On December 3, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported updated interim data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC). These results in Bacillus Calmette-Guérin (BCG)-Naïve NMIBC patients will be featured during a poster session at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) in Phoenix, Arizona.

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"These positive results continue to support TARA-002’s potential in the NMIBC treatment landscape, and we look forward to finalizing a regulatory pathway for TARA-002 in BCG-Naïve patients," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We remain on track to provide an update on the registrational BCG-Unresponsive patient cohort in the ADVANCED-2 trial in the first quarter of 2026 and expect to complete enrollment of this cohort in the second half of 2026."

"These encouraging TARA-002 results demonstrate meaningful and durable activity in BCG-Naïve NMIBC patients," said Mark Tyson, M.D., MPH, Vice Chair for Research and a Professor in the Department of Urology with the Mayo Clinic in Phoenix, Arizona, and ADVANCED-2 study investigator. "The clinically meaningful response rates at six and 12 months, coupled with a favorable safety and tolerability profile and simple administration that is even more streamlined than BCG, make TARA-002 a compelling potential treatment option in the BCG-Naïve setting."

Updated Interim Results

The dataset includes 31 BCG-Naïve patients who received at least 1 dose of TARA-002; 29 patients completed at least one response assessment and were evaluable for efficacy as of a November 7, 2025 data cutoff. Patients received an induction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months. Re-induction was permitted for eligible patients with residual CIS and/or recurrent high-grade Ta disease. Complete response (CR) rates at the six months and 12 months landmark time points include all participants who were either evaluable at that time point or had experienced disease progression or treatment failure prior to the scheduled visit.

The CR rate at any time was 72% (21/29).
The CR rate was 69% (18/26) at six months and 50% (7/14) at 12 months.
Among initial responders, 88% (14/16) maintained their response through six months and 100% (3/3) through 12 months.
Re-induction therapy successfully salvaged most initial non-responders, resulting in high conversion rates and durable responses: 80% (4/5) of re-induced patients converted to a CR at 6 months, and 100% (4/4) of those responders maintained their CR at 12 months.
Safety and Tolerability

The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient with no Grade 3 or greater TRAEs as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly occurring TRAEs were dysuria (13%), fatigue (13%), and hematuria (6%).

Regulatory Update

The Company remains in ongoing dialogue with the U.S. Food and Drug Administration (FDA) on an expansion of the agreed upon registrational path forward for TARA-002 beyond the BCG-Unresponsive NMIBC patient population. The FDA has provided written feedback supporting a registrational design for a controlled trial in BCG-Naïve patients (who have never been exposed and those who have not received BCG within the last 24 months and are ineligible to receive BCG or contraindicated, cannot tolerate BCG, do not have access to BCG, or refuse BCG). The FDA has agreed that BCG is not required as a comparator and that intravesical chemotherapy is an acceptable comparator to TARA-002 in BCG-Naïve patients. The FDA also is aligned with the primary endpoint of the trial as the CR rate at month 6 with duration of response as a key secondary endpoint. The Company has engaged the FDA to determine how to include BCG-Exposed patients in its clinical trials of TARA-002, for whom no FDA-approved treatments are available and who have limited options to access investigational treatment through clinical trials.

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 (Cohort B N=75-100) or BCG-Naïve (Cohort A N=31). Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.

The Company remains on track to report interim results from approximately 25 six-month evaluable NMIBC patients from ADVANCED-2 with carcinoma in situ or CIS (± Ta/T1) who are BCG-Unresponsive in the first quarter of 2026 and expects to complete enrollment in this cohort in the second half of 2026.

Conference Call and Webcast

Protara will host a conference call and webcast today at 8:30 am ET to review the data reported this morning. The live event and accompanying slides can be accessed by visiting View Source, or via 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 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. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. 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 sixth 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

(Press release, Protara Therapeutics, DEC 3, 2025, View Source [SID1234661107])

On December 3, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano reported new pharmacokinetic (PK) and tissue-distribution results demonstrating that Sapu003, the company’s intravenous (IV) Deciparticle formulation of everolimus, substantially reduces gastrointestinal (GI) drug accumulation, addressing one of the most significant and well-recognized limitations of oral everolimus (Afinitor). The data indicate that Sapu003 may offer improved tolerability while preserving the drug’s intrinsic metabolic profile and enabling more consistent systemic exposure.

