On October 5, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported an oral presentation and a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, taking place in Boston, MA or virtually from November 8 to 12, 2022 (Press release, CRISPR Therapeutics, OCT 5, 2022, View Source [SID1234621713]).

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Title: CTX130 allogeneic CRISPR-Cas9–engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: Results from the Phase 1 COBALT-RCC study
Abstract Number and Type: 558, oral
Session Number: 113, Cellular Therapies + Bispecifics
Date and Time: Thursday, November 10, 2022, 5:37 PM ET

Title: CRISPR/Cas9 gene-edited, allogeneic anti-CD83 CAR-T cells demonstrate potent activity in GvHD and AML tumor models
Abstract Number and Type: 367, poster
Date and Time: Thursday November 10, 2022, 9:00 am – 9:00 pm

On October 5, 2022 The Case Comprehensive Cancer Center (Case CCC) reported that it received a $2 million grant through the Alliance for Equity in Cancer Care (the Alliance), an initiative funded by the Merck Foundation (the Foundation) and designed to make cancer care more equitable in the United States by helping patients living in underserved communities receive timely access to high-quality, culturally responsive care (Press release, Case Western Reserve University, OCT 5, 2022, View Source [SID1234621712]).

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"This is a very transformative initiative," said Stan Gerson, dean of the Case Western Reserve University School of Medicine and acting director of the Case CCC. "The funding provided by this award will help Case Comprehensive Cancer Center and our partnering organizations address the needs of our region’s most medically vulnerable by creating a multi-level intervention model that promotes delivery of cancer-care services to ensure earlier detection, earlier-stage diagnoses, informed cancer treatment decision-making and patient tailored treatment."

Nearly 40% of Americans will be diagnosed with cancer in their lifetime, according to the National Cancer Institute. Members of racial and ethnic minority groups, those living in rural areas, low-income individuals and the uninsured are disproportionately affected by cancer, yet often have limited access to cancer screenings, care and treatment.

In 2019, Cleveland proper was ranked in U.S. Census data as the poorest "big city" in the country and, based on the Ohio Cancer Incidence Surveillance System, is observed to have among the sharpest racial/ethnic disparities in lung, prostate, breast and colorectal cancer mortality in Northeast Ohio.

Data from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System study reveals far lower-than-recommended mammogram and colorectal cancer screening rates throughout the Case CCC’s 15-county service area.

Through the Alliance, a new collaborative effort has been forged by Case CCC, Care Alliance Health Center, El Centro, University Hospitals Accountable Care Organization, University Hospitals Seidman Cancer Center and The Gathering Place, titled PARTNERS: Promoting Access, Resources and Treatment through Novel and Equitable Solutions for Cancer Care.

Erika Trapl (left) and Jennifer Cullen
PARTNERS, led by Erika Trapl, associate director of community outreach and engagement, and Jennifer Cullen, associate director of cancer population sciences—both members of Case CCC and faculty at the Case Western Reserve School of Medicine—will address cancer disparities in access to screening and fragmentation of care for cancer patients. The project will implement patient navigation to improve access to cancer screening, timely follow-up care for suspicious findings and, ultimately, timely cancer treatments and psychosocial cancer support.

PARTNERS aims to serve those experiencing the greatest cancer burden in the Case CCC and those who are in greatest need for intervention to improve equity in cancer care: men and women 45 years and older who are African American or Latino/Latina and /or individuals with incomes near or at the poverty level.

"The severity of the need to take action on advancing equity in cancer care cannot be overstated and will not be overlooked," said Carmen Villar, CEO of the Merck Foundation. "We must move with urgency and work together to provide all people living with cancer access to high-quality care and treatment. The creation of the Alliance is an important step toward ensuring social determinants of health no longer factor into an individual’s ability to receive vital healthcare."

In addition to Case CCC, the Alliance program grantees include: Boston Medical Center; Conquer Cancer, the ASCO (Free ASCO Whitepaper) Foundation; Mary Bird Perkins Cancer Center; Memorial Sloan Kettering Cancer Center; RWJ Barnabas Health; and University of Kentucky Markey Cancer Center. The Foundation is also supporting a National Program Office at Virginia Commonwealth University (VCU) Massey Cancer Center, in partnership with the VCU Center on Health Disparities, which will assist Alliance program grantees in building partnerships with community-based organizations and provide technical assistance to support their programs.

The Alliance program grantees will meet regularly with the National Program Office to discuss lessons learned, share insights, , and explore tangible actions to support the delivery of equitable cancer care within their local communities and beyond. The National Program Office will evaluate the effectiveness of Alliance programs and identify and promote best practices that can enhance the delivery of cancer care in the United States.

On October 5, 2022 Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies that are safe and accessible to cancer patients, reported that an abstract highlighting further in vivo and in vitro preclinical data for AB-101, the Company’s clinical-stage ADCC-enhancer product candidate, was accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, to be held virtually and at the Boston Convention & Exhibition Center from November 8 to 12, 2022 (Press release, Artiva Biotherapeutics, OCT 5, 2022, View Source [SID1234621710]).

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Details of the presentation are as follows:

The abstract will be available for viewing on November 7 at 8:00 am EST at the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC) website (JITC link to be provided on the SITC (Free SITC Whitepaper) Annual Meeting website at View Source). The poster will also be available for viewing on November 10 at 9:00 am EST at View Source.

The poster will present data on the universal use of an ADCC-enhancer NK cell, AB-101, in combination with ADCC-mechanistic therapeutic antibodies and will describe a broader set of antibody combinations beyond rituximab. Artiva is conducting a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.

On October 5, 2022 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported that GSK’s study PERLA, a head-to-head trial of JEMPERLI vs. Keytruda in patients with metastatic non-squamous non-small cell lung cancer, met its primary endpoint of objective response rate (ORR) of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy as assessed by blinded independent central review per RECIST v1.1 (Press release, AnaptysBio, OCT 5, 2022, View Source [SID1234621709]).

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GSK expects to present full results from the PERLA trial, including the primary endpoint of ORR and the key secondary endpoint of progression-free survival, with results by programmed death ligand-1 (PD-L1) expression subgroups, at an upcoming scientific meeting.

AnaptysBio also announced today that GSK is advancing both arms of the COSTAR Lung clinical trial from Phase 2 to Phase 3, testing both doublet and triplet combinations of dostarlimab plus chemotherapy, and cobolimab plus dostarlimab plus chemotherapy in advanced non-small cell lung cancer. This decision follows the recommendation of the trial’s Independent Data Monitoring Committee, reflecting the achievement of pre-specified efficacy and safety criteria per the COSTAR protocol.

The COSTAR Lung Phase 3 trial is a randomized, open label 3-arm trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy. AnaptysBio expects to receive a $5 million milestone payment from GSK upon dosing of the first patient with cobolimab in the Phase 3 portion of COSTAR.

JEMPERLI and cobolimab were discovered at AnaptysBio and licensed to TESARO, Inc., now a part of the GSK group of companies, under a Collaboration and Exclusive License Agreement signed in March 2014. GSK is responsible for the ongoing research, development, commercialization and manufacturing of each of these monoclonal antibody therapies under the agreement.

"We are encouraged to see immuno-oncology molecules discovered at Anaptys delivering differentiated outcomes and advancing on multiple fronts by GSK," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We intend to leverage our strong capital position, which has been supported in part from the partial monetization of potential future royalty streams from this immuno-oncology portfolio, as we focus on the R&D of our novel immune cell modulator pipeline. This includes our two checkpoint agonists in clinical-stage development, rosnilimab, a PD-1 agonist, and ANB032, a BTLA-agonist, which act directly on cell types mediating disease pathology and have the potential to treat a broad range of autoimmune and inflammatory disorders."

About PERLA
The PERLA phase 2 trial is a global, randomized, double-blind trial of 243 patients evaluating the efficacy and safety of dostarlimab plus chemotherapy compared to pembrolizumab plus chemotherapy in patients with metastatic non-squamous NSCLC without a known sensitizing epidermal growth factor receptor, anaplastic lymphoma kinase, or receptor tyrosine kinase-1 mutation, V600E mutation of the BRAF gene or other genomic mutation for which an approved targeted therapy is available. Patients were randomized 1:1 to receive either dostarlimab 500 mg intravenous (IV) or pembrolizumab 200 mg IV every three weeks in combination with chemotherapy. Patients were stratified by PD-L1 expression (TPS <1% versus 1%–49% versus ≥50%) and smoking status (never vs former/current). The primary endpoint was objective response rate of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy assessed by blinded independent central review per RECIST v1.1. Secondary endpoints include overall survival, investigator-assessed progression-free survival per RECIST v1.1, and safety.

