viagenpumatucel-L (HS-110) / Scorpius Holdings - LARVOL DELTA

"All for One and One for All": The Secreted Heat Shock Protein gp96-Ig Based Vaccines. (PubMed, Cells) - "In this review, we will highlight three major principles of the gp96-Ig vaccine strategy: (1) presentation of pathogenic antigens to T cells (specificity); (2) activation of innate immune responses (adjuvanticity); (3) priming of T cells to home to the epithelial compartments (mucosal immunity). In summary, we provide a paradigm for a vaccine approach that can be rapidly engineered and customized for any future pathogens that require induction of effective tissue-resident memory responses in epithelial tissues."

Journal • Review • Infectious Disease • Oncology

Viagenpumatucel-L (HS-110) plus nivolumab in patients with advanced non-small cell lung cancer (NSCLC). (ASCO-SITC 2019) - P1b/2; "The combination of HS-110 and nivolumab is safe with encouraging preliminary efficacy data. The study is ongoing and additional populations are being explored."

Clinical • IO Biomarker • PD(L)-1 Biomarker

[VIRTUAL] Impact of adding viagenpumatucel-L to nivolumab in non-small cell lung cancer (NSCLC) patients with low levels of tumour infiltrating lymphocytes (ESMO 2020) - "Legal entity responsible for the study: Heat Biologics, Inc. Funding: Heat Biologics, Inc."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

DURGA: A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2 | N=121 | Active, not recruiting | Sponsor: Heat Biologics | Completed ➔ Active, not recruiting | Trial completion date: Aug 2022 ➔ Nov 2022

Combination therapy • Enrollment closed • Trial completion date • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DURGA: A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2 | N=121 | Completed | Sponsor: Heat Biologics | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Heat Biologics | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Immunology • Oncology • Solid Tumor

Secreted heat shock protein gp96-Ig and OX40L-Fc combination vaccine enhances SARS-CoV-2 Spike (S) protein-specific B and T cell immune responses. (PubMed, Vaccine X) - "Thus, a cell-based gp96-Ig vaccine/OX40-L fusion protein regimen provides encouraging translational data that this vaccine platform induces pathogen-specific CD8+, CD4+ T and B cell responses, and may cohesively work as a booster for FDA-approved vaccines. Our vaccine platform can be rapidly engineered and customized based on other current and future pathogen sequences."

Journal • Immune Modulation • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CD4 • CD8 • PROS1

Heat Biologics Unveils Enhanced Allogeneic Cell Manufacturing Process (GlobeNewswire) - "'We are excited to rollout our new 3-D allogeneic cell manufacturing capabilities to replace our current 2-D HS-110 manufacturing. This new process is designed to increase yield, improve operating efficiency, as well as provide both a rapid and scalable solution to support Phase 3 trials and commercialization.'"

Commercial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Heat Biologics Provides Year-End 2021 Business Update (GlobeNewswire) - "...'we presented favorable survival data at The American Association of Cancer Research (AACR) of HS-110 in combination with checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). We recently submitted meeting requests to the FDA for separate Type B ('End of Phase 2 Meeting') and Type C (Phase 3 'CMC Readiness Meeting') meetings to receive feedback on our proposed trial design and regulatory path forward. We anticipate these meetings will be scheduled for the second quarter of 2022'."

FDA event • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Heat Biologics Announces New PTX-35 Preclinical Data in Organ Transplantation and Provides Update on HS-110 (GlobeNewswire) - "...'We are also making significant progress with HS-110 and expect to file for an End of Phase 2 meeting with the FDA this quarter. Our goal for this meeting is to discuss potential Phase 3 registration pathways for HS-110. Although this submission is taking longer than expected, we believe we have prepared a very comprehensive package and look forward to the FDA’s feedback'."

FDA event • Oncology

Heat Biologics Provides Third Quarter 2021 Business Update (GlobeNewswire) - "...'We are also preparing for an end of Phase 2 meeting with the FDA for HS-110 to discuss potential Phase 3 registration pathways'."

FDA event • Oncology

DURGA: A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2; N=121; Active, not recruiting; Sponsor: Heat Biologics; Trial primary completion date: Aug 2021 ➔ May 2021

Clinical • Combination therapy • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors (clinicaltrials.gov) - P1; N=15; Active, not recruiting; Sponsor: Heat Biologics; Recruiting ➔ Active, not recruiting; N=30 ➔ 15

Enrollment change • Enrollment closed • Immunology • Oncology • Solid Tumor

Viagenpumatucel-L (HS-110) plus nivolumab in patients with advanced non-small cell lung cancer (NSCLC). (ASCO-SITC 2019) - P1b/2; "The combination of HS-110 and nivolumab is safe with encouraging preliminary efficacy data. The study is ongoing and additional populations are being explored."

