On October 27, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported the first patient has been dosed in the Phase 2 expansion portion of the study evaluating DSP-7888, an investigational immunotherapeutic cancer vaccine that targets Wilms Tumor 1 (WT1), in combination with checkpoint inhibitor pembrolizumab, in patients with platinum-resistant ovarian cancer (PROC) (Press release, Sumitomo Dainippon Pharma, OCT 27, 2020, View Source [SID1234569167]).

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!

The Phase 1b/2 open-label, multicenter study consists of two parts. The Phase 1b portion evaluated the safety and tolerability of the combination of DSP-7888 with a PD-1 checkpoint inhibitor in adult patients with solid tumors. Based on the known high prevalence of WT1 in ovarian cancer and the findings from the Phase 1b portion of this study, the Phase 2 part will evaluate the antitumor activity of DSP-7888 in combination with pembrolizumab in patients with PROC.

"Patients with platinum-resistant ovarian cancer have a high unmet need with limited treatment options; therefore, we are excited to advance the study of DSP-7888 plus pembrolizumab and evaluate its role and potential benefits," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "Furthermore, we look forward to better understanding how these combined mechanisms may be able to sensitize this patient population to immunomodulators and improve clinical benefits."

The primary objective for the Phase 2 portion of the study is to evaluate the preliminary antitumor activity of DSP-7888 in combination with pembrolizumab in terms of the objective response rate (ORR) in patients with PROC. Secondary objectives of the Phase 2 portion of the study are to evaluate the preliminary clinical activity of DSP-7888 in combination with pembrolizumab in terms of duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), 6-month PFS rate and overall survival (OS) in this patient population. Additional secondary objectives of the Phase 2 portion of the study include evaluating ORR, DCR and PFS per iRECIST of DSP-7888 administered in combination with pembrolizumab in patients with PROC. Exploratory objectives of the Phase 2 portion of the study include determining the progression-free survival ratio (PFSr) as an evaluation of treatment benefit of DSP-7888 administered with pembrolizumab.

Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States.1 Patients with ovarian cancer who relapse within six months of completing first-line therapy are classified as being "platinum resistant" and typically have low response rates to subsequent chemotherapy, with a median survival under a year.2 Therefore, more efficient treatment methods are warranted to improve the survival of patients with ovarian cancer. In addition, the majority of ovarian cancer patients with serous histology are positive with WT1 in their tumors.3

The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03311334).

About DSP-7888 (ombipepimut-S*)

DSP-7888 is an investigational immunotherapeutic cancer vaccine containing two peptides that induce WT1-specific cytotoxic T lymphocytes (WT1-CTL) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.4

DSP-7888 is currently being investigated in combination with bevacizumab in a Phase 2 trial in patients with recurrent or progressive glioblastoma (NCT03149003) and in a Phase 1/2 trial in combination with nivolumab or pembrolizumab in patients with advanced solid tumors (NCT03311334). In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for DSP-7888 in MDS and brain cancer.

*Adegramotide/nelatimotide is also assigned as the international nonproprietary name (INN).

On October 27, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the Company will present the latest preclinical data from its C5aR program, TJ210 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 – 14, 2020 (Press release, I-Mab Biopharma, OCT 27, 2020, View Source [SID1234569165]). The preclinical data will provide a rationale for the use of TJ210 as a monotherapy or in combination with immune checkpoint inhibitors such as anti PD-1 therapies as anti-tumor agent.

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!

Complement component fragment 5a receptor (C5aR1, CD88) is a G-protein coupled receptor (GPCR) and is being investigated as a potential new drug target in the field of immuno-oncology. C5a is produced in the tumoral microenvironment which acts as a chemoattractant to recruit through one of its receptors namely C5aR1 pro-tumor cells such as myeloid derived suppressive cells (MDSCs), neutrophils and M2 macrophages to the tumor site to suppress the human immune system attacking on the cancer and accelerate tumor progression.

TJ210 is an anti-C5aR monoclonal antibody in-licensed from MorphoSys, designed to bind to a unique epitope on C5aR1, thereby aimed to block the recruitment of pro-tumor cells into the tumor microenvironment.

Details of the oral presentation are as follows:

Title

TJ210 (MOR210), A Differentiated Anti-C5aR Antibody for Anti-Cancer Therapy

Abstract #

607

Presenting Author

Jane Meng, PhD, I-Mab Biopharma

Presentation Time

11:30 am – 11:45 am (EST), Thursday, November 12

Visit SITC (Free SITC Whitepaper) website for more abstract information.

About TJ210/MOR210

TJ210/MOR210 is a novel human antibody directed against C5aR derived from MorphoSys’s HuCAL Platinum technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function and enabling immune cells to attack the tumor.

HuCAL and HuCAL Platinum are registered trademarks of MorphoSys AG.

On October 27, 2020 Celsius Holdings, Inc., (Nasdaq: CELH), maker of the leading global fitness drink, CELSIUS, reported that it will release financial results for the third quarter ended September 30, 2020 on Thursday, November 12, 2020, before the market open (Press release, Celsius Therapeutics, OCT 27, 2020, View Source [SID1234569164]). Management will then host a conference call that same day at 10:00 a.m. Eastern Time to discuss the results with the investment community.

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!