About COSTAR Lung
The COSTAR Lung trial (NCT04655976) is a phase 2/3 global, randomized, open-label trial of 750 patients. The study evaluates the efficacy and safety of cobolimab plus dostarlimab plus docetaxel and dostarlimab plus docetaxel compared to docetaxel in patients with advanced non-squamous and squamous NSCLC whose disease had progressed on prior therapy with an anti-PD-(L)1 agent and a platinum doublet-based chemotherapy given in combination or in sequence. The study does not include patients with a known sensitizing epidermal growth factor receptor, anaplastic lymphoma kinase, or receptor tyrosine kinase-1 mutation, for which an approved targeted therapy is available. Patients are randomized 2:2:1 to receive either cobolimab 300 mg plus dostarlimab 500mg plus docetaxel 75 mg/m2 intravenous (IV) every three weeks (Q3W) or dostarlimab 500mg plus docetaxel 75 mg/m2 IV Q3W or docetaxel 75 mg/m2 IV Q3W. Patients are stratified by prior line of therapy (1 vs 2), PD-L1 expression (TPS ≥50% versus <50%) and histology (non-squamous vs squamous). The primary endpoint at interim analysis 1 (IA1) was objective response rate between arms as assessed by blinded independent central review per RECIST v1.1 and evaluated by an independent data monitoring committee (IDMC). The primary endpoint at final analysis is overall survival.

About JEMPERLI (dostarlimab-gxly)
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.vii JEMPERLI is being investigated in registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumors or metastatic cancers. JEMPERLI is not approved anywhere in the world in combination with chemotherapy in first-line patients with metastatic non-squamous NSCLC or in combination with other agents to treat patients with advanced NSCLC who have progressed on prior anti-PD-L1 therapy and chemotherapy.

About Cobolimab
Cobolimab is an investigational monoclonal antibody against the inhibitory receptor, T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3), with potential immune checkpoint inhibitory and antineoplastic activities.

On October 5, 2022 4D pharma plc (AIM: DDDD) (in administration), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting (SITC 2022), held from November 8-12, 2022 (Press release, 4d Pharma, OCT 5, 2022, View Source [SID1234621708]). The two e-posters will be available from 2.00 pm GMT (9.00 am ET) on November 10, 2022, via the 4D pharma website at www.4dpharmaplc.com.

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"With these two presentations at SITC (Free SITC Whitepaper) 2022, 4D pharma continues to generate clinical data deepening our understanding of the mechanisms driving the activity of MRx0518 to both overcome resistance to checkpoint inhibitors, and act as a monotherapy in the treatment of solid tumors," commented Alex Stevenson, Chief Scientific Officer, 4D pharma. "These data are further evidence of the positive effects of a single strain Live Biotherapeutic on both the human immune system and the microbiome, leading to better treatment outcomes for patients."

Poster presentation details are as follows:

Presentation Title: Combination of MRx0518 and anti-PD-1 overcomes checkpoint inhibitor resistance via myeloid modulation

Presenting Author: Dr. June Li, Research Scientist, Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center

Abstract Number: 838

Presentation Title: Oral administration of MRx0518 in treatment-naïve cancer patients is associated with compositional taxonomic and metabolomic changes indicative of anti-tumorigenic efficacy

Presenting Author: Dr. Mark P. Lythgoe, Academic Clinical Fellow in Medical Oncology and Pharmacist, Imperial College London

Abstract Number: 627

On 24 June 2022, David Pike and James Clark of Interpath Advisory were appointed as administrators of 4D pharma plc. The administrators have had no oversight of or involvement in the preparation of the SITC (Free SITC Whitepaper) 2022 poster presentations nor in any materials which will be circulated in advance of or during SITC (Free SITC Whitepaper) 2022. Therefore, the administrators make no statement or representation in respect of the materials shared or discussed in advance of or during SITC (Free SITC Whitepaper) 2022.

About MRx0518

MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumors. It is currently being evaluated in three clinical trials in cancer patients. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients who have previously progressed on anti PD-1 therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. A fourth clinical trial is planned, in collaboration with Merck KGaA and Pfizer Inc., of BAVENCIO (avelumab) in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.