On July 24, 2019 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 a corporate update. "Trillium continues to make progress with both our intratumoral and intravenous development programs for TTI-621, our novel CD47 immune checkpoint inhibitor," said Robert L. Kirkman, M.D., Executive Chair of Trillium (Press release, Trillium Therapeutics, JUL 24, 2019, View Source [SID1234537704]). "We believe the single agent anti-tumor activity we have observed in our trials of TTI-621 to date is unique and, as we move these programs forward, positions Trillium to be a leader in this exciting new approach to the treatment of cancer."

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Trillium is focusing the intratumoral administration of TTI-621 for the treatment of cutaneous T-cell lymphoma (CTCL). The U.S. Food and Drug Administration (the FDA) has accepted the Company’s request for an in-person meeting, currently scheduled to take place later this quarter, to discuss the Company’s proposed pivotal pathway for intratumoral administration of TTI-621 in early-stage CTCL. This proposal builds upon the anti-tumor activity observed in the ongoing phase 1b expansion trial (NCT02890368). As reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2018, a reduction in Composite Assessment of Index Lesion Severity (CAILS) scores, which measure local lesion responses, was observed in 91% (20/22) of CTCL patients receiving intratumoral TTI-621.

The current goal of Trillium’s intravenous program for TTI-621 is the identification of a recommended phase 2 dose. Trillium has amended the intravenous study protocol (NCT02663518) to enable dosing beyond 0.5 mg/kg and is currently enrolling the first cohort in the new dose-escalation design. The Company also has completed enrollment for the first Simon’s 2-stage CTCL cohort in the TTI-621 intravenous study. The Safety Review Committee reviewed the preliminary data from this cohort and recommended that patients on study continue to be followed until all response assessments are available. The Company has decided not to initiate the second Simon’s 2-stage cohort until the outcome of the ongoing dose escalation is known. "While we have seen meaningful activity of intravenous TTI-621 in a variety of malignancies at the current doses, we believe it is important to identify the optimal dose before proceeding with additional studies," said Yaping Shou, M.D., Chief Medical Officer at Trillium. "We believe this approach is the best use of resources and will maximize the opportunity for success."

"Obtaining guidance from the FDA regarding the development pathway for intratumoral TTI-621 in early-stage CTCL will be an important step for Trillium, as we believe this indication may be a potential first-to-market approach for this product candidate," said Dr. Kirkman. "In addition, identifying an optimal dose for intravenous TTI-621 and building on what we believe is its unique single agent activity should enable a significant expansion of our opportunities."

On July 24, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s menin-mixed lineage leukemia (menin-MLL) inhibitor KO-539 for the treatment of acute myeloid leukemia (AML) (Press release, Kura Oncology, JUL 24, 2019, View Source [SID1234537702]).

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"Orphan Drug Designation for AML represents a significant milestone in the development of KO-539," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "This decision by the FDA follows the clearance of our investigational new drug (IND) application in March 2019 and recognizes the potential for KO-539 to address a high unmet need for patients suffering from AML. We are very encouraged by our preclinical data in genetically defined subsets, such as tumors with MLL fusions and rearrangements and NPM1 mutations, and we are in the final stages of study startup for our Phase 1 clinical trial in relapsed or refractory AML."

The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

About KO-539

KO-539 is a potent and selective small molecule inhibitor of the menin-MLL protein-protein interaction. MLL-rearranged leukemias are characterized by chromosomal translocations of the MLL gene that are primarily found in patients with AML and acute lymphoblastic leukemia (ALL). These translocations form oncogenes encoding MLL fusion proteins, which play a causative role in the onset, development and progression of MLL-rearranged leukemias. The target genes of the MLL fusion proteins are also found to be overexpressed in a broader subset of AMLs characterized by oncogenic driver mutations in genes such as NPM1. These mutations also appear to be dependent on the interaction between menin and MLL, suggesting that the menin-MLL complex is a central node in epigenetic dysregulation driven by distinct oncogenic driver mutations known to be important in AML and other hematologic malignancies. In preclinical studies, KO-539 has demonstrated potent and selective inhibition of the proliferation of MLL-rearranged leukemia cell lines. Kura has also generated preclinical data showing robust and durable efficacy in multiple in vivo models of AML characterized by MLL-rearrangements or oncogenic driver mutations in genes such as NPM1.

