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.

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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."

On April 16, 2019 BioAtla , LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics for the oncology market, reported that Himalaya Therapeutics SEZC, a Cayman Island corporation and majority owned subsidiary of BioAtla, has the exclusive license from BioAtla to develop and commercialize several specific, differentiated product candidates for the Greater China market of the PRC, Hong Kong, Macau and Taiwan (Press release, BioAtla, APR 16, 2019, View Source [SID1234621324]). The Himalaya Therapeutics portfolio includes two CAB candidates, CAB-AXL-ADC and CAB-ROR2-ADC, each currently in Phase 1/2 clinical trials conducted by BioAtla at sites in the United States. In addition, Himalaya Therapeutics will participate in BioAtla’s potential Greater China derived returns from the recently announced BioAtla and BeiGene, Ltd. global co-development and collaboration agreement for the development, manufacture and commercialization of CAB-CTLA-4 (BA3071). Himalaya will also support BioAtla’s global clinical trials effort in Greater China.

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"We believe that Himalaya’s product development and business related activities directly addressing Greater China will maximize the strategic opportunities for both BioAtla and Himalaya in the world’s second largest pharmaceutical market," stated Carolyn Short, General Manager of Himalaya Therapeutics. "The access to clinical development capabilities in China can accelerate the global development and potential commercialization of the BioAtla product portfolio and effectively address markets with strong growth potential and high unmet medical need," added Scott Smith, President of BioAtla.

Recent sweeping changes to the China regulatory processes for the development of pharmaceutical products now closely align them with those in the United States and broadens the use of clinical data for regulatory purposes between the two nations. Consequently, close coordination of clinical development in the U.S. and China of a pharmaceutical candidate is highly desireable and more efficient. Furthermore, the access to capital markets for early-stage biotechnology companies in China has recently been greatly enhanced especially with the revision to the stock listing requirements on the Hong Kong Stock Exchange. Himalaya Therapeutics is expected to fund its operations independent from BioAtla. These were primary motivating factors for Beijing Sinobioway Group Company and its related investor groups to contribute all of their rights to certain and any future CAB candidates that were part of their 2015 collaboration agreement with BioAtla in exchange for a minority equity position in Himalaya Therapeutics.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

On April 16, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 629 million in the first quarter of 2019 (Press release, Genmab, APR 16, 2019, View Source [SID1234535147]). Net sales were USD 352 million in the U.S. and USD 277 million in the rest of the world. Genmab will receive 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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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.1 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).1,2,3,4,5

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 16, 2019 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that Axumin (fluciclovine (18F)) has recently been added to the European Association of Urology (EAU) 2019 Clinical Practice Guidelines in Oncology for Prostate Cancer (PCa) (Press release, Blue Earth Diagnostics, APR 16, 2019, View Source [SID1234535148]). The EAU PCa Guidelines assist clinicians in making informed decisions, taking into consideration the scientific data available and individual circumstances of patients. These updated EAU PCa Guidelines state that "18F – Fluciclovine has been approved in the US and Europe, and therefore is currently the only PCa-specific radiotracer widely commercially available."

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Axumin is the first and only novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize recurrent prostate cancer. Axumin is commercially available in Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics said "We are delighted that Axumin has been included in the EAU Guidelines as it is an important recognition of the clinical value of our product. Inclusion in these guidelines can help facilitate increased access, in concurrence with our commitment to maximize access to Axumin to patients and clinicians in Europe."

Prostate cancer is a leading cause of cancer death in men in Europe, with around 450,000 new cases diagnosed each year1.

The European Association of Urology (EAU) is the leading authority within Europe on urological practice, research and education, with a mission to raise the level of urological care throughout Europe and beyond.

On April 16, 2019 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host its annual Science Day for analysts and investors on Tuesday, May 7, 2019 at 8:00 a.m. ET in Cambridge, MA (Press release, Moderna Therapeutics, APR 16, 2019, View Source [SID1234535149]).Moderna also announced that it will report its first quarter 2019 financial results before the market opens on Wednesday, May 8, 2019 and, subsequently, host a conference call to discuss these results and provide a corporate update.

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Science Day:

Moderna’s Science Day will feature presentations from Stephen Hoge M.D., president and Melissa Moore Ph.D., chief scientific officer of Moderna’s mRNA Research Platform with a focus on the Company’s newest advances from its commitment to basic and applied sciences. Moderna will also host a tour of the Norwood manufacturing facility in the afternoon.

First Quarter 2019 Financial Results:

Moderna’s first quarter 2019 financial results and corporate update conference call will begin at 8:00 a.m. ET on May 8, 2019. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international), and refer to conference ID 8273939.

Both events will be webcast live under "Events & Presentations" in the Investors section of the Moderna website at View Source The archived webcasts will be available on Moderna’s website approximately two hours after each event and will be available for 30 days following the events.