On February 7, 2020, OncoSec Medical Incorporated (the "Company") reported the closing (the "Closing") of its previously announced strategic transaction (the "Transaction") with Grand Decade Developments Limited, a direct, wholly-owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings Limited, a company formed under the laws of the British Virgin Islands ("CGP"), and its affiliate, Sirtex Medical US Holdings, Inc., a Delaware corporation ("Sirtex" and, together with CGP, the "Buyers") (Filing, 8-K, OncoSec Medical, FEB 10, 2020, View Source [SID1234554091]). On October 10, 2019, the Company and the Buyers entered into Stock Purchase Agreements (as amended, the "Purchase Agreements") pursuant to which the Company agreed to sell and issue to CGP and Sirtex 10,000,000 shares and 2,000,000 shares, respectively, of the Company’s common stock for a total purchase price of $30 million.

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!

As contemplated by the Purchase Agreements, and in connection with the Closing, on February 7, 2020, the Company entered into Registration Rights Agreements with each of CGP and Sirtex (the "Registration Rights Agreements"), pursuant to which, among other things, CGP and Sirtex will each have the right to deliver to the Company a written notice requiring the Company to prepare and file with the Securities and Exchange Commission a registration statement with respect to resales of shares of some or all of the common stock of the Company held by CGP and Sirtex.

The description of the Registration Rights Agreements does not purport to be complete and is subject to, and qualified in its entirety by the full text of the Registration Rights Agreements, copies of which are filed as Exhibits 4.1 and 4.2 to this Current Report and are incorporated by reference herein.

Concurrently with the execution and delivery of the Purchase Agreements, the Company and CGP entered into a License Agreement (the "License Agreement"), which became effective upon the Closing. In addition, the Company and Sirtex entered into a Services Agreement (the "Services Agreement") which also became effective upon the Closing. For a full description of both the License Agreement and Services Agreement, see the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 11, 2019.

On February 10, 2020 Certara, the global model-informed drug development and decision support leader, reported that its discovery research relationship with Arvinas has expanded to include a greater diversity of small molecule drug discovery projects and data sources. Arvinas’ current drug discovery focus areas include metastatic prostate cancer, locally-advanced or metastatic breast cancer, and neurodegenerative diseases (Press release, Arvinas, FEB 10, 2020, View Source [SID1234554109]).

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!

Arvinas is the pioneer and clinical-stage leader in the exciting new area of targeted protein degradation. Its proprietary PROTAC (proteolysis-targeting chimera) protein degraders are chimeric, modular small molecules, which harness the body’s natural protein disposal system, the ubiquitin‐proteasome system, to induce the degradation of disease‐causing proteins.

"Arvinas is employing Certara’s D360 scientific informatics platform to increase the speed and efficiency of its lead identification and optimization processes. D360 is specifically designed to allow scientific researchers to access, understand and share drug discovery data quickly," explained Dr. David Lowis, Senior Director of Product Management at Certara. "Medical research is moving so rapidly, especially in oncology, that gaining access to novel technology and fast, accurate drug discovery results will determine how quickly new medicines can be brought to patients."

"We need to be able to query, pivot and dive deep into our drug discovery data, and D360 is the best platform we have found for that," said Dr. Keith Hornberger, Director, Chemistry at Arvinas. "We have increased the number of data sources and complexity of data, which are now seamlessly integrated providing complete transparency to our end users. We currently have around 70 scientists using D360, running over 700 distinct D360 queries. Compared to our previous research informatics solution, D360 is saving us hundreds of hours annually on data analysis. That is an important contribution to our research."

"The Certara team is tenacious and resourceful. They always find a solution. That’s what has made our relationship so successful," added Dr. Hornberger.

Designed to meet clients’ specific research goals, D360 features small molecule discovery, biologics discovery, and pre-clinical toolkits for both large and small biopharmaceutical companies.

On February 10, 2020 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported the formation of a Scientific Advisory Board (SAB) for its Explorations in Global Health (ExGloH) division within the Leidos Health Group (Press release, Leidos, FEB 10, 2020, View Source [SID1234554125]). The ExGloH SAB is an esteemed group of experts in oncology and drug development chosen to advance ExGloH in its development of their pre-clinical pipeline of peptide-based immune modulators.

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!

ExGloH is dedicated to developing new immunotherapies for cancer and infectious diseases. ExGloH SAB members will work closely with ExGloH leadership to evolve the pre-clinical development of its lead drug candidate LD10, a novel peptide-based, immuno-modulator for the treatment of cancer and infectious diseases.

"We are excited and privileged to have the opportunity to work with this group of oncology and infectious disease thought leaders on drug development initiatives from discovery through drug commercialization," said James Pannucci, Ph.D., vice president and director of ExGloH. "Their insights will help advance our pipeline of peptide-based checkpoint inhibitors, beginning with LD10 clinical development."

