On May 21, 2020 OncoSec Medical Incorporated (the "Company" or "OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported that it will present new pre-clinical data demonstrating the utility of OncoSec’s next-generation product candidate, TAVOPLUS (enhanced interleukin-12 or "IL-12" plasmid), and its electroporation gene delivery system as a promising approach for patients with melanoma and other solid tumors (Press release, OncoSec Medical, MAY 21, 2020, View Source [SID1234558379]). The data were selected for two late-breaking poster presentations at the American Association for Cancer (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II being held June 22-24, 2020.

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The following posters will be presented during the session titled, Late-Breaking Research: Immunology 2, on June 22, 2020 from 9:00 a.m. – 6:00 p.m. EDT:

Title: Intratumoral electroporation of plasmid-encoded IL-12 and membrane-bound anti-CD3 increases tumor immunogenicity and augments the function of T cell subsets
Poster Number: 14
Abstract Number: LB-390

Title: Amplification of the CXCR3/CXCL9 axis via intratumoral electroporation of CXCL9 synergizes with IL-12 gene therapy (TAVO) to elicit robust anti-tumor immunity
Poster Number: 20
Abstract Number: LB-396

Full abstracts are available online at www.aacr.org. Posters will be available on OncoSec’s website following the presentations.

On May 21, 2020 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and ACEA Therapeutics, Inc. ("ACEA") reported that they have entered into a binding term sheet for an exclusive license to ACEA’s Abivertinib across all indications for all territories outside of China (Press release, Sorrento Therapeutics, MAY 21, 2020, View Source [SID1234558378]). The final terms of the license will be set forth in a definitive agreement to be entered into between the parties.

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Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK).

More than 600 patients have been treated with Abivertinib at different oral doses up to 300 mg bid in multiple trials through registration trial (NCT03856697) in patients with non-small cell lung cancer (NSCLC) and B cell malignancies (Phase 1) conducted in China. Favorable safety, tolerability and efficacy in patients with NSCLC or relapsed/refractory B-cell malignancies were demonstrated in separate studies.

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in 2019, the results of an interim analysis of 209 response-evaluable patients (n=227 total) with NSCLC was presented. Of the 209 patients, the investigators determined that 90% (188/209) had tumor size reduction, with 52% of the patients (109/209) demonstrating a confirmed partial response, 5% (11/209) of the patients demonstrating an unconfirmed partial response, 30% of the patients (64/209) demonstrating stable disease and 12% of the patients (25/209) demonstrating progressive disease. The progression free survival (Kaplan-Meier) was 7.5 months at the time. An estimate of the median overall survival was 25 months at the time of the presentation with the study still ongoing. All patients (n=227) experienced at least one adverse event (AE). Grade 3/4 (in severity) AEs were reported in 46% of the patients (104/227), of which treatment related grade 3/4 AEs were reported in 30% of the patients (67/227). None of the grade 5 AEs (4%, 9/227) were deemed treatment-related. Most treatment-related AEs were grade 1 or 2, the most common of which were transaminase elevations and diarrhea, which are generally considered common for TKIs. Other common treatment-related AEs included anemia, neutropenia and thrombocytopenia, and all generally considered typical AEs with long-term use of TKIs. No unexpected AEs were reported.

Promptly following the execution of the definitive license agreement, Sorrento expects to meet with the FDA to discuss the data and the path forward to seek approval for oncologic indications.

On May 21, 2020 Alethia Biotherapeutics reported that the U.S. Food and Drug Administration has cleared its Phase 2 Investigational new drug (IND) application for AB-16B5, a potent inhibitor of the epithelial to mesenchymal transition (EMT) (Press release, Alethia Biotherapeutics, MAY 21, 2020, View Source [SID1234558327]).This allows the Company to initiate a multi-center trial of AB-16B5 in combination with docetaxel in previously treated subjects with metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody.

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"We are extremely pleased to have achieved this important milestone in the development of AB-16B5 and to continue to advance the clinical development of this promising antibody" commented Yves Cornellier, President and CEO of Alethia. "EMT is a central enabler for solid tumor progression because it triggers metastatic invasion, resistance to several classes of anti-cancer drugs and contributes to immune evasion. There is also increasing evidence that EMT contributes to resistance to immune checkpoint inhibitors. AB-16B5 may play an important role in overcoming these problems", added Dr. Mario Filion, Chief Scientific Officer.

Study overview

This multicenter, open-label, Phase 2 study of AB-16B5 in combination with docetaxel (NCT04364620) will enroll approximately 40 subjects with advanced NSCLC who have previously been treated with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody, a patient population with very limited options. The primary objectives are to assess the anti-tumor efficacy of AB-16B5 in combination with docetaxel as measured by objective response rate and to determine the safety and tolerability of the combined drugs. Secondary objectives of the study include clinical benefit rate, percentage of subjects with complete response or partial response, duration of stable disease, progression-free survival and overall survival.

About AB-16B5

AB-16B5 is a humanized IgG2 monoclonal antibody that selectively binds and inhibits tumor-associated secreted clusterin, a protein expressed in many cancers. Tumor-associated secreted clusterin is induced early in the EMT cascade and its inhibition with AB-16B5 stops and reverts EMT in animal models. A Phase 1 study in subjects with advanced carcinomas demonstrated that AB-16B5 was safe and well tolerated and provided clinical benefit to several subjects. Stable disease was observed in several patients for up to one year. There was also evidence of EMT inhibition in tumor biopsies.

