On February 5, 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has closed its previously announced merger agreement with Insight Genetics (IG) (Press release, Oncocyte, FEB 5, 2020, View Source [SID1234553890]). The acquisition expands the decision points addressed by Oncocyte’s portfolio of tests with the addition of a potentially transformative immuno-oncology diagnostic test and will also add diverse technology and pharma service offerings including targeted therapeutic panels and a pharma trial lab compliant with 21 C.F.R Parts 820 and 11.

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"The Insight Genetics’ IM Score test was an ideal addition to the Oncocyte portfolio, and while our current focus is on lung cancer, this acquisition significantly expands our suite of proprietary tests to manage key decision points potentially across multiple stages and types of cancers," said Ron Andrews, CEO of Oncocyte. "With immunotherapies currently approved for thirteen solid tumors and additional clinical trials in progress to advance these treatments to earlier stages of cancer, there is a growing need for accurate immunotherapy response prediction tests. Data presented at SITC (Free SITC Whitepaper) in November show our new IM Score test outperforms two currently marketed tests for immunotherapy selection suggesting this may be a transformative test to identify immunotherapy responders. This acquisition is an important step in the evolution of Oncocyte as it not only expands our impact to a broader patient population but also provides us access to a CLIA certified lab with the certifications required to submit data to regulatory agencies around the world. Having the ability to truly partner with pharma companies and assist in their global regulatory approvals will help us grow significant new opportunities for pharma services in the expanding immunotherapy and companion diagnostic markets. We are proud of our exceptional progress and look forward to continued growth as we establish Oncocyte as leaders in lung cancer diagnostics and beyond."

At closing, Oncocyte delivered $6.4 million in cash, which was net of a $0.6 million cash holdback, plus 1.9 million shares of Oncocyte common stock valued at $5 million.

This general description is qualified in its entirety by the terms of the Agreement and Plan of Merger that will be filed as an exhibit to Oncocyte’s Form 8-K on or about February 5, 2020.

On February 5, 2020 Genprex, Inc Presented the corporate Presentation (Presentation, Genprex, FEB 5, 2020, View Source [SID1234553889]).

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On February 5, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, reported a clinical update and focus for its Oncoprex immunogene therapy program for 2020, prioritizing the development of Oncoprex in combination with osimertinib for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, FEB 5, 2020, View Source [SID1234553888]).

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On January 14, 2020, the Company received U.S Food and Drug Administration (FDA) Fast Track Designation for its Oncoprex immunogene therapy in combination with the EGFR tyrosine kinase inhibitor (TKI) osimertinib (AstraZeneca’s Tagrisso, which had worldwide sales in 2018 of $1.86 billion and $2.31 billion in the first nine months of 2019, and it is currently AstraZeneca’s highest grossing product) for the treatment of NSCLC patients with EFGR mutations that progressed after treatment with osimertinib alone. Oncoprex consists of the TUSC2 (Tumor Suppressor Candidate 2) gene, the active agent in Oncoprex, complexed with a lipid nanovesicle.

The Company’s current Phase I/II clinical trial utilizes the combination of the EGFR inhibitor erlotinib (marketed by Genentech in the U.S. and elsewhere by Roche as Tarceva) and Oncoprex against NSCLC. The current Phase I/II trial is active but is not currently enrolling patients, though the Company had planned to resume enrollment in mid-2020. Tumor shrinkage in patients resistant to erlotinib enrolled in this trial showed that Oncoprex can overcome resistance to TKIs and provided support for the Fast Track Designation.

Osimertinib is now considered a new standard of care for NSCLC patients with an EGFR mutation. Given this and receipt of FDA’s Fast Track Designation for use of Oncoprex combined with osimertinib in patients whose tumors progress on osimertinib, the Company has decided to prioritize this drug combination and patient population. Therefore, the Company plans to initiate a Phase I/II clinical trial of Oncoprex combined with osimertinib in mid-2020 at multiple cancer centers across the United States, and it does not intend to reopen enrollment in the current Phase I/II trial using the combination of Oncoprex and erlotinib at this time.

