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]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

‘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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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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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

On March 24, 2020 Norgine B.V. ("Norgine") reported the acquisition of Azanta A/S, a specialty biopharmaceutical company operating within women’s healthcare, addiction medicine and oncology (Press release, azanta, MAR 24, 2020, View Source [SID1234555807]). Azanta becomes a wholly-owned subsidiary of Norgine.

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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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As a result of the transaction, Norgine acquires Azanta’s portfolio of products, including Angusta for labour induction and Nimorazole, a hypoxic radiosensitizer for the treatment of head and neck cancer patients undergoing primary radiotherapy. Angusta was approved in Q1 2017 in the Nordics, and in Q4 2017 in France and 10 CEE countries. Regulatory approval for the rest of Europe is expected to be filed in H1 2020. Nimorazole has EMA orphan drug status and is ready for Phase III stage development.

Azanta A/S is headquartered in Denmark with pharmaceutical sales subsidiaries in the other Nordic countries and in France. Norgine has a direct presence in 12 European countries, as well as Australia and New Zealand and has a strong track-record of successfully bringing products to market across Europe. Norgine also has a strong global network of partnerships in non-Norgine markets. Norgine’s European experience, fully integrated infrastructure and exceptional partnership approach enables it to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access.

This acquisition further strengthens Norgine’s position as a leading European specialist pharmaceutical company.

Peter Stein, CEO of Norgine, says: "Our commitment to transforming people’s lives drives everything we do and we are very proud to welcome the Azanta team and their portfolio of specialty products to Norgine. This transaction will enable us to strengthen our business in Europe and ultimately to help more patients."