On January 16, 2019 NeoImmuneTech, Inc., an immunotherapy drug development company focused on advanced cancer treatments, and Genexine, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate the combination of Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq) in patients with high-risk skin cancers (Press release, NeoImmuneTech, JAN 16, 2019, View Source [SID1234532681]).

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The phase 1b/2a clinical study will be led by NeoImmuneTech and the Immune Oncology Network (ION), a network of clinical research investigators from leading cancer centers and universities in North America that conducts multicenter trial of high priority immunotherapy agents. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of Hyleukin-7 in combination with Tecentriq in approximately 80 patients with anti-PD-(L)1 naïve or relapsed/refractory high-risk skin cancers. The planned multi-center open-label trial will be conducted in the US. ION is headquartered at the Fred Hutchinson Cancer Research Center in Seattle Washington.

Martin A. "Mac" Cheever, M.D., Director of ION and the National Cancer Institute’s Cancer Immunotherapy Trials Network had stated, "Hyleukin-7 has shown in multiple studies to substantially increase the total body complement of T cells with little toxicity. Hyleukin-7 is designed to be effective when used in concert with a variety of different immunotherapy regimens, including the combination with anti-PD-(L)1 that is being tested in this trial."

"Patients with high-risk skin cancers have very poor prognosis and limited treatment options," NgocDiep Le, M.D.,Ph.D., NeoImmuneTech Chief Medical Officer added. "Although anti-PD-1/PD-L1, including Tecentriq, can induce remarkable responses in a subset of patients with skin cancers, PD-(L)1 blockade fails to induce complete responses in most patients, especially those with low tumor infiltrating lymphocytes. Based on the mechanism of action of Hyleukin-7, we believe that combining Hyleukin-7 with a checkpoint inhibitor, such as Tecentriq, would increase the frequency and/or depth of responses to PD-1/PD-L1 inhibition."

Brian Gastman, M.D., the Principal Investigator of this trial, a surgeon and otolaryngologist of Cleveland Clinic, a member of ION, also said, "With the exciting advances in checkpoint inhibitor-based immunotherapy, we are at an inflection point to identify the next generation of cancer treatments to enhance both survival outcome and quality of life for our patients. Hyleukin-7 has all of the aspects of a therapy that should work to enhance current immunotherapies especially in the various high-risk skin cancer patient populations. I am personally excited to witness this class of drug entering the clinical trial phase as the pre-clinical results have been so promising and the need for an additional novel immunotherapy class of drugs has never been so pressing."

About Hyleukin-7TM
Hyleukin-7 TM (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell amplifier comprising a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc. IL-7 is known to be a critical factor for T cells, acting to increase both the number and functionality of T cells. Hyleukin-7 could play a pivotal role in reconstituting and reinvigoratiing T cell immunity in the treatment of patients with cancer and lymphopenia, as well as providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy. NeoImmuneTech and Genexine, Inc. (Genexine) are collaborating for clinical trials in advanced solid tumors, glioblastoma, etc. in the US and Korea.

On January 16, 2019 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (View Source) reported an agenda for the investor conference call to be presented today, Wednesday January 16, at 4:00 p.m. Eastern time (Press release, Generex, JAN 16, 2019, View Source [SID1234532682]). Joseph Moscato, Chief Executive Officer of Generex will outline the company’s strategic and financial plans, including details on financing transactions pertaining to the previously reported acquisitions of the Veneto Group assets and Olaregen. Additionally, Mr. Moscato will review the recent anticipated acquisitions of several profitable and innovative companies in the medical and surgical supply business, which include Pantheon Medical, MediSource, and most recently, Fuse Medical, a publicly traded company with nearly $30 million in projected annual revenues. In addition, Generex has signed a letter of intent for $15 million equity line of credit on more favorable terms than the equity line of credit previously reported.

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Importantly, tomorrow, January 17, 2019 (the report date), Generex will declare a dividend in the company’s wholly-owned subsidiary, NuGenerex Immuno-Oncology (formerly Antigen Express). The dividend will be structured such that for every 4 shares of Generex stock held on February 25, 2019 (the projected dividend payment date), investors will receive 1 share of NuGenerex Immuno-Oncology. Immediately following the dividend payout, Generex plans to list NuGenerex Immuno-Oncology on a public exchange. Additional details on this dividend will be provided on the conference call and in subsequent announcements.

