On April 4, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported agreement with Memorial Sloan Kettering Cancer Center (MSK) for the conduct of an investigator-sponsored clinical trial of SELLAS’ Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, galinpepimut-S (GPS), in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab, in patients with malignant pleural mesothelioma (MPM) (Press release, Sellas Life Sciences, APR 4, 2019, View Source [SID1234535011]). The Phase 1 open-label clinical study will enroll patients with MPM who harbor relapsed or refractory disease after having received frontline standard of care multimodality therapy with study drug provided by both SELLAS and Bristol-Myers Squibb. The principal investigator for the study will be Dr. Marjorie G. Zauderer, MD, Co-Director, Mesothelioma Program, Team Lead, Thoracic Disease Management Team, and Assistant Attending Physician in the Division of Thoracic Oncology, Department of Medicine at MSK.

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The purpose of the trial is to determine if the administration of GPS in combination with nivolumab has the potential to demonstrate antitumor immune responses and meaningful clinical activity in the presence of macroscopic disease in MPM patients. The study will also investigate the tolerability of the combination, evaluate the immunogenicity of the two agents administered together, by CD4+ and CD8+ T-lymphocytes (both peripherally and at the tumor site), and gauge the degree of clinical benefit by assessment of the overall response rate with the combination in comparison with that reported with nivolumab alone in historical comparable patient populations. In a randomized, controlled, blinded Phase 2 clinical trial in MPM patients completed in 2017, GPS monotherapy, given as maintenance after first line tumor-debulking multimodality treatment, demonstrated meaningful clinical activity with median survival of 22.8 months vs. 18.3 months in the control group (N=41) and with associated sustained immune responses (both CD4+ and CD8+) against the WT1 antigen while adverse events were mainly comprised of low grade reactions at the site of the injection.

"SELLAS is excited to embark upon this trial, as we look to expand the utility of GPS in combination with PD-1 inhibitors, and specifically nivolumab. The nivolumab/GPS immunotherapy combination is well positioned to exploit the unique features of each of these two agents through potential synergistic immune-based mechanisms of antitumor action. If positive, this clinical effort will allow us to consider advancing the clinical development of the combination of GPS and nivolumab in relapsed or refractory MPM as a potentially promising approach to treat patients with this recalcitrant thoracic malignancy," stated Dr. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"The rationale for this innovative clinical effort is based upon the presumed immunobiologic and pharmacodynamic synergy between the two investigational agents. We hypothesize that the negative influence of tumor microenvironment factors on the immune response is mitigated by nivolumab, thus providing the opportunity for the patients’ own immune cells to invade and destroy cancerous growth deposits specifically sensitized against WT1 by GPS. WT1 is both a densely and frequently expressed tumor-associated antigen in MPM, and we believe it represents the optimal target for directly immunizing, vaccine-type therapies such as GPS against this tumor type," commented Dr. Nicholas J. Sarlis, MD, PhD, Chief Medical Officer and Executive Vice President of SELLAS.

Data from a Phase 1 open-label clinical study of patients with WT1+ ovarian cancer in second or greater remission suggested clinical activity for the combination of GPS plus nivolumab, with a progression-free survival (PFS) rate of 70% at one year among patients who received at least three doses of GPS in combination with nivolumab (7/10), while historical 1-year PFS rates with best standard treatment do not exceed 50% in this disease setting.

GPS is also currently being studied in combination with Merck’s anti-PD-1 therapy, pembrolizumab, in patients with measurable tumor burden in the context of a Phase 1/2 open-label, non-comparative, multicenter, multi-arm ‘basket’-type clinical study in five indications.

On April 3, 2019 Advaxis, Inc. (Nasdaq: ADXS) (the "Company"), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the pricing of an underwritten public offering of 2,500,000 shares of its common stock at a price to the public of $4.00 per share (Press release, Advaxis, APR 3, 2019, View Source [SID1234534960]). The gross proceeds to Advaxis, Inc. from this offering are expected to be approximately $10,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses. The offering is expected to close on April 5, 2019, subject to satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

The Company intends to use the net proceeds from this offering to fund its continued research and development initiatives in connection with its product pipeline including, but not limited to, (i) investment in its ADXS-HOT program in both monotherapy and combination therapy and new cancer types; (ii) investment in ongoing clinical research in ADXS-PSA and ADXS-NEO, in combination therapy; and (iii) general corporate purposes.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 30, 2018. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC on April 2, 2019 and are available on the SEC’s website at www.sec.gov. The final prospectus supplement and accompanying prospectus related to the proposed offering will be filed and made available on the SEC’s website. Electronic copies of the preliminary prospectus supplement and the final prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or via email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

