On October 17, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it will host its R&D Day 2022 for analysts, investors and financial press on Friday, 4 November 2022 (Press release, Galapagos, OCT 17, 2022, View Source [SID1234622067]).

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The live event will take place at the Yale Club in New York City from 8:00 am to 10:30 am EDT (13.00 to 15.30 CET). The event will feature presentations by key opinion leaders (KOLs) and management on the company’s strategic objectives, scientific pipeline and commercial progress. The company will also discuss its third quarter financial results, which are scheduled to be published on 3 November 2022.

A live webcast of the event will be accessible through the Investor Center on the company’s website and will be available for replay following the event. Interested parties can register for the webcast utilizing the following link: webcast registration, and participate in the Q&A by telephone conference via the following link: telephone conference registration.

On October 17, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the first patient has been dosed in the Phase 2 portion of its registrational Phase 1/2 clinical trial evaluating GC007g for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) being conducted in China (Press release, Gracell Biotechnologies, OCT 17, 2022, View Source [SID1234622066]).

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GC007g is Gracell’s allogeneic, human leukocyte antigen (HLA)-matched, donor-derived, CD19-directed CAR-T cell therapy candidate under development for the treatment of a subset of B-ALL patients who relapsed after allogeneic human stem cell transplant (allo-HSCT). This donor-derived CAR-T approach has been designed for r/r B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other unsuitable conditions.

Data from the Phase 1 trial showed encouraging efficacy and a favorable safety profile. The registrational Phase 2 trial is being conducted in China and will further assess the safety and efficacy of GC007g in r/r B-ALL patients at the recommended Phase 2 dose.

"B-ALL patients that relapse after allo-HSCT therapy often face poor prognoses, and remain a patient population with a clear unmet medical need. Donor-derived CAR-T therapy could provide a new option to some of these patients who might be ineligible for other treatments including autologous CAR-T therapy," said Dr. Wendy Li, Chief Medical Officer of Gracell. "We believe GC007g is a potential first-in-class donor-derived allogeneic CAR-T therapy in China. GC007g is also Gracell’s first therapeutic candidate to enter a registrational trial, marking an important milestone in our quest to transform cell therapy."

About GC007g

GC007g is an allogeneic CD19-targeted CAR-T cell therapy, derived from HLA-matched donors, under development for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy.

About ALL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with an estimated 6,660 new cases to be diagnosed in the United States in 2022 [1]. B-ALL accounts for 75% of ALL diagnoses in adults.

On October 17, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that an abstract reporting on preclinical studies of two the company’s oncology pipeline products targeting multiple types of cancer has been accepted for presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy 2022 (Press release, PDS Biotechnology, OCT 17, 2022, View Source [SID1234622065]). The AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Conference is being held October 21-24, 2022, in Boston.

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Versamune is PDS Biotech’s novel investigational T cell activating platform designed to stimulate a precise immune system response to cancer-specific proteins. The abstract accepted for presentation at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Conference highlights the development of Versamune based drug formulations containing multi-epitope peptide antigen sequences of the tumor-associated protein TARP (T cell receptor gamma chain Alternate Reading frame Protein) and modified sequences of novel Mucin 1 oncoprotein (MUC1). This research provided the foundation for the development of PDS0102 as a potential treatment for TARP-associated acute myeloid leukemia (AML), prostate, and breast cancers, and PDS0103 as a potential treatment for MUC1-associated breast, colon, lung, ovarian, and other cancers.

"Our Versamune platform provides an opportunity to address a myriad of cancers by combining the technology with unique proteins or peptides that are specific to the cancer. The research accepted for presentation at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Conference highlights this important versatility of the platform and, specifically, the rationale for our PDS0102 and PDS0103 programs," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "We welcome the opportunity to present at such a highly influential conference. Based on recently reported clinical results from our ongoing studies of PDS0101 in HPV-positive cancers such as anal, cervical, head and neck, penile, vaginal, and vulvar cancers, we continue to expand our Versamune based programs into TARP-associated AML, prostate and breast cancers, and MUC1-associated breast, colon, lung, ovarian and other cancers."

