On November 4, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that initial translational data from the ongoing Phase 1 study of CX-801 in patients with advanced melanoma will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, being held in National Harbor, MD on November 7-9, 2025.

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"CX-801 was intentionally designed to unlock the powerful immune-modulating effects of interferon alpha-2b by leveraging our PROBODY therapeutic platform. We are excited to share initial Phase 1 biomarker data for CX-801 which suggest the molecule is working as designed by inducing tumor-localized activation of immune cell populations and interferon-stimulated genes in paired tumor biopsies, including PD-1 and PD-L1," said Marcia Belvin, Ph.D. SVP, chief scientific officer of CytomX Therapeutics.

"We are pleased with the Phase 1 progress for CX-801 to-date, including initial evidence that CX-801 is generally well tolerated and can modulate the immune tumor microenvironment in patients with metastatic melanoma refractory to prior immune checkpoint inhibitor therapy. These initial data support the rationale for the ongoing Phase 1 combination study of CX-801 combined with KEYTRUDA in melanoma, an area of significant unmet need. We look forward to providing Phase 1 clinical data of CX-801 combined with KEYTRUDA in 2026," said Dr. Wayne Chu, M.D., chief medical officer of CytomX Therapeutics.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Details for CytomX Therapeutics Presentations at SITC (Free SITC Whitepaper) 2025

CX-801 poster presentation:
Presentation Title: Pharmacodynamic Activity of CX-801, a Masked IFNα2b PROBODY Cytokine, in Patients with Advanced Melanoma
Abstract Number: 606
Session Date and Time: Saturday, November 8, 2025, 5:10 pm – 6:35 pm ET

Preclinical Masked T-cell Engager Targeting CDH3:
Presentation Title: CX-908, a PROBODY T Cell Engager Targeting CDH3 and CD3, Induces Tumor Regressions and Improves the Therapeutic Window in Preclinical Studies
Abstract Number: 961
Session Date and Time: Friday, November 7, 2025, 5:35 pm – 7:00 pm ET

(Press release, CytomX Therapeutics, NOV 4, 2025, View Source [SID1234659350])

On November 4, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the third quarter ended September 30, 2025. The quarter was distinguished by significant operational momentum in its "Win-in-MRD" strategy, headlined by increasing clinical tests delivered and robust clinical evidence generation.

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Third Quarter 2025 and Recent Business Highlights

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Accelerated Clinical Adoption: Delivered 4,388 clinical tests, demonstrating robust 26% sequential increase over Q2 2025 and a 364% year-over-year growth fueled by increasing physician adoption of the NeXT Personal platform for cancer monitoring.
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Submitted for Medicare Lung Cancer Coverage: Submitted a third dossier for Medicare coverage. The Company has three pending indications and remains confident its evidence will meet the standard for coverage.
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Presented New Lung Cancer Data: Presented positive new data from AstraZeneca’s Phase 3 NeoADAURA trial in lung cancer. The findings show NeXT Personal is a strong predictor of patient outcomes and a more sensitive and accurate measure of MRD in the neoadjuvant setting. Data from the LAURA trial was also presented at ESMO (Free ESMO Whitepaper) that showed NeXT Personal could detect recurrence 5 months ahead of blinded expert review and NeXT Personal could be utilized for treatment response monitoring in adjuvant lung cancer.
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Launched Prospective Breast Cancer Utility Study: Launched the CATE clinical trial in collaboration with Yale Cancer Center. The study aims to demonstrate the utility of NeXT Personal in guiding treatment decisions for patients with HR+/HER2- breast cancer to prevent metastatic relapse.
"Our third-quarter results demonstrate clear progress in our strategy to Win-in-MRD," said Chris Hall, Chief Executive Officer and President of Personalis. "The 364% year-over-year growth in our clinical test volume is a powerful indicator of physician enthusiasm for NeXT Personal. We believe the compelling data from the AstraZeneca NeoADAURA and LAURA studies and the launch of our CATE trial with Yale are helping to build an unimpeachable evidence base for our technology. With our third indication submitted for Medicare coverage, we are well positioned for success in this large market."

Third Quarter 2025 Financial Results Compared with 2024

Revenue of $14.5 million for the third quarter of 2025 compared with $25.7 million. The decrease of 44% was primarily due to the expected decline of $4.6 million in revenue from Natera, a decrease in population sequencing revenue of $4.2 million, and a decrease in revenue from pharma tests and services, and other customers of $2.5 million.

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Pharma tests and services, and other customers of $13.2 million for the third quarter of 2025 compared with $15.7 million, a decrease of 16%.

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Population sequencing of $0.2 million for the third quarter of 2025 compared with $4.4 million, a decrease of 95%.

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Gross margin of 13.2% for the third quarter of 2025 compared with 34.0%. The decrease was primarily due to a reduction in fixed cost absorption from the lower revenue volume and increased unreimbursed clinical test costs demonstrating the interest in our tests as we await reimbursement.

