On March 8, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, reported three abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place April 8-13, 2022, in New Orleans, Louisiana (Press release, Gritstone Oncology, MAR 8, 2022, View Source [SID1234609677]). In the poster presentations, Gritstone representatives will review data from individualized neoantigen program, GRANITE, and the "off-the-shelf" neoantigen vaccine program, SLATE. In the oral presentation, Christine D Palmer, PhD will discuss how immunodominant human T cell responses to tumor specific neoantigens presented by the same HLA in a first-generation construct informed development of a second-generation candidate that exhibits immunogenic superiority over version 1 in preclinical models within SLATE. This optimized candidate, SLATE-KRAS, exclusively includes KRASmut epitopes and is now in Phase 2 testing in solid tumor patients.

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Abstracts associated with these presentations are now available on the conference website. Details of the presentations are as follows:

Oral Presentation Details

Abstract 3578: Optimization of shared neoantigen vaccine design to increase vaccine potency: From bench to bedside and back
Date/Time: Tuesday Apr 12, 2022, 2:30 PM – 4:30 PM ET
Session: Clinical Research Excluding Trials; Resistance Mechanisms & New Advances in Immunotherapeutics
Presenter: Christine D Palmer, PhD
Location: New Orleans Convention Center, Theater B
Poster Presentation Details

Abstract 4149: Lower doses of self-amplifying mRNA drive superior neoantigen-specific CD8+ T cell responses in cancer patients versus high doses
Date/Time: Wednesday Apr 13, 2022, 9:00 AM – 12:30 PM ET
Session: Clinical Research Excluding Trials; Vaccines/Immunomodulatory Agents & Interventions
Presenter: Amy Rappaport, PhD
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 34, Poster Board 13
Abstract 1238: Comprehensive ctDNA monitoring provides early signal of clinical benefit with a novel personalized neoantigen directed immunotherapy for late-stage cancer patients
Date/Time: Monday Apr 11, 2022, 9:00 AM – 12:30 PM ET
Session: Clinical Research Excluding Trials; Biomarkers Predictive of Therapeutic Benefit 1
Presenter: Matthew Davis, PhD
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 30, Poster Board 10

On March 8, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for Guardant360 TissueNext under the existing local coverage determination (LCD) (MolDX: Next-Generation Sequencing for Solid Tumors) (Press release, Guardant Health, MAR 8, 2022, View Source [SID1234609693]). Guardant360 TissueNext is the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

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The policy covers Guardant360 TissueNext for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service. "We are pleased that Medicare has taken this important step to make complete genomic profiling more widely available for patients with advanced cancers," said Helmy Eltoukhy, Guardant Health co-CEO.

Medicare’s policy decision adds to the coverage of Guardant Health tests for patients with advanced stage cancer. In December 2019, Palmetto GBA expanded LCD of the Guardant360 assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumor cancers.

On March 8, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the presentation of preclinical data for its first VDC product candidate, AU-011 which is being developed for the treatment of life-threatening cancers with high unmet need, including primary choroidal melanoma and non-muscle invasive bladder cancer (Press release, Aura Biosciences, MAR 8, 2022, View Source [SID1234609710]). The results demonstrate the potential wide applicability of AU-011 in targeting a number of solid tumor types and will be presented as part of the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 8-13, 2022 in New Orleans, LA.

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"The data that will be presented at AACR (Free AACR Whitepaper) provide evidence for AU-011’s activity in tumors that express specifically modified heparan-sulfate proteoglycans on the tumor cell surface. Activity was observed in every tumor type tested, indicating that there are numerous solid tumors we can consider to expand the clinical development of AU-011, including those derived from neural or epithelial lineages," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "The correlative gene expression analysis has deepened our understanding of the genes and biological pathways involved in the expression of HSPGs by different types of tumor cells."

Details for the poster presentation are as follows:

Title: Biological Assessment of the Virus-Like Drug Conjugate AU-011 to Specifically Target a Breadth of Human Cancer Types
Presenter: Rhonda Kines, Aura Biosciences
Poster Session: ETO1 Drug Discovery
Date and time: April 8, 2022, 1:00 PM ET
Location: E-poster
Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Discovery
Abstract Number: 5331

On March 8, 2022 Blueprint Medicines Corporation (NASDAQ: BPMC) reported plans to present new clinical and preclinical data for multiple programs across its precision therapy portfolio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, April 8 to 13 (Press release, Blueprint Medicines, MAR 8, 2022, View Source [SID1234609727]). The presentations highlight Blueprint Medicines’ next wave of therapeutic candidates in its growing pipeline. These investigational treatments could bring the promise of precision medicine to broad patient populations with genomically defined cancers, including lung, ovarian and breast cancers.

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"At AACR (Free AACR Whitepaper), we plan to unveil a constellation of data highlighting our scientific leadership in precision therapy, and reflecting our commitment to rapidly translate research into transformative medicines for patients," said Fouad Namouni, M.D., President of Research and Development at Blueprint Medicines. "With multiple drug candidates entering clinical trials, our AACR (Free AACR Whitepaper) presentations feature initial results from the Phase 1/2 SYMPHONY study of BLU-945 in EGFR-driven non-small cell lung cancer, as well as data reinforcing our programs’ differentiated preclinical profiles and significant potential to advance patient care."