On July 24, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported that the first patient has been treated in the adjuvant (pre-temozolomide maintenance) trial arm of VAL-083’s Phase 2 study in MGMT-unmethylated glioblastoma multiforme (GBM) being conducted at the University of Texas MD Anderson Cancer Center (MDACC) (Press release, DelMar Pharmaceuticals, JUL 24, 2019, View Source [SID1234537701]). This recently-approved arm of the study will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with temozolomide (TMZ) but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.

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"Treating patients with MGMT promoter unmethylated glioblastoma is particularly challenging," commented principal investigator Dr. Barbara O’Brien, assistant professor of Neuro-Oncology at the MD Anderson Cancer Center. "These tumors are inherently resistant to temozolomide, leaving physicians and patients without viable alternative treatments, so I’m particularly pleased that we have added this additional trial arm to our ongoing study. Better therapies are greatly needed for both newly-diagnosed and recurrent glioblastoma, and VAL-083 has so far shown a favorable safety profile and provided early, but encouraging, results from the trial that is currently underway."

This adjuvant arm, which was recently approved by the MDACC Institutional Review Board, will provide early disease data on VAL-083, in contrast to those patients enrolling in the Company’s original recurrent trial arm of the MDACC clinical study who have typically been heavily pre-treated with TMZ prior to disease recurrence. In the recurrent setting, the Company previously announced that MDACC had approved up to 35 additional patients to this recurrent GBM study at a dose of 30 mg/m2, allowing for a total of up to 83 patients to be enrolled. To date, 56 recurrent patients have been enrolled. DelMar is actively enrolling patients for both trial arms of the clinical study at MDACC.

Concurrently, the Company is conducting a Phase 2 clinical study of VAL-083 as first line treatment for GBM in combination with radiotherapy in China at the renowned Sun Yat-sen University Cancer Center for which it provided an update on June 3, 2019. This update can be accessed via the company’s website at View Source VAL-083 has been granted orphan drug designations 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. It has also been granted fast-track status for the treatment of recurrent GBM by the U.S. FDA.

"Enrolling and treating the first adjuvant patient in this study is an important milestone as it provides us with the opportunity to understand the best use for VAL-083 in the clinical setting – whether as first-line therapy along with radiation, as adjuvant therapy immediately following chemoradiation or in the recurrent setting. We firmly believe in the potential for this compound and look forward to providing an opportunity for a larger patient population to benefit from VAL-083 treatment. We look forward to providing updates on the progress of all of our clinical programs," commented Saiid Zarrabian, DelMar’s Chief Executive Officer.

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. Further details regarding these studies can be found at:

View Source

On July 24, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that two-year clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the treatment of primary choroidal melanoma, reported that it will be highlighted in an oral presentation at the 37th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) being held July 26- 30, 2019 in Chicago, Illinois (Press release, Aura Biosciences, JUL 24, 2019, View Source [SID1234537700]).

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"There is an urgent unmet medical need for targeted treatment options for patients suffering from primary choroidal melanoma, a life-threatening form of eye cancer," said Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center. "Emerging results from the Phase 1b/2 trial of light-activated AU-011 demonstrate tumor control and visual acuity preservation, warranting continued development of the program."

Title: Two-Year Results of an Ongoing Phase 1b/2 Open Label Clinical Trial of AU-011 for the Primary Treatment of Small to Medium Choroidal Melanoma,

Presenter: Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center

Session: Ocular Oncology Symposium

Date and time: Monday, July 29, 2019; 9:35 -9:41am CDT

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On July 24, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 10,360,499, a key component of Anixa’s Cchek technology for early detection of cancer (Press release, Anixa Biosciences, JUL 24, 2019, View Source [SID1234537699]).

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This patent provides broader coverage for the use of Anixa’s technology in a wider range of applications and protects critical new improvements developed for Anixa’s cancer detection technology, utilizing flow cytometry and artificial intelligence.

"The claims of this patent were allowed in March of this year as noted in a previous announcement, and we are pleased that this key patent has finally been issued," stated Dr. Amit Kumar, President and CEO of Anixa. "We are pleased to receive further patent protection on our liquid biopsy technology and look forward to launching a prostate cancer confirmatory test as the first product utilizing this technology later this year."

The patent is titled, "METHODS FOR USING ARTIFICIAL NEURAL NETWORK ANALYSIS ON FLOW CYTOMETRY DATA FOR CANCER DIAGNOSIS." Inventors of the patent include Dr. Amit Kumar, John Roop, Anthony Campisi, and Dr. George Dominguez. This patent is held exclusively by Anixa and is not licensed to any third parties.