On November 28, 2023 PRISM BioLab, Co. Ltd. ("PRISM"), a leading discovery and development biotechnology company designing small molecule inhibitors of protein-protein interaction (PPI) targets, reported that it has entered into a License and Collaboration Agreement with Eli Lilly and Company ("Lilly") (Press release, PRISM Pharma, NOV 28, 2023, View Source [SID1234638022]).

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Under the agreement, PRISM and Lilly will collaborate to discover small molecule inhibitors of a PPI target selected by Lilly utilizing PRISM’s proprietary PepMetics technology. Lilly has the option to add up to two more targets to the collaboration and is responsible for the clinical development and commercialization of resulting products. PRISM will receive upfront payments and is eligible to receive up to $660 million in pre-clinical, clinical and commercial development milestones payments, as well as royalties on product sales.

"We are very excited to enter into this collaboration with Lilly as we apply our technology to expand the field of drug discovery into a novel approach to drug the PPI targets," said Dai Takehara, President and Chief Executive Officer of PRISM Biolab. "Our PepMetics technology holds promise to change the current paradigm in drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules. This collaboration with Lilly, an innovative global pharma company, could help us realize this vision and expand the field of druggable targets for the benefit of patients."

On November 28, 2023 Physician-scientists from Rutgers Cancer Institute of New Jersey and RWJBarnabas Health reported that it will present an extensive array of hematology/oncology data from their clinical research program at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held in San Diego, California (and virtually) from December 9-12, 2023 (Press release, Rutgers Cancer Institute of New Jersey, NOV 28, 2023, View Source [SID1234638021]). A total of 36 abstracts have been accepted, comprising clinical data and analyses that advance the understanding, treatment, and prognosis of blood cancers such as lymphoma, leukemia, and myeloma. Rutgers Cancer Institute of New Jersey, in partnership with RWJBarnabas Health, is New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state.

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"Our devoted and highly esteemed team of cancer specialists and researchers at Rutgers Cancer Institute of New Jersey and RWJBarnabas Health remain dedicated to pioneering advancements that transform treatments, patient care, and outcomes by leveraging innovation and evolving novel therapies," said Matthew Matasar, MD, MS, Chief of Blood Disorders at Rutgers Cancer Institute of New Jersey and RWJBarnabas Health. "As the leading cancer program in the state, our commitment to advancing oncology care is unwavering. We strive to make a meaningful difference in the lives of those affected by cancer, and through innovative science and research, we can uncover new insights that may transform the landscape of cancer care in the future."

Highlights of the accepted abstracts include the following oral and poster presentations:

Data from a randomized phase 3 trial conducted by the National Clinical Trials Network evaluating the tolerability and progression-free survival rate of Nivolumab-AVD compared to Bv-AVD in patients aged ≥60 with newly diagnosed advanced-stage Hodgkin lymphoma (AS-HL). The primary endpoint of the study was progression-free survival (PFS), and secondary endpoints included overall survival (OS), event-free survival (EFS), and detailed toxicity and safety events. Response and progression were assessed by investigators using 2014 Lugano Classification.
Data from a phase 3 trial evaluating the progression-free survival and toxicity with Nivolumab-AVD compared to Bv-AVD in pediatric patients aged ≥12 years with stage 3-4 Classic Hodgkin Lymphoma (cHL). The trial was led by SWOG and conducted by the National Clinical Trials Network. The primary endpoint was progression-free survival (PFS), and secondary endpoints included overall survival (OS), event-free survival (EFS), and safety.
Evaluation of the A-HIPI model in generating risk groups with input on strengths and limitations for patients with advanced stage classical Hodgkin lymphoma (AS-HL). This prognostic model, developed and validated by the Hodgkin Lymphoma International Study for Individual Care (HoLISTIC) Consortium, generates the individualized probability of a progression-free survival (PFS) event or death within the first 5 years from diagnosis in patients based on continuous variables.
Development and validation of the modern-day model, E-HIPI, in the prediction of progression-free survival of early-stage Hodgkin lymphoma (E-HL) within the first five years since diagnosis. The model incorporates detailed individual patient data from international clinical trials and prospective registry data that were standardized, normalized, and harmonized as part of the HoLISTIC Consortium. The primary outcome was progression-free survival (PFS).
Data from a clinical trial evaluating the feasibility, safety, and efficacy of home-based intravenous administration of trans-retinoic acid (ATRA) and arsenic trioxide in the treatment of Acute Promyelocytic Leukemia (APL). Patients were given the option of receiving at-home treatment through a partnership with Qualitas Specialty Pharmacy and were evaluated for any adverse effects.
The full list of presentations at this year’s ASH (Free ASH Whitepaper) Annual Meeting and Exposition follows:

Oral Presentations

Abstract and
Session No.

