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 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.