On December 4, 2025 Immorta Bio reported the publication of a landmark preclinical study in the Journal of Translational Medicine demonstrating that its novel immunotherapy, SenoVax, dramatically reduces multiple types of solid tumors in murine models. Earlier this year, Immorta Bio filed IND #30745 with the FDA for a first-in-human trial in advanced lung cancer.

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The paper, titled "Reduction of Solid Tumors by Senescent Cell Immunization," was authored in collaboration with leading researchers from the University of Miami, Cedars-Sinai, UC San Diego, the Institute for Human Optimization, George Washington University, and Translational and Advanced Biosciences.

Full text: View Source In well-characterized mouse models of aggressive cancers, SenoVax, a personalized autologous immunotherapy that trains the immune system to attack senescent cells, achieved significant tumor shrinkage across lung, glioblastoma (brain), pancreatic, and breast cancers.

Senescent cells, which accumulate with age and chronic stress, are increasingly implicated in creating an immunosuppressive, pro-tumor microenvironment. By targeting antigens uniquely expressed on these cells, SenoVax appears to reprogram the tumor microenvironment, turning immunologically "cold" tumors "hot" by boosting CD8⁺ T-cell infiltration and reducing immune-suppressive cell populations. Key findings:

Statistically significant tumor growth inhibition and prolonged survival in both orthotopic and syngeneic models

Robust CD8⁺ T-cell infiltration and depletion of immunosuppressive cells in treated tumors

Strong activity as monotherapy and in combination with other treatments
"These data provide compelling proof-of-concept that immunizing against senescent cells represents an entirely new therapeutic modality in oncology," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio and lead author of the study. "We have already filed IND #30745 with the FDA for a first-in-human trial in advanced lung cancer and are completing the GMP manufacturing required to begin the study."

Dr. Gilberto Lopes, Chief of Thoracic Medical Oncology at the Sylvester Comprehensive Cancer Center (University of Miami) and study co-author, commented: "Many deadly solid tumors remain resistant to current immunotherapies because they are immunologically ‘cold.’ Converting the tumor microenvironment into a more inflamed, T-cell-friendly state by eliminating senescent cells could dramatically broaden the reach of checkpoint inhibitors and other immune therapies."

Dr. Boris Reznik, Chairman and CEO of Immorta Bio and senior author, added: "This publication lays a strong translational foundation for bringing senescent-cell-targeted therapies into the clinic, not only for cancer, but potentially for the many age-related diseases driven by pathologic cellular senescence."

The publication describes preclinical experiments in validated murine models demonstrating that immunization with SenoVax—a personalized, autologous immunotherapy designed to elicit immune responses against senescent cells—was associated with reduced tumor burden in lung, brain, pancreatic, and breast cancer settings. Senescent cells are increasingly recognized as contributors to tumor progression, immune evasion, and chronic inflammation. The work builds on prior evidence that removing senescent cells can modify the tumor microenvironment and may enhance antitumor immunity.

"These findings support further investigation of senescent-cell–targeted immunotherapy in oncology," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio and first author of the study. "Immorta Bio has submitted IND #30745 to the FDA for a planned first-in-human study in lung cancer and is completing the required GMP manufacturing run to enable initiation."

"Therapeutic resistance remains a major challenge, particularly in tumors with limited immune infiltration," said Dr. Gilberto Lopes, Chief of Medical Oncology at the University of Miami and second author of the publication. "These preclinical results raise the possibility that targeting senescent cells could improve immune responsiveness and complement existing treatment approaches."

Dr. Boris Reznik, Chairman and CEO of Immorta Bio and senior author, added: "This study provides foundational evidence for clinical development of senescent-cell–directed therapies in oncology, with potential future application to other aging-related biological processes."

