On November 13, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025, at 9:00 a.m. GMT.

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

(Press release, CytomX Therapeutics, NOV 13, 2025, View Source [SID1234659895])

On November 13, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported additional efficacy and safety data from the Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC).

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"We continue to be encouraged by ORIC-944 combination data, which further demonstrate its potential as a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "The tolerability and efficacy data to date provide compelling validation for the doses we’ve selected for the dose optimization portion of the Phase 1b trial. We look forward to sharing dose optimization data in 1Q 2026 ahead of initiating our first global Phase 3 registrational trial in mCRPC in the first half of next year."

ORIC-944 Phase 1b Dose Exploration Data
Patients were previously treated with a median of three prior lines of therapy, including abiraterone acetate, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median does not include background androgen deprivation therapy or first-generation AR inhibitors that the patients may have received. Patients were treated once daily with 400 mg, 600 mg, 800 mg, or 1,200 mg of ORIC-944 in combination with 240 mg of apalutamide once daily or with 600 mg of darolutamide twice daily. PSA data for 20 patients with mCRPC includes 17 patients previously reported in May 2025. Circulating tumor DNA (ctDNA) was assessed for 17 patients with mCRPC who had available ctDNA samples and evidence of ctDNA at baseline prior to study entry. PSA response data and ctDNA data are as of September 22, 2025.

Preliminary antitumor activity analysis
PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels and were also observed at comparable rates in combination with apalutamide or with darolutamide.

PSA activity

55% of patients (11/20) achieved a PSA50 response, confirmed in 40% (8/20).
20% of patients (4/20) achieved a PSA90 response (all confirmed).

ctDNA activity
ctDNA serves as a useful biomarker to predict the duration of treatment benefit and survival in prostate cancer. Detectable ctDNA at baseline is associated with poor prognosis, and non-detectable ctDNA at baseline or upon treatment is associated with longer progression-free survival and overall survival. In the Phase 1b trial, 88% of patients had detectable ctDNA at baseline (higher than precedent trials with standard of care agents in comparable mCRPC patient populations), and ORIC-944 in combination with apalutamide or with darolutamide demonstrated:

Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% of patients (13/17) achieving >50% ctDNA reduction.
59% of patients (10/17) achieved ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.

Preliminary safety analysis
ORIC-944 in combination with apalutamide or with darolutamide continues to be well tolerated to date. Both combination regimens demonstrated a safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition. As of the September 22, 2025 cutoff date, only one patient experienced a Grade 3 TRAE, and there were no Grade 4 or Grade 5 AEs attributed to ORIC-944, apalutamide or darolutamide.

Next Steps
Based on these efficacy and safety results, ORIC has selected provisional recommended Phase 2 doses (RP2Ds) of ORIC-944 to be tested in combination with the approved doses of darolutamide and apalutamide in the dose optimization portion of the Phase 1b trial: 400 mg and 600 mg once daily of ORIC-944 in combination with 600 mg twice daily of darolutamide; and 600 mg, 800 mg and 1,200 mg once daily of ORIC-944 in combination with 240 mg once daily of apalutamide. Enrollment in the dose optimization portion of the trial is ongoing, and the company plans to announce preliminary dose optimization data in 1Q 2026. Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the first global Phase 3 registrational trial in mCRPC, which the company expects to initiate in 1H 2026.

ORIC-944 Phase 1b Trial Design
ORIC-944 is being evaluated in a Phase 1b dose optimization trial in combination with ERLEADA (apalutamide), Johnson & Johnson’s AR inhibitor, and NUBEQA (darolutamide), Bayer’s AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an androgen receptor pathway inhibitor (ARPI) and up to one prior chemotherapy. The primary objective of the trial is to determine the recommended Phase 2 dose (RP2D), and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity.

(Press release, ORIC Pharmaceuticals, NOV 13, 2025, View Source [SID1234659911])

On November 13, 2025 ImmunoScape Pte. Ltd., an A*STAR spin out backed by Amgen Ventures and EDBi that is developing next-generation TCR-based cancer immunotherapies, reported an exclusive in-licensing deal with Cue Biopharma Inc. (Nasdaq: CUE) to lead the development of a distinct new class of therapies to attack solid tumor cancers. The deal provides ImmunoScape with exclusive access to Cue Biopharma’s clinical-stage Immuno-STAT molecules in oncology.

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By combining Cue Biopharma’s technology with its precision T cell receptor (TCR) therapy, ImmunoScape is pioneering a new "Seed-and-Boost" approach to immunotherapy, that addresses the shortcomings of current cell therapies by enabling potent in vivo expansion of infused tumor targeting T-cells—producing large numbers of highly effective tumor killing T cells in a controlled manner in the patient.