Genprex plans to file an amendment to its Investigational New Drug (IND) application with the FDA for the Oncoprex and osimertinib combination therapy trial within the first quarter of 2020. Upon FDA acceptance of the amendment, the Company expects to be in a position to enroll patients shortly thereafter. The Company believes that enrollment in the new clinical trial may be rapid, as the tumors of almost all patients who are treated with osimertinib progress after treatment, and these patients may be candidates for its clinical trial combining Oncoprex with osimertinib, for which the Company received Fast Track Designation.

Thus, given the changing landscape in NSCLC and the recent Fast Track Designation, the Company believes prioritizing the combination therapy of Oncoprex with osimertinib represents the most efficient way to advance its lead drug candidate through the clinical process for FDA approval, to have the best commercial success in the $17.9 billion global lung cancer market and to make its treatment available to patients as soon as possible.While prioritizing the combination therapy of Oncoprex with osimertinib, the Company will also proceed with its plan to file an IND for the additional combination therapy of Oncoprex combined with the immunotherapy drug pembrolizumab (marketed as Keytruda by Merck in the U.S.) for NSCLC.

On February 5, 2020 MaaT Pharma announced today an €18 million Series B financing round including a microbiome-focused US investor, SymBiosis, LLC, and support from its existing investors Seventure Partners, Crédit Mutuel Innovation, and Biocodex (Press release, MaaT Pharma, FEB 5, 2020, View Source [SID1234553886]). The funding will enable the continued clinical development of the company’s current pipeline, as well as the expansion into additional oncological indications where restoring a functional microbiome could provide significant therapeutic benefit when combined with other cancer treatments such as immune checkpoint inhibitors.

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"We are excited to have added a US-based investor to our syndicate based on the strategic importance of the US market for our future development. I would like to thank our existing investors and our network of scientific advisors for their continued support as we enter into this next development phase for the company," said Hervé Affagard, co-founder and CEO of MaaT Pharma. "A growing body of evidence suggests that a functional microbiome can improve cancer outcomes, and we look forward to continue building on our initial proof of concept by going beyond hematological malignancies into solid tumors."

The proceeds will be used to complete the ongoing HERACLES Phase II clinical trial (NCT03359980) of MaaT’s lead compound, MaaT013, in patients that developed steroid-refractory, gastrointestinal-predominant, acute Graft-versus-Host-Disease (SR aGvHD) following allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). In addition, the company will accelerate the development of a capsule formulation of MaaT013, MaaT033, which will ease administration and facilitate the expansion of the company’s pipeline into new oncological indications, including the initiation of a Phase 1b clinical trial with MaaT033. Recent studies demonstrated that restoring a balanced microbiome can significantly improve the clinical outcomes of checkpoint inhibitors, and MaaT Pharma will investigate this potential in a combination trial in solid tumors. Preliminary data from the safety and dose-finding Phase 1b trial of MaaT033 is expected in H2 2020.

MaaT Pharma’s product candidates are based on the company’s proprietary MaaT Microbiome Restoration Biotherapeutics (MMRB) platform. MaaT Pharma’s lead product candidate, MaaT013, is an enema formulation characterized by a high consistent richness of microbial species, whose specific bacteria are protected thanks to a proprietary formulation, derived from pooling the full intestinal ecosystems of stringently vetted, healthy donors. The product is manufactured at MaaT’s centralized European cGMP production facility. Apart from the ongoing HERACLES Phase II trial, from which results are expected in 2020, MaaT has provided MaaT013 to a compassionate use program for patients who had failed to respond to previous treatments for SR aGvHD. In total, over 50 patients with severe hematological malignancies have been treated with the company’s product candidate. The data collected up to date demonstrate that reintroduction of a full-ecosystem microbiota is well tolerated in these patients and provides initial signs of therapeutic benefit. Initial results from the company’s compassionate use program were presented at the 2019 ASH (Free ASH Whitepaper) conference in Orlando, Florida.