(Press release, Immorta Bio, DEC 4, 2025, View Source [SID1234661134])

On December 4, 2025 Orano Med, a subsidiary of the Orano group specializing in nuclear medicine, reported that its long-standing collaboration with the multinational pharmaceutical company Roche (SIX: RO, ROG; OTCQX: RHHBY) is entering the next phase. Over the past years, the companies have conducted extensive preclinical research to develop a potential novel cancer treatment approach called "two-step pretargeted radioimmunotherapy" (or PRIT). This innovative technology, which pretargets the tumor with an antibody that is subsequently able to capture chelated lead-212 (212Pb) to target tumor cells, is now ready to advance into clinical development in humans. Orano Med will be responsible for the manufacturing of 212Pb, utilizing its industrial manufacturing platform in France and the US.

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Nicolas Maes, Chief Executive Officer of the Orano group, commented: "We are very pleased about the progress made in collaboration with Roche for the development of a potential new treatment approach for cancer patients. After the licensing agreement signed with Sanofi last year for our most advanced clinical program, AlphaMedix, the achievement with this potential new drug candidate marks an important milestone that we accomplished jointly with another major player in the pharmaceutical industry. It illustrates our capacity to execute our long-term strategy, aimed at developing a solid pipeline of 212Pb-targeted alpha therapies to treat multiple oncology indications. In addition, thanks to the Orano Group’s expertise in the nuclear industry and its access to thorium-232, a scarce raw material required for producing 212Pb, Orano Med is also responsible for the entire production and distribution chain for these isotopes."

Julien Torgue, Chief Scientific Officer of Orano Med, commented: "The application of two-step pretargeted radioimmunotherapy represents a potentially game-changing advancement in radioligand therapies and cancer treatment more broadly. Instead of delivering radiation and targeting vector together, the novel technique separates the process into two precise steps: first, allowing time for antibodies to accumulate on the tumor, and then capturing the alpha particle emitting radioactive isotope lead-212, which allows for the precise targeting of cancer cells while sparing healthy tissue. In preclinical studies, we could already demonstrate both strong efficacy and, importantly, a reduction in off-target uptake in healthy tissues. If these results translate to the clinic, this could bring us a major step closer to a more effective and for patients also safer form of radioligand therapy. We are looking forward to further continue the development of this innovative approach with Roche."

Under the terms of the agreement, Orano Med and Roche have committed to develop this new therapeutic solution targeting a specific antigen known as carcinoembryonic (CEA), a cell surface glycoprotein overexpressed in several cancers. This antigen serves as a marker for various types of cancer, such as colorectal, pancreatic, and gastric cancers, as well as certain lung cancers. These are cancers for which the current therapeutic options are often limited or insufficient to meet patients’ needs. CEA shows restricted expression in normal tissues, making it a very suitable target for antibody-based therapies and radioimmunotherapy.

The Roche sponsored phase 1 clinical trial is expected to start in the first half of 2026, initiating the development of a broader platform dedicated to alpha radioimmunotherapies, underscoring Orano Med’s global leading position in the field of targeted alpha therapies.

About 212Pb two-step PRIT
Compared with conventional radioligand therapies (RLT), where the isotope and targeting moiety are co-delivered, pretargeted radioimmunotherapy (PRIT) uses a sequential approach. A tumor-targeting bispecific antibody (bsAb) is first administered, followed by a radioligand carrying the radioactive payload. The delay gives the bsAb the necessary time to accumulate on the tumor cells while unbound radioligand is rapidly cleared. It thus enables highly specific antibody targeting while remaining compatible with the relatively short half-life of 212Pb (10.6 hours). By introducing the cytotoxic radioligand only after the bsAb has largely cleared from circulation, radiation is concentrated in the tumor. This sequential approach is designed to minimize systemic radiation exposure, achieve high tumor-to-nontumor ratios, and thus improve safety and tolerability compared to other RLTs.

One of the main challenges of the PRIT approach has been to ensure fast excretion of the radioactive payload while maintaining high affinity for the slower-clearing pretargeting molecule. An intermediate step to clear or neutralize circulating pretargeting antibodies has often been employed to prevent off-tumor capture of the radioligand, but this adds complexity and safety risks, posing challenges to the clinical implementation of PRIT.

The new approach developed by Roche and Orano Med represents a novel two-step PRIT regimen for CEA-positive tumors that eliminates the need for an intermediate clearance step. This strategy combines a complementary bispecific antibody pair with the chelated ²¹²Pb, demonstrating both high efficacy and improved tolerability in preclinical studies compared with three-step PRIT.

