On December 14, 2020 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological and COVID-19 research, reported that the Company’s CEO John W. Huemoeller II will be presenting at the 13th Annual LD Micro Main Event investor conference on Monday, December 14, 2020, at 11:00 a.m. PST/2:00 p.m. EST (Press release, AXIM Biotechnologies, DEC 14, 2020, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-to-present-at-the-13th-annual-ld-micro-main-event-investor-conference-on-monday-december-14 [SID1234572924]).

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During the 10-minute presentation, Huemoeller will discuss AXIM’s COVID-focused research and testing tools, including an update on progress around the Company’s Emergency Use Authorization (EUA) application on its rapid point-of-care COVID-19 neutralizing antibody test. Directly following his presentation, Huemoeller will take questions from a panel of investors and analysts.

AXIM Biotech CEO John W. Huemoeller II commented: "As we move close to having the first COVID-19 vaccines available in the U.S., our rapid COVID-19 neutralizing antibody test can serve as an easy, quick and relatively inexpensive way for researchers to determine the efficacy of their vaccines. I look forward to presenting on this topic and the other highlights of AXIM’s COVID-focused research during the LD Micro Main Event investor conference."

To register for the conference, visit ve.mysequire.com/. The LD Micro Main Event investor conference will take place on December 14th and 15th, exclusively on the Sequire Virtual Events platform.

On December 14, 2020, Allogene Therapeutics, Inc. (the "Company") and Overland Pharmaceuticals (CY) Inc. ("Overland")reported that Allogene Overland Biopharm (CY) Limited (the "JV Company") for the development, manufacturing and commercialization of certain of the Company’s allogeneic chimeric antigen receptor ("CAR") T cell therapies for patients in China, Taiwan, South Korea and Singapore (the "Territory") pursuant to a Share Purchase Agreement and a Shareholders’ Agreement (Filing, 8-K, Allogene, DEC 14, 2020, View Source [SID1234572867]). In connection with the formation of the joint venture, the Company also entered into a License Agreement with the JV Company.

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Pursuant to the Share Purchase Agreement, the Company acquired Seed Preferred shares in the JV Company representing 49% of the JV Company’s outstanding stock as partial consideration for the License Agreement, and Overland acquired Seed Preferred shares representing 51% of the JV Company’s outstanding stock for $117 million in upfront and certain quarterly cash payments. The JV Company shall use $77 million of such cash for operating capital and $40 million of such cash as upfront cash payment to the Company under the License Agreement described below. The Share Purchase Agreement includes customary representations and warranties on behalf of the Company, Overland and the JV Company.

Under the terms of the Shareholders’ Agreement, the board of directors of the JV Company will be comprised of five directors, with two directors designated by the Company, two directors designated by Overland and one director serving as the chief executive officer of the JV Company. The Shareholders’ Agreement provides each of the Company and Overland certain shareholder-level consent rights, certain director-level consent rights, registration rights, information rights, and pre-emptive rights for future equity issuances. The Shareholders’ Agreement shall terminate upon the consent of the parties, provided that its provisions with respect to director designation rights, shareholder-level consent rights, director-level consent rights, information rights, and pre-emptive rights shall terminate upon a qualified IPO or sale of the JV Company or its assets.

Pursuant to the License Agreement, the Company will grant the JV Company an exclusive license to develop, manufacture and commercialize specific Company product candidates targeting BCMA, CD70, FLT3, and DLL3 (the "Licensed Products") in the Territory. The Company retains exclusive rights to, among other things, develop, manufacture and commercialize the Licensed Products outside the Territory.

The Company will receive an upfront cash payment of $40 million described above as well as up to $40 million in total development milestones. In addition, the Company will receive tiered low to mid single-digit royalties on net sales in the Territory, subject to reductions in specified circumstances.

Under the License Agreement, each party has granted the other party specified intellectual property licenses to enable the other party to perform its obligations and exercise its rights under the License Agreement, including license grants to enable each party to conduct development, manufacturing and commercialization activities pursuant to the terms of the License Agreement. The Company plans to supply the JV Company with ALLO-647, which is intended to be used as part of the lymphodepletion regimen for certain CAR T cell product candidates in the Territory, pursuant to a supply agreement and for agreed upon consideration.

The License Agreement will remain in effect on a Licensed Product-by-Licensed Product and jurisdiction-by-jurisdiction basis, unless terminated earlier, until the expiration of the royalty term with respect to such Licensed Product in such jurisdiction. Each party has the right to terminate the License Agreement for the other party’s material breach of its obligations under the License Agreement, subject to cure rights. Additionally, the JV Company may terminate the License Agreement in its sole discretion and in its entirety after a certain time period with sufficient prior written notice. The Company may also terminate the licenses of specified patent rights upon notice if the JV Company challenges the enforceability or validity of any patent rights belonging to the Company that are licensed to the JV Company. Either party to the License Agreement may terminate the License Agreement if the other party declares bankruptcy. Upon termination, any license granted by the Company to the JV Company will terminate.

