On December 12, 2018 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, reported that the Company will be presenting key results from its Phase II clinical programme with selective AXL inhibitor bemcentinib at the DNB’s 9th Annual Nordic Healthcare Conference in Oslo, Norway, today at 10:15-10:40 CET (Press release, BerGenBio, DEC 12, 2018, View Source [SID1234532017]).

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The slides are available for download at the Company’s website: www.bergenbio.com/investors/presentations/

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We have made significant progress during 2018 establishing clinical proof of concept for the remarkable utility of bemcentinib in cancers with high unmet clinical need and large market potential. We have shown that our once-a-day, oral selective AXL inhibitor is well tolerated as a monotherapy and in combination with immune-, targeted and chemotherapies. What is more, consistently we have seen that efficacy scales with AXL biomarker expression leading to superior response rates in AXL biomarker positive relapsed/refractory AML and MDS as a monotherapy as well as non-small cell lung cancer where we are combining with the immunotherapy blockbuster Keytruda. We have met all our operational milestones this year and are looking forward to starting a randomised phase II programme towards the end of H1 2019 based on key results obtained this year".

On December 12, 2018 Apexian Pharmaceuticals reported is shedding light on the question of how pre-leukemic cells transform into full-blown leukemia (Press release, Apexian Pharmaceuticals, DEC 12, 2018, View Source [SID1234532036]).

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Genetic mutations by themselves are rarely enough to flip the switch. Inflammation also plays a role. But, until now, the question of "how" remained unanswered.

Apexian Chief Science Officer Mark Kelley, PhD, and his colleagues presented their findings at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s December 1, 2018 meeting in San Diego, California. When a putative tumor-suppressor gene called TET2 does not function well, acute inflammation or infection can enhance the production of myeloid stem and progenitor cells in the bone marrow that are precursors to circulating mature myeloid cells. The TET2 loss of function amplifies; inflammatory proteins increase, and myeloid cells rapidly mature, increasing in sheer numbers as well as developing resistance to programmed cell death.

Myeloid cells, which contribute to immunity, are normally very short-lived. However, when those cells live too long or become too numerous, dangerous levels of inflammation can result. Using a mouse model, Kelley and his colleagues demonstrated that Apexian’s flagship compound APX3330 can prevent precancerous cells from proliferating and block cells from making inflammatory proteins.

Such anti-inflammatory therapy could be of clinical value in people carrying TET2 mutations.

"Apexian continues to develop a robust portfolio of APE1/Ref-1 compounds that have broad utility in oncology, hematology and other diseases," says Steve Carchedi, President and CEO. "We are excited by the recent scientific findings and continue to expand our research and development beyond solid tumors."

APX3330 also has clinical utility with solid tumors. A Phase 1 trial for patients with advanced solid tumors is concluding

On December 12, 2018 NETRIS Pharma, a clinical-stage company developing novel anticancer therapies targeting dependence receptors, reported successful completion of the first-in-human study on the effects of netrin-1 inhibition in patients with advanced solid tumors (Press release, Netris Pharma, DEC 12, 2018, View Source [SID1234532018]). The Phase 1 dose-escalation study showed that NP137, a first-in-class monoclonal anti-netrin-1 blocking antibody, was safe and well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT), meeting the primary objective. In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective response.

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"We are very pleased with the safety and tolerability profile of NP137 in this study, which enabled evaluation of netrin-1 inhibition in advanced solid tumors," said Philippe Cassier, MD, PhD, Head of Phase 1 unit at Centre Léon Bérard and Principal Investigator of the NP137 study.

"I am really impressed by the preliminary anti-tumor activity observed in this study with patients showing objective response and prolonged one-year disease control," added Professor Jean Yves Blay, MD, Ph.D. General Director of the Centre Léon Bérard and past president of EORTC.

The Phase 1 study was designed to evaluate the maximum tolerated dose, pharmacokinetics and pharmacodynamics, and establish the recommended dose for the Phase 1b/2 expansion study. NP137 was dosed every other week starting from 1 mg/kg up to 20mg/kg in heavily pre-treated patients with advanced solid tumors. Additional study objectives were to evaluate the adverse events (AE), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of NP137. The study enrolled a total of 19 patients in three French centers, the Centre Léon Bérard in Lyon, the Institut Claudius Régaud in Toulouse and the Institut de Cancérologie de l’Ouest in Nantes. A Phase 1 extension study with an additional 24 patients is ongoing to confirm the safety and tolerability of NP137, collect biopsies before and after treatment to allow measurement of potential biomarkers and confirm the preliminary clinical activity seen during dose escalation. The final phase 1a data will be submitted for presentation at an upcoming international medical conference.

