On June 23, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the quarter and fiscal year (FY) ended April 30, 2020 on June 30, 2020 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, JUN 23, 2020, View Source [SID1234561398]). Members of Avid’s senior management will discuss financial results for the quarter and FY ended April 30, 2020 and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

On June 23, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that it has entered into definitive agreements with several healthcare-focused institutional investors for the purchase and sale of 38,888,892 of the Company’s ordinary shares represented by American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 19,444,446 ADSs, at a combined purchase price of $0.90 per ADS and associated warrant, in a registered direct offering, for aggregate gross proceeds of approximately $35.0 million (Press release, Kitov Pharmaceuticals , JUN 23, 2020, View Source [SID1234561397]). Each ADS represents one ordinary share, no par value, of Kitov. The offering is expected to close on or about June 25, 2020, subject to satisfaction of customary closing conditions.

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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

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $0.90 per ADS and will be exercisable at any time upon issuance and will expire five years from the date of issuance.

Kitov intends to use the net proceeds of this offering to fund the development of its oncology drug candidates, acquisition of new assets and for general working capital purposes.

The securities described above are being offered by Kitov pursuant to a "shelf" registration statement on Form F-3 (File No. 333- 235327) previously filed with the U.S. Securities and Exchange Commission (the "SEC") on December 2, 2019 and declared effective by the SEC on December 13, 2019. The offering of such securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On June 23, 2020 Notable, which is redefining cancer treatment by taking a functional approach to precision oncology in hematological cancers, reported that the results of a Stanford study using its drug sensitivity screening platform have been published in Blood Advances (June 23, 2020; Volume 4, Issue 12) (Press release, Notable Labs, JUN 23, 2020, View Source [SID1234561396]).

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This study was designed to evaluate Notable’s drug sensitivity screening platform in patients with myelodysplastic syndrome (MDS) and related myeloid neoplasms. After piloting the platform in 33 patients, the authors conducted a prospective feasibility study, enrolling 21 MDS patients refractory to standard therapies: azacitidine (Vidaza) or decitabine (Dacogen). The primary endpoint of the study was to determine if the drug sensitivity results could be returned to a Tumor Board within a clinically actionable timeframe (<30 days) to inform personalized treatment recommendations. The study met its primary endpoint with drug sensitivity data provided to the Tumor Board at a median turnaround time of 15 days, and these data helped identify potentially useful drugs and drug combinations for MDS patients refractory to standard therapies. Among 21 patients who received a therapy that was tested in Notable’s platform, the authors demonstrated a positive predictive value of 92%, negative predictive value of 82%, and overall accuracy of 85% of the platform in predicting clinical responses.

Additional key details of the study are listed below:

54 patients were enrolled at Stanford University Medical Center between September 2016 and March 2019 and had a diagnosis of MDS, MDS/myeloproliferative neoplasm (MPN), or acute myeloid leukemia (AML).
Blood samples and bone marrow aspirate samples were provided to Notable Labs, and ex vivo drug sensitivity screening was performed using Notable’s fully automated high-throughput platform, evaluating sensitivity to a panel of 74 individuals drugs and 36 drug combinations.
Notable’s platform identified three groups of patients with distinct drug sensitivity patterns.
Correlations were observed between genotype and phenotype, with specific gene mutations associated with distinct drug sensitivity patterns.
Notable and Stanford are currently enrolling a second cohort of patients to validate the initial data set.

"We set out to explore whether this platform could produce accurate results in a timely manner, and the answer is yes," said Peter Greenberg, MD, Professor of Medicine (Hematology) and Director, Stanford MDS Center at Stanford University Cancer Center. "These data demonstrate the utility of this approach for identifying potentially useful and often novel therapeutic drugs for patients with myeloid neoplasms refractory to standard therapies."

"This peer-viewed research is a substantial clinical milestone for Notable and for precision medicine in oncology," said Laurie Heilmann, CEO of Notable. "One significant aspect of this research is the dataset Notable is amassing. Our bioinformatics and machine learning models are generating vast datasets that will help inform future drug development. These data are critical for biotech and pharma companies who want to accelerate their go-to-market. We look forward to working closely with Stanford to continue this important research."

In Jan. 2020, Notable announced the launch of its new observational clinical trial. The trial is being conducted at multiple sites across the country and will focus on hematologic malignancies (blood cancers). The primary objective is to establish a tumor registry with annotated clinical outcomes. Exploratory objectives will include correlation of ex vivo drug screening results with clinical outcomes as well as identification of potential biomarkers that correlate clinical responses with genotype and/or phenotype. More details on Notable’s Institutional Review Board-approved clinical trial is available at View Source

On June 23, 2020 Cellaria reported it is presenting data on the value of modeling the metastatic niche, and the benefits of using patient-derived cancer cell models, mesenchymal stem cells (MSCs), and optimization of oxygen level and extracellular matrix (ECM) to study antitumor drug response, personalized therapy, and disease mechanisms (Press release, Cellaria, JUN 23, 2020, View Source [SID1234561395]). The data, featured in a poster at 2020 AACR (Free AACR Whitepaper) Annual Meeting II, results from Cellaria’s spheroid system using five cancer cell models (pancreatic, lung adenocarcinoma, colon adenocarcinoma, endometrioid ovarian and high-grade serous carcinoma). With this 3D system, Cellaria is addressing an unmet need to improve predictions of the safety and efficacy of new drugs in preclinical testing and clinical trials.

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By using patient-specific cell models, translational scientists are able to go beyond traditional cell lines, to address the complexity and individuality of the disease and identify treatments that better meet the needs of each patient. Specificity in cell models enables researchers to derive the answers they need earlier in the drug development life cycle and with a continuous, direct connection to the patient.

"This data demonstrates the power of using patient specific cell models in a 3D format to model the tumor microenvironment and gain more actionable information from drug screening studies" comments David Deems, CEO, Cellaria Inc. "By using specific model patient populations that maintain their heterogeneity and individuality, users can test targets on our highly characterized cell models and select the mutation profile that is most important to their research."

On June 23, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), reported the first patient has been dosed in the Company’s phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC) (Press release, Oncolytics Biotech, JUN 23, 2020, View Source [SID1234561394]). The study, known as BRACELET-1, is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business in the US and Canada as EMD Serono, and Pfizer Inc. (NYSE: PFE). Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck KGaA, Darmstadt, Germany and Pfizer’s anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio).

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The randomized BRACELET-1 study is designed to support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment, by demonstrating pelareorep’s ability to induce a robust anti-tumor immune response in an identical patient population (patients with HR+/HER2- mBC). The ability of pelareorep-induced immune responses to enhance anti-PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort. Importantly, the trial also aims to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- mBC, which may aid in future registrational trial study design and patient selection.

For more information about the BRACELET-1 study, refer to ClinicalTrials.gov (NCT04215146).

About BRACELET-1
The BRACELET-1 (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:
•Cohort 1 (n=15): paclitaxel
•Cohort 2 (n=15): paclitaxel + pelareorep
•Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio)

Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response

rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.