On July 21, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that its partner Bayer AG has reported that a phase 2 clinical study examining anetumab ravtansine as monotherapy in patients with recurrent malignant pleural mesothelioma did not meet the primary endpoint of progression-free survival (Press release, MorphoSys, JUL 21, 2017, View Source [SID1234556342]). Anetumab ravtansine is an antibody-drug conjugate (ADC) directed against mesothelin, comprising an antibody made using MorphoSys’s HuCAL technology. Malignant pleural mesothelioma is a rare cancer and is commonly caused by occupational or environmental exposure to asbestos.

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"The outcome of this phase 2 study with anetumab ravtansine in recurrent malignant pleural mesothelioma is disappointing, in particular for the patients suffering from this serious and extremely difficult to treat disease", said Dr. Markus Enzelberger, Interim Chief Scientific Officer of MorphoSys AG. "Nevertheless, Bayer remains committed to further evaluating the potential of this compound across multiple tumor types with significant unmet medical need. We are proud of our long-standing relationship with Bayer, and we look forward to further updates about the development program with anetumab ravtansine going forward."

The phase 2 clinical trial is a randomized, open-label, active-controlled, multicenter superiority study evaluating the safety and efficacy of anetumab ravtansine as second-line treatment in 248 patients with advanced or metastatic mesothelin-positive malignant pleural mesothelioma whose disease had progressed after treatment with first-line platinum/pemetrexed-based chemotherapy.

Bayer reported further that anetumab ravtansine is currently being investigated, as monotherapy and in combination, in additional studies, including a Phase Ib multi-indication study in six different types of advanced solid tumors, as well as a Phase Ib combination-study in patients with recurrent platinum-resistant ovarian cancer. According to Bayer, based on the available data, Bayer remains committed to further evaluating the utility and safety of anetumab ravtansine across multiple tumor types with significant unmet medical need. Bayer further announced that, in the trial reported, the safety and tolerability of anetumab ravtansine were consistent with earlier clinical findings and that detailed study results are expected to be presented at an upcoming medical meeting.

Further detailed information about mesothelioma and the clinical study can be found in a press release issued by Bayer or at clinicaltrials.gov.

There is no change to MorphoSys’s financial guidance for Fiscal Year 2017.

About anetumab ravtansine
Anetumab ravtansine is an antibody-drug conjugate (ADC) that specifically targets mesothelin, a surface marker protein overexpressed in many cancers. After binding to mesothelin, anetumab ravtansine is taken up inside the tumor cells, where degrading enzymes release cytotoxic DM4, a maytansinoid tubulin inhibitor, which induces cell cycle arrest and apoptosis in dividing cells. Anetumab ravtansine comprises an antibody made using MorphoSys’s HuCAL technology.

On July 20, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that it received notification of acceptance for its lead patent application from the Chinese Patent Office (Press release, Propanc, JUL 20, 2017, View Source [SID1234519834]). The patent application provides broad coverage of a pharmaceutical composition of trypsinogen and chymotrypsinogen to treat certain cancers.

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The acceptance of this key patent application is a first in China, representing yet another significant milestone for the Company, as it progresses its lead product, PRP, towards First-In-Human studies. Given that China accounts for more than 20% of the world’s population, significant growth in this pharmaceutical market is anticipated due to greater healthcare coverage for a rising middle class. The Company is considering filing a divisional application with the Chinese Patent Office to pursue additional claims based off the initial accepted application.

"Acceptance of our first Chinese patent is a significant achievement for our Company, and indicates the strong growth of intellectual property portfolio worldwide," said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. "We continue to advance a number of different patent applications in key regions around the world. This provides a solid foundation for future licensing discussions. By having major regions and territories covered, it means we have greater flexibility selecting strategic partners, either by global reach, or local market penetration."

The Company’s key patent application has now been accepted, or granted, in Australia, Indonesia, Israel, Japan, China, New Zealand, Singapore, South Africa and the US.

The Company’s lead product, PRP, is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.

On July 19, 2017 Spherix Incorporated ("Spherix" or the "Company") (NASDAQ: SPEX), an intellectual property development company committed to fostering of technology and monetization of intellectual property, reported that it has priced a firm commitment underwritten public offering of 1,250,000 shares of its common stock at a price to the public of $2.00 per share (Press release, Spherix, JUL 19, 2017, View Source [SID1234538990]). In addition, Spherix has granted the underwriter a 45-day option to purchase up to 187,500 additional shares of common stock to cover over-allotments, if any. The offering is expected to close on or about July 24, 2017, subject to satisfaction of closing conditions.

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The total gross proceeds of the offering are expected to be approximately $2.5 million. After deducting the underwriter’s discount and other estimated offering expenses payable by Spherix, the net proceeds to the Company are expected to be approximately $2.1 million. These amounts assume no exercise of the underwriter’s over-allotment option.