"Meeting the primary objective of the dose-escalation part of this study and generating preliminary positive efficacy data, particularly in such chemotherapy-resistant patients, provide an important confirmation of our dependence receptor science and lay the groundwork for larger clinical studies with NP137 as a targeted approach to treat solid tumors in combination with chemotherapy, immune checkpoint inhibitors and tyrosine kinase inhibitors, » said Prof. Patrick Mehlen, Chief Executive Officer of NETRIS Pharma. « Additionally, we would like to thank the investigators, patients and caregivers for their participation in this study, and for contributing to our understanding of NP137 as we work to address a significant medical need. »

About NP137

Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers. Expression of netrin-1 often correlates with disease severity and no therapy has ever been tested against this new pathway.

NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. NP137 prevents the binding of netrin-1 on its dependence receptors, thereby re-inducing cancer cell death and impacting tumor cell plasticity. Pre-clinical studies show NP137 to have an anti-cancer effect as a monotherapy as well as synergistic effects in combination with chemotherapy, immune checkpoint inhibitors or tyrosine kinase inhibitors.

On December 12, 2018 Generex Biotechnology Corporation (OTCQB:GNBT) reported that the FDA had reviewed the company’s investigational new drug (IND) application and given notification that the study can proceed (Press release, Generex, DEC 12, 2018, View Source [SID1234532037]). The study: A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer, is sponsored by Generex and conducted under a collaboration agreement with Merck and a clinical trial agreement with the NSABP Foundation, Inc. (NSABP).

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The combination study builds on previous clinical studies of both AE37 and Keytruda. AE37, a cancer vaccine, was the subject of a 300 patient prospective, randomized and single-blinded Phase II study in patients with breast cancer. That study showed a strong trend toward reduced relapses,particularly in patients with triple negative breast cancer. Keytruda also has shown encouraging results in patients with triple negative breast cancer when used as monotherapy. The complementary mechanisms of action of the two drugs suggest the combination may have the potential to be better than either alone.

AE37 is unique among therapeutic cancer vaccines in that it ensures specific activation of CD4+ T helper cells, which are critical in generating an effective immune response. Its improved immunological potency, along with an excellent safety profile, offers particular advantages for combination studies. In addition to the Phase II study in breast cancer patients, AE37 also has been tested in a Phase I study in prostate cancer patients. AE37 treated patients have consistently displayed a robust, long-lasting and specific response to the vaccine.

Liesha Emens, M.D., Ph.D., Principal Investigator for the study and Professor of Medicine at the University of Pittsburgh Medical Center commented: "So far, metastatic triple negative breast cancer patients treated upfront with immunotherapy benefit clinically from immune checkpoint immunotherapy only if their tumors contain PDL1+ cells. Increasing the number of patients with immune-activated tumors should bring the benefit of immunotherapy to even more patients. This Phase II trial will test whether the AE37 vaccine may trigger immunity in triple negative breast cancer patients, priming them for clinical benefit from immune checkpoint blockade."

Eric von Hofe, President of NuGenerex-ImmunoOncology commented: "We are gratified to see this important trial moving forward. While we have tested AE37 in breast and prostate cancer patients, there is good rationale for inclusion of AE37 in the treatment regimen of a variety of additional cancer types of high unmet need. Gastric, colon, ovarian and bladder cancers all express the same tumor target expressed in breast and prostate cancer that AE37 activates the immune system to recognize."

About AE37

AE37 is an investigational therapeutic cancer vaccine being developed to treat certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

AE37 does not directly target HER2, but rather acts as a vaccine to activate the immune system to recognize the HER2 protein, which is expressed on cancer cells as foreign. AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response.

On December 12, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that it has commenced an underwritten public offering of its common shares (Press release, VBI Vaccines, DEC 12, 2018, View Source [SID1234532101]). VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares offered in the public offering. The offering is subject to market and other conditions and 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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BMO Capital Markets, Canaccord Genuity LLC, and Oppenheimer & Co. Inc. are acting as joint book-runners for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its research and development programs, which include, among other things, funding the continued clinical development of Sci-B-Vac, including the ongoing Phase 3 clinical program in the United States, Europe and Canada; the Phase 1/2a clinical study of the therapeutic vaccine candidate, VBI-1901, for glioblastoma (GBM); the prophylactic vaccine candidate, VBI-1501, for cytomegalovirus (CMV); and the immuno-therapeutic candidate, VBI-2601, for hepatitis B. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on June 8, 2017. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036 or by e-mail at [email protected], or from Canaccord Genuity LLC, Attention: Equity Syndicate Department 99 High Street, 12th Floor, Boston, MA 02110 or by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

The securities will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.