On February 5, 2020 The University of Texas MD Anderson Cancer Center reported that results from a Phase I/IIa trial treatment with cord blood-derived chimeric antigen receptor (CAR) natural killer (NK)-cell therapy targeting CD19 resulted in clinical responses in a majority of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), with no major toxicities observed (Press release, MD Anderson, FEB 5, 2020, View Source [SID1234553885]).

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The trial results were published today in the New England Journal of Medicine. Of the 11 patients participating in the study, eight (73%) responded to therapy and seven of those achieved a complete response, meaning they no longer showed evidence of disease at a median follow-up of 13.8 months. Post-remission therapy was administered to five of the responding patients. No patients experienced cytokine release syndrome or neurotoxicity.

Responses to the CD19 CAR NK cell therapy were evident within one month following infusion, and persistence of these cells was confirmed out to one year post-infusion.

"We are encouraged by the results of the clinical trial, which will launch further clinical studies to investigate allogeneic cord blood-derived CAR NK cells as a potential treatment option for patients in need," said corresponding author Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy.

Rezvani led the development of MD Anderson’s CAR NK platform with the support of the adoptive cell therapy (ACT) platform, Chronic Lymphocytic Leukemia Moon Shot and B-Cell Lymphoma Moon Shot, all part of the institution’s Moon Shots Program, a collaborative effort to rapidly develop scientific discoveries into meaningful clinical advances that save patients’ lives.

CAR NK cells are allogeneic, meaning the cells are taken from a non-related healthy donor rather than the patient themselves. Thus, CAR NK cells have the potential to be manufactured in advance and stored for off-the-shelf immediate use. In contrast, currently commercially available CAR T cells require the use of a patient’s own genetically modified T cells, created through a multi-week manufacturing process.

At MD Anderson, NK cells are isolated from donated umbilical cord blood and genetically engineered to express the desired CAR, which recognizes cancer-specific targets. The CAR NK cells also are ‘armored’ with IL-15, an immune signaling molecule that is designed to enhance proliferation and survival of the cells. The CD19 CAR NK cells used in this study were designed to target B-cell malignancies.

On the clinical trial, 11 patients received a single dose of cord blood-derived CD19 CAR NK cells, administered at one of three dose levels. Five patients had CLL and six had NHL. All patients were treated with a minimum of three and maximum of 11 lines of prior therapy. The first nine patients treated received CD19 CAR NK cells that were partially matched according to the individual’s human leukocyte antigen (HLA) type, but the protocol allowed the final two patients to be treated with no HLA matching.

Side effects experienced by participants were primarily related to the conditioning chemotherapy given before cell infusion and were resolved within one to two weeks, said Rezvani. No patient required admission to an intensive care unit for management of treatment side effects.

"Due to the nature of the therapy, we’ve actually been able to administer it in an outpatient setting," said Rezvani. "We look forward to building upon these results in larger multi-center trials as we work with Takeda to make this therapy available more broadly."

MD Anderson’s CAR NK cell therapy platform was licensed to Takeda Pharmaceutical Company Limited in 2019. As part of the license agreement and research agreement, Takeda has exclusive rights to develop and commercialize up to four CAR NK programs, including the CD19 CAR NK cell therapy (TAK-007) and B-cell maturation antigen (BCMA)-targeted CAR NK cells.

With continued support from the ACT platform, the Department of Lymphoma and Myeloma, and MD Anderson’s Therapeutics Discovery division, Takeda and MD Anderson are collaborating to initiate a pivotal clinical trial for the CD19 CAR NK-cell therapy TAK-007 in 2021. MD Anderson will implement an Institutional Conflict of Interest Management and Monitoring Plan for this research.