On July 21, 2017 Syros Pharmaceuticals (NASDAQ: SYRS) reported that data providing the foundation of its clinical development strategy for SY-1425, its first-in-class selective retinoic acid receptor alpha (RARα) agonist currently in a Phase 2 clinical trial in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), were published online in Cancer Discovery, a peer-reviewed journal of the American Association of Cancer Research. Syros is on track to present initial data from the Phase 2 clinical trial this fall (Press release, Syros Pharmaceuticals, JUL 21, 2017, View Source [SID1234519876]).

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The publication highlights Syros’ discovery of a subset of AML patients with a super-enhancer associated with the RARA gene, which was shown in preclinical studies to be predictive of response to SY-1425. Syros also found a subset of MDS patients with high expression of the RARA gene and demonstrated in ex vivo studies that RARA-high MDS had a similar response to SY-1425 as that seen in AML driven by the RARA super-enhancer.

"The publication of our work in Cancer Discovery is a demonstration of our pioneering approach for analyzing non-coding regulatory regions of the genome to identify disease-driving genes with the goal of developing new medicines that make a meaningful difference for patients," said Eric Olson, Ph.D., Chief Scientific Officer of Syros. "Although genetic mutations associated with AML and MDS in protein-coding regions of the genome are well known, there are limited targeted therapy options in these diseases and there remains a high unmet need. Our investigation of the regulatory genome adds a new dimension to the understanding of AML and MDS disease biology that offers the potential to address these underserved patient populations and improve their prognosis and treatment."

In collaboration with the Majeti lab at Stanford University School of Medicine, Syros used its gene control platform to analyze 66 AML patients’ tumor samples and identified six distinct patient subsets based on super-enhancer profiles, including one enriched for a super-enhancer associated with the RARA gene. The data show that:

· Super-enhancer profiles were strongly associated with survival outcomes, often independent of known genetic mutations in AML.

· The RARA super-enhancer was associated with high expression of the RARA gene, which codes for a transcription factor targeted by SY-1425.

· The RARA super-enhancer was predictive of response to SY-1425. In AML cells with high RARA expression, SY-1425 reduced proliferation and promoted differentiation. Moreover, SY-1425 decreased tumor burden and prolonged survival in patient-derived xenograft (PDX) models of AML with high RARA expression, while no effect was found on AML cells or PDX models with low RARA expression. Notably, ATRA, a less potent and non-selective retinoid, produced no survival benefit in PDX models with high RARA expression.

· SY-1425 induced profound transcriptional changes promoting cell differentiation in AML cells with high RARA expression but little to no transcriptional changes in AML cells with low RARA expression.

· DHRS3 was the most strongly and rapidly induced gene in response to treatment with SY-1425, leading to the identification of DHRS3 induction as a pharmacodynamic marker for use in the ongoing Phase 2 clinical trial as an early indicator of whether SY-1425 is affecting the targeted biology in defined subsets of AML and MDS patients.

· SY-1425 induced transcriptional and epigenomic changes in AML cells with high RARA expression similar to those seen in acute promyelocytic leukemia (APL) cells treated with SY-1425. SY-1425 is approved in Japan as Amnolake (tamibarotene) to treat relapsed or refractory APL, a form of AML that is driven by fusions of the RARA gene, and has a well-established safety and efficacy profile in those patients.

The Phase 2 clinical trial of SY-1425 is assessing the safety and efficacy of SY-1425 as a single agent in four AML and MDS patient populations, as well as in combination with azacitidine, a standard-of-care therapy, in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy. All patients in the trial are prospectively selected using biomarkers for high expression of RARA or IRF8, which are genes associated with the RARA pathway. Additional details about the trial can be found using the identifier NCT02807558 at www.clinicaltrials.gov

LIDDS has entered into a research agreement with Ferring Pharmaceuticals which has an exclusive option right to leverage the NanoZolid technology for the development of an injectable, controlled-release formulation for cancer treatment (Press release, Lidds, JUL 21, 2017, View Source [SID1234555959]).