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Net loss of $21.7 million, and net loss per share of $0.24 based on a weighted-average basic and diluted share count of 88.7 million in the third quarter 2025, compared with a net loss of $39.1 million, and net loss per share of $0.64 based on a weighted-average basic and diluted share count of 61.1 million; the prior year net loss included a $26.0 million non-cash expense from warrants which were exercised in the third quarter of the prior year.

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Cash, cash equivalents, and short-term investments of $150.5 million as of September 30, 2025; cash usage of $23.4 million from operations and capital equipment additions in the third quarter of 2025.

Fourth Quarter and Full Year 2025 Outlook

Personalis expects the following for the fourth quarter of 2025:

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Total company revenue to be in the range of $15.7 to $20.7 million
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Revenue from pharma tests and services, and all other customers to be in the range of $12.0 to $17.0 million
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Revenue from population sequencing and enterprise sales of approximately $3.7 million

Personalis now expects the following for the full year of 2025 (updated guidance):

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Total company revenue in the range of $68.0 to $73.0 million (reduced range from prior guidance of $70.0 to $80.0 million)
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Revenue from pharma tests and services, and all other customers in the range of $50.0 to $54.0 million (reduced range from prior guidance of $52.0 to $58.0 million)
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Revenue from population sequencing and enterprise sales in the range of $16.5 to $17.0 million (increased range from prior guidance of $15.0 to $16.0 million)
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Revenue from clinical tests reimbursed in the range of $1.5 to $2.0 million (reduced range from prior guidance of $3.0 to $6.0 million to account for reimbursement milestone later in 2025)
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Gross margin in the range of 22% to 24% (no change from prior guidance), which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical use of NeXT Personal ahead of reimbursement
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Net loss of approximately $85 million (no change from prior guidance)
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Cash usage of approximately $75 million (no change from prior guidance)

Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter financial results, as well as plans for the remainder of 2025, after market close on Tuesday, November 4, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

(Press release, Personalis, NOV 4, 2025, View Source [SID1234659366])

On November 4, 2025 Catalent, Inc., a leading global contract development and manufacturing organization, reported new innovations from its SMARTag antibody-drug conjugate (ADC) technology platform. The company announced preclinical efficacy and tolerability data demonstrating the potential of CAT-09-833, a SMARTag ADC targeting MUC1, for the treatment of platinum-resistant ovarian cancer. The company also introduced SMARTag Enhanced Conjugates, a new class of ADCs that combines different payload types to benefit more patients by amplifying efficacy without compromising safety.

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The updates were presented at the 16th World ADC San Diego conference in a session in the Translational Medicine track entitled "SMARTag Enhanced Conjugates: Novel Payload Combinations to Enhance ADC Efficacy & Payload Delivery." The presentation was made by Ayodele Ogunkoya, Ph.D., Bioconjugation Group Leader, Catalent. World ADC provides a leading opportunity for Catalent to spotlight its ADC technologies and services to more than 1,400 ADC biopharma attendees actively seeking new partnerships and solutions.

"There is a growing appreciation for the role that ADCs may play in ovarian cancer treatment. The MUC1 tumor-associated antigen, which is highly expressed in ovarian tumors, demonstrates expression complementary to that of other ovarian ADC targets, such as folate receptor alpha," said Penelope Drake, Ph.D., Head of R&D Bioconjugates, Catalent. "Our novel antibody offers a unique way to access this target with an ADC, and the data thus far suggest that CAT-09-833 has a promising preclinical profile. We look forward to seeing the molecule advance and learning more about its potential to help cancer patients."

Catalent’s new SMARTag Enhanced Conjugates incorporate both cytotoxic and non-cytotoxic payloads to create unique dual- and triple-payload ADCs that can be optimized to the specific biology of the target tumor to amplify the effect of the cytotoxic payload without compromising safety. They are enabled by the SMARTag platform, which allows for a tunable drug-to-antibody ratio (DAR). Catalent presented data from a xenograft model demonstrating that the use of certepetide as a non-cytotoxic payload can yield improved ADC efficacy and broaden the distribution of the ADC cytotoxic payload and antibody in the tumor microenvironment. Certepetide is an internalizing RGD (iRGD) cyclic peptide that Catalent licensed (along with its analogs) from Lisata Therapeutics, Inc. for use with its SMARTag technology platform, with a goal of selectively targeting and penetrating solid tumors with ADCs more effectively.

Mike Blank, General Manager, Catalent, said, "We have a history of innovation dating back to 2008 when we spun the SMARTag technology out of the Bertozzi lab at UC Berkeley. Since then, we have made continuous progress on expanding the capabilities of the platform and understanding the design elements that underpin a successful ADC. We believe the new SMARTag Enhanced Conjugates represent the latest innovation in ADCs, allowing for the creation of an entirely new class of molecules that we hope will expand the scope of treatable cancer indications, reaching—and ultimately helping—more patients in need."

