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CEL-SCI Corporation to Present at the 13th Annual LD Micro Main Event Conference

On December 14, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that it will be presenting at the 13th Annual LD Micro Main Event Conference on Tuesday, December 15, 2020 at 10:00 a.m. ET. Geert Kersten, Chief Executive Officer of CEL-SCI, will be presenting to a live virtual audience (Press release, Cel-Sci, DEC 14, 2020, View Source [SID1234572823]).

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CEL-SCI’s presentation will be broadcast live at View Source or on the Investor Relations section of CEL-SCI’s website at cel-sci.com/new-investor-information/.

LD Micro’s Main Event will feature a new format, with companies presenting for 10 minutes, followed by 10 minutes of Q&A by a panel of investors and analysts.

Propanc Biopharma Provides Shareholder Update

On December 14, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported on the progress of the Company, recent developments and forecast for 2021, as the Company prepares for entering clinical development for its lead product candidate, PRP, for the treatment and prevention of metastatic cancer (Press release, Propanc, DEC 14, 2020, View Source [SID1234572822]). PRP represents a novel therapeutic approach, targeting and eradicating cancer stem cells, but leaving healthy stem cells alone, making it less toxic compared to current standard treatment options, like chemotherapy and radiotherapy. PRP does not suppress the immune system, and therefore in a post pandemic world, can offer support to cancer sufferers who are at risk of infection.

"Whilst navigating the challenges presented during the global pandemic, Propanc management believes the Company has the fundamentals in place to progress PRP to a Phase Ib, First-In-Human (FIH) study in advanced cancer patients," said James Nathanielsz, Propanc’s Chief Executive Officer. "We continue to work on publishing our latest scientific research and exploiting further patent opportunities for our expanding intellectual property portfolio. PRP represents a novel approach that offers a real alternative to standard treatment options which is less toxic and supports immune function when compared to standard treatment options. In a post COVID world, we need to support cancer sufferers whose lives have been significantly affected by cancer and the threat of post treatment secondary infection, which can be life threatening. We look forward to expending every effort to meet our goals in 2021."

Recent Developments

The Company recently raised $209,000 for operating expenses. Furthermore, an S-1 Registration Statement received a notice of effectiveness from the Securities and Exchange Commission for a lead institutional investor as part of a financing agreement entered into earlier this year of up to $3 million with a total of $626,035 of securities purchased to date. The Company will continue to work with the lead institutional investor for future funding tranches to prepare the Company’s lead product candidate, PRP, for a Phase Ib, FIH study in advanced cancer patients suffering from solid tumors.

Forecast for 2021

In 2021, funds raised from the Company’s institutional investor will be used to undertake an engineering run and full scale Good Manufacturing Practice (GMP) manufacture of PRP, the Company’s lead product candidate, as well as validation of the pharmacokinetics method to analyze the distribution of the drug in advanced cancer patients for a Phase Ib, FIH study, which the Company intends to undertake in the second half of 2021, at the Peter Mac Center in Melbourne, Australia’s biggest cancer hospital.

Lead Product Candidate – PRP

PRP is a pharmaceutical composition consisting of two pancreatic proenzymes trypsinogen and chymotrypsinogen for treating cancer. PRP is a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian and colorectal cancers. PRP is a novel therapy based on the science that enzymes stimulate biological reactions in the body, especially enzymes secreted by the pancreas and could represent the body’s primary defense against cancer.

To date, preclinical development has been completed for PRP, including pharmacology and safety toxicology studies, process development activities and bioanalytical method development. Propanc Biopharma is collaborating with contract research organizations, manufacturing partners and its consultants to complete the activities prior to preparing the CTA for the Phase Ib, FIH study.

Joint Research and Drug Discovery Program – POP1

The POP1 joint research and drug discovery program is designed to produce a backup clinical compound to the lead product candidate, PRP. With the aim of producing large quantities of trypsinogen and chymotrypsinogen for commercial use, exhibiting minimal variation between lots and without sourcing the proenzymes from animals, Propanc Biopharma is undertaking a challenging research project in collaboration with the Universities of Jaén and Granada, led by research scientist Mr. Aitor González, supported by Dr. Macarena Perán, Ph.D. and Dr. Julian Kenyon, M.D. as joint supervisors, representing the Universities and Propanc, respectively.

