On November 12, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the presentation of preliminary results from its ongoing Phase 1 dose escalation study evaluating COM902, Compugen’s anti-TIGIT antibody, in patients with advanced solid tumors at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held on November 10-14, 2021 (Press release, Compugen, NOV 12, 2021, View Source [SID1234595496]).

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"The primary objective of this Phase 1 dose escalation study of COM902 monotherapy was to evaluate safety and tolerability and we were pleased to see that COM902 was well tolerated with a favorable safety profile. A maximum tolerated dose of COM902 was not reached." said principal investigator and presenting author, Ecaterina Elena Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center. "It is encouraging to achieve a disease control rate of 50% in these heavily pretreated patients who typically do not respond to PD- (L)1 inhibitors. I look forward to enrolling patients in the combination study with COM701 to continue exploring new therapeutic options for patients in need."

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "COM902 high- affinity anti-TIGIT antibody was well tolerated, showed early signs of anti-tumor activity in heavily pretreated patients with advanced solid tumors and as we expected avoided depletion of major TIGIT positive expressing lymphocytes, supporting our rationale for choosing a reduced Fc effector function anti-TIGIT antibody. These data are encouraging, in line with our science suggesting that TIGIT is a combination agent and serves as the basis for exploring our differentiated TIGIT combination strategy. In addition to our triplet study blocking PVRIG, TIGIT and PD-1 pathways, we are already enrolling patients in our Phase 1 study of COM902 in combination with COM701 for the first clinical evaluation of dual blockade of TIGIT and PVRIG in a PD-(L)1-free regimen."

Key findings from the poster presentation titled, "COM902 (Anti-TIGIT antibody) monotherapy – preliminary evaluation of safety, tolerability, pharmacokinetics and receptor occupancy in patients with advanced solid tumors," (NCT04354246) with a cutoff of September 3, 2021, include:

Key findings from the study

The study enrolled 18 patients with advanced solid tumors who exhausted all available standard therapies
The study population was heavily pretreated with the median number of prior therapies was 7, with a minimum of 2 and maximum of 16
COM902 administered IV Q3W was well tolerated with a favorable safety profile. A maximum tolerated dose of COM902 was not reached.
o One patient in the 0.01 mg/kg dose cohort reported a dose limiting toxicity (DLT) of Grade 2 vomiting, and one patient in the 1 mg/kg dose cohort had a DLT of Grade 3 atrial fibrillation; these were assessed by the investigator as possibly related to study treatment with COM902
o No DLTs were reported at any other COM902 doses including higher doses (3 mg/kg, 10 mg/kg)
COM902 3 mg/kg IV Q3W has been selected as the recommended dose for expansion
Best response of stable disease (SD) was reported in 9 patients (50%), with 6 patients (67%) having confirmed SD and 3 patients (17%) with SD of at least 6 months
No depletion of major lymphocyte populations expressing TIGIT (NK, CD4 and CD8 T cells) in the peripheral blood analysis
Study Progress

COM902 monotherapy expansion cohort is enrolling up to 10 patients
A PD-(L)1-free regimen of COM902 cohort expansion in combination with COM701 has been initiated
The poster is available to conference attendees for the duration of the SITC (Free SITC Whitepaper) Congress and will be archived on the Publications section of Compugen’s website.

On November 12, 2021 OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported that it has published a study identifying three distinct proteome subtypes that are associated with response from a cohort of non-small cell lung cancer (NSCLC) patients undergoing immunotherapy (Press release, OncoHost, NOV 12, 2021, View Source [SID1234595495]). The study was conducted using OncoHost’s first-of-its-kind, AI-based platform, PROphet, and its research and findings will be presented as an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Anniversary Annual Meeting.

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Although the approval of immune checkpoint inhibitor (ICI)-based therapy has improved lung cancer outcomes, most patients still do not respond to treatment. Moreover, a growing body of evidence demonstrates that in some cases, the interplay between the treatment, tumor and host can lead to a counterintuitive effect, supporting tumor progression and spread. Understanding the biological processes that drive resistance to treatment is critical in order to improve clinical outcomes. This study seeks to take a deeper look into the host’s micro-environment to identify biomarkers for response to immunotherapy, as well as to gain insights into mechanisms of resistance to treatment and understand the resistance biology.

