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Mateon Therapeutics Reports Third Quarter 2018 Financial Results

On November 14, 2018 Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported third quarter 2018 financial results (Press release, Mateon Therapeutics, NOV 14, 2018, View Source [SID1234531307]).

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For the three months ended September 30, 2018, Mateon reported a net loss of $0.7 million, compared to a net loss of $3.5 million reported for the three months ended September 30, 2017. As of September 30, 2018, Mateon had cash of $1.1 million.

"We are inching closer to finalizing our regulatory submission for a new clinical phase 2a study of CA4P combined with the checkpoint inhibitor anti-PD1 in patients with advanced melanoma. I believe that our scientific approach for increasing the anti-tumor immunity of checkpoint inhibitors by inducing ischemic necrosis of tumor cells with CA4P is as good as any of the other checkpoint inhibitor approaches, although it is certainly less well-recognized," stated William D. Schwieterman, M.D., Chief Executive Officer of Mateon Therapeutics. "In addition, we are continuing to screen patients for enrollment into our study of OXi4503 for relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. Our target is a total of approximately ten patients at the 9.76 mg/m2 dose currently being evaluated."

Seattle Genetics Initiates Phase 1 Clinical Trial of SEA-BCMA for Patients with Relapsed or Refractory Multiple Myeloma

On November 14, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reported dosing of the first patient in a phase 1 clinical trial evaluating the safety and tolerability of SEA-BCMA for patients with relapsed or refractory multiple myeloma (MM) (Press release, Seattle Genetics, NOV 14, 2018, View Source [SID1234531306]). SEA-BCMA is an investigational antibody empowered using Seattle Genetics’ proprietary Sugar Engineered Antibody (SEA) technology designed to enhance antibody dependent cellular cytotoxicity. The target of SEA-BCMA, the cell surface protein B-cell maturation antigen (BCMA), is broadly expressed on malignant plasma cells in multiple myeloma. SEA-BCMA has demonstrated encouraging antitumor activity in preclinical studies.

"Despite recent advances in the treatment of multiple myeloma, it remains an incurable disease with a need for active and well-tolerated agents," said Roger D. Dansey, M.D., Chief Medical Officer of Seattle Genetics. "BCMA is a validated therapeutic target for multiple myeloma. SEA-BCMA represents a novel empowered antibody treatment approach that has demonstrated antitumor activity and an acceptable safety profile in preclinical evaluation to date. We look forward to evaluating SEA-BCMA through our clinical development program and hope to meaningfully improve outcomes for multiple myeloma patients."

The phase 1 trial is an open-label, multi-center, dose-escalation and expansion clinical study designed to enroll approximately 65 patients with relapsed or refractory MM in the United States. The study is expected to be conducted in two parts, with a dose escalation cohort to evaluate safety and tolerability and to determine the maximum tolerated dose of SEA-BCMA, followed by an expansion cohort to obtain further data regarding safety and antitumor activity.

Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 demonstrate that SEA-BCMA exhibits encouraging preclinical antitumor activity and has the potential to be an active, tolerable and combinable agent.

For more information about the phase 1 study of SEA-BCMA for patients with multiple myeloma and enrolling centers, please visit www.clinicaltrials.gov (Identifier: NCT03582033).

About Multiple Myeloma

Multiple myeloma (MM) is an aggressive cancer that forms in white blood cells called plasma cells. Cancerous plasma cells can crowd out healthy blood cells, impair bone strength and weaken the immune system. MM is the second most common blood cancer in the United States. According to the American Cancer Society, more than 30,000 new cases of MM were expected in the U.S. in 2018, with over 12,500 deaths. Despite recent medical advances, MM still remains an incurable disease. It is managed with sequential lines of treatment that typically yield shorter durations of disease control with each subsequent relapse, and some patients receive more than four lines of treatment over the course of their disease.

About SEA-BCMA

SEA-BCMA is a novel investigational antibody empowered using Seattle Genetics’ proprietary Sugar Engineered Antibody (SEA) technology that leads to enhanced antibody dependent cellular cytotoxicity. SEA-BCMA is a non-fucosylated BCMA-directed antibody that is designed to block proliferative tumor cell signaling, mediate antibody dependent cellular phagocytosis and induce enhanced cell lysis through antibody dependent cellular cytotoxicity. The cell surface protein BCMA is expressed on cells of several cancer types, including multiple myeloma and other B-cell malignancies. BCMA is a validated therapeutic target for multiple myeloma.

Trillium Therapeutics Reports Third Quarter 2018 Financial and Operating Results

On November 14, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the nine months ended September 30, 2018 (Press release, Trillium Therapeutics, NOV 14, 2018, View Source [SID1234531305]).

2018 Third Quarter Highlights:

Presented an update at the European Organisation for Research and Treatment of Cancer, Cutaneous Lymphoma Task Force (EORTC CLTF) meeting on the safety and efficacy of the ongoing multicenter, open-label phase 1 intratumoral trial of TTI-621 in 23 patients with relapsed/refractory mycosis fungoides/Sézary syndrome, 20 of whom only received induction therapy consisting of 1-6 injections over 2 weeks. Local delivery of TTI-621 was well tolerated, with no treatment-related > Grade 3 adverse events or dose-limiting toxicity observed. Reductions in CAILS scores, which measure local lesion responses, were observed in 89% of patients, with 44% exhibiting reductions of 50% or greater. These responses occurred rapidly within the 2-week induction period. Similar CAILS scores changes were seen in adjacent non-injected lesions, suggesting locoregional effects that were not confined to the site of injection. Evidence of a systemic effect was observed in 1 of 2 patients receiving continuation monotherapy beyond the 2-week induction therapy. In addition, data suggest a combination effect with pegylated IFN-alpha-2a.

Presented an update at the Discovery on Target conference on the safety and efficacy of the ongoing multicenter, open-label phase 1a/b intravenous trial of TTI-621 in patients with relapsed/refractory hematologic malignancies. Based on an expanded data set of 163 patients, weekly infusions of TTI-621 were shown to be well tolerated. Thrombocytopenia was the most frequent grade 3 or higher treatment-emergent adverse event, occurring in 20% of patients. Platelet reductions, however, were shown to be transient and pre-dose platelet levels remained steady during the course of the study. Notably, the reversible thrombocytopenia did not lead to an increased risk of bleeding and had no impact on drug delivery, nor was there a significant impact of TTI-621 on hemoglobin levels. Monotherapy efficacy was observed in patients with mycosis fungoides (19% ORR, n=21), peripheral T-cell lymphoma, or PTCL (25% ORR, n=12), and diffuse large B-cell lymphoma, or DLBCL (25% ORR, n=8), and in DLBCL patients when combined with rituximab (25% ORR, n=24). This clinical activity was observed in patients receiving relatively low doses of drug (0.2 mg/kg for monotherapy or 0.1 mg/kg in combination with rituximab). Dose intensification beyond 0.2 mg/kg is currently ongoing, and doses of 0.5 mg/kg have been well tolerated for up to 27 weeks.
"The growing body of data from the TTI-621 intratumoral trial in patients with CTCL continues to look encouraging, and we believe that there are several potential paths forward in this indication, and possibly in other accessible tumors," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "Additionally, data from over 160 patients in our intravenous trial indicate that systemically delivered TTI-621 has single-agent and combination activity at relatively low doses, and ongoing efforts to dose intensify appear encouraging. We believe that flexibility is the best way to address this new IO pathway, and having two development candidates in the clinic, and options of intravenous and intratumoral delivery, as monotherapy or in combination, gives Trillium the most comprehensive approach to targeting CD47."

Third Quarter 2018 Financial Results:

As of September 30, 2018, Trillium had cash and cash equivalents and marketable securities, and working capital, of $52.1 million and $41.8 million, respectively, compared to $81.8 million and $68.9 million, respectively, at December 31, 2017. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in operations of $30.8 million, net of an unrealized foreign exchange gain of $1.3 million. The decrease in working capital was due mainly to cash used in operations, increases to amounts receivable and prepaid expenses, and a decrease to accounts payable and accrued liabilities due to clinical trial payments.

Net loss for the nine months ended September 30, 2018 of $33.9 million was lower than the loss of $34.4 million for the nine months ended September 30, 2017. The net loss was lower mainly due to a net foreign currency gain of $1.5 million for the nine months ended September 30, 2018, compared to a net foreign currency loss of $4.9 million in the prior year period, and lower manufacturing costs, partially offset by higher clinical trial expenses and the expense relating to the amendment of the SIRPaFc license agreement.

DelMar Pharmaceuticals Announces First Quarter Fiscal Year 2019 Financial Results

On November 14, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the first quarter ended September 30, 2018 (Press release, DelMar Pharmaceuticals, NOV 14, 2018, View Source [SID1234531304]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on November 20, 2018 at 4:30 p.m. Eastern Time.

"During the quarter, we continued to focus on advancing our Phase 2 clinical trials for MGMT-unmethylated GBM patients at the MD Anderson Cancer Center in Houston, Texas, and at Sun Yat-sen University Cancer Center in Guangzhou, China where we have seen accelerated enrollment in both studies," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "Furthermore, we launched an initiative with Oppenheimer & Co. Inc. to explore and evaluate strategic opportunities to facilitate shareholder value generation."

RECENT HIGHLIGHTS

Continued enrolling patients in Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme ("GBM") study being conducted at the MD Anderson Cancer Center (the "MDACC study").
As of October 31, 2018, forty-four patients have been enrolled in the MDACC study, which continues the accelerated enrollment rates observed since spring, 2018
The dosing levels used in the MDACC study have continued to demonstrate a safety profile well within the existing safety monitoring guidelines described in the present study protocol
Similar to prior clinical experience, myelosuppression has been the most common adverse event observed

Continued enrolling patients in Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen University Cancer Center.
As of October 31, 2018, ten patients have been enrolled in this study
Observed increased enrollment rates in the recent quarter

At the annual meeting of the Society for Neuro-Oncology being held from November 15 to 18, 2018, the Company will provide clinical trial updates on both of its Phase 2 studies in MGMT-unmethylated GBM patients. In addition, updated preclinical data on VAL-083 in combination with Avastin, and VAL-083 as a potential treatment of pediatric diffuse intrinsic pontine glioma ("DIPG") will be presented.
Based on overall clinical and corporate development progress achieved to date, we expect to have cash available to fund planned operations into the middle of calendar 2019
For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s Form 10-K filed with the SEC on September 24, 2018, as well as the Company’s Quarterly Report on Form 10-Q for the three month ended September 30, 2018 filed with the SEC on November 13, 2018: View Source

CONFERENCE CALL DETAILS

DelMar will host a conference call to discuss its financial results for quarter ended September 30, 2018 and provide a corporate update on November 20, 2018, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1-877‑876‑9174 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2018

At September 30, 2018, the Company had combined cash and cash equivalents and clinical trial deposits on hand of approximately $4.6 million.

For the quarter ended September 30, 2018, the Company reported a net loss of $1,991,804 or $0.09 per share, compared to a net loss of $2,666,406, or $0.18 per share, for the quarter ended September 30, 2017.

The following represents selected financial information as of September 30, 2018. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis, as filed.

RedHill Biopharma Announces Presentation on YELIVA® (opaganib) for Multiple Myeloma at EORTC-NCI-AACR Symposium

On November 14, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases and cancer, reported a poster presentation on YELIVA (opaganib, ABC294640)1 for multiple myeloma at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium2 on Molecular Targets and Cancer Therapeutics, on Friday, November 16th in Dublin (Press release, RedHill Biopharma, NOV 14, 2018, View Source [SID1234531300]).

The abstract3 (poster board number PB-045), which will be presented by Yubin Kang, MD, of Duke Health, is entitled "Sphingosine kinase 2 (SK2) targeting in the treatment of multiple myeloma: preclinical and phase I studies of opaganib, an SK 2 inhibitor, in multiple myeloma". The abstract describes data from preclinical studies and a Phase Ib/II study conducted by Dr. Kang with YELIVA for the treatment of multiple myeloma.

The open-label, dose escalation Phase Ib/II study evaluating YELIVA in patients with refractory or relapsed multiple myeloma that were previously treated with proteasome inhibitors and immunomodulatory drugs is ongoing at Duke University Medical Center. Enrollment for the Phase Ib portion of the study has been completed with a total of 11 patients enrolled and treated in three dose cohorts. Results from the Phase Ib portion of the study did not show any dose-limiting toxicities. Additionally, while efficacy was not the primary endpoint of the Phase I study, it was observed that out of 10 evaluable subjects, two subjects had stable disease for over four months and one patient achieved a very good partial response (VGPR).
In addition, results from preclinical studies demonstrated that SK2 is overexpressed in multiple myeloma cell lines and in human multiple myeloma specimens and plays a critical role in myeloma cell growth, proliferation and survival. Additional preclinical studies described in the abstract demonstrated that treatment with YELIVA effectively inhibited myeloma tumor growth in vitro and in vivo in mouse xenograft models. The authors conclude that YELIVA as a single agent or in combination with a B-cell lymphoma 2 (Bcl-2) inhibitor has the potential for treatment of relapsed/refractory multiple myeloma patients that were previously treated with proteosome inhibitors and immunomodulatory agents.

The Phase Ib/II study with YELIVA for multiple myeloma is supported by a $2 million grant from the National Cancer Institute (NCI) Small Business Innovation Research Program (SBIR) awarded to Apogee Biotechnology Corp., in conjunction with Duke University, with additional support provided by RedHill.

Dr. Yubin Kang, MD, associate professor in the division of hematologic malignancies and cellular therapy in the department of medicine at Duke University School of Medicine, is the lead investigator for the Phase Ib/II study with YELIVA for multiple myeloma, as well as the head of the laboratory performing the preclinical studies.

YELIVA is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor being developed by RedHill and targeting multiple oncology, inflammatory and gastrointestinal indications. A single-arm Phase IIa study evaluating the activity of YELIVA as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma is being conducted at renowned clinical institutions in the U.S.

About YELIVA (opaganib, ABC294640):
YELIVA (opaganib, ABC294640), a new chemical entity, is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI and radioprotection models, as well as a Phase I clinical study in cancer patients with advanced solid tumors. YELIVA received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute.

The ongoing studies with YELIVA (opaganib, ABC294640) for cholangiocarcinoma, multiple myeloma and advanced hepatocellular carcinoma (HCC) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.