Clinical • IO Biomarker • PD(L)-1 Biomarker

Viagenpumatucel-L (HS-110) plus nivolumab in patients with advanced non-small cell lung cancer (NSCLC) after checkpoint inhibitor treatment failure. (ASCO 2019) - P1b/2; "The combination of HS-110 and nivolumab is well tolerated. Pts continue to be enrolled in this cohort and early data suggest that the addition of HS-110 to nivolumab may restore responsiveness after tumor progression on prior CPI therapy. Clinical trial information: NCT02439450"

Checkpoint inhibition • Clinical • IO Biomarker • PD(L)-1 Biomarker

Treating advanced non-small lung cancer (NSCLC) patients after checkpoint inhibitor treatment failure with a novel combination of Viagenpumatucel-L (HS-110) plus nivolumab (SITC 2019) - "The combination of HS-110 and nivolumab is well tolerated, and does not appear to increase the incidence of immune-related AEs as compared to CPI monotherapy. Patients continue to be enrolled into this cohort. Data suggest that re-challenging the immune system with nivolumab and HS-110 after CPI treatment failure restores responsiveness and clinical benefit for some patients."

Checkpoint inhibition • Clinical • IO Biomarker • PD(L)-1 Biomarker

[VIRTUAL] Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings. (ASCO 2021) - P1b/2 | "HS-110 was well tolerated when administered in combination with NIVO . In previously treated pts with advanced NSCLC, we observed (1) significantly longer PFS and OS in ISR+ pts in both CPI naïve and CPI progressor cohorts; (2) significantly longer OS in PD-L1+ patients in the CPI naïve cohort; and (3) a trend of improved OS in bTMB-L pts in the CPI progressor cohort . Further clinical evaluation of HS-110 is warranted in both CPI naïve and CPI progressor NSCLC patients."

Clinical • IO biomarker • Dermatology • Fatigue • Hematological Malignancies • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor • PD-L1 • TMB

[VIRTUAL] Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab. (ASCO 2020) - P1b/2 | "The combination of HS-110 and nivolumab appears safe and well tolerated. OS was improved in pts whose tumors express ≥ 8 shared antigens with HS110, as well as in those who specifically expressed ZNF492. Further exploration of antigen expression as a predictor for treatment outcome with HS110 plus nivolumab is ongoing."

Clinical • IO Biomarker • Fatigue • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • CD8

Viagenpumatucel-L (HS-110) plus nivolumab in patients with advanced non-small cell lung cancer (NSCLC). (ASCO-SITC 2019) - P1b/2; "The combination of HS-110 and nivolumab is safe with encouraging preliminary efficacy data. The study is ongoing and additional populations are being explored."

Clinical • IO Biomarker • PD(L)-1 Biomarker

"$HTBX HS-110 Presentation at ASCO #ASCO21 #antibodies - https://t.co/ubHKAkMNJ8" (@ahighelevation)

"$HTBX HS-110 Presentation at ASCO #ASCO21 #CellTherapy - https://t.co/KcWGxlwmxY" (@ZacksSmallCap)

Heat Biologics to Showcase Favorable Survival Data of HS-110 in Previously Treated Non-Small Cell Lung Cancer Patients at 2021 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - P1/2, N=121; NCT02439450; Sponsor: Heat Biologics; "Heat Biologics...presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting...At this year’s ASCO meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO® (nivolumab)...Median overall survival (mOS) of 24.6 months was observed in previously treated, CPI naïve patients with advanced NSCLC (Cohort A, n=47). This data compares favorably with published data of Checkmate 057...mOS of 11.9 months was reported in NSCLC patients who were previously treated with CPI and whose disease had subsequently progressed (Cohort B, n=68). Published data from other studies stated median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after CPI progression."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Heat Biologics Provides First Quarter 2021 Business Update; Reports Continued Progress on Oncology and COVID-19 Vaccine Programs (GlobeNewswire) - "We recently announced promising new preclinical data around PTX-35, our potential first-in-class T-cell co-stimulatory antibody at the AACR Annual Meeting 2021. We are completing enrollment in our Phase 1 PTX-35 trial in patients with solid tumors and expect to share interim data later this year...We are currently reviewing a variety of possible Phase 3 registration settings for HS-110 in combination with checkpoint inhibitors, following positive interim data from our Phase 2 trial in patients with advanced non-small cell lung cancer (NSCLC)."

Enrollment status • New P3 trial • P1 data • Preclinical • Oncology • Solid Tumor

[VIRTUAL] Heat Biologics (BIO 2021) - "The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials."

Immune Modulation • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology

Heat Biologics Announces Promising Survival Data of HS-110 in Two Treatment Settings of Lung Cancer; Selected for Presentation at 2021 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "Heat Biologics, Inc...announced that the latest data from HS-110, the Company’s lead product, has been accepted for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021...Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology