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.

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 Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported business highlights and financial results for the first quarter ended February 28, 2021 (Q1 Fiscal 2021) (Press release, Theratechnologies, APR 14, 2021, View Source [SID1234578039]).

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"Theratechnologies is at a unique point in its evolution, and we have a tremendous opportunity ahead of us," said Paul Levesque, President and Chief Executive Officer at Theratechnologies. "We are particularly pleased with the swift advancement of our Phase 1 oncology program, which has dosed its first patient, and the continued progress we have made toward advancing our Phase 3 trial in NASH.

"We believe we are well-positioned for growth when we begin to emerge from the COVID-19 pandemic. In line with these efforts is our continued focus on strengthening our business with the addition of key talent and resources. While first-quarter revenues were relatively flat year-over-year, we believe that we have aligned our organization to provide an optimal landscape to further validate and drive value for our commercial and R&D opportunities," concluded Mr. Levesque.

On April 14, 2021 TriSalus Life Sciences, an emerging immuno-oncology company committed to transforming outcomes for patients with liver and pancreatic tumors, reported data presented at the American Association of Cancer Research showing that regional delivery of oligodeoxynucleotide 2395 (ODN2395) activated the toll-like receptor 9 (TLR9), resulting in reduced tumor burden of liver metastases in mice (Press release, TriSalus Life Sciences, APR 14, 2021, View Source [SID1234578037]).1

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ODNs bind and activate TLR9 to initiate an immune response against certain cancer cells.2 TLR9 agonists (TLR9A) activate both the innate and adaptive immune systems, and play an important role in antiviral and anti-tumor immunity.3 TLR agonists have been administered via different routes based on the therapeutic purpose, however, delivery of TLR agonists into liver tumors by direct needle injection has been clinically challenging, particulary in the setting of a large tumor burden.

The pre-clinical study presented at AACR (Free AACR Whitepaper), conducted by Chandra C. Ghosh and fellow researchers at Roger Williams Medical Center, examined the impact of metastatic liver disease in 12 mice, which were randomized to receive either 1, 3, 10 or 30 micrograms of the TLR9A, ODN2395, through the portal vein (PV) or 30 micrograms administered intravenously (IV). The study showed regional delivery of the TLR9A through the PV at the 30 micrograms dose level was superior to systemic IV administration with respect to control of liver metastases and reduction of liver myeloid-derived suppressor cells (MDSC), which play a crucial role in solid tumor immunosuppression, in addition to favorable effects on liver macrophage subsets.

"Understanding the impact of delivery route on the ability of TLR9 agonists to control liver metastases and favorably modulate the immune microenvironment may help unleash the potential to use the immune system to fight cancer," said Steven Katz, M.D., Chief Medical Officer, TriSalus Life Sciences. "This foundational work will help us tap into the potential of integrating novel therapeutics with drug delivery technology to better penetrate solid tumors."

Solid tumors continue to represent one of the single biggest hurdles to successful cancer treatment.4 High levels of pressure inside solid tumors prevent the delivery of oncology therapeutics, with less than 1% of therapy penetrating solid tumors in some circumstances.5,6 TriSalus developed PEDD to deliver immuno-oncology therapeutics directly into the vasculature of solid tumors with the potential for minimizing systemic toxicity.

On April 14, 2021 Exact Sciences Corp. (NASDAQ: EXAS) reported that it has completed its previously announced acquisition of Ashion Analytics, LLC (Press release, Exact Sciences, APR 14, 2021, View Source [SID1234578036]).

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"As a leader in cancer testing, we’re committed to providing earlier answers and life-changing treatment guidance to support patients along every step of their cancer journey," said Kevin Conroy, chairman and CEO of Exact Sciences. "With Ashion, we’ve added a talented team, a CLIA-certified and CAP-accredited lab, deep sequencing capabilities, and one of the most comprehensive genomic cancer tests available on the market today with GEM ExTra. This expertise will be integral in helping us extend our leadership in precision oncology and in serving more patients across the cancer continuum, including therapy selection and minimal residual disease testing."

Exact Sciences and The Translational Genomics Research Institute (TGen) are expanding their multi-year collaboration to further benefit from TGen and City of Hope’s expertise in developing better advanced cancer diagnostics and establishing the clinical evidence necessary to support their adoption.