The strategy uses a minimal dose of the patient’s own T cells, engineered with a tumor-specific TCR (Seed), followed by periodic administration of TCR-matching and interleukin-2 (IL-2) carrying Immuno-STAT molecules (Boost). This combination immunotherapy enables, for the first time, the establishment of a true therapeutic index for IL-2 by selectively delivering it to tumor-reactive T cells. The potential breakthrough approach offers to eliminate systemic cytokine toxicity, streamline manufacturing, and may deliver a deeper, more durable attack on malignant cells.

ImmunoScape’s clinical program targets cancers of high unmet medical need

ImmunoScape’s first Seed-and-Boost program targets the WT1 antigen, which is expressed across many recalcitrant solid tumors — including lung, pancreatic, colorectal, ovarian, gastric, melanoma, and head and neck cancers — as well as certain hematologic malignancies that still represent significant unmet clinical needs. ImmunoScape’s Singapore lab has generated compelling preclinical data across multiple solid tumor models, which is supportive of IND-enabling studies that will enable clinical trials to commence by 2027.

"Our Singapore-based in vivo cancer models demonstrate the efficacy of this new approach in multiple solid tumors" said Dr. Kar Wai Tan PhD, ImmunoScape’s Vice President of Discovery.

The Company’s modular Seed-and-Boost platform technology has the potential to transform cell therapy, through the delivery of safe, tolerable and effective therapies against cancer while simplifying the patient journey. In addition to targeting solid tumors, the platform may also be used to enhance existing classic autologous and in vivo T cell therapies. ImmunoScape’s clinical studies will include cancers and immune types that are relevant to Asian populations.

"ImmunoScape is pioneering the next wave of cancer therapeutics," said Michael Fehlings, PhD, CEO of ImmunoScape. "Through our next-generation Seed-and-Boost strategy, we aim to deliver clinically meaningful improvements in patient outcomes in multiple cancers."

ImmunoScape Strengthens Leadership with Key Appointments

As it transitions to becoming a global leader in cancer immunotherapy development, ImmunoScape is pleased to announce additions to its leadership structure:

Usman "Oz" Azam, MD, Joins the Board of Directors: Dr. Azam, President and CEO of Cue Biopharma and former global head of Novartis’ Cell and Gene Therapy business, brings the support of Boston-based Cue Biopharma and extensive expertise in cell therapy development, manufacturing and commercialization. Dr. Azam served as Chief Executive Officer of Inspirna, Inc., a privately held clinical stage biopharmaceutical company focused on the discovery and development of novel cancer drugs and President and CEO of Tmunity Therapeutics, where he was involved in developing genetically engineered CAR-T cell therapies for solid tumor applications in cancer.
Adrian Bot, MD/PhD, Joins the Board of Directors: Dr. Bot brings 27 years of experience in discovery, development and commercialization of immunotherapies including CAR and TCR-engineered T cell products. He was the founding CSO for Capstan Therapeutics focused on in vivo CAR therapies and has held leadership positions including CSO and Global Head of Translational Medicine and Research at Kite Pharma developing groundbreaking gene engineered T cell therapies.
"Immunotherapy in solid tumors is at a juncture, when sophisticated, precision medicine tools are needed to effectively orchestrate a durable clinical response, I am convinced that the novel immunotherapeutic tools of ImmunoScape will push the boundaries towards better addressing the needs of cancer patients in a broad range of cancer types. Their innovative Seed and Boost approach is of global significance in the cancer field," said Dr. Bot.

Pamela Munster, MD, Joins Scientific Advisory Board: Dr. Pamela Munster, a distinguished medical oncologist and Director of the early-stage oncology clinical trials program at UCSF, joins and complements the existing experts on the Scientific Advisory Board, bringing unparalleled clinical insights into unmet solid tumor patient needs. Dr. Munster is the author of the award-winning book, Twisting Fate: My Journey with BRCA―from Breast Cancer Doctor to Patient and Back.

(Press release, immunoSCAPE, NOV 13, 2025, View Source [SID1234659940])

On November 12, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, reported a business and financial update for the third quarter 2025.

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"During the third quarter of 2025 and early in the fourth quarter, the Company made tremendous progress from having successfully implemented a plan of optionality and laying the necessary groundwork for future growth," said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. "I am deeply proud of the Cue team and believe we are strategically positioned to further advance our differentiating Immuno-STAT platform and lead autoimmune asset, CUE-401, toward the clinic to address a major unmet need in autoimmune disease treatment."

