On April 14, 2021 GeneLeap Bio., a subsidiary of Luye Life Sciences specializing in the development of nucleic acid therapeutics, reported that an ePoster entitled ‘Hydrogel encapsulated TLR9 agonists show sustained tumor growth inhibition and prolong survival of CT26 tumor-bearing mice’ at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting (Press release, GeneLeap Bio, APR 14, 2021, View Source [SID1234578058]). The preclinical study shows that compared with using TLR9 agonist on its own, a hydrogel encapsulated TLR9 agonist, independently developed by GeneLeap Biotech, can significantly improve antitumor performance, while demonstrating tumor growth inhibitory effects similar to that of TLR9 agonist without hydrogel encapsulation.

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AACR Annual Meeting is one of the world’s biggest and most eminent conferences related to cancer research, covering the latest discoveries and drug developments across the spectrum of cancers and highlighting the work of the best minds in research and medicine from institutions all over the world. The meeting was held virtually this year, from April 10 to 15 and May 17 to 21.

TLR9 is one of the most promising targets in current cancer immunotherapies, whose agonist has emerged as a potential monotherapy or in combination with other anticancer therapies. As an innate immune stimulator, TLR9 agonist can be combined with checkpoint inhibitors to increase its anti-tumor effects. By activating the innate immune system, it provides increased immunological impetus against checkpoint inhibitor resistant and refractor tumors.

However, there are certain drawbacks in the clinical application of TLR9 agonist, such as increased toxicity seen with systemic administration. Local injection of the TLR9 agonist is well-tolerated but the drug can degrade in the local tissues or dissipate from the site of action rapidly, resulting in reduced efficacy. Thus, in such cases a weekly or biweekly dosing of TLR9 agonist is usually required to maintain the anti-tumor efficacy.

To address this medical need, GeneLeap Biotech has made a breakthrough by encapsulating TLR9 agonists in injectable hydrogels containing poloxamer for a slow and sustained release of TLR9 agonist over a period of time. GeneLeap’s researchers have conducted preclinical studies in a mouse tumor model to examine whether a single dose of Hydrogel encapsulated TLR9 agonist can be effective over a longer period in immune activation without toxicity.

The current preclinical study showed that a single administration of hydrogel encapsulated TLR9 agonist demonstrates tumor growth inhibition and non-toxicity similar to that of a multiple dose of TLR9 agonist without hydrogel encapsulation. This indicates that for those patients who are resistant or refractory to checkpoint inhibitors, hydrogel encapsulated TLR9 agonist could enhance the immune response to checkpoint inhibitors for a longer time. "Based on the positive preclinical data obtained in a mouse tumor model, we believe this novel formulation – hydrogel encapsulation – will ease frequency of dosing schedules of TLR9 agonists in clinic," said Dr. Jason Zhang, CSO of GeneLeap Biotech.

This preclinical study is also of pioneering significance in exploring further applications of hydrogel formulations. "To our knowledge, this is the first study using hydrogel encapsulation to improve the frequency of dosing of TLR9 agonists in cancer patients," said CEO of GeneLeap Biotech, Dr. Sean Fu. "It helps us enhance understanding of hydrogel formulations and has laid a good foundation for more in-depth clinical research in the area of therapeutic modalities including mRNA and oligonucleotides. As a pharmaceutical biotech focusing on frontier science, GeneLeap Biotech is committed to promoting pioneering science, developing nucleic-acid drugs for tumors and severe infectious diseases, and providing patients with innovative treatments to meet their health needs."

On April 14, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate and host 1:1 meetings at the virtual Kempen Life Science Conference, taking place April 21, 2021 (Press release, Hookipa Pharma, APR 14, 2021, View Source [SID1234578019]).

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Additional information will be available within the Investors & Media section of HOOKIPA’s website at View Source

On April 14, 2021 Veracyte (Nasdaq: VCYT) reported a key milestone in its companion diagnostics program with Acerta Pharma, the hematology research and development arm of AstraZeneca (LSE/STO/NYSE: AZN) (Press release, Veracyte, APR 14, 2021, View Source [SID1234578040]). The first patient has been enrolled and randomized in Acerta Pharma’s Phase 3 ESCALADE trial, which is using Veracyte’s LymphMark lymphoma subtyping test to identify patients with untreated diffuse large B-cell lymphoma (DLBCL) who may benefit from Acerta and AstraZeneca’s acalabrutinib (Calquence) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy.

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The randomized, double-blind, placebo-controlled ESCALADE study is designed to evaluate the efficacy and safety of acalabrutinib with R-CHOP therapy as compared to placebo plus R-CHOP in patients aged 18-65. The study is expected to enroll up to 600 participants at centers around the world. Study investigators are using the investigational LymphMark genomic test to select patients with non-germinal center B-cell (non-GCB) subtype DLBCL, an aggressive form of the disease that is associated with worse outcomes following the traditional chemoimmunotherapy regimen (R-CHOP).