On May 20, 2020 OBI Pharma reported that Taiwan Hao Ding (TPEx: 4174) will publish a paper at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) online annual meeting from 29 to 31 this month, explaining its research and development products, including the new breast cancer drug Adagloxad Simolenin (OBI) that has entered the third phase of clinical trials -822), Globo H antibody small molecule drug complex OBI-999 and AKR1C3 small molecule chemotherapy prodrug OBI-3424 progress (Press release, OBI Pharma, MAY 20, 2020, View Source [SID1234561054]).

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Due to the epidemic situation, ASCO (Free ASCO Whitepaper) 2020, a globally-focused cancer medical conference, was changed online this year. Hao Ding is currently the leader in the field of immunotumor therapy with the Globo series of antigens as the target. It will present the clinical research data of the first cancer breakthrough new drugs for different tumors against Globo H and AKR1C3 antigens.

These studies will be introduced by the main researchers of Hao Ding at the meeting to introduce the first anti-Globo H cancer vaccine Adagloxad Simolenin (OBI-822) and the antibody small molecule complex OBI-999 and the chemical small molecule prodrug OBI-3424 for AKR1C3.

Dr. Tillman Pearce, Chief Medical Officer of Hao Ding, pointed out that in order to meet the high medical needs of effective treatments, Hao Ding is honored to present the first breakthrough medical treatments including ABI-822, OBI-999 And OBI-3424 test progress. He sincerely hopes that the future development of these anti-Globo H and AKR1C3 targeted therapies can provide potential therapeutic benefits for cancer patients.

Hao Ding ASCO (Free ASCO Whitepaper) published online three papers as follows, 5 Yue 29 Ri will also be published on the official website of Taiwan Ding Hao www.obipharma.com

1. Abstract: TPS599 / Poster: 91
Title:
Phase 3, randomized, double-blind, placebo-controlled study of adagloxad simolenin (OBI-822) clinical trial to evaluate OBI-822/821 against high-risk early-stage triple negative breast cancer (TNBC) Patient’s treatment effectiveness and safety. Speaker : Hope S. Rugo, Professor of Medicine, San Francisco Helen Diller Family Comprehensive Cancer Center, FASCO University, San Francisco, California
, USA
Report Group: Breast Cancer-Local/Regional/Assisted

Report Time: 29/05/2020 (Friday) 8:00 AM am – 11:00 am (Eastern Coast Time)
link: View Source

2. Abstract: TPS3657 / Poster: 387
Title: OBI-999
A phase I/II, clinical phase I/II open trial, dose escalation and population expansion test to evaluate the safety of OBI-999 in patients with advanced solid tumors , Pharmacokinetics and therapeutic activity.
Report categories: Development Therapy – molecular target drugs and tumor biology
Speaker: MD Anderson Cancer Center professor of medicine at the University of Texas Apostolia Maria Tsimberidou.
Report Date: 29/05/2020 (Friday) morning 8:00 am – 11:00 am (Eastern Coast Time)
link: View Source

3. Abstract: TPS3658 / Poster: 388
Title: OBI-3424
OBI-3424 is a chemical prodrug that selectively acts on AKR1C3 aldehyde and ketone reductase and is currently undergoing Phase I/II clinical trials to include hepatocellular carcinoma (HCC) Patients with advanced cancer of castration-resistant prostate cancer (CRPC) were the subjects.
Report categories: Development Therapy – molecular target drugs and tumor biology
Speaker: MD Anderson Cancer Center professor of medicine at the University of Texas Apostolia Maria Tsimberidou.
Report Date: 29/05/2020 (Friday) morning 8:00 am – 11:00 am (Eastern Coast Time)
link: View Source

On May 20, 2020 UCLA Jonsson Comprehensive Cancer Center and peer institutions reported that it has been awarded a $5.75 million grant from the National Cancer Institute to study the correlation between obesity, inflammation and pancreatic cancer (Press release, University of California at Los Angeles, MAY 20, 2020, View Source;gt052020.php [SID1234558428]). The scientists hope their findings may help people avoid getting this cancer.

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"We know that the biological mechanisms of obesity, such as inflammation, can lead to the development of pancreatic cancer," said Dr. Guido Eibl, professor-in-residence in the department of surgery at the David Geffen School of Medicine at UCLA and a Jonsson Cancer Center researcher.

"This study will help us better understand not only how those mechanisms influence the formation of pancreatic tumors but also how we can develop preventions that help people who are at a higher risk for this cancer."

The five-year study will be structured into three projects, with participating researchers from Cedars-Sinai Medical Center in Los Angeles and the University of California, San Diego, joining the team at UCLA. Each project’s leader is highly experienced in the study of pancreatic cancer.

The first project, overseen by Eibl, will examine the inflammation of body fat and how this chronic condition can lead to pancreatic cancer. The second, led by Jonsson Cancer Center researcher Dr. Enrique Rozengurt, who holds the Hirshberg Memorial Chair in Pancreatic Cancer Research at UCLA, will focus on the use of medications, and their mechanisms, in helping to prevent pancreatic cancer from developing in high-risk people.

The third project, led by Dr. Stephen Pandol of Cedars-Sinai, will study the pancreatic cancer microenvironment, which includes cancer tissues and surrounding tissues that support the cancer’s growth, to understand how the environment is changed as a result of obesity and inflammation.

The UCLA pancreatic cancer study is funded by the National Cancer Institute’s P01 grant. These grants support research programs that include multiple projects and investigators working together toward a common goal.

The UCLA research team also includes Dr. David Dawson, Dr. Vay Liang Go, Dr. Oscar Joe Hines and Gang Li.