One specific objective of the project will be to synthesize both proenzymes by an in vivo (i.e., a living organism) system to produce crystalized proteins that could be maintained for long periods without suffering degradation, even in absence of refrigeration. This will be particularly useful for a longer shelf life as well as global distribution of the drug product, particularly in warmer climates and developing regions where refrigeration may not be available.

The POP1 joint research and drug discovery program has produced synthetic recombinant versions of the two proenzymes, trypsinogen and chymotrypsinogen. Propanc Biopharma’s joint scientific researchers developed a novel expression system and are in the process of optimizing conditions to achieve high titers of recombinant trypsinogen and chymotrypsinogen. Further, the anticancer effects of the synthetic versions will be tested against the naturally derived proenzymes from bovine origin.

Propanc Biopharma recently entered into a second two-year joint research and collaboration agreement with the University of Jaén who are undertaking the research activities for the POP1 program.

TROPION-Lung05 Phase 2 Trial of Datopotamab Deruxtecan Initiated in Patients with Advanced or Metastatic NSCLC with Actionable Genomic Alterations

On December 14, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca reported the initiation of TROPION-Lung05, a global phase 2 trial of datopotamab deruxtecan (Dato-DXd; DS-1062), a TROP2 directed antibody drug conjugate (ADC), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with actionable genomic alterations previously treated with kinase inhibitor therapy and platinum-based chemotherapy with or without immunotherapy (Press release, Daiichi Sankyo, DEC 14, 2020, View Source [SID1234572821]).

Targeted therapy with tyrosine kinase inhibitors (TKIs) is recommended as first-line or in subsequent lines of treatment in patients with advanced or metastatic NSCLC that tests positive for certain genomic alterations as TKIs offer improved response rates or survival compared to traditional chemotherapy.1 However, once a patient develops acquired resistance to TKIs, treatment options become more limited.1,2

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.3,4,5 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.

"Following preliminary findings of durable responses observed in TROPION-PanTumor01, the ongoing phase 1 trial of datopotamab deruxtecan in non-small cell lung cancer, we will evaluate whether targeting TROP2 with our DXd ADC technology could be a new treatment strategy for patients with previously treated advanced or metastatic non-small cell lung cancer with actionable genomic alterations," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo.

"Many patients with NSCLC will ultimately develop resistance to available targeted therapies, and treatment options for advanced NSCLC are limited," said Cristian Massacesi, Senior Vice President, Head of Late Stage Development Oncology R&D, AstraZeneca. "TROPION-Lung05 provides an opportunity to evaluate datopotamab deruxtecan, a targeted ADC approach with promise in this patient population."

About TROPION-Lung05

The global, multicenter, single-arm, open-label phase 2 study will evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) in patients with advanced or metastatic NSCLC with actionable genomic alterations with progression on or after at least one tyrosine kinase inhibitor and at least one regimen of platinum-based chemotherapy (with or without other systemic therapies). Patients with one or more genomic alterations including EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET exon 14 skipping who received up to four prior lines of treatment are eligible for the study.

The primary trial endpoint is overall response rate as assessed by blinded independent central review. Secondary efficacy endpoints include duration of response, best percentage change in the sum of diameters of measurable tumors, disease control rate, clinical benefit rate, progression-free survival, time to response, objective response rate and overall survival. Safety endpoints include treatment emergent adverse events and other safety parameters. Pharmacokinetic and immunogenicity endpoints also will be evaluated.