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

On April 3, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its collaboration partner, Janssen Biotech, Inc. ("Janssen") plans to start a new Phase III study of daratumumab in multiple myeloma (Press release, Genmab, APR 3, 2019, View Source [SID1234534961]). The study (MMY3021) will compare subcutaneous daratumumab in combination with lenalidomide versus lenalidomide alone as maintenance treatment in patients with newly diagnosed multiple myeloma who are minimal residual disease (MRD) positive after frontline autologous stem cell transplant (ASCT). The primary end point of the study is MRD conversion rate, from MRD positive to MRD negative status, at twelve months. The study is planned to start in the first half of 2019. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are pleased to see Janssen’s continual commitment to evaluating the use of daratumumab in a wide array of settings and combinations. We are hopeful that the study will provide evidence of daratumumab’s potential to provide a benefit to patients with multiple myeloma beyond current standard of care treatments in the maintenance phase of treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the MMY3021 study
The Phase III study is a randomized, open-label, multicenter study that will include up to 214 newly diagnosed patients with multiple myeloma who are MRD positive after autologous stem cell transplant and who have no prior anti-CD38 exposure. Patients will be randomized to receive either subcutaneous daratumumab in combination with lenalidomide or lenalidomide alone. In the daratumumab treatment arm, patients received 1,800 mg of subcutaneous daratumumab weekly for Cycles 1-2, every two weeks for Cycles 3-6 and every four weeks thereafter. Lenalidomide will be administered at 10 mg orally on days 1-28 with 15 mg given daily if it is well tolerated after three cycles. Both arms will continue until disease progression or for 36 cycles. The primary endpoint of the study is MRD-conversion at 12 months.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On April 3, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, reported data from its preclinical program for TP-2846, the Company’s new pipeline candidate for acute myeloid leukemia (AML) discovered using Tetraphase’s proprietary total synthesis platform (Press release, Tetraphase, APR 3, 2019, View Source [SID1234534963]). The data were presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29-April 3 at the Georgia World Congress Center in Atlanta. The posters showed results from preclinical in vitro and in vivo studies demonstrating the activity, potency and unique mechanism of action (MOA) of TP-2846.

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"Preclinical testing has characterized TP-2846 as a novel, potent, synthetic tetracycline with activity across multiple in vitro and in vivo cancer models," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "We are very encouraged by these early data, which suggest that TP-2846 holds the potential to benefit AML patients regardless of their mutation status. Further, these data show that because of its unique MOA, TP-2846 may have antileukemic activity in patients whose cancer has progressed while on different treatment regimens."

"TP-2846 has a new MOA that has never before been fully explored clinically as a viable approach to treating AML," said Jacques Dumas, Chief Scientific Officer of Tetraphase. "Our preclinical data demonstrated high potency across multiple AML cell lines, along with in vivo tumor responses at well-tolerated doses. These early data are very encouraging and support the continued preclinical evaluation of TP-2846 as a potential new antileukemia agent."

TP-2846 binds to the mitochondrial ribosome, inhibiting protein translation and inducing apoptosis. Mechanistic assays demonstrated changes in protein and gene expression – all consistent with disruption of mitochondrial translation.

TP-2846 showed antiproliferative activity against cultured AML cell lines in vitro, as well as bone marrow samples derived from AML patients in ex vivo assays. The data available to date also suggest that TP-2846’s activity is independent of p53 status. Because of its novel MOA, TP-2846 maintained antiproliferative activity in cell lines that are resistant to anthracyclines, cytarabine and venetoclax, which are currently approved treatments for AML.

In vivo efficacy studies were also performed, comparing TP-2846 to cytarabine and tigecycline, a tetracycline antibacterial, in two AML mouse xenograft models. In these studies, TP-2846 demonstrated potent, dose-dependent in vivo efficacy, including greater than 50 percent tumor shrinkage in 19 out of 20 animals treated with TP-2846, while none in the comparator treatment groups achieved a tumor response in the same studies. TP-2846 was well tolerated in both models.

On April 3, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory, cancer and other diseases, reported that Allan Reine, Senior Vice President and Chief Financial Officer of Pieris Pharmaceuticals, Inc. will present at the 2019 H.C. Wainwright Global Life Sciences Conference in London, U.K. on Monday, April 8, 2019 at 1:30 PM (GMT) (Press release, Pieris Pharmaceuticals, APR 3, 2019, View Source [SID1234534981]). A webcast of the company’s presentation will be available at this link.

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