"By conducting plasma proteomic profiling and assessing multidimensional clinical and biological data, we have achieved success in analyzing, clustering and predicting response in NSCLC patients," said Professor Yuval Shaked, founder and Chief Scientific Advisor at OncoHost, and Professor of Cell Biology and Cancer Science at the Technion – Israel Institute of Technology. "This research is helping us take significant strides in understanding the biological processes that are driving resistance in patients, and we are honored to play a role in the evolution of cancer care."

The study included a cohort comprised of 143 patients from whom plasma samples were collected pre-treatment and in the early stages of treatment, along with comprehensive clinical data. Using PROphet, OncoHost’s advanced machine learning and bioinformatics platform, researchers divided the cohort into three patient clusters, each with distinct biological and clinical characteristics. While the patients in all three clusters may have had the same diagnosis, they all fit into just one of three proteome subtypes, which are associated with their treatment responsiveness.

"Painting a distinct proteome picture, this study has shown us that PROphet can predict response and analyze resistance for every patient, sub-grouping and differentiating them based on their resistance assessment," said Ofer Sharon, CEO of OncoHost. "In order to provide oncologists and patients with tangible, actionable clinical insights, it’s not enough to predict which patients will be more responsive to treatment; we should also understand the reason behind it. PROphet has allowed us to reach this deep level of resolution and insight."

The clinical study was conducted in collaboration with Sidney Kimmel Medical College at Thomas Jefferson University, The Ohio State University Wexner Medical Center, Sheba Medical Center, the Technion Institute of Technology and Tel Aviv University. The presentation will take place at SITC (Free SITC Whitepaper) on November 12, 2021, at 13:03 EST. This study will be published as a full peer-reviewed manuscript in 2022.

On November 12, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported three data presentations for its I-O pipeline at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Nektar Therapeutics, NOV 12, 2021, View Source [SID1234595494]).

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Initial clinical results were presented from the dose-escalation stage of a Phase 1/2 study of NKTR-255 in combination with cetuximab in a late-breaking abstract presented by Mehmet Altan, MD, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center on Friday, November 12th. Collaborator presentations of translational data for bempegaldesleukin in combination with nivolumab and bempegaldesleukin in combination with NKTR-262 data were also featured in two poster presentations by Arika S. Feils at the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health and Annah Rolig, PhD, Earle A. Chiles Research Institute, Providence Cancer Institute, respectively, on Friday, November 12th.

"The data presented at this year’s SITC (Free SITC Whitepaper) meeting highlight the strength of our cytokine portfolio and in particular the potential of NKTR-255 in the treatment of patients with solid tumors," said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. "We were excited to see early evidence of clinical benefit in the first patients treated in the dose-escalation portion of the study for NKTR-255 in combination with cetuximab which reinforces the promising synergy of IL-15 in combination with an antibody-dependent cellular cytotoxicity agent for the treatment of solid tumors."

2021 SITC (Free SITC Whitepaper) presentations are available for download at View Source

Highlights from the presentations are as follows:

Abstract 957: "NKTR-255 Plus Cetuximab in Patients with Solid Tumors: Interim Safety and Efficacy Results from the Phase 1b Dose Escalation Study", Altan, M., et al.

The combination of NKTR-255 + cetuximab was well tolerated at NKTR-255 doses of 1.5 and 3.0 μg/kg every three weeks (Q21D) and treatment-related adverse events were generally low-grade, transient, and easily managed.
Early evidence of on-target biological activity was observed with treatment with NKTR-255 leading to expansion and proliferation of Natural Killer (NK) cells and CD8+ T cells.
Early evidence of clinical activity was observed in 9 patients that were evaluable for efficacy [6 colorectal (CRC) patients, 3 squamous cell carcinoma of head and neck (SCCHN) patients] with 1 CRC patient achieving a confirmed partial response (PR) with 52% tumor reduction by RECIST and 5 patients experiencing stable disease (SD) by RECIST [3 CRC, 2 SCCHN] in this heavily pre-treated and highly refractory patient population. 8 of the 9 patients evaluable for efficacy had also received prior treatment with an EGFR-targeted therapy and/or a checkpoint inhibitor.
The maximum tolerated dose and recommended Phase 2 dose have not been reached yet and dose escalation of NKTR-255 + cetuximab is ongoing in patients with R/R SCCHN and CRC.
Abstract 59: "Associations between KIR/KIR-ligand genotypes and clinical outcome for patients with advanced solid tumors receiving BEMPEG plus nivolumab combination therapy in the PIVOT-02 trial", Feils, AS., et al.

