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Nordic Nanovector: Safety Review Committee Approves Advancing to Final Dosing Regimen in Phase 1 Trial of Betalutin® in DLBCL

On April 16, 2019 Nordic Nanovector ASA (OSE: NANO) reported that the Safety Review Committee (SRC) for the ongoing LYMRIT 37-05 clinical trial of single-administration Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for stem cell transplantation (SCT) has now reviewed safety data from the first three cohorts of patients (Press release, Nordic Nanovector, APR 16, 2019, View Source [SID1234553452]). Based on the data, the SRC approved advancing the trial to the next and final cohort with the dose regimen 20 MBq/kg Betalutin and a lilotomab pre-dose of 100 mg/m2.

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The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin. Up to 24 patients are planned to be enrolled in the US and Europe in total. More information on this study can be found at www.clinicaltrials.gov (NCT02658968). Preliminary results are expected in the second half of 2019.

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are pleased to be moving ahead with the final cohort of patients in the study, which will enable the selection of a recommended dose for further evaluation of safety and preliminary efficacy in additional patients."

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by SCT (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed cases of DLBCL in the US and Europe in 2016 was 26,500 and 17,200, respectively. These numbers are expected to reach 31,500 (US) and 19,000 (Europe) by 2024 (ref. 2).

The National Centre for Research and Development Awards Orion Biotechnology With a Grant to Progress Development of a Treatment for Advanced Colorectal Cancer

On April 16 2019 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, reported that its European subsidiary Orion Biotechnology Polska Sp. z.o.o. was awarded a grant of just under two million U.S. dollars by the Polish National Centre for Research and Development (NCBR) (Press release, Orion Biotechnology, APR 16, 2019, View Source [SID1234535183]). The grant will help co-fund a project to advance development of the company’s innovative oncological drug candidate (OB-002O). Pre-clinical evaluation and a Phase 1 clinical trial are planned as part of the project.

OB-002O is a first-in-class chemokine analog drug candidate being testing by Orion Biotechnology for use in the treatment of solid tumors including colorectal cancer (CRC). The active agent in OB-002O is 5P12-RANTES, a CCR5 receptor antagonist, or chemokine analog, being developed by Orion Biotechnology for a range of clinical indications including cancer, neuroinflammation and HIV prevention.

"Our goal for OB-002O is to block the CCL5/CCR5 pathway which plays a critical role in cancer biology in order to inhibit tumor growth and metastasis," explained Ian McGowan, chief medical officer for Orion Biotechnology. "NCBR’s financial support will help us to investigate the potential for OB-002O to treat late-stage cancers, including CRC, for which there is no effective treatment available today."

"OB-002O represents an exciting new class of drugs – chemokine analogues – that falls under the broad and promising category of immunotherapy," said Mark Groper, CEO of Orion Biotechnology. "We are very pleased that the National Centre for Research and Development has demonstrated confidence in our technology and company by providing this sizable investment."

Results of Single Center Prospective Study on Delcath’s PHP Therapy Presented at ECIO 2019

On April 16, 2019 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results from a prospective phase 2 study conducted by Leiden University Medical Center (LUMC) in the Netherlands on the use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with metastatic ocular melanoma with liver metastases were presented at the European Conference on Interventional Oncology (ECIO) annual meeting (Press release, Delcath Systems, APR 16, 2019, View Source [SID1234535164]).

The LUMC study, Percutaneous hepatic perfusion with melphalan in patients with unresectable liver metastases from ocular melanoma using the Delcath System’s second-generation hemofiltration system: a prospective phase II study, was conducted by a team led and presented by Dr. Mark Burgmans. The study evaluated 35 patients with unresectable liver metastases from ocular melanoma treated with CHEMOSAT between February 2014 and June 2017. The 35 patients underwent a total of 72 PHP treatments, and tumor response was evaluable in 32 patients. Primary endpoints were overall response, overall survival, and progression free survival. Secondary measures included safety measures and hematologic toxicity.

Results of the study showed that one patient had a complete response and 22 had partial response, for a combined overall response rate of 74.1%. Overall survival was 20.3 months and mean progression free survival was 8.1 months.

Safety analysis showed a total of 14 serious adverse events were recorded. The hematologic toxicities were in a majority of the cases self-limiting and manageable. Investigators concluded that "PHP Therapy with the Generation Two version of CHEMOSAT is an effective and safe treatment for patients with hepatic metastases from ocular melanoma."

