Nexus Pharmaceuticals announces FDA approval of Busulfan Injection

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.

Generex Biotechnology Announces Investor Conference Call Agenda Wednesday, January 16, at 4:00 p.m. Eastern

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

NeoImmuneTech Receives Authorization to Proceed from the FDA for IND Application to Evaluate Hyleukin-7 in Combination with a PD-L1 Inhibitor in Advanced High-Risk Skin Cancers

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.

Janssen announces European Commission approval of ERLEADA® (apalutamide) for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease

On January 16, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has granted marketing authorisation for ERLEADA (apalutamide), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (Press release, Johnson & Johnson, JAN 16, 2019, View Source [SID1234532680]).

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The EC approval is based on data from the pivotal Phase 3 SPARTAN study, which was published in The New England Journal of Medicine. The study assessed the efficacy and safety of apalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in patients with nmCRPC who had a rapidly rising prostate specific antigen (PSA) level despite receiving continuous ADT. Findings from the study showed that apalutamide plus ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.001). The median MFS was improved by over two years (40.5 months vs. 16.2 months) in patients with nmCRPC whose PSA is rapidly rising.1

"One of the key goals in prostate cancer treatment is to delay the disease from spreading. Once the cancer spreads, it can become less responsive to treatment, impacting patients’ quality of life and ultimately worsening their prognosis. Median survival for these patients is approximately three years," said Dr Simon Chowdhury, Consultant Medical Oncologist, Guy’s and St Thomas’ Hospitals, London. "It is crucial that we delay the development of metastases for as long as possible. Therefore, the approval of apalutamide, a treatment which can significantly increase time without metastases, is a major step-forward for patients with prostate cancer."*

"Today’s approval of apalutamide is a significant milestone and we are pleased that we can now offer patients with high-risk non-metastatic castration-resistant prostate cancer a new treatment option," said Dr Ivo Winiger-Candolfi M.D., Janssen Oncology Solid Tumor Therapy Area Lead, Europe, Middle East and Africa, Cilag GmbH International. "Bringing medicines to patients at earlier stages of disease is vital, and the approval of apalutamide could mark a step change in how we treat prostate cancer in the future. Crucially, treating patients at this stage could delay the cancer from spreading, a key part of our commitment to patients living with this disease and to their families."

The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension (14.3 percent vs. 11.8 percent), rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent). Treatment discontinuation due to adverse events was 11 percent in the apalutamide arm compared to 7 percent in the placebo arm. Rates of serious adverse events were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent respectively).1

ENDS

About Non-Metastatic Castration-Resistant Prostate Cancer

Non-metastatic castration-resistant prostate cancer (CRPC) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a bone scan or CT scan.2 Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dL.3 Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.3 The relative 5-year survival rate for patients with distant stage castration sensitive or castration resistant prostate cancer is 30 percent.4,5

About apalutamide

Apalutamide is a next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.6

In the United States, apalutamide received approval from the Food and Drug Administration for the treatment of patients with nmCRPC in February 2018, shortly followed by approvals in Canada, Australia, Argentina and Brazil.7,8,9,10

Alpine Immune Sciences Announces $25 Million Private Placement

On January 16, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company dedicated to developing innovative treatments for patients suffering from cancer and autoimmune/inflammatory diseases, reported it has entered into a definitive securities purchase agreement for the sale of units consisting of shares of common stock and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to the Company of approximately $25.3 million, before deducting placement agent commissions and other offering expenses (Press release, Alpine Immune Sciences, JAN 16, 2019, View Source [SID1234532679]). The private placement is being led by Decheng Capital with participation from existing investors OrbiMed Advisors, Frazier Healthcare Partners, Alpine BioVentures, and BVF Partners L.P. Effective on the closing of the private placement, the Company expects to appoint Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, to the Alpine Board of Directors.

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Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Alpine will issue units representing an aggregate of approximately 4.7 million shares of common stock and warrants to purchase an aggregate of approximately 1.8 million shares of common stock. The aggregate purchase price of each unit, which consists of one share of common stock plus a warrant to purchase 0.39 shares of common stock, is $5.37. The warrants to purchase common stock will have a per share exercise price of $12.74 and will be exercisable at any time on or after the closing date and through the fifth anniversary of the closing date. The price per unit was based in part upon the average of the last five closing prices of the common stock on the Nasdaq Global Market.

The private placement is expected to close on or about January 18, 2019, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Alpine with the Securities and Exchange Commission ("SEC").

Alpine intends to use the net proceeds to fund development of lead programs ALPN-101 in autoimmune and inflammatory indications and ALPN-202 in cancer.

Piper Jaffray & Co. acted as sole placement agent in the transaction.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Alpine has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.