Preclinical studies have confirmed proof of mechanism and therapeutic efficacy of the two-step PRIT, showing a favorable biodistribution with substantial uptake in CEA-positive tumors and rapid clearance of unbound 212Pb-DOTAM, with limited accumulation in kidneys and other organs. This confirms the excellent 212Pb tumor specificity and its high potential to significantly delay tumor growth.

(Press release, Orano Med, DEC 4, 2025, View Source [SID1234661150])

On December 4, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, and Crescent Biopharma, Inc. ("Crescent") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported that the companies have entered into a strategic partnership to develop and commercialize oncology therapeutics, including novel combinations.

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The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026.

Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China. The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105. Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.

Dr. Michael Ge, chief executive officer of Kelun-Biotech, said, "We are pleased to have entered into a partnership with Crescent for two innovative assets, CR-001 and SKB105. This collaboration complements and strengthens our differentiated oncology pipeline by the addition of CR-001 and also enables us to advance the development of SKB105 in the global market, bolstering its potential commercial value and our global collaboration network. Our creative global partnership combines the capabilities of both companies to explore novel monotherapies and combination strategies for tumor treatments with SKB105 and CR-001. By leveraging China’s abundant clinical resources and execution efficiency, we aim to expedite clinical development while rigorously maintaining the highest global standards. We believe this partnership creates a powerful synergy to maximize the potential of these two drug candidates for the treatment of patients in both China and the rest of the world."
"We are thrilled to be partnering with Kelun-Biotech, an established leader in the development and commercialization of ADCs who shares our commitment to bringing next generation therapeutics that can improve outcomes for people living with cancer," said Joshua Brumm, chief executive officer of Crescent. "This collaboration expands our pipeline with the addition of SKB105, furthers our strategy of advancing multiple modalities across our portfolio, and accelerates our efforts to deliver synergistic combinations with CR-001, which has the potential to be a foundational backbone therapy. We look forward to working with Kelun-Biotech to drive innovative therapeutics with the potential to address multiple tumor types and transform cancer care."

Under the collaboration, Kelun-Biotech will receive an upfront payment of US$80 million from Crescent and is also eligible to receive additional milestones of up to US$1.25 billion, plus tiered middle single-digit to low double-digit royalties on net sales of SKB105. Kelun-Biotech is also eligible to receive additional payment from Crescent if Crescent undergoes a near-term change of control or enters into a sublicense agreement with a third party. Crescent will receive an upfront payment of US$20 million from Kelun-Biotech and is also eligible to receive additional milestones of up to US$30 million, plus tiered low to middle single digit royalties on net sales of CR-001.

About CR-001 (also known as SKB118)

CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with antibody-drug conjugates (ADCs). A global Phase 1/2 trial of CR-001 in patients with solid tumors is anticipated to commence in the first quarter of 2026.

About SKB105 (also known as CR-003)
SKB105 is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. The molecule incorporates proprietary Kthiol irreversible conjugation technology, designed to enhance stability and tumor-specific payload delivery while reducing adverse effects. SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models. A Phase 1/2 clinical trial of SKB105 in patients with solid tumors is anticipated to commence in the first quarter of 2026.

(Press release, Crescent Biopharma, DEC 4, 2025, View Source [SID1234661121])

On December 4, 2025 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported that the company has been awarded a $10.8 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the continued clinical investigation of IMGS-001 in patients with solid tumors. IMGS-001, the company’s lead program, is a cytotoxic immune checkpoint inhibitor targeting PD-L1 and PD-L2 and is being studied in a phase 1a/b dose-escalation and dose-expansion trial (NCT06014502). The focus of this grant, the company’s second from CPRIT, will be to support the phase 1b dose-expansion portion of the trial across multiple solid tumor cohorts.

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The phase 1b expansion focuses on demonstrating safety and initial clinical benefit in multiple solid tumor cohorts characterized by a high degree of immune exclusion where CD8 T cells—the immune system’s soldiers—are present but locked out of the tumor. IMGS-001 has been specifically engineered to drive clinical benefit in this patient population through its multifunctional mechanism of cell killing and PD-1 signal blockade.