Title

Presentation Date/Time

Abstract 181
(Session 624)

Nivolumab-AVD Is Better Tolerated and
Improves Progression-Free Survival
Compared to Bv-AVD in Older Patients
(Aged ≥60 Years) with Advanced Stage
Hodgkin Lymphoma Enrolled on SWOG
S1826 Clinically Relevant Abstract

Saturday, December 9, 2023:
2:00 PM PT

Abstract 308
(Session 627)

Improved Survival of R/R Double Hit/Triple
Hit Lymphoma in the Era of CD19 Chimeric
Antigen T Cell (CART) Therapy

Saturday, December 9, 2023:
4:15 PM PT

Abstract 382
(Session 905)

Treatment Patterns and Outcomes for Patients
with Classic Hodgkin Lymphoma (cHL) and
Cardiomyopathy with Low Ejection Fraction
(EF): Real-World Evidence (RWE) from 16
US Academic Centers

Saturday, December 9, 2023:
4:45 PM PT

Abstract 497
(Session 905)

Outcomes of Patients with Richter
Transformation without Prior
Chemoimmunotherapy for CLL/SLL: An
International Multicenter Retrospective Study

Sunday, December 10, 2023:
10:30 AM PT

Abstract 603
(Session 623)

Mosunetuzumab Monotherapy Continues to
Demonstrate Durable Responses in Patients
with Relapsed and/or Refractory Follicular
Lymphoma after ≥2 Prior Therapies: 3-Year
Follow-up from a Pivotal Phase II Study

Sunday, December 10, 2023:
5:00 PM PT

Abstract 607
(Session 624)

Results from an Intergroup Randomized
Phase II Study of the Combinations of
Ipilimumab, Nivolumab and Brentuximab
Vedotin in Patients with Relapsed/Refractory
Classic Hodgkin Lymphoma: A Trial of the
ECOG-ACRIN Research Group (E4412)

Sunday, December 10, 2023:
4:30 PM PT

Abstract 610
(Session 624)

Progression-Free Survival (PFS) and Toxicity
with Nivolumab-AVD Compared to
Brentuximab Vedotin-AVD in Pediatric
Advanced Stage (AS) Classic Hodgkin
Lymphoma (cHL), Results of SWOG S1826

Sunday, December 10, 2023:
5:15 PM PT

Abstract 614
(Session 627)

Mosunetuzumab Monotherapy Demonstrates
Activity and a Manageable Safety Profile in
Patients with Relapsed or Refractory
Richter’s Transformation

Sunday, December 10, 2023:
4:45 PM PT

Abstract 981
(Session 623)

Pirtobrutinib in Relapsed/Refractory (R/R)
Mantle Cell Lymphoma (MCL) Patients with
Prior cBTKi: Safety and Efficacy Including
High-Risk Subgroup Analyses from the Phase
1/2 BRUIN Study

Monday, December 11, 2023:
5:00 PM PT

Poster Presentations

Abstract and
Session No.

Title

Presentation Date/Time

Abstract 1079

(Session 101)

Congenital Dyserythropoietic Anemia Type
II: An Update from the Congenital
Dyseryhtropoietic Anemia Registry of North
America (CDAR)

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1404

(Session 603)

Acetyl Transferase EP300 Deficiency Leads
to Chronic Replication Stress in Adult T-Cell
Leukemia/Lymphoma

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1551

(Session 616)

A Phase Ib/II Study Evaluating Navitoclax
after Failure of Hypomethylating Agent and
Venetoclax for Treatment of Relapsed or
Refractory High-Risk Myelodysplastic
Syndrome

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1651

(Session 622)

Alterations in Immune Cell Composition
during First-Line Therapy with
Mosunetuzumab for Follicular or Marginal
Zone Lymphoma

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1660

(Session 623)

Pirtobrutinib, a Highly Selective, Non-
Covalent (Reversible) BTK Inhibitor in
Relapsed / Refractory Marginal Zone
Lymphoma: Results from Phase 1/2 BRUIN
Study

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1727

(Session 626)

Multicenter Pilot Trial of Intrathecal
Liposomal Cytarabine Combined with FAB
Chemoimmunotherapy with Reduced
Doxorubicin in CAYA with Mature De-Novo
B-NHL

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1737

(Session 626)

Pirtobrutinib in Richter Transformation:
Updated Efficacy and Safety Results with 18-
Month Median Survival Follow-up from the
Phase 1/2 BRUIN StudyClinically Relevant
Abstract

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1738

(Session 627)

Immune Reconstitution and Infection Patterns
Following CAR T-Cell Therapy in Patients
with Aggressive LymphomaClinically
Relevant Abstract

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 1908

(Session 642)

Treatment Effectiveness with Venetoclax-
Based Therapy after Bruton Tyrosine Kinase
Inhibitors in Chronic Lymphocytic Leukemia:
An International Real-World Study

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 2085

(Session 703)

CD22 TCR-Engineered T Cells Exert Anti-
Leukemia Cytotoxicity without Causing
Inflammatory Responses

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 2110

(Session 704)

Preliminary Results of Nathali-01: A First-in-
Human Phase I/IIa Study of UCART20x22, a
Dual Allogeneic CAR-T Cell Product
Targeting CD20 and CD22, in Relapsed or
Refractory (R/R) Non-Hodgkin Lymphoma
(NHL)

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 2185

(Session 722)

Outcomes after RIC and Abatacept-Based
Acute and Chronic Gvhd Prophylaxis in
Allogeneic Transplantation for Sickle Cell
Disease – Can Calcineurin Inhibitor Use be
Curtailed?

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 2357

(Session 903)

No Place like Home: Home-Based
Intravenous Arsenic Trioxide for the
Treatment of Acute Promyelocytic Leukemia
(APL)

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 2407

(Session 905)

Exploration of Language As a Barrier to the
Assessment and Management of CAR T-Cell
Therapy Associated Toxicities

Saturday, December 9, 2023,
5:30 PM-7:30 PM PT

Abstract 3052

(Session 623)

GLOBRYTE: A Phase III, Open-Label,
Multicenter, Randomized Trial Evaluating
Glofitamab Monotherapy in Patients with
Relapsed or Refractory Mantle Cell
Lymphoma

Sunday, December 10, 2023,
6:00 PM-8:00 PM PT

Abstract 3058

(Session 624)

Development and Validation of the Early-
Stage Hodgkin Lymphoma (HL) International
Prognostication Index (E-HIPI): A Report
from the Hodgkin Lymphoma International
Study for Individual Care (HoLISTIC)
Consortium

Sunday, December 10, 2023,
6:00 PM-8:00 PM PT

Abstract 3067

(Session 624)

Identification of Risk Categories from the
Advanced-Stage Hodgkin International
Prognostic Index (A-HIPI) Model: A Detailed
Analysis from the Hodgkin Lymphoma
International Study for Individual Care
(HoLISTIC) Consortium

Sunday, December 10, 2023,
6:00 PM-8:00 PM PT

Abstract 3084

(Session 624)

AHOD2131: A Randomized Phase 3
Response-Adapted Trial Comparing Standard
Therapy with Immuno-Oncology Therapy for
Children and Adults with Newly Diagnosed
Stage I and II Classic Hodgkin Lymphoma

Sunday, December 10, 2023,
6:00 PM-8:00 PM PT

Abstract 3359

(Session 652)

Health-Related Quality of Life (HRQoL)
Among Patients with Triple-Class Exposed
Relapsed/Refractory Multiple Myeloma
(RRMM) Treated with Linvoseltamab in
Linker-MM1: Interim Assessment up to 36
Weeks of TreatmentClinically Relevant
Abstract

Sunday, December 10, 2023,
6:00 PM-8:00 PM PT

Abstract 4455

(Session 624)

Age-Based Validation of the Advanced-Stage
Hodgkin Lymphoma International Prognostic
Index (A-HIPI) in a Real-World Danish
Study: Suboptimal Performance in Older
Patients

Monday, December 11, 2023,
6:00 PM-8:00 PM PT

Abstract 4461

(Session 626)

Odronextamab Demonstrates Durable
Complete Responses in Patients with Diffuse
Large B-Cell Lymphoma (DLBCL)
Progressing after CAR-T Therapy: Outcomes
from the ELM-1 Study

Monday, December 11, 2023,
6:00 PM-8:00 PM PT

Abstract 4746

(Session 653)

Patterns of Response to 200 Mg
Linvoseltamab in Patients with
Relapsed/Refractory Multiple Myeloma:
Longer Follow-Up of the Linker-MM1 Study

Monday, December 11, 2023,
6:00 PM-8:00 PM PT

Abstract 4901

(Session 721)

Abatacept-Prophylaxis Based Haploidentical
Transplantation May Allow Sustained
Engraftment and Offset Gvhd in Non-
Malignant Disorders

Monday, December 11, 2023,
6:00 PM-8:00 PM PT

Education Program

N/A

MRD Directed Therapy in CLL- Ready for Primetime?