Individuals who were positive for KIR2DL2 and its HLA-C1 ligand had significantly greater TS (p=0.01) and longer PFS (p=0.04) with a trend towards increased ORR (p=0.07).
No significant associations were found between an individual’s clinical outcome and their KIR3DL1 and HLA-Bw4 ligand status.
Individuals who were positive for both KIR2DL2 and KIR3DL1 with their HLA-C1 and HLA-Bw4 ligands, respectively, had significantly greater TS (p=0.04) and increased ORR with a trend towards longer PFS (p=0.07).
No significant associations were found between an individual’s clinical outcome and their KIR/KIR-ligand present versus missing status.
Abstract 596: "Combining Bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) pairs local innate activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.

BEMPEG+NKTR-262 preclinical efficacy is superior to BEMPEG+RT efficacy and relies on CD8+ T cells.
BEMPEG+NKTR-262 combination therapy produces a higher fraction of activated, tumor antigen-specific cytotoxic CD8+ T cells systemically, correlating with superior anti-tumor efficacy relative to BEMPEG+RT in preclinical models.
In preclinical models, BEMPEG+NKTR-262 therapy induces active (GzmA+, Ki-67+) AH1-A5-CD8+ T cell that are supported by type 1 IFN signaling, suggesting bystander T cell activity.
In preclinical models, BEMPEG+NKTR-262 combination therapy induces intratumoral CD8+ T cells that have increased activity as demonstrated by increased granzyme expression, increased cytolytic capacity, and reduced conversion to an exhausted phenotype (PD-1+).
Analyst Call with Cancer Specialist:

Nektar management will host an analyst and investor conference call to review the data presentation for NKTR-255 at SITC (Free SITC Whitepaper) 2021. The call will also include two invited speakers:

Mehmet Altan, MD, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center
Alan Tan, MD, Director of GU Medical Oncology and Assistant Professor in the Division of Hematology, Oncology and Cell Therapy at Rush University Medical Center
Date and Time: Friday, November 12, 2021 at 12:00 p.m. EST

Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 1769208)

Investors and analysts can also view slides and listen to the live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

Biography for Mehmet Altan, MD

Mehmet Altan, MD, is an Assistant Professor in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Dr. Altan is one of the lead investigators in the phase 1/2, dose-escalation and dose-expansion study of NKTR-255 in combination with cetuximab in patients with refractory 2nd and 3rd line metastatic colorectal cancer or metastatic head and neck cancer. His current research areas include identification of mechanisms for primary and secondary resistance to immunotherapies and predictive markers for immunotherapy toxicities. He also works on translational research projects for identification of spatiotemporal dynamics of the tumor microenvironment in response to immunotherapy to define potential therapeutic targets.

Biography for Alan Tan, MD

Alan Tan, MD, is an Assistant Professor in the Division of Hematology, Oncology and Cell Therapy at Rush Medical College. He specializes in kidney cancer, bladder cancer, prostate cancer and melanoma. He also has an extensive background in hematologic malignancies. Dr. Tan has clinical research interest in designing and implementing clinical trials to test novel immunotherapies and targeted therapies for renal cell carcinoma and GU malignancies. He also has interest in precision genomic cancer medicine, identifying molecular alterations that will serve as targets for individualized treatment strategies.

On November 12, 2021 Second Genome, a biotechnology company that leverages its proprietary platform sg-4sight to discover and develop precision therapies and biomarkers, reported that preclinical data demonstrating that the Company’s CXCR3-positive allosteric modulator, SG-3-00802, can reverse resistance to anti-programmed death protein-1 (PD-1) therapy, illustrating that the microbiome directly interacts with the human immune system to enhance immunity and impact antitumor activity (Press release, Second Genome, NOV 12, 2021, View Source [SID1234595493]). The data (E-Poster #569) were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, held virtually and in Washington, D.C. November 10-14.