"CPRIT has played a pivotal role in enabling ImmunoGenesis’ growth. The first award of $15.5 million in 2020 allowed us to establish our Texas headquarters, complete essential nonclinical studies, obtain IND clearance, and begin the phase 1a trial of IMGS-001," said James Barlow, CEO of ImmunoGenesis. "With this second award, we can build on the early signs of clinical activity and accelerate evaluation of IMGS-001 for immune-excluded tumor cohorts with high unmet need."

The award underscores CPRIT’s mission to support novel research. IMGS-001 is based on discoveries made by the laboratory of Dr. Michael A. Curran at The University of Texas MD Anderson Cancer Center and the Oncology Research for Biologics & Immunotherapy Translation (ORBIT) platform, part of MD Anderson’s Therapeutics Discovery division. Dr. Curran founded ImmunoGenesis and the technology was licensed to the company in 2019.

"ImmunoGenesis was previously awarded a CPRIT grant in 2020 to fund early development of IMGS-001," said CPRIT CEO Kristen Doyle. "The company successfully hit the goals and objectives of the original grant. Given this initial grant and the CPRIT funding provided to Dr. Curran in the early development work, CPRIT’s expert review panel that recommended funding saw this as an exciting opportunity for CPRIT to continue to support a novel molecule that has shown initial promise in early clinical testing."

ImmunoGenesis is headquartered in Houston, and the CPRIT award will enable the company to continue strengthening its leadership team and corporate infrastructure within the biotech community. Mr. Barlow added, "We are thrilled to contribute to, and grow within, the dynamic biotech ecosystem in Houston and across Texas."

(Press release, ImmunoGenesis, DEC 4, 2025, View Source;research-institute-of-texas-cprit-to-accelerate-the-clinical-development-of-imgs-001-for-patients-with-immune-excluded-tumors-with-high-unmet-need-302632467.html [SID1234661135])

On December 4, 2025 Mission Bio, Inc., a leader in single-cell multi-omic solutions for precision medicine, reported that its Tapestri Platform and custom assay development supported initial exploratory biomarker analysis data presented by Incyte at the ASH (Free ASH Whitepaper) 2025 conference in Orlando, Florida, in December. The data demonstrate Tapestri Platform’s ability to accelerate the understanding of Myeloproliferative Neoplasms (MPNs) disease biology at the single-cell level.

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Myeloproliferative neoplasms (MPNs) are a type of blood cancer caused by genetic mutations in blood-forming stem cells. These mutations—found in the JAK2, TPO-R, or CALR genes—lead to uncontrolled growth of certain blood cells. INCA033989, an investigational monoclonal antibody, targets mutant calreticulin (CALR), a key driver in MPN pathogenesis.

The data presented at ASH (Free ASH Whitepaper) 2025 illustrate how the Tapestri’s single-cell data was leveraged to understand disease persistence and clonal expansion in MPNs. Subsequently, Tapestri’s single-cell DNA and protein profiling was applied to gain deeper insights into clonal evolution, disease progression, and treatment response in patients with MPNs.

The Tapestri Platform enables high-resolution detection of co-occurring mutations and cell surface protein expression, providing a more comprehensive picture of tumor heterogeneity and immune interactions in MPNs. By incorporating Mission Bio’s single-cell technology, Incyte was able to better characterize clonal diversity, track resistance mechanisms, and refine patient stratification strategies to help advance the development of precision therapies for MPNs.

"Our collaboration with Incyte highlights the role of single-cell multi-omics as an advanced clinical biomarker tool and the potential power of single-cell analysis in supporting targeted therapy development in the clinic," said Brian Kim, CEO at Mission Bio. "By unraveling the complexity of MPNs at the single-cell level, we can enhance complex biomarker analysis for targeted therapies in this space."

To learn more about Mission Bio, the Tapestri Platform, and Pharma Assay Development (PAD) services, please visit www.missionbio.com.

(Press release, Mission Bio, DEC 4, 2025, View Source [SID1234661151])