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Under the terms of the agreement, LIDDS will conduct feasibility studies fully funded by the other party. Upon completion of the development work, the right to exercise its option and enter into an exclusive agreement with LIDDS to further develop the novel formulation based on NanoZolid.

– LIDDS is committed to provide the NanoZolid technology to enhance the performance of drugs by either reducing its side effects or facilitate longer acting pharmaceuticals to improve compliance and quality of life for patients. We are very pleased with the new agreement which adds another exciting project that does not compete with LIDDS own development portfolio, says Monica Wallter, CEO of LIDDS.

LIDDS has several ongoing development projects in oncology. The prostate cancer project is currently in Phase IIb and there are several promising preclinical projects where NanoZolid is combined with cytotoxic drugs and with immuno active substances such as antibodies.

On July 21, 2017 Bayer reported that a Phase II clinical trial evaluating its investigational oncology compound anetumab ravtansine (BAY 949343) as a monotherapy in patients with recurrent malignant pleural mesothelioma (MPM), who were previously treated, did not meet its primary endpoint of progression-free survival (Press release, Bayer, JUL 21, 2017, View Source [SID1234519851]). The safety and tolerability of anetumab ravtansine were consistent with earlier clinical findings. Detailed study results are expected to be presented at an upcoming medical meeting.

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"Malignant pleural mesothelioma is a very difficult-to-treat tumor, and we had hoped for a better outcome for patients," said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer. "We would like to thank the patients and their caregivers, as well as the study investigators for their participation and contributions in this study. Based on the available data, we remain committed to further evaluating the utility and safety of anetumab ravtansine across multiple tumor types with significant unmet medical need."

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.

About the Phase II Study
The phase II clinical trial (NCT02610140) is a randomized, open-label, active-controlled, multicenter superiority study investigating anetumab ravtansine as second line treatment in patients with advanced or metastatic mesothelin-positive malignant pleural mesothelioma (MPM), whose disease had progressed after treatment with first-line platinum/pemetrexed-based chemotherapy. The trial randomized 248 patients in a 2:1 ratio to receive either anetumab ravtansine (6.5 mg/kg intravenously every three weeks) or vinorelbine (30 mg/m2 intravenously every week).

The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, as well as other indicators of efficacy, such as patient-reported outcomes, objective tumor response rate, duration of response, disease control rate, and durable response rate. Safety and tolerability of patients were also continuously monitored.

About Mesothelioma
Malignant pleural mesothelioma (MPM) is a rare and deadly cancer affecting more than 25,000 people globally, with about 3,000 new cases being diagnosed in the US and more than 12,000 in Europe each year. It is commonly caused by occupational or environmental exposure to asbestos. The majority of patients with MPM are not diagnosed until the disease has progressed to an advanced stage, with the onset of the disease in many cases occurring 20 to 40 years after exposure. Due to its aggressive nature, the estimated median overall survival is approximately one year from diagnosis. Rapid deterioration and poor survival are hallmarks of MPM. In first line therapy, cisplatin/pemetrexed has become the standard of care but nearly all MPM-patients progress during or after first-line treatment. In the second-line setting, the lack of an accepted standard of care treatment underscores the substantial unmet need in the treatment of MPM.

About Anetumab Ravtansine (BAY 949343)
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.

In a Phase I clinical trial in patients with advanced solid tumors, anetumab ravtansine demonstrated promising efficacy with durable responses in patients with malignant pleural mesothelioma (MPM), and a manageable safety profile. In addition to the Phase II clinical trial in MPM, anetumab ravtansine is currently being investigated in a variety of other mesothelin-positive tumors, including a Phase Ib multi-indication study in six different types of advanced solid tumors (NCT03102320), as well as a Phase Ib combination-study in patients with recurrent platinum-resistent ovarian cancer (NCT02751918).

Anetumab ravtansine is a compound developed by Bayer. In the development, the following collaborators were involved: The antibody was derived from the HuCAL technology platform of MorphoSys AG. In a 2008 license agreement with ImmunoGen, Inc., Bayer was granted exclusive rights for using their maytansinoid ADC technology to develop anti-tumor therapies targeting mesothelin. Both partners are entitled to milestone payments and royalties on commercial sales, if any.

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.