On January 12, 2026 Tempus, a leader in artificial intelligence and precision medicine, and NYU Langone Health, one of the nation’s premier academic medical centers, reported a multi-year strategic collaboration aimed at transforming cancer care through advanced molecular profiling and data-driven insights. The collaboration will support NYU Langone Health’s Center for Molecular Oncology at the Laura and Isaac Perlmutter Cancer Center, a comprehensive, pan-cancer initiative to more deeply understand disease biology over time.

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The research seeks to enhance genomic diagnostics to improve patient outcomes, inform future clinical practice, and accelerate the development and validation of novel assays and algorithmic diagnostics. As part of this work, the two organizations are launching a prospective observational study titled, "Serial Molecular Profiling and Monitoring of Human Cancer," in which patients enrolled in the study will be sequenced throughout their treatment journey in an effort to collect the longitudinal data critical to this research. The collaboration, which evolved independently from Tempus’ relationship as a trusted provider of NGS testing services, also includes a series of subsequent studies focused on assay validation, biomarker discovery, biological modeling, real-world data analysis, and the development of AI-powered predictive algorithms.

"Through the integration of advanced genomic technologies and data science, we are deepening our understanding of cancer’s complexity and pioneering transformative approaches for patient monitoring and treatment," said Ezra Cohen, MD, Chief Medical Officer, Oncology at Tempus. "Our research is focused on generating actionable insights through better understanding of cancer response, resistance, and trajectory that will not only refine and enhance current assays, but also drive the creation of innovative diagnostic tools and algorithms that can empower clinicians to deliver truly individualized care to their patients."

"This strategic collaboration will further our ability to analyze cutting-edge serial molecular profiling technology in the routine care of patients at the Perlmutter Cancer Center at NYU Langone Health," said Shridar Ganesan, MD, PhD, Director of the Center for Molecular Oncology at Perlmutter Cancer Center. "This approach will enable us to better understand the biology of individual cancers, inform our ability to implement and develop targeted therapies, and assess response and emerging resistance."

(Press release, Tempus, JAN 12, 2026, View Source [SID1234661996])

On January 12, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported recent updates and anticipated 2026 milestones.

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"On the heels of a remarkable year marked by meaningful progress across the entirety of our pipeline, we are entering 2026 with unwavering resolve to continue to execute on our mission to deliver transformative therapies to patients with cancer and rare diseases," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "For our non-muscle invasive bladder cancer (NMIBC) program, our growing body of clinical data continue to support that TARA-002 could serve as a differentiated, easy to administer treatment option across the NMIBC treatment landscape. Following our recent ADVANCED-2 update in which TARA-002 demonstrated meaningful and durable activity in BCG-Naïve NMIBC patients, we look forward to providing an interim update on the registrational BCG-Unresponsive trial later this quarter."

Mr. Shefferman added, "We have also made important progress in our rare disease programs. Following positive results from the ongoing Phase 2 STARBORN-1 trial of TARA-002 in lymphatic malformations (LMs), we were pleased that the FDA granted this program both Breakthrough Therapy and Fast Track designations and we expect to provide a regulatory update defining the path to registration in the first half of this year. Additionally, we were pleased to announce that the first patient has been dosed in our registrational THRIVE-3 trial of IV Choline Chloride in patients on long-term parenteral support (PS) and expect to provide an interim analysis in the second half of 2026. We believe we are well positioned for continued success with several key milestones anticipated in the year ahead."

Recent Company Updates and Planned 2026 Milestones

TARA-002 in NMIBC

Protara remains on track to report in the first quarter of 2026 interim results in approximately 25 six-month evaluable patients from its ongoing Phase 2 open-label ADVANCED-2 trial in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive.

In December 2025, the Company reported positive interim results from its ongoing Phase 2 open-label ADVANCED-2 trial in NMIBC patients with CIS (± Ta/T1) who are BCG-Naïve at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) in which TARA-002 demonstrated meaningful response rates at six and 12 months and a favorable safety and tolerability profile. Based on feedback from the U.S. Food and Drug Administration (FDA), the Company plans to commence a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-naïve patients in the second half of 2026.

Protara continues to evaluate subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatments with TARA-002 in NMIBC patients with CIS.

TARA-002 in LMs

Protara recently announced that the FDA granted TARA-002 both Fast Track and Breakthrough Therapy designations for the treatment of pediatric patients with macrocystic and mixed cystic LMs. TARA-002 previously was granted Rare Pediatric Disease designation for the treatment of LMs.

The Company plans to share a regulatory update on the path forward for registration for TARA-002 in LMs in the first half of 2026.

TARA-002 Manufacturing Update

Protara recently announced that TARA-002 has been selected to participate in this year’s FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. The initiative is designed to promote earlier and more structured engagement between sponsors and FDA on CMC development strategies, and since its inception, has led to increased collaboration with the FDA so sponsors can confidently scale up manufacturing capacity while clinical development is ongoing.

IV Choline Chloride for Patients on PS

The Company recently announced that the first patient has been dosed in THRIVE-3 (NCT06910943), a seamless Phase 2b/3 trial designed to assess the efficacy and safety of low and high dose IV Choline Chloride in adolescent and adult patients receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated. Following an 8-week Phase 2b open-label, dose-confirmation trial in 24 patients, approximately 105 additional patients will be enrolled in a 24-week Phase 3 double-blinded, randomized, placebo-controlled trial. The primary endpoint of the trial is the change in plasma choline concentration from baseline compared to placebo. The Company expects to report interim results in the second half of 2026.

