On June 16, 2020 Mateon Therapeutics Inc. (OTCQB:MATN) reported the fruition of its licensing of OT-101/IL-2 combination to Autotelic BIO based on an agreement entered into between Oncotelic and Autotelic BIO, a South Korean Company, during 2018 (Press release, Mateon Therapeutics, JUN 16, 2020, View Source [SID1234561128]).

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OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies. Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN) Immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma.

"In addition to additional milestone payments under said agreement, Mateon also entitled to profit sharing and royalties arising from the commercialization and/or licensing of OT-101/IL-2 by Autotelic BIO", stated Amit Shah, CFO of Mateon Therapeutics. "We look forward to continue our collaboration with Autotelic BIO and to make this unique immunotherapy available to patients."

On June 16, 2020 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that Stéphane Bancel, Chief Executive Officer, will participate virtually in the BMO 2020 Prescriptions for Success Healthcare Conference on June 23rd at 3:00 p.m. ET (Press release, Moderna Therapeutics, JUN 16, 2020, View Source [SID1234561144]).

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A live webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.

On June 16, 2020 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems ("Ichor"), a privately held biotech company based in San Diego, CA, reported that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001 (Press release, Immunomic Therapeutics, JUN 16, 2020, View Source [SID1234561129]).

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ITI will leverage Ichor’s TriGrid Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

"We are excited to partner with Ichor on our ITI-1001 program. Their TriGrid technology is a great match for our nucleic acid approach. By combining our technologies, we aim to enhance immune responses to the viral antigens of Cytomegalovirus (CMV) expressed in GBM patients, and potentially achieve immune responses that target CMV-expressing GBM tumor tissue in the brain in our upcoming Phase I study with ITI-1001," said Dr. William Hearl, CEO of Immunomic Therapeutics. "We are pleased to collaborate with a recognized leader in the delivery of nucleic acid-based medicines and we look forward to initiating patient dosing in 2021."

ITI-1001, which leverages ITI’s proprietary and investigational UNITE platform to treat patients with newly diagnosed GBM, is designed to target the pp65, IE-1, and gB viral antigens of CMV, expressed in GBM, but not in normal brain cells. In March 2020, ITI announced that it had completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

In the planned First-In-Human Phase I trial, ITI will evaluate the safety, tolerability, immunogenicity and preliminary efficacy of ITI-1001 in patients with newly-diagnosed GBM having unmethylated MGMT promoter mutations. The Phase I trial is anticipated to start in 2021.

"DNA vaccines are a promising platform for both therapeutic and prophylactic applications. Randomized, placebo-controlled trials have demonstrated that the TriGrid improves the potency of DNA vaccines compared to conventional injection," said Ichor CEO Bob Bernard. "We are eager to deploy our TriGrid technology with ITI’s UNITE-based GBM DNA vaccine to target an aggressive cancer for which novel therapies are desperately needed."

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On June 16, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported it has entered into a securities purchase agreement, jointly led by biotech-focused fundamental institutional investors, Acorn Bioventures and CAM Capital, at the closing price as of June 15, 2020 (Press release, Cardiff Oncology, JUN 16, 2020, View Source [SID1234561145]). The financing includes common stock, non-voting Series E preferred stock and warrants for aggregate gross proceeds of $13.5 million. The proceeds will be used to accelerate the development of onvansertib and associated capital expenditures.

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"We are thrilled to have the long-term investment and support of Acorn Bioventures and CAM Capital to help continue advancing our prioritized clinical programs towards value inflection milestones," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "Broadening our institutional investor base will also provide the opportunity for us to gain valuable insight and input from our new investors as part of their role as non-voting observers to our Board of Directors. We believe this financing will allow us to build on the momentum from the recent positive clinical data presented at ASCO (Free ASCO Whitepaper) in KRAS-mutated metastatic colorectal cancer. Ultimately, our goal is to provide cancer patients with more effective therapeutic options through development of combination regimens across a number of difficult-to-treat cancers."

The common stock is being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-232321), previously filed with the Securities and Exchange Commission ("SEC") on June 25, 2019 and declared effective on July 1, 2019. Such shares of common stock are being offered only by means of a prospectus supplement. A prospectus supplement and the accompanying prospectus relating to the registered direct offerings may be obtained, when available, on the SEC’s website at View Source or by contacting Cardiff Oncology, Inc.

The Series E preferred stock and warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Rule 506(b) of Regulation D promulgated thereunder and, along with the common stock underlying the Series E preferred and the warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the Series E preferred stock, warrants and underlying common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from 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 June 16, 2020 Perrigo Company plc ("Perrigo" or the "Company") (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that Perrigo Finance Unlimited Company, an indirect wholly-owned finance subsidiary of Perrigo (the "Issuer"), commenced a registered public offering of senior notes (the "Notes") (Press release, Perrigo Company, JUN 16, 2020, View Source [SID1234561130]). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by the Company. The exact terms and timing of the offering will depend upon market conditions and other factors.

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Perrigo intends to use the net proceeds of the Notes offering to fund the redemption of the Issuer’s 3.500% Senior Notes Due March 15, 2021 and 3.500% Senior Notes Due December 15, 2021, with the balance, if any, for general corporate purposes, which may include the repayment or redemption of additional indebtedness.

BofA Securities, J.P. Morgan and Wells Fargo Securities are the joint book-running managers in the offering.

The offering is being made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission. The offering will be made only by means of a prospectus supplement relating to the offering and the accompanying base prospectus, copies of which may be obtained by contacting: BofA Securities, Inc. at [email protected] or toll-free at (800) 294-1322; or by calling J.P. Morgan Securities LLC collect at (212) 834-4533; or by calling Wells Fargo Securities, LLC toll-free at (800) 645-3751 or emailing [email protected].