The ECIO 2019 conference was held April 8-11 in Amsterdam, the Netherlands.

ImmunoPrecise to Present at the 2019 Bloom Burton & Co. Healthcare Investor Conference

On April 16, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC PINK: IPATF) reported that Jennifer Bath, President and CEO of ImmunoPrecise Antibodies, will present at the upcoming 2019 Bloom Burton & Co. Healthcare Investor Conference (Press release, ModiQuest Therapeutics, APR 16, 2019, View Source [SID1234535163]).

Date: May 1st, 2019
Time: 2:00 p.m. Eastern Time
Location: Metro Toronto Convention Centre, 255 Front St W, Toronto, Ontario

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

Investors interested in arranging a meeting with Dr. Bath during this conference should contact ImmunoPrecise or Bloom Burton & Co.’s conference coordinator.

About Bloom Burton & Co.

Bloom Burton & Co. (Bloom Burton Securities Inc.) is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies. Bloom Burton has an experienced team of medical, scientific, pharmaceutical, legal and capital markets professionals who perform a deep level of diligence, which combined with our creative and entrepreneurial approach, assists our clients in achieving the right monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, advisory on direct investing and company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF)

Rexahn and BioSense Global Announce Collaboration and License Agreement for RX-3117 in Greater China

On April 16, 2019 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage, biopharmaceutical company focused on oncology, and BioSense Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical company, reported a collaboration and license agreement to advance the development and commercialization of RX-3117 for pancreatic cancer and other cancers in Greater China (Press release, Rexahn, APR 16, 2019, View Source [SID1234535162]).

Under the agreement, Rexahn will grant BioSense an exclusive license to develop and commercialize RX-3117 in Greater China. Rexahn will receive an upfront payment and will be eligible to receive additional development, regulatory and commercial milestones up to a total of $226 million contingent on achieving regulatory and commercial goals related to pancreatic cancer and additional indications. Rexahn will also be eligible to receive tiered royalties in the low double digits to mid teens on annual net sales in the territory. The companies will collaborate to develop RX-3117 for pancreatic cancer and other indications. BioSense will fund all activities related to the development and commercialization of RX-3117 in Greater China and will initiate a Phase 2 study to evaluate the drug candidate in up to three additional indications not previously studied by Rexahn.

"Rexahn is focused on developing novel therapies for people with difficult-to-treat cancers. This partnership will enable us to extend the development of RX-3117 to patients in Greater China and also to evaluate RX-3117 in additional indications in collaboration with BioSense," said Douglas Swirsky, President and CEO of Rexahn. "We are excited to work with the experienced regulatory and development team at BioSense to advance the development of RX-3117 towards regulatory approval in Greater China."

Andy Li, PhD, President and CEO of BioSense Global, added, "We are delighted to partner with Rexahn to develop RX-3117 for the Greater China markets. Cancer is the leading cause of death in China with over four million new diagnoses and almost three million deaths per year. Prognosis is poor for certain cancers and treatment options are limited. Despite the significant success of immunotherapy, chemotherapy will remain a critical component of treatment regimens for many cancers. With its unique tumor-targeting mechanism, we believe RX-3117 could become a safer, more efficacious yet affordable treatment option to patients and doctors. We are excited to advance the development of RX-3117 for cancers that are especially prevalent among Chinese patients."

Additional information on the collaboration and license agreement can be found in the Current Report on Form 8-K being filed by Rexahn today with the Securities and Exchange Commission.

About RX-3117

RX-3117 is a novel, investigational, oral, small molecule nucleoside compound. Once intracellularly activated (phosphorylated) by UCK2, it is incorporated into the DNA or RNA of cells and inhibits both DNA and RNA synthesis, which induces apoptotic death of tumor cells. Due to the high level of over expression of UCK2 in cancer cells, RX-3117 offers the potential for a targeted anti-cancer therapy with an improved efficacy and safety profile. RX-3117 is currently being studied in a Phase 2a clinical trial in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) in first line metastatic pancreatic cancer patients and a Phase 2a clinical trial in patients with advanced or metastatic bladder cancer. It has received Orphan Drug designation for the treatment of pancreatic cancer. Additional information on RX-3117 can be found at: View Source

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.