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IV Sapu003 Reduces GI Exposure to Everolimus by 67-Fold Compared With Oral Dosing

New tissue-distribution data show that Sapu003, delivered intravenously, eliminates the extreme gastrointestinal accumulation characteristic of oral everolimus. After oral dosing, everolimus reaches 2,448× plasma levels in the stomach, 750× plasma in the small intestine, and 323× plasma in the large intestine, confirming that the gut is the dominant exposure site for the oral formulation.

In contrast, IV Sapu003 demonstrates only 36-48× plasma levels across the same GI tissues, representing a 67-fold reduction in stomach exposure, a 15.7-fold reduction in small-intestinal exposure, and a 7.4-fold reduction in large-intestinal exposure.

These findings provide a clear mechanistic explanation for the well-documented GI toxicity of oral everolimus-including stomatitis, mucositis, abdominal discomfort, and diarrhea.

Presentation information: PS4-06-05. Sapu003: Everolimus for Injection – Pharmacokinetic Rationale for Phase I Evaluation in HR /HER2 Metastatic Breast Cancer. Wen-Han Chang, John Lopp, Sheng-Hao Min, Robert Hoff, Nancy Chang, Tanjina Hoque, Ann Park, and Cynthia Lee.

Potential for Improved Clinical Tolerability and Antitumor Potency

By bypassing the gastrointestinal tract and delivering the drug directly into circulation, Sapu003:

Avoids the high local GI concentrations associated with oral toxicity
Produces more consistent systemic exposure
Enhances drug penetration into tumor-relevant tissues

These PK advantages complement previously reported efficacy findings in which Sapu003 achieved 97-98% tumor inhibition in glycolysis-addicted xenograft while outperforming paclitaxel.

Management Commentary

"The fundamental challenge with oral everolimus is that the majority of the drug ends up in the gut, leading directly to the GI toxicity that limits its use," said Dr. Cynthia Lee, VP of R&D. "These new data show that IV Sapu003 avoids that problem entirely. By reducing GI accumulation by up to 67-fold, Sapu003 has the potential to offer a far more tolerable and clinically versatile version of everolimus."

About Sapu003

Sapu003 is a novel intravenous nanoparticle formulation of everolimus engineered using Sapu Nano’s proprietary Deciparticle technology. It is designed to overcome the poor bioavailability, intestinal toxicity, and variable patient exposure seen with oral everolimus while enabling reliable, predictable weekly IV dosing.

About the Deciparticle Platform

The Deciparticle platform is a proprietary nanotechnology engineered to encapsulate hydrophobic molecules as uniform, sub-20 nm nanoparticles for intravenous administration. The platform improves systemic exposure, reduces GI deposition, and supports precision delivery while maintaining manufacturability at clinical scale.

(Press release, Oncotelic, DEC 3, 2025, View Source [SID1234661109])

On December 3, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following global update on FLAMINGO-01.

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Flamingo-01 Progress to Date

The Company has achieved a major milestone by screening over 1,000 patients in Flamingo-01, continuing its screening rate of approximately 150 patients per quarter or the equivalent of 600 patients per year in approximately 40 US sites and 100 EU sites for a total of 140 active sites. The Company is considering a strategy to continue enrolling in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses are conducted and the appropriate size of each arm can be further assessed.

CEO Snehal Patel commented, "Reaching 1,000 screened patients confirms that the interest from doctors and patients is high. The clinical site start-up activities in Europe in 2025 have further increased the momentum in the study. We are also receiving interest from other countries to join FLAMINGO-01, driven by patient interest. The high screening rate will give the Company many options, including the opportunity to continue enrollment through multiple interim analyses, the potential to realize higher enrollment rates and event rates, and the potential to maximize indications by analyzing efficacy across multiple HLA types in larger patient populations."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, DEC 3, 2025, View Source [SID1234661092])

On December 3, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing solid tumors. STRO-004 is the Company’s TF-targeting exatecan ADC engineered for best-in-class stability, potency, and tumor selectivity using Sutro’s proprietary cell-free platform.