(Press release, Catalent, NOV 4, 2025, https://www.catalent.com/catalent-news/catalents-smartagadc-pipeline-and-new-enhanced-conjugates-offering-featured-at-16th-world-adc-san-diego/ [SID1234659383])

On November 4, 2025 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, reported the publication online of Part 1 results from its Phase 1 first-in-human study of tolododekin alfa in Nature Communications in the September 29, 2025, issue. Ankyra recently completed dose escalation of a phase 1 first-in-human study of monotherapy tolododekin alfa, the first anchored IL-12 designed for local tumor retention. The study was conducted at several centers in the United States and Canada in patients with progressive solid tumors. Data from Part 1 of the study focused on patients with superficially accessible tumors. "Tolododekin alfa demonstrated a tolerable safety profile and treatment was associated with monotherapy clinical activity in several types of cancers", said Howard L. Kaufman, MD. "This data opens the door for realizing the therapeutic potential of interleukin-12 for patients with cancer."

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"The emerging data supports the proposed mechanism action for tolododekin alfa", stated Joe Elassal, MD, chief medical officer at Ankyra Therapeutics, "and provides initial proof of concept for the anchored drug conjugate platform". The company has an emerging pipeline and will be presenting initial data with their ANK-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 7, 2025.

Ankyra Therapeutics Announces Multiple Scientific Presentations at SITC (Free SITC Whitepaper) Meeting

Highlights include:

NKT Cells as Predictive Biomarkers of Response to IL-12 Conjugate Immunotherapy Abstract# 189 (oral presentation)
Exploratory analysis of phase 1 solid tumor patients treated demonstrates baseline levels of circulating natural killer T (NKT) cells may serve as predictive biomarkers of response to anchored IL-12 treatment.
First-in-Class ANK-201 Data Abstract # 999
Preclinical results from Ankyra’s next-generation candidate, ANK-201, will be presented for the first time, highlighting the expansion of the company’s pipeline beyond cytokines.
Combination anchored IL-12 and HDAC inhibitor therapy improves therapeutic responses Abstract #631
Results from an ongoing collaboration with the National Cancer Institute Center for Immuno-Oncology will report on anchored murine IL-12 in combination with a histone deacetylase (HDAC) inhibitor in checkpoint-refractory tumor models.
Pharmacologic evaluation of a canine anchored IL-12 (JEN-101) in dogs with melanoma Abstract #1195
In collaboration with Timothy M. Fan, DVM, PhD from the Department of Veterinary Clinical Medicine and Cancer Center at Illinois, University of Illinois at Urbana-Champaign and Jenga Biosciences, new data will be presented from a clinical trial of weight-based versus volume-based dosing of JEN-101, a canine anchored IL-12 conjugate, in dogs with melanoma.
"We are pleased with the data to be presented at the SITC (Free SITC Whitepaper) meeting showing the therapeutic potential of anchored immunotherapy", stated Howard Kaufman, MD.

About Tolododekin alfa (ANK-101)
Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

(Press release, Ankyra Therapeutics, NOV 4, 2025, View Source [SID1234659400])

On November 4, 2025 Boehringer Ingelheim and CDR-Life, Inc. reported a new global licensing agreement to develop CDR-Life’s unique antibody-based molecule CDR111 for autoimmune diseases. CDR111 is a trispecific M-gager, an antibody-based T-cell engager designed to selectively target and deplete B cells, with the goal of achieving immune system reset.

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Dysregulated B cells play a central role in driving many autoimmune and inflammatory conditions such as lupus, multiple sclerosis and certain forms of arthritis. Therefore, an approach that can deeply deplete these cells could have broad and far-reaching potential across multiple indications.

The agreement builds on the companies’ successful collaboration on an investigational antibody fragment. Boehringer has developed this molecule with technology licensed from CDR-Life, with the goal of preserving vision in people living with geographic atrophy (GA). It is currently being investigated in the VERDANT Phase 2 trial (NCT06722157).

"Our expanded collaboration with Boehringer underscores the growing recognition of our platform’s ability to design high quality biologics that may translate into meaningful therapeutic advances," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "Having already demonstrated encouraging clinical progress together in GA, this new agreement further validates the versatility of our T-cell engager technology, and we are excited to see Boehringer advance CDR111 toward the clinic."

"We are excited to expand upon our work with CDR-Life and apply their trispecific M-gager approach to autoimmune and inflammatory diseases with high unmet need, further broadening our differentiated pipeline," said Carine Boustany, US Innovation Unit Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. "We see strong potential for CDR111 to demonstrate a deep and durable immune reset that may deliver transformative options for patients living with serious autoimmune disease."

Under the terms of the agreement, CDR-Life is eligible for up to a total of CHF 456 million (approximately USD 570 million)in payments including CHF 38 million (approximately USD 48 million)in upfront and near-term payments, plus tiered royalties on future sales.

(Press release, CDR-Life, NOV 4, 2025, View Source [SID1234666503])