trial, aPROMISE demonstrated a high reproducibility with an intraclass correlation coefficient (ICC) of 0.99 (95%CI 0.99 – 0.99). In metastatic prostate cancer patients, the sensitivity of aPROMISE in a pre-selection of lesions was 92% for regional lymph nodes, 91% for distant lymph nodes, and 87% for bone.

"The Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria has proposed a uniform language for objective reporting to assist physicians in assessing a patient’s tumor burden and also provides clinically meaningful information to physicians for developing therapeutic plans," said Matthias Eiber, Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany. "With the introduction of automation to the PROMISE criteria, the software is able to facilitate adherence to standardized reporting in clinical practice by reducing reporting time and limitations of manual assessment."

"The aPROMISE CE Mark clearance is an exciting milestone for Lantheus on the path to possible U.S. approval later this year," said Etienne Montagut, Sr. Vice President, Corporate Development. "We believe aPROMISE is a unique offering that could complement and strengthen our PSMA assets portfolio by improving their value and ease of use while assisting treating clinicians in their patient management decisions."

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States – an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, 248,530 new cases of prostate cancer will be diagnosed, and 34,130 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.3

About PyL

PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer both localized as well as metastatic to lymph nodes, bone and soft tissue to detect and localize recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus submitted a new drug application (NDA) for PyL which was accepted and granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021.

OSPREY Phase 2/3 Trial

The OSPREY trial was designed to assess the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high-risk prostate cancer (Cohort A) and confirm distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). The primary endpoints for the trial were sensitivity and specificity of PyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A. A key secondary endpoint of the trial was the sensitivity of PyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B.

In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. PyL showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% meeting the specificity but not the pre-established sensitivity co-primary endpoint. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

Safety results showed PyL was well tolerated. The most frequent adverse events reported were dysgeusia (2.6%), headache (1.8%), and fatigue (1.3%).