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"Dosing the initial patients in this trial marks an important milestone in bringing forward new treatment options for patients with TF–expressing cancers—many of whom face limited therapy options and difficult prognoses. We’ve seen strong engagement from our clinical investigators, who recognize the potential of STRO-004 to address a pressing need in oncology—and we’re proud of the speed and precision with which our team brought the program into the clinic," said Jane Chung, Chief Executive Officer of Sutro Biopharma. "STRO-004 is engineered to deliver potent, sustained anti-tumor activity and higher exposure compared to approved therapies, with the goal of reaching tumors that are resistant to standard approaches. Through this trial, we aim to generate early insights into safety and activity that will guide development in areas of urgent unmet need. We are deeply grateful to the patients and investigators participating in this study and look forward to sharing initial data in mid-2026."

The Phase 1 open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 in patients with advanced TF-expressing solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, cervical cancer, colorectal cancer, pancreatic ductal adenocarcinoma, and bladder cancer. The dose-escalation phase includes multiple cohorts with ascending dose levels, supported by strong tolerability in non-human primates at up to 50 mg/kg. Sutro’s design enables high entry doses, with the goal of rapidly identifying a recommended Phase 2 dose and early signs of clinical activity.

More information can be found at: View Source

About STRO-004
STRO-004 is a next-generation antibody-drug conjugate (ADC) targeting tissue factor (TF), a clinically validated tumor-associated antigen expressed across multiple solid tumors. In preclinical studies, STRO-004 demonstrated robust anti-tumor activity, favorable tolerability, and higher exposure compared to approved therapies. Developed using Sutro Biopharma’s proprietary cell-free platform, STRO-004 features an Fc-silent, high affinity antibody, with site-specific β-glucuronidase cleavable linker and exatecan payload at a drug-to-antibody ratio of 8 (DAR8). This design aims to enhance stability, reduce off-target toxicity, and maximize efficacy. It is currently being evaluated in a Phase 1 trial in patients with a range of TF-expressing solid tumors.

(Press release, Sutro Biopharma, DEC 3, 2025, https://ir.sutrobio.com/news-events/news-releases/detail/224/sutro-biopharma-announces-first-cohort-of-patients-dosed-in-phase-1-trial-of-stro-004-a-next-generation-tissue-factor-adc-in-tf-expressing-solid-tumors [SID1234661110])

On December 3, 2025, ADC Therapeutics SA (the "Company") reported updated data from the ongoing LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).

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As of the November 17, 2025 cutoff date, a total of 49 patients were efficacy evaluable with a minimum of 6 months of follow-up from treatment initiation. Key highlights of the data are as follows:

· Best overall response rate (ORR) was 89.8% (44/49 patients), as assessed by Lugano criteria
o ORR was 95.2% at the 120 µg/kg dose and was 85.7% at the selected 150 µg/kg dose
· Complete response (CR) rate was 77.6% (38/49 patients)
o Of these, 33/38 patients achieving CR remain in CR as of the data cutoff; the 5 patients who did not remain in CR included 2 patients with progressive disease, 2 patients with Grade 5 AEs which occurred during CR, and one censored patient
o CR rate was 81.0% at the 120 µg/kg dose and was 75.0% at the selected 150 µg/kg dose
· Strong efficacy in both the relapsed and primary refractory populations across both dose levels
o In the 24 relapsed patients, ORR was 100% and CR rate was 91.7%
o In the 25 primary refractory patients, ORR was 80% and CR rate was 64%
· 14 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 13 patients, respectively)
· Of the 8 patients previously treated with CAR-T, 6 achieved a CR
· The combination was generally well tolerated with a manageable safety profile
o Grade 3 or higher treatment emergent adverse events (TEAEs) observed in > 5% of patients included neutropenia (32.7%), GGT increased (16.3%), anemia (10.2%), WBC decreased (8.2%), generalized oedema (8.2%), ALT increased (8.2%), AST increased (6.1%), and thrombocytopenia (6.1%)
o Grade 5 AEs occurred in 2 (4.1%) patients, one at each dose level; the one at the 120 µg/kg dose was treatment-related per the investigator
o Cytokine release syndrome (CRS) of all grades across dose levels was 36.7%
§ CRS all grades was 25.0% at the selected 150 µg/kg dose and 52.4% at the 120 µg/kg dose, with all but one were low Grade
o Immune effector cell-associated neurotoxicity syndrome (ICANS) was 4.1% across dose levels, with only Grade 1/2

(Press release, ADC Therapeutics, DEC 3, 2025, View Source [SID1234661192])