On March 24, 2020 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological and cannabinoid research, reported that its subsidiary Sapphire Biotech, Inc. ("Sapphire") has completed pre-clinical drug studies on a new compound, SPX-1009, demonstrating 10 times greater potency than its parent compound, SBI-183, in inhibiting metastasis (Press release, Sapphire BioTech, MAR 24, 2020, https://sapphirebiotech.com/axim-biotechnologies-completes-pre-clinical-drug-studies-on-new-compound-proving-tenfold-greater-inhibition-of-tumor-metastasis-than-parent-compound/?utm_source=rss&utm_medium=rss&utm_campaign=axim-biotechnologies-completes-pre-clinical-drug-studies-on-new-compound-proving-tenfold-greater-inhibition-of-tumor-metastasis-than-parent-compound [SID1234558651]).

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"Cancer is a leading cause of death worldwide and distant metastases are the major cause of patient mortality," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "Our scientists at Sapphire are aiming to slow down this death rate through their emphasis on metastasis and these positive early findings are nothing but spectacular."

Quiescin Sulfhydryl Oxidase 1 (QSOX1), an enzyme that is over-expressed by tumor cells in numerous cancers, has been shown to be involved in cancer invasion and metastasis. Earlier this year, Sapphire acquired exclusive license rights to a small molecule, SBI-183. SBI-183 has been proven to inhibit the enzymatic activity of QSOX1 and suppress tumor cell invasion in vitro and metastasis of MDA-MB-231 breast tumor cells in vivo. In a non-metastatic xenograft of kidney cancer, SBI-183 suppressed primary kidney tumor growth by 51 percent and in a metastatic xenograft breast cancer model (MDA-MB-231-luc TNBC), SBI-183 reduced lung metastasis by 76 percent compared to control.

A photo accompanying this announcement is available at View Source

Sapphire scientists have tested over 70 analogs of SBI-183 and discovered that SPX-1009 was tenfold more potent in comparison to SBI-183, in suppressing tumor invasion and metastasis in vitro. SPX-1009 was first screened in a cell-free enzymatic assay for its ability to inhibit QSOX1 and then tested for its ability to inhibit growth and invasion of triple-negative breast cancer (TNBC) cells (MDA-MB-231), sarcomatoid kidney cancer cells (RCJ-41T2) and pancreatic adenocarcinoma cells (MIAPaCa2). MTT assays were used to measure the effect of the compounds on tumor growth. 2D invasion assays and 3D tumor spheroid assays were employed to measure the effect of the compounds on invasion.

Testing results demonstrated in vitro that SPX-1009 suppressed invasion of breast, kidney and pancreas tumor cells in 2D and 3D invasion assays at tenfold lower concentrations than the parent compound SBI-183.

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Sapphire intends to initiate animal studies to demonstrate the greater potency of SPX-1009 to suppress tumor growth and metastasis in mice bearing MDA-MB-231-luc breast cancer orthotopic xenografts. Sapphire’s intellectual property related to the SBI-183 and SPX-1009 technology is the subject of numerous patent-pending applications.

"We are extremely excited with the results that the in vitro testing showed," said Catalina Valencia, Chief Executive Officer of Sapphire Biotech. "This potential therapeutic treatment could someday help control tumor cell proliferation and metastasis with our inhibitor."

On April 17, 2020 Rafael Pharmaceuticals, Inc. (‘Rafael’ or the ‘Company’), a leader in the growing field of cancer metabolism-based therapeutics, reported that it has enrolled more than 75% of the 500 patients needed for its pivotal Phase 3 clinical trial for metastatic pancreatic cancer (AVENGER 500), which is evaluating the efficacy and safety of Rafael’s lead compound CPI-613️ (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy (Press release, Rafael Pharmaceuticals, MAR 24, 2020, View Source [SID1234556415]).

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‘We are continuing to enroll patients ahead of schedule, as the patients in our trials suffer from life-threatening diseases and are in dire need of treatment; patient safety is our top priority,’ said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. ‘In order to support our clinical trial sites and enrolled patients during this unsettling and unprecedented time, we have established a COVID-19 task force to closely monitor our clinical trials and make changes as needed. We want to express our deepest gratitude to all of the principal investigators, nurses, hospital staff, patients and their families for their continued support and cooperation.’