To participate in the conference call, please call one of the following telephone numbers at least 10 minutes before the start of the call:

The conference may also be accessed by going to: View Source;passcode=13668240&h=true&info=company&r=true&B=6, for the live audio webcast of the call, which will subsequently be available for replay.

On October 27, 2020 Syntrix Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class product candidates focused on emerging immune control mechanisms in oncology indications, reported it completed initial SX-682 dosing in Phase 1/2 trials in myelodysplastic syndromes (MDS) and metastatic melanoma (Press release, Syntrix, OCT 27, 2020, View Source [SID1234569162]). The drug was well tolerated and absorbed with excellent dose-proportional drug levels in blood. The trials are being conducted at the Moffitt Cancer Center, Massachusetts General Hospital, Dana-Farber Cancer Institute, Mayo Clinic and the University of Rochester.

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!

There is a major need for new cancer treatments targeting novel immune control mechanisms in cancer since existing immunotherapies induce a durable response in only a small percentage of patients. SX-682 is the company’s lead drug from its tumor-microenvironment (TME) discovery platform targeting key molecular pathways cancer uses to shield itself from immune attack. High-profile scientific publications from major cancer centers report SX-682 potently eradicates cancer and extends survival: National Cancer Institute (JCI Insight, J Immunother Cancer), Fred Hutchinson Cancer Research Institute (JCI Insight), and MD Anderson (Nature and Cancer Cell).

Based on these promising results, additional Phase 1/2 trials are now also opening for SX-682 in pancreatic cancer at the University of Rochester, in colorectal cancer at the MD Anderson Cancer Center, and in advanced tumors including breast and head and neck cancers at the National Institutes of Health Clinical Center.

"The CXCR1/2 pathway blocked by SX-682 suppresses anti-tumor immunity," said John Zebala, MD, PhD, president at Syntrix. "Patients with low CXCR1/2 activity survive significantly longer compared to patients with high activity. We are hopeful the same effect can be achieved by pharmacologically blocking the pathway with SX-682. We believe the breadth of the SX-682 clinical program positions it for major read-outs."

ABOUT SX-682: SX-682 is a clinical-stage oral allosteric small-molecule inhibitor of CXCR1 and CXCR2 (CXCR1/2). CXCR1/2 is a "master switch" of the immunosuppressive tumor microenvironment. In patients there is an inverse correlation between CXCR1/2 activation and survival. SX-682 has been validated in major tumor models where it exhibits mono-agent activity, extends survival, blocks metastasis, activates infiltration and killing by immune effector cells, and enhances cancer checkpoint and cell therapies.

On October 27, 2020 Genome & Company (KONEX: 314130), a global pioneer company of microbiome therapeutics, reported that initiated clinical trials of GEN-001, an anti-cancer microbiome therapeutic (NCT04601402) (Press release, Genome & Company, OCT 27, 2020, View Source;company-announces-first-patient-dosed-in-phase-11b-study-of-gen-001-an-immuno-oncology-microbiome-therapeutic-in-combination-with-avelumab-301158564.html [SID1234569161]).

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!

GEN-001 is an oral microbiome therapeutic candidate of Genome & Company. In this clinical trial, it will be administered to cancer patients by combining an immune checkpoint inhibitor for the first time among Asian microbiome development companies.

The phase 1 study aims to determine the RP2D (recommended Phase 2 dose) of GEN-001 in combination with BAVENCIO (avelumab). Avelumab is an anti-PD-L1 checkpoint inhibitor co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. In the phase 1b study, the safety and preliminary efficacy of the combination therapy at the RP2D of GEN-001 in combination with BAVENCIO for patients with specific solid tumors will be investigated.

A total of three clinical sites including OHSU Knight Cancer Institute located in Portland, Oregon will complete the dose escalation cohort within the first half of 2021. The OHSU Knight Cancer Institute is a globally renowned cancer center and one of the 51 National Cancer Institute (NCI) designated Comprehensive Cancer Centers in the U.S. Amid harsh conditions due to COVID-19, close collaboration among OHSU, contract research organization and Genome & Company enabled this clinical trial to initiate only after six months since its FDA IND clearance.

"We are pleased to offer our patients access to a new clinical trial of the drug GEN-001 in combination with avelumab," said Shivaani Kummar, M.D., head of the division of hematology and medical oncology in the OHSU School of Medicine, and co-director of the OHSU Knight Cancer Institute Center for Experimental Therapeutics. "Our goal is to learn more about whether this combination therapy will be effective in overcoming acquired resistance to anti-PD-(L)1 therapy in patients with advanced solid tumors whose disease has progressed on prior anti-PD-(L)1 therapy."

Dr. Jisoo Pae, CEO of Genome & Company stated, "The study outcome of GEN001-101 is expected to demonstrate preliminary efficacy of GEN-001 in various cancers. We hope to see clinically meaningful results fairly soon that would allow us to continue to progress GEN-001 through clinical trials, with the potential to eventually become an alternative therapeutic option in the immuno-oncology market."

In December 2019, Genome & Company inked a Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab, a human anti-PD-L1 therapy, in multiple cancer indications. Under the terms of this agreement, Genome & Company will be the sponsor of the study, and Merck KGaA, Darmstadt, Germary and Pfizer will supply avelumab for the phase 1/1b clinical trial.

BAVENCIO is a trademark of Merck KGaA, Darmstadt, Germany.

Avelumab Approved Indications

Avelumab (BAVENCIO) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO monotherapy include lymphopenia; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.