Poster Number: B24
Abstract Title: Development of targeted T cell cancer immunotherapies based on a novel enantiomeric cationic lipid that promotes antigen cross-presentation and upregulation of type I interferons
Authors: Siva K. Gandhapudi, Karuna Sundarapandiyan, Martin Ward, Afsheen Fatima, Mania Dorrani, Mary Banoub, Joe Dervan, Lauren Wood, Greg Conn, and Jerold G. Woodward
Session Date and Time: Sunday, October 23 at 6:00-8:30 pm ET

On October 17, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported the award of a U.S. Federal Supply Schedule contract which includes the Veterans Health Administration providing care for U.S. Veterans and Military Health System providing care for active-duty service members and their families (Press release, Biodesix, OCT 17, 2022, View Source [SID1234622064]). The contract covers the company’s entire lung diagnostic portfolio: Nodify XL2, Nodify CDT, VeriStrat, GeneStrat ddPCR, and GeneStrat NGS testing. The U.S. Department of Veterans Affairs ("VA") is the largest integrated health care system in the United States and provides care at 1,298 health care facilities, including 171 VA Medical Centers and 1,113 outpatient sites of care of varying complexity to over 9 million veterans enrolled in the VA health care program.

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"Partnering with the VA health system represents a large opportunity for Biodesix to help improve care for Veterans by integrating our five diagnostic tests into our country’s largest health system," said Scott Hutton, CEO of Biodesix. "An estimated 900,000 Veterans face an elevated risk and a 25% higher likelihood of developing lung cancer compared to the general population. We pride ourselves on being a patient-centric lung disease company, focused on providing healthcare professionals with diagnostic tools capable of transforming the standard of care and improving outcomes. We are pleased to be aligning with the VA in this effort to improve care for our Veterans."

Lung cancer is the deadliest cancer worldwide and despite the large number of treatments available to improve patient outcomes, it remains an area of unmet needs. Biodesix offers healthcare providers and patients a comprehensive suite of diagnostic tests capable of supporting clinical decision-making across the lung cancer continuum – from initial risk assessment of lung nodules with the Nodify Lung testing strategy, to post-cancer diagnosis treatment guidance and monitoring with the IQLung testing strategy. The Biodesix Nodify Lung testing strategy consists of two blood-based proteomic tests, the Nodify CDT and Nodify XL2 tests, designed to help healthcare professionals quickly and confidently decipher the risk of malignancy of a lung nodule. The Company’s IQLung Treatment Guidance testing consists of three blood-based tests, the GeneStrat NGS and the GeneStrat ddPCR genomic tests, and the VeriStrat proteomic test, which together provide a broader view of each patient’s disease state and empower healthcare professionals with a testing strategy for any stage of non-small cell lung cancer (NSCLC), delivering timely biological insights to help expedite personalized treatment decisions.

On October 17, 2022 NKGen Biotech, Inc., a biotechnology company harnessing the power of the body’s immune system through the development of natural killer (NK) cell therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to commence a Phase 1, open-label, dose-escalation study of its cryopreserved "off-the-shelf" allogeneic blood-derived NK cell therapy (SNK02) to evaluate safety and tolerability in participants with pathologically confirmed solid tumors refractory to standard of care therapy (Press release, NKMax America, OCT 17, 2022, View Source [SID1234622063]).

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"We are excited to be able to proceed with our SNK02 clinical trial plans for treating refractory cancer patients who are left with limited options," said Paul Song, M.D., Vice Chairman of NKGen Biotech. "I believe that SNK02 is the first cryopreserved allogeneic NK cell therapy that does not require lymphodepletion before administration unlike other cell therapies. This clearance for SNK02 is an important milestone in our pursuit to bring life-changing therapies to cancer patients and will be our second clinical NK cell therapy program focusing on solid tumors, following our SNK01 autologous product entering Phase 2 studies next year."

The SNK02 clinical study will be a multi-center, open label, Phase 1 study of SNK02 in patients with advanced solid tumors who have failed at least one prior standard of care therapy. The objectives are to evaluate the safety and tolerability of SNK02 and to determine the maximum tolerated dose. Initiation of the Phase 1 study in the U.S. is expected in Q1 2023.

NKGen Biotech’s patented manufacturing process produces billions of NK cells with a high level of purity and receptor expression while our cryopreservation process allows us to maintain significant cytotoxicity making SNK02 an ideal candidate for clinical trials treating solid tumors. The company expects to see promising clinical results in the future as it continues to advance its cell therapy pipeline to address areas of unmet medical needs.