On April 4, 2022 Jeremy BASTID, CEO of OREGA Biotech, reported that it will participate to the upcoming AACR (Free AACR Whitepaper) annual meeting to be held on April 9-13 in New Orleans, Louisiana (Presentation, OREGA BIOTECH, APR 4, 2022, View Source [SID1234611406]).

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On April 4, 2022 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported details for a planned investor webinar to coincide with the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place April 8-13 (Press release, Genocea Biosciences, APR 4, 2022, View Source [SID1234611405]). The presentation, beginning at 4:30 PM EDT on Friday, April 8th will be followed by a Q&A session. The Genocea team will discuss previously announced AACR (Free AACR Whitepaper) presentations, including late-breaking data from the TiTAN clinical trial for the neoantigen-targeted peripheral T cell therapy product candidate GEN-011, and results demonstrating successful production of GEN-011 using Genocea’s PLANET manufacturing process.

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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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Featured speakers include:

Melissa Johnson, MD, Medical Oncologist at Sarah Cannon Research Institute at Tennessee Oncology
Chip Clark, President & Chief Executive Officer, Genocea Biosciences
Tom Davis, MD, Chief Medical Officer, Genocea Biosciences
Jessica Flechtner, PhD, Chief Scientific Officer, Genocea Biosciences
Ray Stapleton, PhD, Chief Technology Officer, Genocea Biosciences
Attendees can register HERE for the event. Access to the webcast will be available on the investor relations section of Genocea’s website, including an archived replay of the webcast at View Source

About GEN-011
GEN-011 is a neoantigen-targeted peripherally derived T cell therapy candidate comprised of autologous CD4+ and CD8+ T cells that are specific for up to 30 ATLAS-identified neoantigens to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are devoid of Inhibigen-specific cells which may be detrimental to clinical response.

About the GEN-011 TiTAN clinical trial
TiTAN is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. The TiTAN clinical trial is testing two dosing regimens, a repeated fractional dose regimen of GEN-011 without lymphodepletion and a single dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells.

On April 4, 2022 Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported a publication in Nature Communications on the preclinical development of davoceticept, Alpine’s lead immuno-oncology therapeutic candidate uniquely designed to combine PD-L1-dependent CD28 costimulation with dual PD-L1 and CTLA-4 checkpoint inhibition (Press release, Alpine Immune Sciences, APR 4, 2022, View Source [SID1234611404]). CD28 is a critical T cell receptor recognized as a principal target of immune checkpoints like PD-1 and CTLA-4.

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"Lack of sufficient CD28 costimulation in the tumor microenvironment may underlie checkpoint inhibitor resistance and, therefore, CD28-directed treatments hold much promise. Davoceticept is an exciting first-in-class CD28-targeting drug that is distinct among others in this space for its triplicate mechanism and structural elegance," said Rafi Ahmed, PhD, Professor of Microbiology and Immunology and Vaccine Center Director at Emory University, and member of Alpine’s scientific advisory board.

"This achievement is the culmination of years of our scientists’ efforts to target CD28 in a highly differentiated fashion," remarked Stanford Peng, MD PhD, President and Head of R&D at Alpine. "It distinctively illustrates the unique yet powerful approach of our discovery platform, and further encourages us to continue to pursue clinical development of davoceticept with vigor."

Davoceticept is being studied in two clinical trials, NEON-1 as monotherapy, and NEON-2 in combination with pembrolizumab, in adults with advanced malignancies. Data from NEON-1 will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans on April 12.

About Davoceticept (ALPN-202)

Davoceticept (ALPN-202) is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor intended for the treatment of cancer. Preclinical studies of davoceticept have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. Completion of dose escalation and initiation of expansion cohorts of NEON-1 (NCT04186637), a Phase 1 monotherapy dose escalation and expansion trial in patients with advanced malignancies, is anticipated in the first half of 2022. NEON-2 (NCT04920383), a combination study of davoceticept (ALPN-202) and pembrolizumab was initiated in June 2021 and is currently on partial clinical hold.

On April 4, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported that three posters featuring two pipeline programs (HFB200603 and HFB101110) and our Drug Intelligent Science (DIS) driven predictive biomarker approach will be presented at AACR (Free AACR Whitepaper) 2022, which will be held April 8-13, 2022, in New Orleans, LA (Press release, HiFiBiO Therapeutics, APR 4, 2022, View Source [SID1234611402]).

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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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"We are excited to share with the oncology research community at AACR (Free AACR Whitepaper) updates for two of our preclinical development programs – HFB200603, a novel anti-BTLA blocking antibody on track for IND submission, and HFB101110, an anti-CCR8 depleting antibody that was recently licensed to FibroGen. We will also present work using our DISTM approach to discover predictive biomarkers of response for our clinical programs HFB200301, a first in class TNFR2 agonist and HFB301001, a differentiated second generation OX40 agonist for the treatment of advanced DISTM selected solid tumors," said Francisco Adrian, Chief Scientific Officer of HiFiBiO Therapeutics. "HiFiBiO’s innovative DIS approach leveraging single cell capabilities is positioned to transform the drug discovery and development paradigm by integrating deep understanding of immune-modulation with a world-leading single cell platform and machine learning-enabled data analysis."

Details on the posters are as follows:

Title: HFB200603, a novel anti-BTLA monoclonal antibody that provides therapeutic potential for immune escape and synergizes with anti-PD-1 treatment
Permanent Abstract Number: 4248
Session: Therapeutic Antibodies 3
Session Date and Time: Wednesday, April 13, 2022; 9:00 am – 12:30 pm
Venue: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 39

Title: Targeting regulatory T cells with HFB101110, a novel anti-human CCR8 antibody for the treatment of solid tumors
Permanent Abstract Number: 2899
Session: Therapeutic Antibodies 2
Session Date and Time: Tuesday, April 12, 2022; 9:00 am – 12:30 pm
Venue: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38

Title: Discovery of predictive biomarkers of response to T cell-targeting biologics using ex vivo single-cell profiling coupled with TCR clonotype characterization
Permanent Abstract Number: 618
Session: Immune Response to Therapies 2 / Immune Monitoring and Clinical Correlates
Session Date and Time: Sunday, April 10, 2022, 1:30 – 5pm
Venue: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 39

On April 4, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that a permanent J-code, J9359, has been issued for ZYNLONTA by the U.S. Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2022 (Press release, ADC Therapeutics, APR 4, 2022, View Source [SID1234611401]).

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J-codes are permanent reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B injectable drugs like ZYNLONTA that are administered by a physician. Claims submission and documentation are simplified with a permanent J-code, facilitating and streamlining the billing and reimbursement process.

The permanent J-code for ZYNLONTA, J9359 (Injection, loncastuximab tesirine-lpyl, 0.075 mg), took effect April 1, 2022. The permanent J-code is also published online on the CMS website here.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.