Laidlaw & Company (UK) Ltd. acted as the sole underwriter for the offering.

The shares are being offered pursuant to a registration statement on Form S-1 (File No. 333-218216) that was declared effective by the Securities and Exchange Commission (SEC) on July 18, 2017. The securities may be offered only by means of a prospectus. A final prospectus supplement related to the offering will be filed with the SEC, and will be available on the SEC’s website at www.sec.gov and may also be obtained from Laidlaw & Company (UK) Ltd., Attention: Syndicate Department, 546 Fifth Avenue, 5th Floor, New York, New York 10036, telephone (212) 953-4900, email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 18, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported the completion of the first site initiation visit at the Dent Neurological Institute ("Dent") for its pivotal Phase 3 Study in Temozolomide-Avastin (bevacizumab) Recurrent GBM ("STAR-3") (Press release, DelMar Pharmaceuticals, JUL 18, 2017, View Source [SID1234519814]). Site initiation visits are generally the final step before patient enrollment.

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The STAR-3 GBM trial is an adaptive design, randomized, controlled pivotal Phase 3 clinical trial to assess the efficacy and safety of VAL-083 versus salvage therapy in patients with late-stage glioblastoma multiforme (GBM) whose disease has progressed following prior treatment with temozolomide and bevacizumab, for whom there is currently no standard-of-care therapy.

The Dent Neurological Institute is the largest private neurology center in North America seeing more than 250,000 patients annually. Dr. Laszlo Mechtler will serve as principal investigator for the STAR-3 trial at Dent. Dr. Mechtler is Medical Director of Dent Neurologic Institute as well as the Chief of Neuro-Oncology at Roswell Park Cancer Institute in Buffalo, NY. He has contributed to numerous publications and is currently the Principle Investigator of multiple clinical research protocols related to Neuro-Oncology. DelMar anticipates the initiation of additional centers and commencement of treatment under the STAR-3 protocol in the coming weeks.

A total of up to 180 eligible patients will be randomized at approximately 25 centers in the United States to receive either the investigational drug (VAL-083) or "investigator’s choice salvage therapy" in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive intravenous VAL-083 at 40 mg/m2 on days 1, 2, and 3 of a 21-day treatment cycle, for up to 12 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation. Up to 60 patients will be randomized to "investigator’s choice" control, limited to temozolomide, lomustine, or carboplatin, until they fulfill one of the criteria for study discontinuation.

The primary endpoint of the trial is overall survival of VAL-083 vs. the control arm. The statistical design between the two arms of the study is 90% power, and is proposed to include an interim analysis at 50% events for futility with O’Brien-Fleming superiority boundary and non-binding, gamma (-5) futility boundary. A detailed description of the STAR-3 trial can be found at clinicaltrials.gov, Identifier Number: NCT03149575.

"The activation of the STAR-3 trial and initiation of recruitment in collaboration with Dr. Mechtler and his team at Dent is a momentous occasion for our Company, and for the patients and their families who we hope will benefit from VAL-083," commented Jeffrey Bacha, chief executive officer of DelMar Pharmaceuticals. "In particular, GBM is a type of cancer that has been devoid of new drug approvals improving overall survival for decades, which is why we believe that VAL-083 represents tremendous value in the oncology treatment market. We are pleased to be launching this pivotal study to validate VAL-083’s potential by meeting the objectives in the STAR-3 trial."

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes.

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details regarding these studies can be found at View Source

The Company’s recent outcomes in Phase 1-2 clinical trials suggested that VAL-083 may offer a clinically meaningful survival benefit for patients with recurrent GBM following treatment with both TMZ and bevacizumab. A well-tolerated dosing regimen of 40mg/m2/day on days 1, 2, and 3 of a 21-day cycle was selected for study in subsequent GBM clinical trials.

DelMar has embarked on human clinical trials for VAL-083 across multiple lines of GBM therapy. These trials include, i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab, improves overall survival, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962); ii) a pivotal, controlled Phase 3 study in temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy (clinicaltrials.gov identifier: NCT03149575); iii) a single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels (clinicaltrials.gov identifier: NCT03050736). The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM.

About Glioblastoma Multiforme (GBM)

Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for O6-methylguanine-DNA-methyltransferase (MGMT); a validated biomarker for TMZ-resistance. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%.

On July 18, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 299 million in the second quarter of 2017 (Press release, Genmab, JUL 18, 2017, View Source [SID1234519819]). Net sales were USD 212 million in the U.S. and USD 87 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.

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States 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 (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe 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. DARZALEX is the first human CD38 monoclonal antibody approved in Europe. For more information, visit www.DARZALEX.com.

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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. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, NKT-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors. 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.