PTX-35 / Scorpius Holdings - LARVOL DELTA

Can Concurrent Traumatic Hemopneumothorax be Safely Observed? (PubMed, J Surg Res) - "Initial observation of concurrent small traumatic HPTX had a lower pulmonary morbidity and LOS but was found to have a clinically significant failure rate. Patients who failed observation had similar outcomes to those who received an early TT."

Journal • Critical care • Respiratory Diseases

PTX-35 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Pelican Therapeutics, Inc. | N=36 ➔ 22 | Trial completion date: Feb 2023 ➔ Jun 2023 | Active, not recruiting ➔ Terminated; Absence of immunological response

Enrollment change • Metastases • Trial completion date • Trial termination • Oncology • Solid Tumor

PTX-35 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Pelican Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2022 ➔ Dec 2022

Enrollment closed • Trial primary completion date • Oncology • Solid Tumor

NightHawk Biosciences to Present at the 4th Annual Treg Directed Therapies Summit on PTX-35 (GlobeNewswire) - "NightHawk Biosciences...announced that Matthew Seavey, Ph.D., MBA, NightHawk’s Vice President of Research will be presenting data on c, and serving on an expert panel discussing modes of Treg activation, at the 4th Annual Treg Directed Therapies Summit being held on May 17-19th in Boston."

Clinical data • Oncology • Solid Tumor

"$HTBX $NHWK NightHawk Biosciences to Present at the 4th Annual Treg Directed Therapies Summit on PTX-35 https://t.co/JHxNq60Z6d" (@stock_titan)

PTX-35 Mediated Engagement of TNFRSF25 Induces an Activated and Immunosuppressive Treg Compartment Capable of Mitigating EAE Autoimmune Disease Severity. (TCT-ASTCT-CIBMTR 2022) - "In contrast, PTX-35 treated mice exhibited minimal EAE clinical scores for the duration of the study. Therefore, expansion of Tregs via TNFRSF25-engagement has been shown to promote an activated and superior Treg population that can mitigate ongoing self-tissue damage, highlighting the therapeutic potential of PTX-35 as a potent Treg immunomodulator."

Late-breaking abstract • CNS Disorders • Immune Modulation • Immunology • Inflammation • Multiple Sclerosis • Oncology • CD4 • CD40 • FOXP3 • TNFA • TNFRSF25

Proper priming of T cells is crucial for the anti-tumor effect of mPTX-35, an anti-TNFRSF25 agonist antibody (AACR 2022) - "Mouse PTX-35 (mPTX-35) is a TNFRSF25 functional agonist derived from a CDR that was humanized and affinity matured, then fused to a mouse IgG1-Fc backbone...In conclusion, these results show that anti-TNFRSF25 agonist antibody demonstrates high anti-tumor efficacy in tumors that are infiltrated with T cells while the absence of properly antigen activated CD8 T cells (such as in cold tumors) incurs primary resistance to TNFRSF25 agonist that is reversed by proper priming of CD8 T cells. These results highlight the importance of optimal priming to limit primary resistance mechanisms and drive an efficacious immune response via the TNSFR25 axis."

Oncology • CD40 • CD8 • TNFRSF25

Heat Biologics Provides Year-End 2021 Business Update (GlobeNewswire) - "...'In September, based on our positive review of the Phase 1 data generated to date, we announced additional dose levels for our Phase 1 clinical trial evaluating the safety of PTX-35 monotherapy in patients with solid tumors and look forward to reporting the results of this trial later this year'."

