On April 27, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that translational data for lifileucel in patients with metastatic melanoma will be highlighted at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, to be held June 3-7, 2022 at McCormick Place in Chicago, Ill. and online (Press release, Iovance Biotherapeutics, APR 27, 2022, View Source [SID1234613034]). The abstract title is as follows:

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Abstract Title: Tumor mutational burden (TMB) in immune checkpoint inhibitor (ICI)-naïve and -experienced patients with metastatic melanoma treated with lifileucel, a tumor-infiltrating lymphocyte (TIL) cell therapy
Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: Hall A and On Demand
Abstract Number: 9524

On April 27, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that it will host an R&D call on Tuesday, May 03, 2022 at 9:00 AM Eastern Time (Press release, Panbela Therapeutics, APR 27, 2022, View Source [SID1234613050]). Panbela’s management team will be joined by leading experts for a deep dive on the company’s investigational drug, SBP-101, as a polyamine metabolism modulator in ovarian cancer.

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Replay Link: View Source

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On April 27, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported an independent, peer-reviewed article published in Clinical Gastroenterology and Hepatology (Press release, Castle Biosciences, APR 27, 2022, View Source [SID1234613067]). The study, which can be viewed here, reinforces the ability of TissueCypher to significantly improve predictions of progression to esophageal cancer in patients with Barrett’s esophagus (BE), compared to predictions based on clinical and pathology variables alone, allowing for more informed disease management decisions.

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"One of the most critical challenges in the management of the nearly 384,000 patients with Barrett’s esophagus who undergo an endoscopy each year is determining which are at risk of progression to esophageal cancer," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "In this study, TissueCypher outperformed expert pathologist evaluations, which relied solely on commonly used clinical and pathologic variables, in risk-stratifying patients for progression, particularly those at highest risk of developing esophageal cancer."

"Of particular importance in this study was the ability of the test to identify high-risk patients who progressed to high-grade dysplasia (HGD) or esophageal cancer, yet were initially diagnosed as non-dysplastic BE (NDBE)," said Prasad G. Iyer, M.D., M.Sc., lead study author and professor of medicine in the Barrett’s Esophagus Unit of the Division of Gastroenterology and Hepatology at the Mayo Clinic, Rochester, Minn. "In clinical practice, the majority of BE patients who develop esophageal cancer are diagnosed as NDBE at their baseline endoscopy. Many of these are missed by traditional standard of care, and importantly, miss the opportunity of early interventions that could potentially prevent their progression to the highly lethal esophageal cancer, or at a minimum, increase their chances of survival."

"TissueCypher has the potential to help change this," added Maetzold.

In the manuscript titled, "Prediction of Progression in Barrett’s Esophagus Using a Tissue Systems Pathology Test: A Pooled Analysis of International Multicenter Studies," Iyer et al. at Mayo Clinic and Case Western Reserve University evaluated the risk-stratification performance of TissueCypher using patient-level data from five published clinical validation studies that included a total of 552 patients with BE.

In the study, 51.8% (n=58) of the 112 patients diagnosed as NDBE who progressed to HGD or esophageal cancer received an intermediate- or high-risk TissueCypher score, representing a sensitivity of 52% in detecting this subset of progressors who are often missed by the current standard of care. Further, a TissueCypher high-risk score was associated with a strong (Odds Ratio (OR)=14.3) independent risk of progression in NDBE patients. When incorporated with expert pathologist review and clinical risk variables, TissueCypher was associated with further improved risk predictions versus those made without the test’s results (c-statistic=0.72 with TissueCypher versus 0.63 without, p<0.0001).

In the study, a TissueCypher high-risk score independently predicted increased risk of progression to HGD/esophageal cancer (OR=6.0, 95% Confidence Interval (CI)=2.99-12.01, p<0.001), with improved accuracy over expert pathologist diagnoses of low-grade dysplasia (LGD) (OR=2.92, 95% CI=1.18-7.24, p<0.021) and indefinite for dysplasia (IND) (OR=2.13, 95% CI=0.76-5.99, p=0.15). Additionally, when the TissueCypher score was incorporated with expert pathologist review of biopsied tissue and other clinical risk variables, the risk prediction accuracy was significantly improved (c-statistic=0.75 with TissueCypher versus 0.68 without, p<0.0001), which suggests that TissueCypher can be added into existing clinical care plans to help guide more personalized and risk-aligned management of BE patients.