Saturday, December 9, 2023,
2:00 PM-3:15 PM PT

N/A

Hodgkin Lymphoma Treatment for Older Persons in the Modern Era

Saturday, December 9, 2023,
4:00 PM-5:15 PM PT

N/A

How is the Management Paradigm Evolving for Hodgkin Lymphoma in 2023?

Saturday, December 9, 2023:
4:00 PM-5:15 PM PT

Program: Special-Interest Sessions

Session 2

General Session 2: Making the Most of Virtual Teaching

Sunday, December 10, 2023,
7:30 AM-9:30 AM PT

On November 28, 2023 Blueprint Medicines Corporation (Nasdaq: BPMC) reported that company management will participate virtually in a fireside chat at the JMP Securities Hematology and Oncology Summit on Tuesday, December 5, 2023 at 11:00 a.m. ET (Press release, Blueprint Medicines, NOV 28, 2023, View Source [SID1234638020]).

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A live webcast of the presentation will be available by visiting the Investors & Media section of Blueprint Medicines’ website at View Source A replay of the webcast will be archived on Blueprint Medicines’ website for 30 days following the presentation.

On November 28, 2023 Montefiore Einstein Comprehensive Cancer Center reported that Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)—are two related blood diseases that disproportionally strike older adults—are notoriously difficult to treat and associated with high relapse rates (Press release, Montefiore Medical Center, NOV 28, 2023, View Source [SID1234638019]). Although new therapies have improved survival, treatment options remain limited, and the prognosis for the 50% of people who experience disease relapse remains poor.

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Aditi Shastri, M.D., the principal investigator of the grant, a member of Montefiore Einstein Comprehensive Cancer Center’s Stem Cell and & Cancer Biology Research Program and Blood Cancer Institute, and associate professor of oncology, medicine, and developmental and molecular biology at Albert Einstein College of Medicine.
Researchers at the National Cancer Institute-designated Montefiore Einstein Comprehensive Cancer Center (MECCC) were recently awarded a four-year, $2.6 million grant from the U.S. Food and Drug Administration (FDA) to conduct an innovative phase 1 clinical trial of a new drug for patients with relapsed and treatment-resistant forms of AML and MDS. It is one of only 10 grants issued this year by the FDA through its Office of Orphan Products Development.

"This is a tremendous opportunity to apply the knowledge we have developed in our MECCC labs over the past decade to develop a novel therapeutic strategy," said Aditi Shastri, M.D., the principal investigator of the grant, a member of MECCC’s Stem Cell and & Cancer Biology Research Program and Blood Cancer Institute, and associate professor of oncology, medicine, and developmental and molecular biology at Albert Einstein College of Medicine.

Drugs that initially work against AML are ineffective when the disease returns. Research suggests that those treatments leave behind leukemic stem cells that are resistant to existing medications and lead to relapsed and drug-resistant AML and MDS.

"We have identified a molecular target in leukemic stem cells and a novel drug that performed well against those stem cells in pre-clinical studies," Dr. Shastri said. "We are eager to see if this drug and its combinations can provide clinical benefit for our patients."

AML and MDS are rare diseases with among the worst prognoses of all cancers: most people who develop relapsed or treatment-resistant disease live for only another 4 to 10 months. Since AML is so difficult to treat, most patients receive care at academic cancer centers. MECCC, with its Blood Cancer Institute and Stem Cell and Cancer Biology Research Program, is one of a few institutions in the country specializing in AML and MDS.

In 2018, Dr. Shastri and colleagues found that relapsed AML and MDS patients with the worst prognosis have leukemic stem cells that express excessive levels of the protein STAT3. In subsequent studies, her lab found that STAT3 does several things to help MDS and AML cancer cells survive; most importantly, STAT3 prevents cancer cells from undergoing apoptosis, known as programmed cell death—the goal of a major AML/MDS drug called venetoclax. Dr. Shastri hypothesized that blunting the impact of STAT3 could make venetoclax more effective and lead to better outcomes for patients.

Dr. Shastri then looked for compounds that specifically targeted STAT3 and identified the novel targeted drug danvatirsen: a STAT3 inhibitor developed by Flamingo Therapeutics and Ionis Pharmaceuticals that is now being developed as a cancer treatment in early-phase clinical trials. After conducting preclinical tests indicating that danvatirsen shows promise against AML/MDS, Dr. Shastri is investigating the drug in a phase 1 clinical trial.

The trial is slated to begin this month and will enroll patients with therapy-resistant MDS and AML at MECCC and MD Anderson Cancer Center in Houston, Texas. "Since this is a phase 1 trial, our first priority is to determine the safety of danvatirsen when used alone and in combination with venetoclax, as well as the optimal dosages for the two drugs," Dr. Shastri said. "We will investigate the effect of danvatirsen, alone and in combination with venetoclax, on leukemic stem cells."

