On February 5, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 197,056 shares of the Company’s common stock, at a purchase price of $8.83 per share, in a registered direct offering priced at-the-market under Nasdaq rules, for gross proceeds of approximately $1.74 million (Press release, Phio Pharmaceuticals, FEB 5, 2020, View Source [SID1234553891]). The Company has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 197,056 shares of common stock. The closing of the offering is expected to occur on or about February 6, 2020, subject to the satisfaction of customary closing conditions.

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!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $8.71 per share of common stock, will be exercisable immediately upon issuance and will expire five and one-half years following the date of issuance.

Phio intends to use the net proceeds from the offering to fund the development of its immuno-oncology programs, other research and development activities and for general working capital needs.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-224031) previously filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. A prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.

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!

"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]).

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!

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]).

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!

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.

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!

"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.