About TissueCypher Barrett’s Esophagus Test

The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). The TissueCypher Barrett’s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by eight peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

On April 27, 2022 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that four abstracts with clinical trial designs and clinical data of its innate cell engagers (ICE) have been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago, IL (Press release, Affimed, APR 27, 2022, View Source [SID1234613158]).

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The events include an oral presentation by Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center with an update of the study that evaluates AFM13 pre-complexed with NK cells in patients with relapsed/refractory CD30-positive lymphomas. In addition, three "Trial in Progress" posters will be presented to provide background information and introduce the study design of the three ongoing AFM24 studies in which patients with EGFR-positive solid tumors are treated with AFM24 monotherapy or combinations with either Roche’s checkpoint inhibitor atezolizumab or NKGen Biotech’s NK cell product SNK01.

Oral presentation details:
Title: Innate cell engager (ICE) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with refractory/relapsed CD30+ lymphoma
Authors: Yago Nieto, Pinaki Banerjee, Indreshpal Kaur, Roland Bassett, Lucila Kerbauy, Rafet Basar, Mecit Kaplan, Lori Griffin, Daniel Esqueda, Christina Ganesh, Melissa Barnett, Amin Alousi, Chitra Hosing, Jeremy Ramdial, Neeraj Saini, Samer Srour, Sairah Ahmed, Swaminathan Iyer, Hun Lee, Ranjit Nair, Raphael Steiner, Karenza Alexis, Andreas Harstrick, Elizabeth J Shpall, Katayoun Rezvani
Oral session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia, Friday, June 3, 2022, 1:00 – 4.00 p.m. CDT

Poster details:
Title: A phase 1/2a open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of AFM24 in patients with advanced solid cancers: Study design and rationale.
Authors: Omar Saavedra Santa Gadea, Elena Garralda, Juanita Suzanne Lopez, Mark M. Awad, Jacob Stephen Thomas, Crescens Diane Tiu, Daniela Morales-Espinosa, Christa Raab, Bettina Rehbein, Gabriele Hintzen, Kerstin Pietzko, Paulien Ravenstijn, Michael Emig, Anthony B. El-Khoueiry

Poster details:
Title: AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale.
Authors: Omar Saavedra Santa Gadea, Eric Christenson, Anthony B. El-Khoueiry, Andres Cervantes, Christa Raab, Ulrike Gaertner, Kerstin Pietzko, Gabriele Hintzen, Paulien Ravenstijn, Daniela Morales-Espinosa, Juanita Suzanne Lopez

Poster details:
Title: The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors.
Authors: Anthony B. El-Khoueiry, Paul Y. Song, Jennifer Rubel, Dorna Y. Pourang, Christa Raab, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada

Poster session for all posters: Developmental Therapeutics – Immunotherapy, Sunday, June 5, 2022, 8:00 – 11:00 a.m. CDT

Abstract release: The full abstracts will become public at 5:00 p.m. EDT on Friday, May 26.

More details about the programs for the ASCO (Free ASCO Whitepaper) Annual Meetings are available online at www.asco.org

About AFM13
AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT, NCT04101331). In addition, The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with relapsed/refractory CD30-positive lymphomas (NCT04074746).

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 in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies as monotherapy and in combinations with other cancer treatments. 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. Furthermore, AFM24 is being evaluated in a phase 1/2a study in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech have initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with SNK01, NKGen Biotech’s NK cell product (NCT05099549).