The ExGloH SAB will be comprised of the following members:

Chairman, Philip Hinds, Ph.D, professor and chair of the Department of Developmental, Molecular, and Chemical Biology (DMCB) at Tufts University School of Medicine (TUSM), specializes in oncology, cell and developmental biology, and molecular biology. His seminal studies were the first to demonstrate that P53 possesses tumor suppressor activity and is subject to inactivating point mutations in human cancers.
Jose Conejo-Garcia, MD, Ph.D., is the chair of the Department of Immunology at H. Lee Moffitt Cancer Research Institute, and co-leader of the Immunology Program at H. Lee Moffitt Cancer Center. An expert in the field of Tumor Immunology, he has been cited in numerous publications for his contributions to elucidate many of the mechanisms driving protective immunity against gynecologic cancers.
Patrick K. Lucy, a founder and current chief business officer (CBO) of Pfenex Inc, is an experienced leader with more than 26 years of experience in the bio-pharmaceutical industry. As CBO he is responsible for the overall portfolio strategy and business development for the company. Lucy also has experience in the areas of alliance management, product and technology licensing, intellectual property, and bio-pharmaceutical processing, operations, facility design, construction and validation.
About ExGloH

ExGloH is a division within the Leidos Health Group dedicated to developing new immunotherapies for cancer and infectious diseases. ExGloH’s strives to develop a new class of anti-cancer and infectious disease peptides which can be used in primary and home care settings. The advancement of the Microtide platform allows for further discovery of checkpoint receptors. For more information, visit www.leidos.com/markets/science/biotechnology/exgloh.

On February 10, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, reported that management will present a company overview at the SVB Leerink 9th Annual Global Healthcare Conference on Thursday, February 27, 2020 at 10:00 AM ET in New York, New York (Press release, Aclaris Therapeutics, FEB 10, 2020, View Source [SID1234554075]).

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!

A live audio webcast of the presentation may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events’ section. An archived version of the presentation will be available for 30 days.

On February 10, 2020 Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the Office of Orphan Product Development division of the FDA has granted orphan drug designation to its leading therapeutic candidate, STP705, for the treatment of Hepatocellular Carcinoma (HCC) (Press release, Sirnaomics, FEB 10, 2020, View Source [SID1234554110]). This is the third such designation for this drug candidate, following the designation for Primary Sclerosing Cholangitis and Cholangiocarcinoma.

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!

Sirnaomics lead product candidate, STP705 is a siRNA (small interfering RNA) therapeutic that takes advantage of the Company’s proprietary dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. Sirnaomics has opened Investigational New Drug (IND) applications under the jurisdiction of the US FDA and Chinese FDA for clinical studies for Non-melanoma skin cancers (NMSC), Cholangiocarcinoma (CCA), and Hypertrophic Scar (HTS) Reduction.

"We are very pleased to reach another significant milestone and very excited to develop our lead product candidate for treatment of HCC with tremendous unmet needs" stated Patrick Lu, PhD, President and CEO. "This third grant of orphan drug designation for STP705 to treat HCC further consolidates our long-term strategy positioning us to take advantage of the regulatory arbitrage by achieving approval in US and then moving to the large market in China."

"Receipt of the orphan drug designation for Hepatocellular Carcinoma is a very important step for Sirnaomics. It provides the pathway allowing us to develop STP705 in a devastating oncology disease for which there is currently no effective therapy," stated Dr. Michael Molyneaux, MD, MBA, Chief Medical Officer. "This orphan drug designation aligns with our mission to alleviate human suffering and target diseases with high unmet clinical need and we anticipate the start of our clinical study for HCC in the second half of 2020."

About STP705 (Cotsiranib)
Sirnaomics leading product candidate, STP705, is an siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of Cholangiocarcinoma, Non-Melanoma skin cancer and Hypertrophic Scar. STP705 has also received Orphan Drug Designation for treatment of Cholangiocarcinoma and Primary Sclerosing Cholangitis. Preclinical animal models using STP705, have demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis.

About Hepatocellular carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults, and is the most common cause of death in people with liver cirrhosis. It occurs in the setting of chronic liver inflammation, and is most closely linked to chronic viral hepatitis infection (hepatitis B or C) or exposure to toxins such as alcohol or aflatoxin. Certain diseases, such as hemochromatosis and alpha 1-antitrypsin deficiency, markedly increase the risk of developing HCC. Metabolic syndrome and NASH are also increasingly recognized as risk factors for HCC. Worldwide, approximately 840,000 people are diagnosed with primary liver cancer each year and about 500,000 of the patients are in China, even though HCC is designated as an orphan drug indication by US FDA. Abundant literature has directly linked high level expression of TGF-β1 to liver epithelial to mesenchymal transition (EMT) and tumorigenesis. Inhibition of COX-2 is able to reverse the drug resistance to the chemo drug treatment of HCC and also increased CD4+ T cells within the tumor.