On April 12, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (Press release, Shanghai Junshi Bioscience, APR 12, 2021, View Source [SID1234578061]). This is the third approved indication for toripalimab in China. In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Following the approval of indications in melanoma and nasopharyngeal carcinoma, toripalimab has reached a new milestone in the treatment of urothelial carcinoma, under the joint efforts of patients, investigators, and our R&D personnel," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Junshi Biosciences has pioneered clinical exploration for unselected UC patients in China and achieved remarkable results, which makes us very excited and confident in the development potential of toripalimab as an anti-tumor drug with a broad therapeutic profile. We also look forward to providing Chinese UC patients with more treatment options that work better and cost less through the company’s collaboration with AstraZeneca."

The supplemental NDA is based on the POLARIS-03 study (NCT03113266) led jointly by Professor Guo Jun of the Peking University Cancer Hospital and Professor Huang Yiran of Renji Hospital affiliated to the Shanghai Jiao Tong University School of Medicine. Among the 136 patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy including neoadjuvant or adjuvant chemotherapy within 12 months, the evaluation results of the Independent Review Committee (IRC) indicated that the overall objective response rate (ORR) was 27.2%, the disease control rate (DCR) was 46.3% and the median overall survival (mOS) reached 14.6 months. The median duration of response (DOR) had not yet reached a mature stage, with 67.1% of patients with objective responses continuing after a 12-month period.

POLARIS-03 is the first pivotal clinical study on the treatment of advanced urothelial carcinoma with an unselected population after failure of first-line standard treatment in China. Data showed that toripalimab demonstrated explicit anti-tumor activity and continuous efficacy among all patients and within each subgroup. ORR of all patients was 27.2%. ORR of PD-L1 positive patients reached 42.2%. ORR of PD-L1 negative patients reached 18.8%. Therefore, advanced urothelial carcinoma patients benefit from toripalimab regardless of PD-L1 expression. In addition, the safety and tolerability of toripalimab were consistent with previous research results.

On April 12, 2021 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported that the first patient has been dosed in the Phase 1 clinical trial of RTX-321 for the treatment of human papilloma virus (HPV) 16-postive cancers (Press release, Rubius Therapeutics, APR 12, 2021, View Source [SID1234584703]). RTX-321 is an allogeneic, off-the-shelf Red Cell Therapeutic product candidate that is engineered as an artificial antigen-presenting cell (aAPC) with a dual mechanism of action: boosting HPV 16-specific CD8+ T cell responses and promoting broad stimulation of both innate and adaptive immune responses. The Phase 1 clinical trial of RTX-321 is enrolling patients with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including cervical cancer, head and neck squamous cell carcinoma (HNSCC) and anal cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In preclinical studies, the surrogate model of RTX-321 induced a broad immune response and epitope spreading, suggesting that in patients, an effective immune response could be generated against multiple HPV antigens," said Christina Coughlin, M.D., Ph.D., chief medical officer of Rubius Therapeutics. "In patients, RTX-321 may also induce tumor-specific memory, potentially enabling the patient’s own immune system to remember a cancer’s identity, which could lead to long-term protection from tumor recurrence. Based on these findings, we believe that RTX-321 may lead to durable responses in patients with HPV 16-positive cancers."

RTX-321 expresses hundreds of thousands of copies of the costimulatory molecule 4-1BBL, the cytokine IL-12 and an HPV peptide antigen bound to major histocompatibility complex (MHC) class I proteins on the cell surface to mimic human T cell-APC interactions. As part of the manufacturing process, Rubius is producing frozen drug substance for the first time, enabling a truly off-the-shelf cellular therapy product candidate with a potential shelf life of up to several years.

"HPV 16 is the most common high-risk strain of HPV and is known to be associated with various types of cancer, including cervical cancer, head and neck squamous cell carcinoma and anal cancer. For patients with advanced HPV 16-positive cancers, the prognosis remains poor with few treatment options beyond the first-line setting," said Howard A. "Skip" Burris, III, M.D., president, clinical operations and chief medical officer, Sarah Cannon Research Institute. "RTX-321 offers a new potential option to treat these patients by utilizing the body’s own immune system. We look forward to working with Rubius Therapeutics to develop RTX-321 for the treatment of patients with HPV 16-positive cancers."

