On December 3, 2024 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, December 5, 2024, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) (Press release, Protara Therapeutics, DEC 3, 2024, https://ir.protaratx.com/news-releases/news-release-details/protara-therapeutics-host-conference-call-and-webcast-review-new [SID1234648759]). The data will be featured during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology on December 5, 2024, at 1:15 p.m. CT.

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The live call can be accessed by registering as a participant here. Upon registration, participants will receive conference call dial-in information. A live webcast of the event can be accessed by visiting the Events and Presentations section of the Company’s website: View Source A replay of the webcast will be archived for a limited time following the event.

About ADVANCED-2

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive (n≈100) and BCG-Naïve (n=27). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the FDA’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment Draft Guidance for Industry. Trial subjects received an induction with or without a reinduction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly installations every three months.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd and also approved in Taiwan. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

On December 3, 2024 Priothera Ltd., a late-stage biopharma company pioneering the development of its oral sphingosine 1 phosphate (S1P) receptor modulator, mocravimod, as an adjunctive and maintenance therapy for hematologic malignancies, reported that it will present a Trial in Progress poster on the MO-TRANS Phase 3 study, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 7-10, 2024, in San Diego, California (Press release, Priothera, DEC 3, 2024, View Source [SID1234648758]).

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Priothera is investigating the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (allo-HCT) in the pivotal MO-TRANS Phase 3 study.

Mocravimod’s unique dual mechanism of action modulates the S1P receptor 1 to retain alloreactive donor T-cells within lymphoid organs, enhancing the graft-versus-leukemia (GvL) effect to eliminate cancer cells, while preventing T-cell egress to peripheral tissues, thereby reducing the risk of graft-versus-host disease (GvHD). This innovative treatment approach offers a promising solution for patients at high risk of relapse following allo-HCT.

The MO-TRANS study (NCT05429632) is a multicenter, global, placebo-controlled trial enrolling patients with AML in complete remission (CR1), including those with intermediate or adverse risk, as well as patients of all risks in second complete remission (CR2). Patients are randomized to receive either mocravimod or a placebo in addition to standard of care. The primary endpoint of the study is relapse-free survival (RFS). Secondary endpoints include overall survival (OS) and the incidence of GvHD.

On December 3, 2024 PharmaMar Group (MSE: PHM) reported that its licensing partner, Luye Pharma Group Ltd. has received conditional marketing approval for Zepzelca (lurbinectedin) from the China National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression during or after platinum-based chemotherapy (Press release, PharmaMar, DEC 3, 2024, View Source [SID1234648757]). China’s NMPA grants conditional approvals to medicines targeting diseases that are severely life-threatening and where there is no effective treatment.

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The NMPA conditional approval is based on the results from a single-arm, dose-escalation, dose-expansion clinical study conducted in China. The study was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lurbinectedin in Chinese patients with advanced solid tumors, including recurrent SCLC. This study confirms the efficacy and safety of lurbinectedin in Chinese patients following the basket trial data that the Food and Drug Administration (FDA) used to grant accelerated approval of lurbinectedin in USA; an open-label, multicenter, single-arm, monotherapy study in 105 adult patients with recurrent metastatic SCLC (including patients with platinum-sensitive and platinum-resistant disease).

The most recent data from 2022 indicates that Lung Cancer is the tumor with the highest incidence in China, with more than 1,000,000 new cases per year, and was the leading cause of cancer deaths with 733,291i. Specifically, globally, Small Cell Lung Cancer accounts for 10-15% of lung cancer diagnoses and is one of most aggressive forms of lung cancerii.

In addition to this approval of lurbinectedin in mainland China, it is already approved in Chinese territory in Hong Kong and Macau and totalling 17 regions around the world. In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in Small Cell Lung Cancer and potentially other indications in mainland China, Hong Kong, and Macau.

On December 3, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that the Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study following their review of initial safety data. Enrollment in this cohort will resume pending final approval from the Paul Ehrlich Institute (PEI), Germany’s medical regulatory body (Press release, Oncolytics Biotech, DEC 3, 2024, View Source [SID1234648756]). Additional updates are expected in 2025, with safety data anticipated in the first half and initial efficacy results in the second half.

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The GOBLET study is a Phase 1/2 randomized, open-label, multicenter trial using a Simon two-stage design to evaluate treatments across multiple gastrointestinal cancers. In cohort 5, the study is assessing pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab (Tecentriq), in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). This cohort is funded by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to speed up the development of new pancreatic cancer treatments.

"We see a promising opportunity for pelareorep to improve treatment options for PDAC patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The current standard of care is primarily chemotherapy, such as gemcitabine + nab-paclitaxel or mFOLFIRINOX. Pelareorep has already shown synergy with gemcitabine, nab-paclitaxel, and atezolizumab in GOBLET Cohort 1, and demonstrating efficacy with mFOLFIRINOX would further establish its potential to benefit PDAC patients. This study also builds on Cohort 1 by evaluating pelareorep’s ability to work with checkpoint inhibitors, which would be a major advance, especially as immune therapies provide little benefit in most patients with this ‘cold’ tumor."

About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

On December 3, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, reported that Chandler Robinson, MD, Monopar’s Chief Executive Officer, will participate in a fireside chat along with one-on-one meetings at the 36th Annual Piper Sandler Healthcare Conference (Press release, Monopar Therapeutics, DEC 3, 2024, View Source [SID1234648755]).

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Presentation Details:

Date: December 5, 2024
Time: 10:30-10:55 am Eastern Time
Location: Lotte New York Palace, NY, NY