On October 5, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported two upcoming poster presentations for CCX559, the Company’s investigational, highly potent, orally administered PD-L1 checkpoint inhibitor, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, held November 8-12, 2022, in Boston, MA (Press release, ChemoCentryx, OCT 5, 2022, View Source [SID1234621736]).

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ChemoCentryx Poster Presentations at SITC (Free SITC Whitepaper) 37th Annual Meeting (November 8-12, 2022):

Results From an Ongoing Open-Label, Multicenter, Phase 1 Trial of CCX559, an Orally Administered Small Molecule PD-L1 Inhibitor, in Patients with Advanced Solid Tumors

Abstract Number: 769
Location: Hall C
Presentation Time: November 10, 2022, 11:40 a.m. – 1:10 p.m. ET
Poster Viewing Time: November 10, 2022, 9:00 a.m. – 9:00 p.m. ET

The Small Molecule PD-L1 Inhibitor CCX559 Preferentially Accumulates in Tumors, Resulting in Depletion of Cell-Surface PD-L1 in a Murine Preclinical Model

Abstract Number: 499
Location: Hall C
Presentation Time: November 10, 2022, 11:40 a.m. – 1:10 p.m. ET
Poster Viewing Time: November 10, 2022, 9:00 a.m. – 9:00 p.m. ET

About CCX559

CCX559 is a highly potent orally administered small molecule PD-L1 checkpoint inhibitor. Preclinical characterization has demonstrated that CCX559 blocks binding to PD-1 and CD80, and prevents PD-L1 inhibition of T cell activation. CCX559, when orally administered in animal models, demonstrated anti-tumor efficacy, including the ability to induce complete responses.

The PD-L1/PD-1 interaction is one of the major immune checkpoints that limits the ability of effector T cells to destroy cancer cells. As a potential next generation therapy, an orally administered small molecule inhibitor of PD-L1 could have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects and convenience of oral administration.

During 2021, ChemoCentryx initiated a first-in-human Phase I dose escalation study to evaluate the safety, tolerability, PK, and PD of CCX559 in patients with various types of advanced cancer. In early 2023, the Company plans to advance CCX559 into a Phase Ib/II clinical trial to measure anti-tumor effects of CCX559 more directly.

On October 5, 2022 Fortress Biotech, Inc. (Common Stock: Nasdaq: FBIO) (Preferred Stock: Nasdaq: FBIOP) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported its board of directors has declared the regular monthly dividend of $0.1953125 per share of the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the "Series A Preferred Stock") for the months of October, November and December 2022 (Press release, Fortress Biotech, OCT 5, 2022, View Source [SID1234621735]). The dividend will be payable on the last day of each month (October 31, November 30, and December 31) to holders of record as of the close of business on the fifteenth of that same month (October 15, November 15, December 15). Dividends will be paid in cash.

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Going forward, future notifications related to dividends for the Series A Preferred Stock will be disclosed on the Fortress website in the Investors section on the FBIOP Announcements page under Resources, View Source In addition, investors will also be able to find Form 8937s related to FBIOP on the same page.

On October 5, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that it will present a Trial in Progress poster at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held in Boston and virtually from November 8 –12, 2022 (Press release, Poseida Therapeutics, OCT 5, 2022, View Source [SID1234621734]).

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The poster presentation will highlight the trial design, dosing regimen, and study protocol for the Company’s ongoing Phase 1 clinical trial of P-MUC1C-ALLO1. The multi-center, open-label, dose escalation study is evaluating patients with locally advanced or metastatic epithelial derived solid tumors that are refractory to standard of care therapy or ineligible or refused another existing treatment. The study is following a 3+3 design and is evaluating the safety, tolerability, and preliminary efficacy of P-MUC1C-ALLO1. The Company expects to report initial clinical data from this trial by the end of 2022 or early 2023.

Details of the presentation are as follows:

Title: Phase 1 study of P-MUC1C-ALLO1 allogeneic CAR-T cells in patients with epithelial-derived cancers
Presenter: Jason Henry, MD, Sarah Canon Research Institute
Session Date and Time: Poster Hall opens Friday, November 11, 2022, 9:00 AM – 8:30 PM ET
Abstract Number: 728
Location: Boston Convention & Exhibition Center, Hall C

The poster will also be available to meeting attendees through the virtual poster hall on the SITC (Free SITC Whitepaper) virtual meeting platform.