About HPV 16-Positive Cancers
Human papillomavirus (HPV) 16 is associated with approximately 70 percent of cervical cancers, approximately 40 percent of head and neck squamous cell carcinoma (HNSCC) arising in the oropharynx, approximately 25-40 percent of HNSCC arising in other locations and approximately 80-85 percent of anal cancers. A critical need remains for better treatment options for advanced HPV 16-associated cancers. The prognosis remains poor for patients with metastatic disease with few treatment options beyond the first-line setting.

About the RTX-321 Clinical Trial
Rubius Therapeutics is enrolling patients in a Phase 1 open-label, multicenter, monotherapy dose escalation, first-in-human study of RTX-321 for the treatment of patients that are HLA-A*02:01-positive with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including unresectable cervical cancer (squamous, adeno, or adenosquamous histology), head and neck squamous cell carcinoma (including of the nasal and oral cavities, larynx, hypopharynx, nasopharynx, and oropharynx) and squamous cell cancer of the anal canal that is not amenable to curative therapy. The purpose of the trial is to determine the safety and tolerability, recommended phase 2 dose and pharmacology, and antitumor activity of RTX-321. For more information about the Phase 1 clinical trial of RTX-321, please visit clinicaltrials.gov (NCT04672980).

About RTX-321
RTX-321 is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex (MHC) class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions.

On April 12, 2021 Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine,reported that promising new preclinical data of PTX-35 is presented at the AACR (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Heat Biologics, APR 12, 2021, View Source [SID1234577891]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

PTX5 is the company’s first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T-cells. 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.

Jeff Wolf, Chief Executive Officer of Heat, commented, "PTX-35 is designed to harness the body’s natural antigen-specific immune activation. We believe our latest data suggest that PTX-35 can help overcome certain mechanisms of cancer immune evasion. We continue to advance our first-in-human Phase 1 study of PTX-35 in patients with solid tumors and look forward to sharing interim data later this year."

Details of the poster presentation are as follows:

Title: PTX-35, a Potential First-in-class 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

Abstract Number: 604

Session: Modifiers of the Tumor Microenvironment

Presenter: Eric Dixon, Director of Discovery Sciences, Heat Biologics

About the AACR (Free AACR Whitepaper) Annual Meeting

The 2021 AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention to cancer biology, translational, and clinical studies, as well as survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world.

On April 12, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that Paul Levesque, President and Chief Executive Officer, will present at the Bloom Burton & Co. Healthcare Investor Conference on Wednesday, April 21, 2021 at 10:30 a.m. ET (Press release, Theratechnologies, APR 12, 2021, View Source [SID1234577908]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The live webcast will be available at View Source The live and archived webcast link will also be available in the ‘News’ section of the Company’s website.

On April 12, 2021 Seneca Therapeutics, Inc. ("STI"), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics based on Seneca Valley Virus (SVV-001), reported the poster presentation of Seneca Therapeutics’ abstract titled "Oncolytic Seneca Valley Virus (SVV) overcomes resistance to checkpoint inhibitor therapies in neuroendocrine and melanoma murine models expressing the receptor for SVV" (Press release, Seneca Therapeutics, APR 12, 2021, View Source [SID1234577925]). Key points from the presentation:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

SVV-001 demonstrates the ability to turn cold tumors hot;
Intratumoral administration of SVV-001 in combination with a checkpoint inhibitor demonstrates up to six fold increase in anti-tumor response over SVV-001 alone or check point inhibitor therapy alone;
SVV-001 specifically targets, infects and kills TEM8 positive cancer cells. No cell killing was observed in normal cells;
RNA seq data confirm up regulation of genes known to stimulate an immune response;
A randomized Phase III clinical study comparing SVV-001 administered IT in combination with Opdivo and Yervoy compared to Opdivo and Yervoy alone in TEM8 positive neuroendocrine tumors and neuroendocrine carcinomas is planned to begin later in 2021. STI is also developing SVV-001 for intravenous use in TEM8 positive tumors as well as developing SVV-001 to deliver armed viruses to TEM8 positive tumor cells.