"Generex is advancing our strategic initiatives to build value for our investors," stated Mr. Moscato. "And we are very happy to announce that Generex has signed a Letter of Intent to acquire Fuse Medical, subject to completed due diligence. The transaction has been structured as an all-stock deal valued at $34 million of Generex common stock at $2.50 per share with the potential for earnouts based on certain performance in 2019. The deal is not dilutive to our shareholders, as the payment is being made from the Generex pool shares that are described in the December 4, 2018 8K filing. Fuse is a publicly-traded surgical supply company with revenues approaching $30 million and EBITDA of approximately $5 million. The company distributes a broad portfolio of specialty surgical products to healthcare providers nationwide, bringing not only sales and distribution channels, but also a network of customers that will advance the Generex mission to deliver innovative end-to-end solutions to our healthcare partners, physicians, and patients. I will provide details on these potential acquisitions as well as on our plan to further expand the company’s footprint through the acquisition of a health system management company with a network of 13 hospitals in several states."

Mr. Moscato continued, "I am also pleased to announce that we have been able to restructure our $35 million debt obligation in a timely manner with the Veneto Group partners, through an agreement on the payment of $15.75 million in Generex common stock at the up-market price of $2.50 per share, that satisfies a significant portion of the $35 million obligation, plus $20 million in cash or stock to follow within 90 Days. The payment to the Veneto Group partners is being made with already accounted for shares in the Generex pool (See 8K on 12/4/18), which is non-dilutive to our current shareholders, as the total number of outstanding shares and capital structure remain the same. Additional information will be discussed at the conference call, followed by an 8k filing. The stock transaction demonstrates the Veneto Groups confidence in our strategic growth plan, because the deal is at a significant premium to our current market valuation. In addition to the Veneto deal, we have agreed to increase the Generex ownership of Olaregen Therapeutix, our regenerative medicine subsidiary, from 51% to approximately 72% through an agreement to acquire all of Olaragen’s outstanding Series A Preferred Stock in exchange for Generex stock and a second payment of either stock or cash. Again, these stock transactions are non-dilutive to our current shareholders, and reserve cash for advancing the company’s strategic plans. Further, we are in discussions with the remaining Olaregen shareholders to acquire up to 100% of the company."

Lastly, by the end of the month, Generex expects to receive the final audit report on the direct to patient pharmacy network, which the company had previously announced in a letter of intent to acquire the network of pharmacies and IT systems. The audit report will enable Generex to finalize the terms and price of the acquisition, thereby providing a path toward integration of the pharmacy network into NuGenerex Distribution Solutions in the near future. "We’re excited about the opportunity to potentially expand our pharmacy network that ultimately will enhance our distribution and direct to patient capabilities. We look forward to integrating the pharmacy’s cutting edge database systems and operational capabilities to grow our Distribution Solutions business with by introducing a number of innovative pharmacy programs," stated Terry Thompson, COO of Generex and President of NuGenerex Distribution Solutions.

On the conference call, Mr. Moscato will provide more in depth details on the Company’s financing initiatives, an overview of the recent potential acquisitions in the medical & surgical supply business, an update on the impending commercial launch of Olaregen’s wound healing product Excellagen, and a review of the pending acquisition of the pharmacy network, IT systems, and direct to patient databases. Mr. Moscato will also provide information regarding the dividend and spin out of NuGenerex Immuno-Oncology, and will wrap up the call with an update on the plan for up-listing Generex to a major stock exchange. Generex will be filing 8Ks with the SEC covering the information shared on the conference call and in corporate communications.

Mr. Moscato concluded, "As always, we will leave sufficient time at the end of call to address any and all questions from our loyal Generex shareholders, and I look forward to an informative discussion on Wednesday afternoon."