‘To Save a Life is to Save a Universe’ – Rafael’s motto – represents its dedication to patients who suffer from rare cancers globally, as well as to its employees and the communities it serves. As such, the company has implemented measures to help ensure the continuity of its clinical trials and programs, while maintaining the safety of patients, clinicians and employees. The COVID-19 task force will closely monitor all clinical trials and collect data relevant to the patients’ study treatments and schedules.

Rafael is working closely with the clinical trial sites to preempt and promptly address any potential challenges and ensure that clinical supplies are available in sufficient quantities in order to support the continuity of care of all enrolled patients. Each clinical trial site has implemented their own safety measures based on guidelines from local authorities. If patients have questions about their clinical trial, they should reach out to the clinical trial coordinator at their medical center.

About CPI-613 (devimistat)
CPI-613 (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. Devimistat is designed to target the mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects. Combination with devimistat represent a diverse range of opportunities to substantially improve patient’s benefit in many different cancers. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s lymphoma. The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.

On April 17, 2020 Rafael Pharmaceuticals, Inc. (‘Rafael’ or the ‘Company’), a leader in the growing field of cancer metabolism-based therapeutics, reported that it has enrolled more than 75% of the 500 patients needed for its pivotal Phase 3 clinical trial for metastatic pancreatic cancer (AVENGER 500), which is evaluating the efficacy and safety of Rafael’s lead compound CPI-613️ (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy (Press release, Rafael Pharmaceuticals, MAR 24, 2020, View Source [SID1234556415]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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‘We are continuing to enroll patients ahead of schedule, as the patients in our trials suffer from life-threatening diseases and are in dire need of treatment; patient safety is our top priority,’ said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. ‘In order to support our clinical trial sites and enrolled patients during this unsettling and unprecedented time, we have established a COVID-19 task force to closely monitor our clinical trials and make changes as needed. We want to express our deepest gratitude to all of the principal investigators, nurses, hospital staff, patients and their families for their continued support and cooperation.’

‘To Save a Life is to Save a Universe’ – Rafael’s motto – represents its dedication to patients who suffer from rare cancers globally, as well as to its employees and the communities it serves. As such, the company has implemented measures to help ensure the continuity of its clinical trials and programs, while maintaining the safety of patients, clinicians and employees. The COVID-19 task force will closely monitor all clinical trials and collect data relevant to the patients’ study treatments and schedules.

Rafael is working closely with the clinical trial sites to preempt and promptly address any potential challenges and ensure that clinical supplies are available in sufficient quantities in order to support the continuity of care of all enrolled patients. Each clinical trial site has implemented their own safety measures based on guidelines from local authorities. If patients have questions about their clinical trial, they should reach out to the clinical trial coordinator at their medical center.

About CPI-613 (devimistat)
CPI-613 (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. Devimistat is designed to target the mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects. Combination with devimistat represent a diverse range of opportunities to substantially improve patient’s benefit in many different cancers. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s lymphoma. The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.

On March 24, 2020, Kura Oncology, Inc. (the "Company") entered into an Office Lease (the "Lease") with East Office Operating Limited Partnership ("Landlord") for the lease of approximately 16,541 square feet of rentable area of the building located at Two Sea Port Lane, Boston, Massachusetts (the "Premises"). The commencement date of the Lease is April 1, 2020. The Company expects to use the Premises for general office use. The initial term of the Lease (the "Initial Term") is four years and three months and the Company has one option to extend the Lease for a period of five additional years. The minimum rent payable by the Company under the Lease will be approximately $105,500 per month for the first year of the Lease, which amount will increase by 2.0% per year over the Initial Term. The Company will also be responsible for the payment of additional rent to cover the Company’s share of the annual operating expenses of the building, the annual tax expenses of the building, the annual utilities costs for the building and parking. In the event of a default of certain of the Company’s obligations under the Lease, Landlord would have the right to terminate the Lease and recover certain unpaid rent and expenses.

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The foregoing description of the Lease does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Lease. The Company intends to file a copy of the Lease with the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.

On March 24, 2020 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense repored that Shawn Iadonato, Kineta Chief Executive Officer, will present an overview of the company at the upcoming Solebury Trout Virtual Investor Conference (Press release, Kineta, MAR 24, 2020, View Source;utm_medium=rss&utm_campaign=kineta-invited-to-participate-solebury-trout [SID1234555825]). The 25 minute presentation includes an interactive Q&A with participants prompted to submit questions electronically. Details for the virtual presentation are as follows:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Date: Thursday, March 26th, 2020

Time: 2:30 PM Eastern Time / 11:30 AM Pacific Time