P1 data • Trial status • Oncology • Solid Tumor

A Phase 1 Study of PTX-35 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Heat Biologics | N=60 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

A Phase 1 Study of PTX-35 in Healthy Volunteers (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Heat Biologics

Clinical • New P1 trial

PTX-35 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Pelican Therapeutics, Inc.; Trial completion date: Feb 2022 ➔ Dec 2022; Trial primary completion date: Sep 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

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

[VIRTUAL] PTX-35, a potential first-in-class TNFRSF25 agonist, reduced the suppressive activity of regulatory T cells and enhanced CD4+ T cell effector responses, in the presence of tumor antigens, in a murine melanoma model (AACR 2021) - "In conclusion, we demonstrate that mPTX-35, in the presence of tumor antigens, resulted in the reprogramming of the Treg cell phenotype, including reduced suppressive activity of Tregs and increased plasticity towards inflammatory Th1 and Th17 cells. PTX-35 has the potential to improve the efficacy of treatment regimens where tumor antigens are released."

IO biomarker • Preclinical • Melanoma • Oncology • Solid Tumor • CD4 • CD40 • CD8 • CTLA4 • FOXP3 • IFNG • IL17A • IL2RA • NRP1 • TNFRSF25

Heat Biologics Announces New Preclinical Data on PTX-35, Demonstrating Decreased Regulatory T-cell (Treg) Activity and Delayed Tumor Progression at American Association for Cancer Research (AACR) Annual Meeting 2021 (Yahoo Finance) - "In a B16F10 melanoma mouse model, PTX-35 in the presence of tumor antigen supplied by Heat's HS-110 immunotherapy, resulted in decreased regulatory T-cell suppression and enhanced T effector responses. These changes were associated with delayed tumor progression."

Preclinical • Melanoma • Oncology

PTX-35 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Pelican Therapeutics, Inc.; Trial completion date: Sep 2021 ➔ Feb 2022; Trial primary completion date: Mar 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

"‣ Complete HS-130 Phase I trial – 1Q:21 ‣ Complete PTX-35 Phase I trial – 1Q:21 ‣ End of Phase II meeting for HS-110 – 1H:21" (@Hojo111111)

P1 data • P2 data

Top Oncology Investigator Dr. Anthony Tolcher (Next Oncology) Selected by Heat Biologics to Lead Novel Phase I Oncology Study (TrialSite News) - "Dr. Tolcher opted to join this study as in part it 'exquisitely targets TNFRSF25' as a 'first-in-class antibody that targets an important pathway to activate antigen-experienced memory CD8+ T cells.' Dr. Tolcher went on to communicate that this novel target could potentially represent a new treatment option for those patients that are not receiving the benefits from their existing cancer therapies. Tolcher commented, 'Immunotherapy is the most exciting and a rapidly growing area of oncology and we are just at the beginning to see the potential for expanding new ventures and targets in harnessing the immune system for the treatment of cancer.'"

Announcement

[VIRTUAL] A novel TNFRSF25 agonist, PTX35, synergizes with Gp96-Ig/OX40L-Ig to enhance effector and memory anti-tumor CD8+ T cell responses and delay tumor growth (AACR-II 2020) - "Preclinical results of mouse HS-130 (mHS-130) in combination with mouse HS-110 (mHS-110) has shown a potent anti-tumor effector and memory CD8+ T cell response, followed by tumor regression. We also assessed if PD-1 antagonist therapies further amplified our responses and found that checkpoint inhibition (CPI) synergizes effectively with PTX-35 and mHS-110. Therefore, the combinations of these treatments along with CPI may translate into an efficacious approach to treating human cancers."

Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • CD8 • TNFRSF25

Heat Biologics Announces First Patient Treated in First-in-Human Clinical Trial of PTX-35 (Yahoo Finance) - "Heat Biologics... announced that the first patient has been treated in the Company's first-in-human Phase 1 clinical trial evaluating PTX-35, the first antibody product candidate developed by Heat Biologics' Pelican Therapeutics subsidiary. This first-in-human study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care."

Enrollment open • Oncology • Solid Tumor

Heat Biologics announces initiation of the lead clinical trial site for PTX-35 (Heat Biologics Press Release) - "Heat Biologics, Inc…announced initiation of the first clinical trial site for PTX-35….A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35."

Financing • New P1 trial • Oncology • Solid Tumor

PTX-35 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Heat Biologics

Clinical • New P1 trial • Gastrointestinal Cancer • Oncology • Solid Tumor