The study will enroll patients at multiple sites in North 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.6 NSCLC accounts for 80 to 85 percent of all lung cancers.7

The majority of patients with advanced NSCLC traditionally received platinum-based chemotherapy as first-line treatment.8 The introduction of targeted therapies and immune checkpoint inhibitors in the past two decades has created new options and shifted treatment to a more personalized approach.8

A number of targeted tyrosine kinase inhibitors, which offer improved survival rates over traditional chemotherapy regimens, are approved for treatment of NSCLC with specific genomic alterations.1 The most common alterations for which kinase inhibitors are approved are EGFR (approximately 10 to 35% frequency) and ALK rearrangement (approximately 3 to 7%). All patients eventually develop resistance to available therapies.2

About TROP2

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is overexpressed in many cancers.9 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.3,4,5 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-Lung05, datopotamab deruxtecan is currently being evaluated in a number of clinical trials, including TROPION-Lung01, a phase 3 study in patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations 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.

Legend Biotech Announces FDA Clearance of the IND for LB1901, an Investigational Autologous Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma

On December 14, 2020 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to evaluate LB1901, the company’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL) (Press release, Legend Biotech, DEC 14, 2020, View Source [SID1234572820]). Under this IND, Legend will initiate a Phase 1 clinical study for LB1901 in the United States.

LB1901 is an investigational CAR-T product targeting CD4, which is a surface membrane glycoprotein uniformly expressed in a majority of TCL subtypes. A Phase 1, first-in-human, open-label, multicenter, multicohort clinical study will enroll patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) in the United States. The primary objectives of the study are to characterize the safety and tolerability of LB1901 and to determine the recommended Phase 2 dose.

TCL is a heterogeneous group of disorders accounting for less than 15 percent of Non-Hodgkin lymphoma cases in the US.1,2 PTCL comprises subtypes which are uncommon and often aggressive, with a 5-year overall survival of 39% that varies by subtype.3,4 Cutaneous T-cell lymphomas are a group of T-cell malignancies, which occur primarily in the skin.5 Despite current treatment options, a substantial proportion of patients with PTCL or CTCL experiences relapse. A high unmet medical need remains for patients with relapsed or refractory PTCL and CTCL.

"The FDA’s clearance of Legend’s IND application for LB1901 is a milestone representative of the company’s scientific expertise in cell therapy innovation," said Ying Huang, PhD, Chief Executive Officer and Chief Financial Officer of Legend Biotech. "We look forward to working with the investigators as we explore its potential in meeting the great unmet medical needs in the TCL population."

Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubice

On December 14, 2020 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, reported that the company conducted a Type B Meeting for omidubicel with the U.S. Food and Drug Administration (FDA) on Friday, December 11, 2020 (Press release, Gamida Cell, DEC 14, 2020, View Source [SID1234572819]).

During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites. The company believes the clinical comparability requirement will be met if the time to neutrophil engraftment in patients from the company’s ongoing expanded access program (EAP) using omidubicel produced at Gamida Cell’s planned commercial manufacturing sites is consistent with the results achieved in the Phase 3 clinical trial. Based on the feedback received at the meeting with FDA, Gamida Cell intends to submit a full BLA for omidubicel in the second half of 2021 in lieu of the company’s previous plan to initiate a rolling BLA submission by the end of 2020. The revised plan could support a potential commercial launch of omidubicel in the United States as early as mid-2022.

"Although we are disappointed by the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA’s reaction to our Phase 3 data as the pivotal trial of omidubicel achieved pre-specified primary and secondary endpoints. Commercial manufacturing readiness activities are underway, and we believe we will be able to complete all the requirements discussed with FDA," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "With this clarity, we look forward to proceeding towards a full BLA submission in the second half of 2021. We continue to prepare for the commercialization of omidubicel on the revised timeline, as we continue to provide omidubicel to patients in need through our expanded access program."

The planned BLA submission for omidubicel is supported by a Phase 3 study which met its primary and secondary endpoints. The international, multi-center, randomized Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. Omidubicel is the first bone marrow transplant cell therapy product to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S. and EU.

As previously announced, given the encouraging Phase 1 data presented at the 2020 ASH (Free ASH Whitepaper) meeting, the company also plans to submit an IND for GDA-201, its expanded natural killer cell investigational therapy, in 2021.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the U.S. Food and Drug Administration or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy has not been established by the U.S. Food and Drug Administration or any other health authority.