The accepted abstracts are listed below and available on the AACR (Free AACR Whitepaper) conference website: View Source

Clinical Trial and Late-Breaking Poster Presentations

Presentation Title: Emerging evidence of activity of BLU-945 in patients with advanced EGFR-mutant NSCLC utilizing circulating tumor DNA (ctDNA) in the phase 1/2 SYMPHONY study
Session Title: Phase I Clinical Trials 2
Session Date & Time: Tuesday, April 12, 2022 from 9:00 a.m. – 12:30 p.m. CT (10:00 a.m. – 1:30 p.m. ET)
Abstract Number: CT184
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33

Presentation Title: Efficacy of a highly potent and selective KIT V654A inhibitor for treatment of imatinib resistant GIST
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Session Date & Time: Wednesday, April 13, 2022 from 9:00 a.m. – 12:30 p.m. CT (10:00 a.m. – 1:30 p.m. ET)
Abstract Number: LB205
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 16

Poster Presentations

Presentation Title: LNG-451,* a potent inhibitor of EGFR exon 20 insertion mutations with high CNS exposure
Session Title: Epigenetic Targets
Session Date & Time: Tuesday, April 12, 2022 from 1:30 p.m. – 5:00 p.m. CT (2:30 p.m. – 6:00 p.m. ET)
Abstract Number: 3261
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 23

Presentation Title: LNG-451* is a potent, CNS-penetrant, wild-type EGFR sparing inhibitor of EGFR exon 20 insertion mutations
Session Title: Tyrosine Kinase and Phosphatase Inhibitors
Session Date & Time: Tuesday, April 12, 2022 from 1:30 p.m. – 5:00 p.m. CT (2:30 p.m. – 6:00 p.m. ET)
Abstract Number: 3332
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 26

Presentation Title: BLU-222, an investigational, potent, and selective CDK2 inhibitor, demonstrated robust antitumor activity in CCNE1-amplified ovarian cancer models
Session Title: Cell Cycle Control and Cell Cycle Regulators as Therapeutic Targets
Session Date & Time: Tuesday, April 12, 2022 from 9:00 a.m. – 12:30 p.m. CT (10:00 a.m. – 1:30 p.m. ET)
Abstract Number: 2306
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 5

Presentation Title: Antitumor activity of BLU-945 and BLU-701 as single agents and in combination in EGFR L858R-driven models of NSCLC
Session Title: Tyrosine Kinase and Phosphatase Inhibitors
Session Date & Time: Tuesday, April 12, 2022 from 1:30 p.m. – 5:00 p.m. CT (2:30 p.m. – 6:00 p.m. ET)
Abstract Number: 3328
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 26

* LNG-451 is now known as BLU-451.

Investor Conference Call Information

Blueprint Medicines will host a live webcast on Friday, April 8, 2022 beginning at 2:00 p.m. ET to discuss the data reported at AACR (Free AACR Whitepaper). On the day of the webcast, poster presentations will be made available on the AACR (Free AACR Whitepaper) conference website at 1:00 p.m. ET. To access the live call, please dial 844-200-6205 (domestic) or 929-526-1599 (international), and refer to conference ID 084402. A webcast of the conference call will be available in the Investors & Media section of Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On March 8, 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 two abstracts with clinical data of its innate cell engagers (ICE) have been accepted for presentation at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), taking place April 8-13, 2022 in New Orleans, Louisiana (Press release, Affimed, MAR 8, 2022, View Source [SID1234609801]).

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The two events include an oral presentation with an update of the study that evaluates AFM13 pre-complexed with NK cells in patients with CD30-positive lymphomas and a poster presentation with data of the dose-escalation phase of the AFM24 monotherapy study for solid tumor treatment.

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

Presentation: CT003

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, Karenza Alexis, Andreas Harstrick, Elizabeth J Shpall, Katayoun Rezvani

Session: Clinical Trials of Cellular Immunotherapies, Sunday, April 10, 1:00 – 3:00 p.m. CDT

Poster details:

Title: A phase 1/2a first-in-human study of AFM24, a CD16A/epidermal growth factor (EGFR) bispecific Innate Cell Engager (ICE), in patients with locally advanced or metastatic EGFR-expressing solid tumors: Preliminary findings from the dose-escalation phase

Abstract number: CT149

Authors: Anthony El-Khoueiry, Juanita Lopez, Omar Saavedra, Mark Awad, Jacob Thomas, Crescens Tiu, Elena Garralda, Bettina Rehbein, Gabriele Hintzen, Kerstin Pietzko, Christa Raab, Erich Rajkovic, Paulien Ravenstijn, Michael Emig

Session: Phase I Clinical Trials 1, Monday, April 11, 1:30 p.m. – 5:00 p.m. CDT

Abstract release: The full abstract will become public at 1:00 p.m. ET on Friday, April 8

More details about the programs for the AACR (Free AACR Whitepaper) Virtual Annual Meetings are available online at www.aacr.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 evaluates AFM24 as a monotherapy (AFM24-101) for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. The first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is 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).