Corporate Update

In December 2025, the Company announced that it closed an underwritten public equity offering of approximately $86 million before deducting underwriting discounts and commissions and offering expenses payable by Protara. The proceeds from the offering are expected to extend the Company’s cash runway into 2028.

(Press release, Protara Therapeutics, JAN 12, 2026, View Source [SID1234661965])

On January 12, 2026 Oricell Therapeutics Holdings Limited ("Oricell" or "the Company"), a global leader in innovative cancer immunotherapy, reported the closing of a $70M Series C1 financing.

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The round was co-led by Beijing Medical and Health Care Industry Investment Fund, Qiming Venture Partners and a leading global healthcare fund, with participation from a sovereign wealth fund, NGS Super (NGS), E-Town Capital, Elikon Venture, and Talon Capital. Proceeds will accelerate Oricell’s global expansion and clinical development, while strengthening its technological capabilities and paving ways to commercialization.

Oricell is advancing a differentiated pipeline of CAR-T cell therapies for solid tumors, underpinned by three proprietary platforms developed over the past decade:

OriAb: antibody discovery and engineering library
OriArmoring: enhancement of T-cell persistence and other crucial functions by TAs（Therapeutic Areas）
OnGo (Fast) CMC: rapid, scalable and effective manufacturing
Oricell has generated proof-of-concept (POC) clinical data across multiple pipeline CAR-T products. Its lead program, Ori-C101, is an autologous GPC3-targeted CAR-T therapy for advanced hepatocellular carcinoma (HCC). Both a Phase I Investigator-Initiated Trial (IIT) and a Phase I IND study of Ori-C101 are completed. With far-leading-industry efficacy and safety profile, Ori-C101’s clinical data have been featured at major academic conferences such as ASCO (Free ASCO Whitepaper) 2021 and ASCO (Free ASCO Whitepaper) 2025. Ori-C101 is entering the registrational pivotal trial and is well positioned to become the world’s first approved CAR-T therapy for HCC.

Beyond Ori-C101, Oricell’s integrated platforms are also yielding multiple next-generation CAR-T products with multi-targets and multi-mechanism designs. The innovative secreting CAR-T, OriC902, has shown groundbreaking efficacy and durability in ultra-late-line and difficult-to-treat solid tumor patients. Additionally, the company has initiated an IIT study to evaluate its proprietary dual-targeted in vivo CAR-T.

"We are deeply grateful for the strong vote of confidence from our investors," said Dr. Helen Yang, Chairlady and CEO of Oricell Therapeutics. "Oricell will continue to push forward the global clinical advancement of our pipeline, as well as continuous R&D of in vivo products and new technologies. Leveraging our deep technical expertise, policy tailwind and expanding market opportunities, we are able to accelerate the development of our CAR-Ts in the clinic at full speed. Our mission is to bring efficacious and affordable cell therapies to cancer patients worldwide with the hope of cure. By doing that, we aim to become a leading global immunotherapy enterprise."

Mr. Peng Ren, Chairman and General Manager of Beijing Medical and Health Care Industry Investment Fund, noted: "We believe cell therapy is a pivotal frontier in the fight against solid tumors, and we are highly impressed by the clinical progress of Oricell’s GPC3 CAR-T in treating HCC. We strongly value the team’s R&D capabilities and commercial vision, and look forward to supporting the company in accelerating global clinical breakthroughs for its core products."

"As an early investor in Oricell, we’ve witnessed the Company’s evolution from a promising startup to a technology powerhouse—from advancing autologous CAR-Ts to secreting CAR-Ts, to pioneering a 3-day rapid manufacturing process, and now to exploring in vivo CAR-T in the clinic," said Mr. Xubo Hu, Managing Partner of Qiming Venture Partners. "Oricell’s relentless innovation efforts continue to impress us and we are delighted to back a team that is committed to building truly global and groundbreaking therapies."

(Press release, OriCell Therapeutics, JAN 12, 2026, View Source [SID1234661981])

On January 12, 2026 Kivu Bioscience, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, reported that the first patient has been dosed in its Phase 1 clinical trial of KIVU-107, a next-generation PTK7-targeting ADC for patients with advanced solid tumors.

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"Dosing the first patient with KIVU-107 marks an important milestone for Kivu and for patients with advanced solid tumors who urgently need better treatment options," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. "Advancing KIVU-107 from preclinical development to first-in-human dosing in under 12 months underscores the efficiency of our platform and our commitment to developing a new generation of ADCs designed to expand the therapeutic window and deliver meaningful benefit to patients."

The first-in-human Phase 1 study (NCT07229313) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KIVU-107 in patients with advanced solid malignancies. KIVU-107 is built using GlycoConnect and HydraSpace site-specific conjugation technologies, enabling precise and stable drug-to-antibody ratios and optimized pharmacokinetics to improve the therapeutic window. KIVU-107 is designed to deliver potent, targeted cytotoxic activity in PTK7-expressing tumors while improving safety and tolerability compared to earlier-generation ADCs. The study has received regulatory approval in the United States and Australia.

(Press release, Kivu Bioscience, JAN 12, 2026, View Source [SID1234661997])

On January 12, 2026 Erasca presented its corporate presentation.

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(Presentation, Erasca, JAN 12, 2026, View Source [SID1234661948])