The License Agreement includes customary representations and warranties on behalf of the Company and the JV Company as are customarily found in transactions of this nature, including representations and operative provisions as to the licensed intellectual property, regulatory matters and compliance with applicable laws. The License Agreement also provides for certain mutual indemnities for breaches of representations, warranties and covenants.

The foregoing description of the material terms of the License Agreement, the Share Purchase Agreement and the Shareholders’ Agreement is qualified in its entirety by reference to the complete text of such agreements, which the Company intends to file with the Securities and Exchange Commission as exhibits to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2020.

On December 14, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca reported the initiation of TROPION-Lung01, a global pivotal phase 3 head-to-head study of datopotamab deruxtecan (Dato-DXd; DS-1062), a TROP2 directed antibody drug conjugate (ADC), versus docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations who have previously received platinum-based chemotherapy and immunotherapy (Press release, Daiichi Sankyo, DEC 14, 2020, View Source [SID1234572856]).

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Patients with advanced or metastatic NSCLC without actionable genomic alterations (such as EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET exon 14 skipping) have demonstrated an unmet need after currently approved front-line and second-line therapies are exhausted. Current treatment guidelines recommend varying combinations of platinum-based chemotherapy and/or immune checkpoint inhibitors in the front-line and second-line settings based on lung cancer subtype, immune biomarker status and other factors.1 For patients whose cancer progresses after initial treatment containing a platinum-based chemotherapy and a checkpoint inhibitor, therapeutic options are limited.1

TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in the majority of adenocarcinoma and squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.

"We recognize the need to continue to improve treatment for patients with NSCLC who are not eligible for currently approved targeted therapies, particularly those who progress following initial treatment with an immunotherapy and platinum-based chemotherapy," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "This head-to-head trial will determine whether targeting TROP2 with datopotamab deruxtecan will improve survival as compared to the standard therapy used in this setting."

"TROP2 is highly expressed in NSCLC and other cancers, making it a promising target for therapeutic development," said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. "This trial will provide an opportunity to evaluate a targeted approach with datopotamab deruxtecan, a potent ADC specifically designed to enhance selective tumor cell death, while reducing systemic exposure to chemotherapy."

TROPION-Lung01 was initiated following the encouraging clinical activity of datopotamab deruxtecan in patients with heavily pre-treated advanced NSCLC observed in the ongoing TROPION-PanTumor01 phase 1 trial, which completed enrollment of patients with lung cancer in October of 2020. Preliminary data from TROPION-PanTumor01 was recently presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (#ASCO20) and updated data will be presented at an upcoming medical meeting.

About TROPION-Lung01

This global, multicenter, randomized, open-label phase 3 trial will evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) versus docetaxel (75 mg/m2) in patients with advanced or metastatic NSCLC without actionable genomic alterations and with progression on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy received either in combination or sequentially.

Approximately 590 patients will be randomized into two arms in a 1:1 ratio to receive either datopotamab deruxtecan or docetaxel. Randomization will be stratified by histology (squamous versus nonsquamous), most immediate prior therapy and geographic region.

The primary trial endpoints are progression-free survival and overall survival. Secondary endpoints include overall response rate, duration of response, time to response, disease control rate and patient reported outcomes. Safety endpoints include treatment emergent adverse events and other safety parameters. Pharmacokinetic and immunogenicity endpoints will also be evaluated.

The study will enroll patients at sites in North America, South America, Europe and Asia. For more information visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide; there were an estimated 2.1 million new cases of lung cancer in 2018 and 1.8 million deaths.5 NSCLC accounts for 80 to 85 percent of all lung cancers.6

For patients with advanced NSCLC that do not carry actionable genomic alterations (i.e., for which no targeted therapies are approved), treatment has traditionally been limited to platinum chemotherapy.7 The introduction of immune checkpoint inhibitors in the past two decades has offered improved survival rates over traditional chemotherapy regimens, creating new options and shifting treatment to a more personalized approach for subsets of patients with NSCLC. Over the past five years, immunotherapies have become part of the treatment paradigm.7

About TROP2

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is overexpressed in many cancers.8 TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in up to 64% of adenocarcinoma and up to 75% of squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.

About Datopotamab Deruxtecan (Dato-DXd; DS-1062)

Datopotamab deruxtecan (Dato-DXd; DS-1062) is one of three lead DXd antibody drug conjugates (ADCs) in the oncology pipeline of Daiichi Sankyo.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker with a drug-to-antibody ratio (DAR) of four.

TROPION is the broad and comprehensive clinical development program to evaluate the efficacy and safety of datopotamab deruxtecan across multiple TROP2 cancers as both a monotherapy and in combination with other anticancer treatments. In addition to TROPION-Lung01, datopotamab deruxtecan is currently being evaluated in a number of clinical trials, including TROPION-Lung05, a phase 2 study in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with actionable genomic alterations previously treated with a kinase inhibitor and platinum chemotherapy and TROPION-PanTumor01, a phase 1 study in patients with advanced solid tumors that have progressed on standard treatments or for whom no standard treatment is available, which has completed enrollment of patients into a unresectable advanced NSCLC cohort and is currently enrolling patients into a triple negative breast cancer (TNBC) cohort.

Datopotamab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About the Collaboration between Daiichi Sankyo and AstraZeneca

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan (a HER2 directed ADC) in March 2019, and datopotamab deruxtecan (a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

On December 14, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the completion of enrollment in the TRYbeCA-1 Phase 3 trial in second-line pancreatic cancer (Press release, ERYtech Pharma, DEC 14, 2020, View Source [SID1234572850]).

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TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has completed patient enrollment. A total of 510 patients participated in the trial, slightly above the target enrollment of 482 patients.

The trial recently accrued the required number of events for the planned interim superiority analysis, to be performed by an Independent Data Monitoring Committee. The results from the interim superiority analysis are expected to be reported in the first quarter of 2021. Since the interim analysis does not include an evaluation for futility, there will be two possible outcomes: the trial will either: (1) continue toward a final analysis, expected in the fourth quarter of 2021, or (2) be concluded early if compelling improvement in overall survival is demonstrated, in which case the Company expects to file for regulatory approval in the United States and in Europe in the second half of 2021.

Earlier this year, the U.S. Food and Drug Administration granted eryaspase Fast Track Designation as a potential second-line treatment for patients with metastatic pancreatic cancer. Eryaspase also benefits from Orphan Drug status in pancreatic cancer in both the United States and Europe.

"We are extremely pleased that the TRYbeCA-1 trial enrollement has continued to progress on schedule despite the challenges caused by the COVID-19 global pandemic," said Dr. Iman El Hariry, Chief Medical Officer of ERYTECH. "This achievement is only possible because of the hard work of the study investigators, hospital staff at the trial sites, patients and their families. We look forward to the outcome of the planned interim analysis for superiority early next year."

"Patients with advanced pancreatic cancer need new treatment options, particularly in the second line setting after failure of gemcitabine-nab-paclitaxel or FOLFIRINOX combinations," added Dr Jean-Philippe Metges, medical oncologist at the University Hospital in Brest (France) and the national coordinator of the TRYbeCA-1 trial for France. "TRYbeCA-1 is one of the largest clinical trials currently open in second-line metastatic pancreatic cancer. If successful, this will lead to a treatment paradigm shift in this disease."

About TRYbeCA-1

TRYbeCA-1 is a randomized controlled Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer. Target enrollment was 482 patients. Five-hundred and ten patient were enrolled in the trial in close to 90 clinical sites in the United States and 11 countries in Europe and randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival (OS). The trial was designed to detect an OS hazard ratio (HR) of 0.725 with close to 90% power at a single-sided alpha level of 2.5%. An interim superiority analysis, to be performed by an independent data monitoring committee (IDMC), is foreseen on two-thirds of total OS events. Demonstration of improved OS with a single-sided p-value below 0.006 will be considered compelling evidence of survival benefit at this interim analysis and can form the basis for the IDMC to recommend early conclusion of the trial for superiority.

About Pancreatic Cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 185,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate below 10%. It is currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life. Approximately 50% of patients are eligible for second-line treatment.

On December 14, 2020 Teon Therapeutics, a private biopharmaceutical company developing a focused portfolio of small molecules that modulate metabolic signaling pathways in the tumor microenvironment, reported that Cancer Research UK, the world’s leading cancer charity dedicated to saving lives, has formally approved Teon’s TT-702 program to enter into a clinical collaboration (Press release, Teon Therapeutics, DEC 14, 2020, View Source [SID1234572841]). TT-702, a first-in-class A2BR-specific antagonist being pursued in prostate cancer and other tumor types, expects to initiate a Phase 1b/2a clinical study in early 2021. In a collaboration, Cancer Research UK would sponsor and oversee the clinical trial, which will be run through the Centre for Drug Development. Future considerations would be contingent upon achievement of TT-702 development milestones by Teon.

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"We are excited for the opportunity to collaborate with Cancer Research UK," said Ken Horne, President and Chief Operating Officer of Teon Therapeutics. "They have helped develop 10 marketed cancer drugs, including Zytiga (abiraterone), Lynparza (olaparib), and Balversa (erdafitinib), so it is a tremendous honor to be approved to partner with Cancer Research UK under its Clinical Development Partnership initiative, which has seen 27 early clinical development collaborations established to date. We look forward to announcing more details around our collaboration in early 2021."