On April 27, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies for the treatment of hard to treat cancers, reported that it has entered into exclusive license and sublicense agreements with CLS Therapeutics ("CLS") to develop its interventional DNase based oncology platform, which is aimed at improving outcomes of existing treatments, including immunotherapies (Press release, Xenetic Biosciences, APR 27, 2022, View Source [SID1234613017]). Xenetic will host a conference call and webcast, today, April 27, 2022, at 8:30 a.m. ET (details below).

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Xenetic Biosciences, Inc., Tuesday, April 26, 2022, Press release picture
Under the terms of the agreements, Xenetic has an exclusive license to CLS’ intellectual property, for uses of DNases in cancer, including systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies. In addition, the licenses cover "DNase-armored" CAR T therapies in which novel CAR T products are engineered to secrete DNases into the tumor microenvironment to potentially improve T-cell infiltration, activity and persistence. As part of the agreements, Xenetic will make an upfront payment of $500,000 in cash and issue 875,000 shares of common stock, and will make future payments based on the achievement of certain clinical and regulatory milestones of up to $13 million per program, as well as issue up to an additional 950,000 shares of common stock based on the achievement of certain milestones. Additionally, Xenetic will pay tiered royalty payments ranging from mid-single to low-double digits on any potential future sales, as well as a percentage share of certain consideration received by Xenetic from sublicensees.

The licensed DNase platform is designed to target Neutrophil Extracellular Traps ("NETs"), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

A substantial amount of scientific literature has implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies such as checkpoint inhibitors and cell therapies). In published reports, elevated levels of NETs have been a biomarker associated with poor prognosis in patients with a variety of cancers.

In addition, resistance to existing therapeutic agents can involve the release of immunosuppressive signaling factors from NETs, or physical barriers created by NETs which can impede the infiltration, activity, and survival of cytotoxic T cells in the tumor microenvironment.

Published pre-clinical models have demonstrated the effectiveness of systemically administered DNase, alone or in combination with other agents, for the elimination of NETs and prevention of tumor growth and metastasis.

"We are excited to in-license this oncology platform. Based on the compelling pre-clinical efficacy data seen to date, we believe the DNase-based oncology platform has the potential to improve the outcomes of chemotherapy and immunotherapy treatments in multiple solid tumor indications," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "This transaction provides Xenetic with near term opportunities for value-driving milestones, and an anticipated timeline to clinic that now positions us as an emerging clinical-stage company. This gives us the confidence to focus our capital and human resources on advancing the DNase pipeline. Our primary efforts are now aimed at advancing the systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers. Our goal is to provide solutions in the treatment of solid tumors by improving response and overcoming resistance to checkpoint inhibitors or chemotherapy. Ultimately, we expect these programs to drive value for shareholders in the near and long term."

Adoptive transfer of CAR T cells has emerged as one of the most promising advances in cancer immunotherapy. Engineered CAR T cells, designed to recognize cancer-associated antigens, are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden. CAR T therapies have exhibited remarkable clinical success against hematological malignancies but thus far have failed to demonstrate success in the context of solid tumors. Published evidence suggests that in addition to immunosuppressive factors, mechanical barriers formed by NETs can impede T-cell penetration and occlude T-cell contact with tumor cells.

"To successfully treat solid tumors, CAR T cells must be able to infiltrate, persist, and maintain anti-tumor function in a hostile tumor microenvironment that is itself adept at immunosuppression and conducive to tumor cell survival. Recent approaches to CAR T design include "armored" CAR-T cells, so named because they can express additional factors to resist immunosuppression or degrade physical components of the tumor’s extracellular matrix, including NETs. We intend to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications," said Curtis Lockshin, Chief Scientific Officer of Xenetic.

Conference Call and Webcast

Xenetic management will host a conference call and webcast presentation for investors, analysts, and other interested parties to discuss the in-licensing today, April 27, 2022, at 8:30 AM ET.

Interested participants and investors may access the conference call by dialing (877) 407-9708 (domestic) or (201) 689-8259 (international). The live webcast will be accessible on the Events page of the Investors section of the Xenetic website, xeneticbio.com, and will be archived for 90 days.