"The initiation of this global study marks an important step in our multi-year companion diagnostics program with Acerta Pharma," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "By distinguishing DLBCL patients based on the genomic underpinning of their disease, we believe the LymphMark test will help identify patients early on who are more likely to respond to targeted therapies such as Calquence that may improve outcomes."

DLBCL patients respond to treatment differently based on the molecular subtype of their tumors. The LymphMark test uses gene-expression profiling of RNA extracted from surgical tissue to classify the "cell of origin" subtype of DLBCL tumors. The World Health Organization recommends gene-expression profiling for patients with DLBCL, which may potentially be mitigated by more specific treatments that are under development.i By identifying the specific subtypes in individual patients’ tumors, physicians can help ensure the right patients are included in clinical trials evaluating these therapies.

Non-Hodgkin lymphoma (NHL) ranks among the top-10 common cancers worldwide, with over 500,000 new cases estimated in 2018.ii DLBCL is the most common type of NHL, accounting for approximately 30 percent of lymphomas.iii

The LymphMark test is intended for use on the nCounter Analysis System. Veracyte acquired the LymphMark test, as well as the exclusive global diagnostic rights to the nCounter system, in December 2019.

On April 14, 2021 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported that three projects have been selected to study oral decitabine (35 mg) and cedazuridine (100 mg) (Press release, Astex Pharmaceuticals, APR 14, 2021, View Source [SID1234578021]). The NCCN ORP convened a Scientific Review Committee to review, evaluate, and select awardees and will provide oversight for the two-year studies—which will commence later in 2021. Research funding will be provided by a grant from Taiho Oncology, who will also supply the decitabine and cedazuridine tablet.

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The selected projects are:

• Michael Byrne, DO, Vanderbilt-Ingram Cancer Center, Moffitt Cancer Center
o Phase 2 Study of Decitabine and Cedazuridine in Combination with Venetoclax for AML Relapse after Allogeneic Hematopoietic Cell Transplantation

• Gurkamal Chatta, MD, Roswell Park Comprehensive Cancer Center
o A Phase 1b Clinical Trial: Improving Outcomes with Androgen Pathway inhibitors by Targeting DNA Methyltransferase Activity

• Martin McCarter, MD, University of Colorado Cancer Center
o Oral Decitabine/Cedazuridine in Combination with Nivolumab as a Strategy to Enhance the Efficacy of Immune Checkpoint Blockade in Unresectable or Metastatic Mucosal Melanoma

"Congratulations to all of the selected investigators," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "We look forward to their work advancing our understanding of this medication combination. The potential for oral medication in place of intravenous delivery is particularly worthy of exploration, as this may provide better options for outpatient therapy with reduced office visits, which in turn improves access to care and helps underserved patient populations.

"Taiho Oncology is pleased to continue our collaboration with the National Comprehensive Cancer Network to help broaden the understanding of oral decitabine and cedazuridine for patients with solid tumors and hematologic malignancies," said Terri L. Washington, DNP, RN, Vice President, Scientific Partnerships and Medical Affairs Operations, Taiho Oncology, Inc. "These grants will help advance critical research and represent a step forward in exploring the full potential of oral decitabine and cedazuridine for patients to help improve outcomes."

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

On April 14, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, reported that it has received authorization to CE mark its proprietary next generation go-to-market gene delivery device, GenPulse, a part of the OncoSec Medical System (OMS) electroporation device platform for use in solid tumors (Press release, OncoSec Medical, APR 14, 2021, View Source [SID1234578041]). The CE mark certification augments the Notified Body certification to the International Organization for Standardization’s (ISO) 13485 standard for the design, development, manufacture and distribution of electroporation devices, which is renewed annually, subject to a successful audit. The GenPulse is the gene electrotransfer device which OncoSec plans to deploy commercially, both in the U.S. and the European Union (EU).

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"This CE certification is an essential regulatory milestone on OncoSec’s road to commercialization in Europe," said Robert Ashworth, Senior Vice President, Regulatory Quality and CMC at OncoSec. "The CE mark on our proprietary GenPulse generator represents the culmination of years of work and demonstrates that OncoSec has the capability to manufacture and develop a device that meets performance, quality and safety requirements in the EU."

A CE mark indicates the OMS electroporation device complies with Directives of the European Commission (EC) and therefore can be marketed within the 31-nation European Economic Area (EEA) and Switzerland. This OMS electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The CE mark certification involved a comprehensive audit of the company’s quality system, as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed.