On January 29, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the publication of previously released interim clinical data in the February 2020 issue of peer-reviewed journal, Glioma (Press release, DelMar Pharmaceuticals, JAN 29, 2020, View Source [SID1234553645]). The article highlights results from the first 22 patients of the Company’s ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM). The article can be accessed online via View Source;year=2019;volume=2;issue=4;spage=167;epage=173;aulast=Guo.

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In the article, which was co-authored by lead investigator Professor Zhong-ping Chen of Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, where the study is currently being conducted, of the 22 patients who had completed at least one cycle of treatment as of that date, median progression-free survival (PFS) with VAL-083 as reported was 9.9 months (confidence interval, or CI, 7.3-12.0 months). For the 18 patients initially receiving the intended treatment dose (30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median PFS as reported was 10.4 months (CI 6.0-12.0 months). While this is not a head-to-head trial, historically, temozolomide (TMZ) has been demonstrated to have 6.9 months PFS in unmethylated GBM patients.

"This publication represents an important additional validation of VAL-083 as a first-line treatment. Given that an external panel of experts reviewed both the protocol and the interim data and were willing to publish based on the results and inclusive of the fact that the data came from a study originating in China. This publication is from a world-renowned journal and we believe it demonstrates the potential to achieve one of the first new treatments for GBM in many years. We look forward to providing continued updates on the development of VAL-083 as they become available," commented Saiid Zarrabian, DelMar’s Chief Executive Officer.

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. In the publication, authors outlined the two parts of the study. The first is a dose escalation and induction format to enroll up to ten patients to receive VAL-083 at 20, 30 or 40 mg/m2/day for three days every 21 days concurrently with standard radiation and VAL-083 for up to eight additional cycles. The second part of the study is an expansion phase to enroll up to 20 additional patients. The publication highlighted the first 23 patients enrolled, 14 of whom had been treated in the expansion phase.

Myelosuppression was the most common adverse event in the patients assessed, and pharmacokinetic assessments indicated that the levels of VAL-083 were as high in the cerebrospinal fluid as in plasma two hours after infusion.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand 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 and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies.

On January 29, 2020 Cerus Corporation (Nasdaq: CERS) reported the pricing of a registered underwritten public offering of its common stock for proceeds of approximately $55.0 million, before deducting estimated offering expenses payable by Cerus (Press release, Cerus, JAN 29, 2020, View Source [SID1234553644]). The offering is expected to close January 31, 2020, subject to customary closing conditions. All of the shares sold in the offering were sold by Cerus. In addition, Cerus has granted the underwriter a 30-day option to purchase up to an additional $8.25 million of shares of its common stock. On January 28, 2020, the last sale price of the shares as reported on The Nasdaq Global Market was $4.15 per share.

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BTIG, LLC is acting as sole book-running manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-219727) relating to the shares of common stock described above was previously filed by Cerus with the Securities and Exchange Commission ("SEC") and declared effective on January 8, 2018. This offering is being made solely by means of a prospectus supplement and accompanying prospectus included in the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Alternatively, copies of the final prospectus supplement, when available, and the accompanying prospectus may be obtained by contacting BTIG, LLC at 65 East 55th Street, New York, NY, 10022, by email at [email protected] or by telephone at (212) 593-7555.

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

On January 29, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 41,279,090 common shares of the Company and 1,250,000 Series II Non-Voting Convertible First Preferred Shares of the Company (the "Offering") (Press release, Trillium Therapeutics, JAN 29, 2020, View Source [SID1234553642]). The common shares and preferred shares were sold at a public offering price of US$2.75 per share. The number of shares sold includes the full exercise by the underwriters of their option to purchase up to an additional 5,547,272 common shares.

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The gross proceeds from the Offering were approximately US$116,955,000, before deducting underwriting commissions and other offering expenses. The Company intends to use the net proceeds of the Offering towards: 1) the clinical development of its CD47 programs; and 2) research, manufacturing and regulatory activities, and working capital and general corporate purposes.

Key investors in the Offering included the Company’s existing significant shareholder New Enterprise Associates, as well as new investors Boxer Capital, Logos Capital, Vivo Capital, and Venrock Healthcare Capital Partners, among others.

"Trillium’s mission is to redefine the oncology treatment paradigm by developing and delivering to patients next-generation immunotherapies. We believe we have two potentially best-in-class CD47 molecules, a clear strategy targeting hematologic malignancies with great unmet medical needs, and now also funding from the top healthcare investors in this country to pursue that mission," said Dr. Jan Skvarka, Trillium’s President and Chief Executive Officer.

Cowen acted as the sole book-running manager for the Offering. Bloom Burton Securities Inc. acted as co-manager for the Offering.

On January 29, 2020 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the company will host a key opinion leader (KOL) event on Wednesday, February 5th, 2020 in New York City (Press release, Aptose Biosciences, JAN 29, 2020, View Source [SID1234553641]). In addition, William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, Gregory K. Chow, Executive Vice President and Chief Financial Officer and Jotin Marango, M.D., Ph.D, Senior Vice President and Chief Business Officer, will present at the upcoming BIO CEO & Investor Conference on Monday, February 10th, 2020 in New York City.

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Presentation Details:

·KOL Symposium on CG-806 FLT3/BTK Inhibitor for Acute Myeloid Leukemia
Date: Wednesday, February 5, 2020
Time: 12:00 PM – 1:30 PM
Location: Lotte New York Palace
Webcast: LINK
The luncheon symposium will feature renowned hematology leaders including Brian J. Druker, M.D., Eytan M. Stein, M.D. and Aaron Goldberg, M.D., Ph.D. Dr. Druker is Professor of Medicine, Division of Hematology/Medical Oncology; Director, Knight Cancer Institute, Oregon Health & Science University and Chair of the Aptose Scientific Advisory Board; Eytan M. Stein, M.D. is a Hematologic Oncologist, Assistant Professor on the Leukemia Service at Memorial Sloan Kettering Cancer Center (MSKCC); and Aaron Goldberg, M.D., Ph.D. is a Hematologic Oncologist, Assistant Attending Physician, Leukemia Service, MSKCC. The hematology experts will review the treatment landscape and the evolution of kinase inhibitors as anticancer drugs in myeloid leukemias, particularly acute myeloid leukemia (AML), and highlight the potential for the mutation-agnostic FLT3/BTK inhibitor CG-806 to address unmet medical needs in these patient populations.

Additionally, Rafael Bejar M.D., Ph.D., Aptose’s Chief Medical Officer, will serve as moderator and provide an overview of the rationale and strategy for the development of CG-806 in myeloid malignancies. CG-806 is currently in an ongoing Phase 1a/b clinical trial for the treatment of patients with relapsed / refractory B-cell malignancies, including CLL and NHL, and in 1H / 2020 is planned to enter a separate clinical trial in patients with relapsed / refractory AML and high-risk MDS.

·BIO CEO & Investor Conference
Date: Monday, February 10, 2020
Time: 1:15 PM EST
Location: Presentation Room Odets, New York Marriott Marquis
Webcast: LINK
The Company also will be hosting institutional investor and partnering meetings at the conference that can be requested through BIO One-on-One Partnering.

On January 29, 2020 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on developing curative cell therapies for cancer, reported it has completed Cohort 1 enrollment with no dose-limiting toxiticies (DLT) observed in the ATTCK-34-01 Phase 1 trial evaluating Unum’s novel Antibody-Coupled T cell Receptor investigational therapy, ACTR707, together with trastuzumab for the treatment of patients with HER2+ advanced cancers (Press release, Unum Therapeutics, JAN 29, 2020, View Source [SID1234553640]).

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Patient enrollment—defined as patients who have signed informed consent forms and met all eligibility criteria—is complete with five patients in this first cohort in the ATTCK-34-01 Phase 1 trial, a multicenter, open-label, single-arm, dose-escalation trial. Of the five patients enrolled, three patients received treatment with trastuzumab (1.0 mg/kg weekly) followed by administration of ACTR707 (25 million ACTR707+ T cells) and completed the DLT review period—defined as approximately six weeks post-ACTR707 administration—with no DLTs observed. Two patients enrolled but discontinued from the trial prior to receiving treatment with trastuzumab and ACTR707. In addition to safety and clinical response assessments, data on ACTR707+ T cell expansion and persistence, trastuzumab pharmacokinetics, and post-treatment biopsy analyses are being collected and are expected to inform subsequent dose escalation. Unum continues to plan to submit data from this Cohort for presentation at a scientific conference in 2020. Investigators have begun screening patients for Cohort 2 that includes treatment with trastuzumab (1.0 mg/kg weekly) followed by administration of ACTR707 (50 million ACTR707+ T cells).

"Understanding the significant unmet need in advanced HER2+ malignancies, ACTR707 was engineered to potentially avoid the on-target, off-tumor toxicity that has hindered the development of traditional CAR T cells for solid tumor cancers," said Jessica Sachs, M.D., Chief Medical Officer of Unum Therapeutics. "We are excited to continue this dose-escalation trial, having passed the DLT safety thresholds in this first, low-dose Cohort and we look forward to reporting additional data from multiple dose cohorts during 2020."

Additional details about the ATTCK-34-01 Phase 1 trial can be found here.

About ACTR707 and the ATTCK-34-01 Phase 1 trial for HER2+ solid tumor cancers
ACTR707 is derived from Unum’s novel proprietary Antibody-Coupled T cell Receptor (ACTR) platform. ACTR is designed to develop autologous engineered T-cell therapies that combine the cell-killing ability of T cells and the tumor-targeting ability of co-administered antibodies to exert potent antitumor immune responses. ACTR707 was engineered for properties that potentially optimize its function in solid tumors including increased proliferation, cytokine secretion, and persistence. Preclinical data demonstrate that, unlike traditional trastuzumab-based CAR-T cells that target HER2, ACTR707+ T cells administered with trastuzumab are highly selective for HER2-overexpressing tumor cells and discriminate against cells from normal tissues that express low levels of HER2. In addition, the preclinical activity of ACTR707+ T cells has been shown to be dose-dependent demonstrating control of ACTR707 activity by modulation of trastuzumab concentration.

While some patients with metastatic breast cancer and gastric cancer receive durable benefit from approved HER2-targeted therapies, many are refractory to or relapse from treatment. Additionally, there are other solid tumors that overexpress HER2 for whom existing HER2-targeted therapies are not approved. ACTR707 used in combination with trastuzumab is being developed in this trial to potentially serve patients whose treatment needs are not met by available HER2-targeted therapies.