On January 23, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 1,242 million in 2017. Net sales were USD 884 million in the U.S. and net sales in the rest of the world were USD 358 million (Press release, Genmab, JAN 23, 2018, View Source [SID1234523485]). Genmab receives royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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DARZALEX was approved in the U.S. in November 2015, in Europe in May 2016 and in Japan in September 2017. Worldwide net sales of DARZALEX in 2016 were USD 572 million, resulting in royalty income of DKK 458 million to Genmab.

On January 23, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that an overview of the Company’s business strategy and commercial and development-stage programs will be given at the Noble Capital Markets’ Fourteenth Annual Investor Conference being held at the W Hotel, Fort Lauderdale, Florida (Press release, Spectrum Pharmaceuticals, JAN 23, 2018, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-noble-capital [SID1234523570]). The Company presentation is on Tuesday, January 30, 2018, at 1:30 PM EST.

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A high-definition, video webcast of the presentation will be available the following day on the Company’s web site at www.sppirx.com under Investor Relations.

On January 23, 2018 GT Biopharma Inc. (OTCQB: GTBP and Euronext Paris: GTBP.PA) reported that it has entered into definitive agreements for a private placement of convertible notes and warrants for gross proceeds of $7,055,000 (Press release, GT Biopharma , JAN 23, 2018, View Source [SID1234539535]). The company intends to use the proceeds from the financing to advance its immuno-oncology programs, which are based on the company’s proprietary Tri and Tetra-specific Natural Killer Cell Engagers (TriKEs and TetraKEs) and bispecific antibody-drug conjugate (ADC) platforms, neurology (CNS) pipeline progress, and for general corporate purposes.

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Oppenheimer & Co. Inc. acted as the sole placement agent for the offering.

The convertible notes are unsecured, have a face amount of $7,760,508, a 0% coupon, an initial conversion price of $4.58, subject to adjustment, and are due July 2018. Investors also received warrants to purchase approximately 1,694,440 shares of GT Biopharma common stock at an initial exercise price of $4.58 per share, subject to adjustment.

Roth Capital Partners also acted as a financial advisor to GT Biopharma for this transaction.

On January 23, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) (TASE: BLRX.TA) a clinical-stage biopharmaceutical company focused on oncology and immunology, reported the publication of data showing that BL-8040, its lead oncology platform, augments the ability of the immune system to fight cancer by increasing the infiltration of anti-tumor-specific T-cells into the tumor microenvironment (TME), resulting in decreased tumor growth and prolonged survival in a murine model of cancer (Press release, BioLineRx, JAN 23, 2018, View Source;p=RssLanding&cat=news&id=2327885 [SID1234523482]). Results of the study will be presented as a poster titled "CXCR4 Antagonist (BL-8040) Enhances Antitumor Effects by Increasing Tumor Infiltration of Antigen-specific Effector T-cells" (Abstract 73) on January 25, 2018 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018, in San Francisco, CA.

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In the preclinical study, a murine model of cancer was used to assess the effects of BL-8040 in combination with a cancer vaccine that primes the immune system against the tumor. The results of the study show that combining BL-8040 with the cancer vaccine leads to a significantly enhanced anti-tumor immune response, which attenuates tumor growth and prolongs mouse survival better than either agent administered alone. The results go on to demonstrate that BL-8040 significantly increases the abundance of tumor-specific T-cells in the TME, suggesting an explanation for the enhanced efficacy of the combination over either agent when administered alone.

"I am highly encouraged by the data generated in this preclinical study, which further demonstrates the therapeutic potential of BL-8040," commented Dr. Samir Khleif, Professor of Oncology and Director of the Loop Immunology-Oncology Laboratory at Georgetown Lombardi Comprehensive Cancer Center. "The results provide further evidence that BL-8040 promotes the infiltration of cytotoxic T-cells into tumors, which is seen as a key objective to improve responsiveness to checkpoint therapy. I look forward to seeing the results from the clinical studies in which BL-8040 is being combined with checkpoint blockade."

"We have shown in numerous preclinical and clinical studies that BL-8040 has various anti-tumor effects, including direct and indirect effects, influencing T-cell location and activity as well as tumor cell survival," commented Philip Serlin, Chief Executive Officer of BioLineRx. "The results of the current study suggest that BL-8040 enhances anti-tumor immune response by increasing the number of anti-tumor T-cells in the TME. These results also suggest that BL-8040, a CXCR4 antagonist, is a promising immune-modulatory agent with potent anti-tumor effects, and we remain on track with our eight ongoing clinical trials for this product in various indications, both in blood cancers as well as in solid tumors."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and preclinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On January 23, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) (TASE: BLRX.TA), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that AGI-134, an immunotherapy compound in development for the treatment of multiple solid tumors, demonstrated successful results in two pre-clinical melanoma studies (Press release, BioLineRx, JAN 23, 2018, View Source;p=RssLanding&cat=news&id=2327860 [SID1234523483]). Results of these studies will be presented as a poster titled "Intratumoral Administration of the Alpha-Gal Glycolipid AGI-134 to Induce Tumor Regression in a Mouse Model of Melanoma" (Abstract 68) on January 25, 2018 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018, in San Francisco, CA.

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The ability of intratumorally injected AGI-134 to induce regression of established primary tumors was assessed in two murine melanoma models. In the two models, there was complete tumor regression in 50% and 67%, respectively, of mice treated with AGI-134. Moreover, treatment with AGI-134 showed a beneficial effect on survival, compared to the control group. In addition, the results show that injection of AGI-134 into the tumors induces activation of the complement system, an important component of the innate immune system. Activation of the complement system within tumors by AGI-134 is predicted to destroy tumor cells and create a pro-inflammatory tumor microenvironment that attracts and activates other immune cells, ultimately resulting in adaptive anti-tumor immunity. Previous studies with intratumoral administration of AGI-134 to primary tumors had shown that AGI-134 protects mice from the development of distant, untreated tumors.

"We are pleased to report these encouraging results for our second lead oncology project at the upcoming ASCO (Free ASCO Whitepaper)-SITC conference," said Philip Serlin, Chief Executive Officer of BioLineRx. "Previous studies have demonstrated that intratumoral administration of AGI-134 induces a systemic anti-tumor response that protects mice from the development of distant tumors. These new studies now show direct regression of established primary tumors after injection with AGI-134, and that this regression is associated with activation of the innate immune system. These compelling pre-clinical data support investigating this approach in a Phase 1/2a study, and we are excited and on track to commence a first-in-man study with this promising novel oncology asset in patients with solid tumors in the first half of 2018."

About AGI-134

AGI-134 is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.