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AXIM® Biotechnologies Completes Acquisition of Oncology Research and Development Company Sapphire Biotech, Inc.

On March 18, 2020 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological and cannabinoid research, reported that the Company has completed the acquisition of leading oncology research and development company Sapphire Biotech, Inc. ("Sapphire") (Press release, Sapphire BioTech, MAR 18, 2020, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-acquiree-sapphire-biotech-inc-signs-sponsored-research-agreement-with-arizona-state-university-to-develop-metastatic-cancer-inhibitor [SID1234558650]).

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In January of this year, AXIM announced that the Company signed a binding term sheet to acquire Sapphire. As part of the acquisition, AXIM has acquired 100 percent of the capital stock of Sapphire and will operate Sapphire as a wholly-owned subsidiary. Sapphire will continue to be led by Catalina Valencia, as Chief Executive Officer. Ms. Valencia has stewarded Sapphire in the development of its unique patent-pending pipeline.

"With this acquisition of Sapphire Biotech, AXIM enters into a new phase as we shift our focus to both oncology and cannabinoid research," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "We chose to acquire Sapphire because of the team it brings and because the company has already made large discoveries in the field of oncology, which hold the potential to help so many lives when coupled with its impressive IP portfolio."

Sapphire has licensed a leading compound, called SBI-183, which inhibits and suppresses invasion in vitro and metastasis in vivo. The company recently announced that it now holds exclusive license rights to SBI-183 and intends to study the compound’s ability to treat cancer. In February, Sapphire signed a Sponsored Research Agreement with a leading cancer research organization to conduct preclinical studies to develop a metastatic cancer inhibitor using the licensed SBI-183 compound.

In addition to its upcoming research on cancer-treating compounds, Sapphire is also developing a novel line of diagnostics for early cancer detection, response to treatment and recurrence monitoring. One of Sapphire’s diagnostic tools is currently being evaluated in a clinical trial for its potential to diagnose pancreatic cancer.

AXIM chose to acquire Sapphire because of its focus on cancer therapeutics for inhibiting cancer growth and metastasis, its diagnostics line, and a world-renowned research team. Through this acquisition, AXIM not only gains Sapphire’s already existing patent-pending portfolio of technologies but also now has the ability to develop new in-house proprietary molecules and potential treatments for numerous diseases.

"Sapphire’s researchers are excited to work alongside AXIM to continue developing novel diagnostic tools for early detection and potential treatments for halting cancer metastasis," said Catalina Valencia, Chief Executive Officer of Sapphire Biotech. "By combining our expert research teams, we intend to extend the scope of our research even further."

OncoOne Launches with EUR 13 Million Series A to Develop Multiple Drug Modalities for Unexplored Target

On March 18, 2020 OncoOne reported the close of a EUR 13 million Series A financing round, marking its industry debut. OncoOne will develop several drug modalities to target oxidized macrophage migration inhibitory factor (oxMIF), an isoform of macrophage migration inhibitory factor (MIF) and an exciting new drug target in solid tumor cancer indications (Press release, OncoOne, MAR 18, 2020, View Source [SID1234555687]). With extensive experience in drug discovery and development, the founders, Randolf Kerschbaumer, PhD, Michael Thiele, PhD and Alexander Schinagl, PhD founded OncoOne to develop multiple proprietary drug modalities targeting oxMIF, with the goal of rapidly entering clinical trials in pancreatic, colorectal, lung and ovarian cancer . Investors participating in the Series A included the Austrian Research Promotion Agency (FFG), the Austria Wirtschaftsservice Gesellschaft (AWS), and two family offices. Further details regarding the funding round have not been disclosed.

"As a target, oxMIF provides a very unique opportunity because in contrast to many other targets currently investigated in cancer therapy, it is generated by a post-translational mechanism and is characterized by a remarkable tumor specificity. OxMIF can be harnessed to attack specific types of tumors through different drug modalities," said Randolf Kerschbaumer, CEO of OncoOne. "Our Company name represents our united ambition to use our combined drug development expertise to access the varied potential of oxMIF and the initial funding will enable us to explore this potential to provide innovative treatments for cancer indications with poor prognosis."

IDEAYA Biosciences Announces IDE196 Monotherapy Phase 2 Dose Selection and Clinical Program Update

On March 18, 2020 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported an update for IDE196, a Protein Kinase C (PKC) inhibitor, in its ongoing Phase 1/2 clinical trial entitled "A Phase 1/2 Study in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385) (Press release, Ideaya Biosciences, MAR 18, 2020, View Source [SID1234555685]).

IDEAYA is pursuing both a monotherapy and combination approach for IDE196 in Metastatic Uveal Melanoma and GNAQ/GNA11 hotspot mutation solid tumors, including Cutaneous Melanoma and Colorectal Cancer. The company selected a Phase 2 monotherapy dose of 400mg BID (with one-week 200mg BID run-in) and achieved first-patient-in (FPI) for the GNAQ/GNA11 non-MUM basket trial. IDEAYA also announced plans to evaluate the clinical combination of IDE196 and binimetinib, a MEK inhibitor. IDEAYA anticipates initiating this clinical combination in mid-2020 as part of its ongoing Phase 1/2 clinical trial.