If the researchers find evidence that the experimental treatment has clinical activity, they will expand the study to a phase 2 trial to further assess the treatment’s effectiveness. The co-principal investigator of the clinical trial is Naval Daver, M.D., at the MD Anderson Cancer Center. MECCC co-investigators on this grant are Marina Konopleva, M.D., and Ulrich Steidl, M.D., Ph.D.

The grant is titled "A phase 1 study investigating the safety & efficacy of danvatirsen as monotherapy followed by combination with venetoclax in patients with relapsed/refractory MDS & AML" (R01FD007836).

On November 28, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported a strategic restructuring to focus on continuation and expansion of development of CAN-3110 as well as the enLIGHTEN Discovery Platform, while reducing the Company’s workforce and expenses associated with enabling commercial readiness of CAN-2409 (Press release, Candel Therapeutics, NOV 28, 2023, View Source [SID1234638017]). The Company expects to present initial activity and biomarker data for repeated injections of CAN-3110 in recurrent high-grade glioma in the second half of 2024 and new data for the second drug candidate based on the enLIGHTEN Discovery Platform in Q3 2024. The Company plans to continue to collect clinical data for key readouts for CAN-2409 in non-small cell lung cancer (NSCLC), with topline overall survival data of the open label phase 2 clinical trial expected in Q2 2024; pancreatic cancer, with an update on overall survival based on an interim analysis of the randomized, open label clinical trial in Q2 2024; and prostate cancer, with topline data for both fully enrolled randomized, blinded, placebo-controlled phase 2 and phase 3 clinical trials in Q4 2024.

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Based on the encouraging clinical activity data for CAN-2409, the large number of patients that might benefit from this treatment, and the investments needed for commercialization, the Company plans to explore the right partnering opportunities for the future development of this asset.

To focus on delivering on the value-creating catalysts in 2024, on November 28, 2023, Candel implemented a reduction in its workforce of approximately 50%. The Company estimates that it will incur a one-time restructuring charge of approximately $0.7 million in the fourth quarter of 2023 related to severance and healthcare and related benefits for terminated employees. Candel expects that the reduction in workforce, coupled with the reduced operating costs, will enable the Company’s existing cash resources to fund its revised operating plan into the fourth quarter of 2024, enabling the achievement of key catalysts next year.

"This decision, unfortunately, impacts our workforce," said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. "I want to express my sincere gratitude for the very important work and valuable contributions of our departing employees. They have done amazing work advancing the pipeline and developing our investigational medicines. In the current market, we need to remain laser focused on delivering on our value-creating inflections points, while managing our expenditures. We have proof of mechanism and proof of concept in each indication that we are currently pursuing, and the value created in the past years will be leveraged in the multiple data readouts planned for 2024."

About the enLIGHTEN Discovery Platform

Candel’s enLIGHTEN Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. In October 2022, the Company announced a discovery collaboration with the University of Pennsylvania Center for Cellular Immunotherapies to identify how viral immunotherapy could enhance the efficacy of CAR-T cell therapy in solid tumors. The enLIGHTEN Discovery Platform is designed to deconvolute the complexity of the tumor microenvironment to identify druggable properties that correlate with clinical outcomes. These discoveries are rapidly translated into optimized multi-gene payloads of tumor modulators that are tailored for specific indications, disease stage, and rationally designed therapeutic combinations. During the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting and the International Oncolytic Virus Conference in November 2023, Candel presented encouraging data on the discovery pipeline, demonstrating the effects of Alpha 201-macro-1, an investigational locally delivered biological oncolytic therapeutic designed to interfere with the CD47/SIRP1a pathway, in a mouse model of breast cancer.

About CAN-3110

CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1 investigator-sponsored clinical trial in patients with recurrent HGG. Earlier this month, the Company announced that Nature published results from this clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported and CAN-3110 plus prodrug was associated with improved survival. Positive HSV-1 serology was a predictor of response and was associated with improved survival. Increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were also associated with improved survival. In the clinical trial, the investigators observed a nearly doubling of the expected median overall survival after a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. By comparison, survival in the anti-HSV1 positive patients treated with CAN-3110 was over 14 months. The Company and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in recurrent HGG, supported by the Break Through Cancer foundation, and expect initial results in H2 2024.

Candel will also initiate IND-enabling work in a second indication characterized by Nestin expression.

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational off-the-shelf replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the disease. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, more than 950 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in NSCLC, borderline resectable pancreatic cancer, and localized, non-metastatic prostate cancer in ongoing clinical trials.