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"We are encouraged by Second Genome’s growing body of preclinical data demonstrating that SG-3-00802’s differentiated mechanism of action has the potential to effectively target the tumor microenvironment and improve responses in combination with existing immunotherapies, such as checkpoint inhibitors and cytokines," said Karim Dabbagh, Ph.D., Chief Executive Officer at Second Genome. "At SITC (Free SITC Whitepaper), we presented new data showing SG-3-00802 potently enhances CXCR3 ligand-induced cell migration, a critical effector cell recruitment mechanism for anti-tumor immunity. We look forward to further advancing our program with an IND submission expected in 2022."

The poster presentation will be available for on-demand viewing on the SITC (Free SITC Whitepaper) website through January 9, 2022, and it will also be made available on the Company’s website at View Source

On November 12, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the third quarter of 2021 (Press release, CASI Pharmaceuticals, NOV 12, 2021, View Source [SID1234595492]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $8.1 million in EVOMELA revenues for the quarter. We remain confident in our guidance for our full-year 2021 revenue growth to exceed 2020 revenues by over 80%. This continued growth further demonstrates our 100+ person sales and marketing team’s ability to cover all major hospitals and key multiple myeloma transplant physicians. We look forward to leveraging this success in the anticipated launch of our next product, Juventas’ CNCT-19, which our partner announced has officially entered phase II of a registered clinical trial, and other products."

Dr. He continued, "Our partner BioInvent announced additional positive, interim top-line data from the Phase 1/2a clinical trial of its novel anti-FcγRIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). BI-1206, in combination with rituximab, demonstrated an objective response rate (ORR) of 50%, with three complete responses and three partial responses seen in twelve patients evaluated for therapeutic benefit. The treatment stabilized the disease in one additional patient, giving a disease control rate of 58% (7 out of 12 patients). We believe BI-1206 has potential application across multiple tumor types in both first-line treatments and relapsed/refractory settings. Additionally, our CNCT-19 CAR-T partner, Juventas, completed a Series C financing round through which it raised more than RMB410 million (approximately $63 million USD). CASI has a 12.01% ownership stake in Juventas and shares global co-commercial and profit-sharing rights for CNCT-19 with Juventas. We believe this financing will allow Juventas to continue the rapid development and registration of CNCT-19 in China. Overall, we are pleased with our momentum and will continue to execute on key milestones across our broad portfolio in the quarters ahead."

Third Quarter 2021 Financial Results

Revenues consist of product sales of EVOMELA that launched during August 2019. Revenue was $8.1 million for the three months ended September 30, 2021 compared to $4.2 million for the three months ended September 30, 2020. Revenues increased by 93% in the third quarter of 2021 as compared to same quarter in 2020 due to the continued strong growth in EVOMELA sales.

Costs of revenues were $3.4 million for the three months ended September 30, 2021, compared to $1.8 million for the three months ended September 30, 2020, which includes royalty payment of $1.6 million and $0.8 million for the same period. Costs of revenues excluding royalty were $1.8 million and $1.0 million for the three months ended September 30, 2021, and 2020. Costs of revenues, excluding royalty as a percentage of revenues, decreased significantly in the three months ended September 30, 2021, compared within the three months ended September 30, 2020, due to the alternate manufacturer in place, resulting in a considerable decrease in the unit cost of inventories of EVOMELA.

General and administrative expenses for the three months ended September 30, 2021 were $5.3 million, compared with $5.3 million for the three months ended September 30, 2020.

Selling and marketing expenses for the three months ended September 30, 2021 were $3.4 million, compared with $2.1 million for the three months ended September 30, 2020. The increase in selling and marketing expenses was due to expansion of sales team in China in 2021.

R&D expenses for the three months ended September 30, 2021 were $2.9 million, compared to $2.8 million for the three months ended September 30, 2020.

Net loss for the three months ended September 30, 2021 was $10 million compared to $16.7 million for the three months ended September 30, 2020 due to the increase in revenues. As of September 30, 2021, CASI had cash and cash equivalents of $53.1 million compared to $57.1 million as of December 31, 2020.
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, can be found at www.casipharmaceuticals.com.

Conference Call

The conference call can be accessed by dialing 1-877-870-4263 (U.S.) or 1-412-317-0790 (international) and ask to be joined into the CASI Pharmaceuticals call to listen to the live conference call.

This call will be recorded and available for replay by dialing 1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and enter 10160251 to access the replay.