Key IDE196 program updates as of March 15, 2020 include:

53 patients enrolled in Phase 1/2 monotherapy study, including 49 in MUM and 4 in Cutaneous Melanoma, from earlier-reported 40 patients in December 2019
Selected 400mg BID (with one-week 200 mg BID run-in) as Phase 2 monotherapy dose; observed approximately 44% higher average steady state exposure of free IDE196 (AUCfree) and approximately 40% higher trough concentration of IDE196 (Cmin) at the higher 400 mg BID run-in dose relative to the 300 mg BID dose
Initiated Phase 2 monotherapy expansion for GNAQ/GNA11 non-MUM basket trial
Phase 1 sub-study evaluation of pharmacokinetic profile for tablet formulation demonstrates targeted equivalence of pharmacokinetic properties with powder-in-capsule (PIC) formulation; 11 MUM patients dosed with the tablet formulation
Targeting initiation of IDE196 and binimetinib combination clinical trial in mid-2020
Interim data from IDE196 monotherapy Phase 1/2 clinical study targeted for second half of 2020
Design and initiation of potential registration-enabling study in MUM will be evaluated based on results of the ongoing Phase 1/2 monotherapy arm and the IDE196 and binimetinib combination arm of the clinical trial, at which time we will provide guidance on potential NDA timing
Cash currently anticipated to be sufficient to fund planned operations into end of 2021 to early 2022, which is an extension from the earlier guided third quarter 2021
"We continue to see robust enrollment of MUM patients in our Phase 1/2 monotherapy study and look forward to providing the interim data update in the second half of 2020," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences. "We have made significant progress in the IDE196 clinical program, including selecting the Phase 2 monotherapy dose, initiating Phase 2 monotherapy expansion for the basket trial for non-MUM patients, and introducing the tablet formulation. In addition, we plan to evaluate a combination strategy targeting multiple nodes of the MAP-Kinase pathway, which we believe may inform the optimal registrational path for MUM."

IDEAYA and Pfizer Enter Clinical Trial Collaboration and Supply Agreement to Evaluate Clinical Combination of IDE196 and Binimetinib in Solid Tumors Harboring GNAQ or GNA11 Hotspot Mutations

On March 18, 2020 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) for an IDEAYA sponsored clinical combination study of IDE196, a Protein Kinase C (PKC) inhibitor, and binimetinib, a MEK inhibitor that Pfizer has exclusive rights to in the U.S. and Canada, in GNAQ or GNA11 hotspot mutated solid tumors, including Metastatic Uveal Melanoma (MUM), Cutaneous Melanoma, and Colorectal Cancer (CRC) (Press release, Ideaya Biosciences, MAR 18, 2020, View Source [SID1234555684]).

IDEAYA and Pfizer will form a Joint Development Committee (JDC), and there will be joint decision making and data sharing of the clinical trial results between the parties. IDEAYA will sponsor the study and Pfizer will supply binimetinib for the study. The clinical combination trial is targeted to initiate in mid-2020.

"The prevalence of GNAQ or GNA11 hotspot mutations in MUM, Cutaneous Melanoma, CRC, and other solid tumors represents approximately 6,000 patients in the U.S. and the five major European countries, and there are no approved targeted therapies for MUM or GNAQ/GNA11 hotspot mutation solid tumors," said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences. "We look forward to testing the clinical potential of binimetinib in combination with IDE196 in this genetically distinct patient population."

The clinical combination study will evaluate whether inhibition of the MAP-Kinase pathway at two nodes, through upstream PKC and downstream MEK, will enhance the response rate and depth and durability of clinical benefit in patients whose solid tumors harbor GNAQ or GNA11 hotspot mutations. The clinical trial will also study pharmacokinetics of each agent and tolerability of the combination.

"We are thrilled to work with Pfizer to evaluate the clinical combination of IDE196 and binimetinib in MUM and other solid tumors with GNAQ or GNA11 mutations," said Julie Hambleton, M.D., Chief Medical Officer, IDEAYA Biosciences. "There is supportive preclinical data and clinical precedence in oncology for targeting multiple nodes in the MAP-Kinase pathway, and we look forward to testing this hypothesis clinically."

Biocept to Release 2019 Fourth Quarter and Full Year Financial Results and Host Investor Conference Call on March 25, 2020

On March 18, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that it will release financial results for the three and 12 months ended December 31, 2019 after the market closes on Wednesday, March 25, 2020 (Press release, Biocept, MAR 18, 2020, View Source [SID1234555683]). The Company will host a conference call for the investment community to discuss the results and answer questions at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

Individuals interested in participating on the conference call may do so by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers, or (412) 902-4109 for other international callers. Those interested in listening to a webcast of the live conference call may do so by visiting View Source

A replay of the conference call will be available for 48 hours following the conclusion of the call by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers, or (412) 317-0088 for other international callers, and entering the replay access code 10140336. A webcast replay will be available for 90 days at http://ir.biocept.com/events.cfm.