The access information for the investor conference call is as follows:

Wednesday January 16, at 4:00 p.m. Eastern time

Domestic US/Canada – 1-(866) 342-8588

Direct Toll / International – 1-(203) 518-9865

Conference ID – 85014

On January 16, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported that it intends to offer and sell, subject to market and other conditions, $75.0 million of shares of its common stock in an underwritten public offering (Press release, Mirati, JAN 16, 2019, View Source [SID1234532703]). Mirati expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares are being offered by Mirati. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan Securities LLC, Citigroup Global Markets Inc., Cowen and Company, LLC, Barclays Capital Inc. and Credit Suisse Securities (USA) LLC are acting as joint book-running managers in the offering.

The securities described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by calling (631) 274-2806; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

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

On January 16, 2019 Nexus Pharmaceuticals Inc. reported the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company’s AP-rated therapeutic equivalent for Busulfex 60 mg/10 mL (6 mg/1 mL) (Press release, Nexus Pharma, JAN 16, 2019, View Source [SID1234532683]).

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"The FDA approval of Busulfan continues to expand our portfolio of difficult to manufacture injectables, in addition to becoming our second oncology generic drug," said Omair Ahmed, Chief Commercial Officer, Nexus Pharmaceuticals. "Busulfan is currently on American Society of Health System Pharmacists drug shortage list. The addition of Busulfan will continue to show our commitment to providing patients and clinicians with access to affordable generic alternatives to critical need medicines that have a history of shortage."

Busulfan is expected to launch in the United States shortly in cartons of eight single-dose vials, each containing 60 mg of busulfan in 10 mL of clear sterile solution. It is Latex and Preservative free.

About Busulfan Injection

Busulfan is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.

On January 16, 2019 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, reported that it has entered into a collaboration with Roche to develop a diagnostic (CDx) in triple-negative breast cancer (TNBC) (Press release, PhoenixMD, JAN 16, 2019, View Source [SID1234553816]). The Roche CDx identifies RSK2 activation in human tumors. In cancer, the PDK-1 and MAPK pathways converge on RSK2 to activate it, moving it from the cytoplasm into the nucleus. Measuring nuclear RSK2 signifies activation and abundance of this emerging drug target.

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Complementing its diagnostic efforts, PhoenixMD has also developed PMD-026, which is the first orally available small molecule inhibitor that targets RSK2, a prime drug target in multiple cancers. The leading focus for PhoenixMD is in the treatment of triple-negative breast cancer (TNBC) given the companies’ core expertise in developing breast cancer therapeutics.

The diagnostic assay developed through the Roche/PhoenixMD collaboration will relay information on how active the RSK2 pathway is in TNBC and other cancers. Preliminary data indicates that 80 percent of cases (52/65 TNBC cases) express activated RSK2. More broadly, researchers have investigated more than 300 biopsies and found that RSK2 is activated in 65 percent of tumors from a study of 13 different tumor types. RSK2 was also detected in breast cancer metastases using this method. Over the coming months, Roche will establish a CAP/CLIA certified protocol as a gateway into clinical tumor analyses. In upcoming clinical trials, PhoenixMD will further refine the precision of the RSK2 CDx in identifying patients that may ultimately benefit from PMD-026. In the near term, PhoenixMD expects to file an IND for PMD-026 and initiate a Phase I/Ib study in women with TNBC.

"By working together, PhoenixMD and Roche are at the forefront of innovation in TNBC, the most deadly breast cancer type with no approved therapies. Creating our diagnostic assay and identifying disease biomarkers, such as RSK2 for TNBC, will dramatically reduce the development time needed to create targeted drugs and will improve a drug’s chance of advancing through clinical trials," said Dr. Sandra E. Dunn, CEO of PhoenixMD. "The top-line data generated from our CDx is encouraging, and we look forward to applying these learnings to identify TNBC patients that may benefit from PMD-026 in our upcoming Phase I/Ib study."

About Triple Negative Breast Cancer (TNBC) and RSK Kinases

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. It is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are no approved targeted therapies available for TNBC.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90 percent of primary TNBC cases express high levels of RSK1 and RSK2. Inhibiting RSK2 eliminates TNBC cells completely, including cancer stem cells, which give rise to cancer recurrence. PhoenixMD, with its novel, targeted approach, is focused on creating patented cancer RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

While there are currently no approved targeted therapies for TNBC, several drugs are involved in research studies and clinical trials. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.