About P-MUC1C-ALLO1
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in Phase 1 development for multiple solid tumor indications. Poseida believes P-MUC1C-ALLO1 has the potential to treat a wide range of solid tumors derived from epithelial cells, such as breast, colorectal, lung, ovarian, pancreatic and renal carcinomas, as well as other cancers expressing a cancer-specific form of the Mucin 1 protein, or MUC1-C. P-MUC1C-ALLO1 is designed to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both triple-negative breast and ovarian cancer.

On October 5, 2022 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting updated data from Part B of the DisTinGuish Study evaluating DKN-01 in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, in second-line gastroesophageal junction/gastric (GEJ/G) cancer patients whose tumors express high levels of DKK1 (DKK1-high) at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting being held in Boston, MA on November 8-12, 2022 (Press release, Leap Therapeutics, OCT 5, 2022, View Source [SID1234621733]).

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Leap will also present preclinical DKN-01 data supporting the DeFianCe Study, a Phase 2 study of DKN-01 in combination with bevacizumab and standard of care chemotherapy in patients with advanced colorectal cancer who have received one prior systemic therapy.

On October 5, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that two abstracts with new data on the company’s novel innate cell engager (ICE) AFM24 have been accepted for poster presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Affimed, OCT 5, 2022, View Source [SID1234621732]). The conference will take place on November 8-12, 2022, in Boston, MA.

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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

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Poster Presentation Details
Poster Number: 729
Title: Targeting Epidermal Growth Factor Receptor (EGFR)-Expressing Solid Tumors with AFM24, a Novel CD16A Bispecific Innate Cell Engager: Comprehensive Correlative Science Findings from a Phase 1 Study
Authors: Gabriele Hintzen, Susanne Wingert, Michael Emig, Pilar Nava-Parada, Kerstin Pietzko, Laura Kohlhas, Uwe Reusch, Melissa M. Berrien‐Elliott, Todd A. Fehniger, Mark Foster, Paolo Nuciforo, Ester Castillo Andreo, Sina Staeble, Paulien Ravenstijn, Bettina Rehbein, Erich Rajkovic, Arndt Schottelius, Joachim Koch
Date, Time, and Location: The poster session will take place on Thursday, November 10, 2022, from 9:00 a.m. to 9:00 p.m. EST, in the Boston Convention & Exhibition Center, Poster Hall C. Required hours are 11:40 a.m. – 1:10 p.m. and 7:30 – 9:00 p.m. (poster reception).

Poster Number: 746
Title: AFM24 and Atezolizumab Combination in Patients with Advanced Epidermal Growth Factor Receptor-expressing (EGFR+) Solid Tumors: Initial Results from the Phase 1 Dose-escalation Study
Authors: Omar Saavedra, Daniela Morales-Espinosa, Juanita Lopez, Eric Christenson, Anthony El Khoueiry, Andrés Cervantes, Christa Raab, Ulrike Gärtner, Kerstin Pietzko, Laura Kohlhas, Daniel Schütz, Gabriele Hintzen, Paulien Ravenstijn, Michael Emig, Pilar Nava-Parada
Date, Time, and Location The poster will be shown on Friday, November 11, 2022, from 9:00 a.m. to 8:30 p.m. EST, in the Boston Convention & Exhibition Center, Poster Hall C. Required hours are: 11:55 a.m. – 1:25 p.m. and 7:00 – 8:30 p.m. (poster reception).

Additional Information
More details about the SITC (Free SITC Whitepaper) Annual Meeting program are available at www.sitcancer.org. Full abstracts will be made public on November 7, 2022, 8:00 a.m. EST. In addition, e-posters will be available on the SITC (Free SITC Whitepaper) 2022’s Virtual ePoster Hall to attendees.

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is evaluating AFM24 as monotherapy and in combinations with other cancer treatments in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450.

AFM24 is also being evaluated in a phase 1/2a study in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442).

Furthermore, Affimed and NKGen Biotech initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with NKGen Biotech’s NK cell SNK01 (NCT05099549).