Business Highlights

•
Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates most notably, CUE-401, the Company’s lead autoimmune asset
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Usman Azam, M.D., appointed President and Chief Executive Officer, effective as of September 29
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CUE-401 is uniquely engineered and designed as a tolerogenic bifunctional molecule harnessing the power of TGF-beta and IL-2 to re-establish immune tolerance and balance
•
Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors
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Upfront total payment of $15 million, $10 million in Q4 2025 and $5 million in November of 2026, as well as a 40% equity stake in ImmunoScape
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Exclusive collaboration and license agreement focuses on advancing novel, T cell therapy "Seed-and-Boost" approach exploiting the mechanism of the CUE-100 series of Immuno-STATs

(Press release, Cue Biopharma, NOV 12, 2025, View Source [SID1234659817])

On November 12, 2025 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"Following a productive meeting with the FDA, we now have a clearly defined pivotal trial design for TSC-101, and we also have an improved commercial-ready manufacturing process in place. We are focused on advancing this promising program for patients with AML and MDS and look forward to sharing updated results from the ALLOHA Phase 1 trial at ASH (Free ASH Whitepaper) next month," said Gavin MacBeath, Ph.D., Chief Executive Officer. "After infusing the first two patients with multiplex TCR-T in our PLEXI-T trial, we have now paused further enrollment to focus on preclinical development of in vivo engineering to treat patients with solid tumors. We believe this approach represents a promising and more cost-efficient way to deliver off-the-shelf, multiplexed TCR-T cells."

Recent Corporate Highlights

•
The Company recently announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding its pivotal trial design for TSC-101. The FDA has agreed to a study design that mirrors the current ALLOHA Phase 1 trial (NCT05473910) using a biologically-assigned internal control arm. TScan believes the design of the pivotal trial, which is expected to begin in the second quarter of 2026, will enable efficient enrollment and streamlined assessment of study endpoints.

In addition, the Company announced that it has implemented a commercial-ready manufacturing process that shortens manufacturing time by five days, both lowering the associated cost of goods and reducing the extent of ex vivo T cell expansion. An initial technology transfer of this process to an external contract development and manufacturing organization has been completed. The commercial-ready process will be used in the ongoing Phase 1 as well as future pivotal study.

•
In early November, the Company made the strategic decision to prioritize the clinical development of its heme program and pause further enrollment in its solid tumor Phase 1 trial, while focusing its preclinical efforts on in vivo engineering for solid tumors and target discovery in autoimmunity. As a result of these actions, the Company’s existing cash, cash equivalents, and marketable securities are now expected to fund its current operating plan into the second half of 2027.

•
In October, the Company presented at the American College of Rheumatology Convergence 2025 where the Company highlighted the potential application of its proprietary TargetScan technology to identify novel targets in T cell-driven autoimmune disorders, including ankylosing spondylitis, scleroderma, and ulcerative colitis. The presentation materials can be found on the Publications tab of the Company’s website at www.tscan.com.

Upcoming Anticipated Milestones

Heme Malignancies Program: TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT) (the ALLOHA trial, NCT05473910).

•
Plans to present updated clinical data from the ALLOHA Phase 1 heme trial, including two-year relapse data on initial patients treated with TSC-101, at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

Title: TSC-101 eliminates recipient hematopoietic cells and demonstrates potential for improved relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT: Updated results from the Phase 1 (ALLOHA) trial.
Publication Number: 2391
Presentation Date and Time: December 6, 2025, 5:30-7:30 PM ET

•
Plans to submit investigational new drug (IND) applications for two additional TCR-T product candidates to expand HLA coverage of the heme program in the fourth quarter of 2025.
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Plans to launch pivotal trial for TSC-101 for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the second quarter of 2026.

Solid Tumor Program: TScan’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity and resistance that may arise from either target or HLA loss (the PLEXI-T trial, NCT05973487).

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PLEXI-T enrollment paused, shifting efforts to preclinical development of an in vivo engineering platform for solid tumors.
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Plans to share safety and efficacy data on patients infused to date in the PLEXI-T solid tumor trial in the first quarter of 2026.

Third Quarter 2025 Financial Results

Revenue: Revenue for the third quarter of 2025 was $2.5 million, compared to $1.0 million for the third quarter of 2024. The increase was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen.

R&D Expenses: Research and development (R&D) expenses for the third quarter of 2025 were $31.7 million, compared to $26.3 million for the third quarter of 2024. The increase of $5.4 million was primarily driven by increased manufacturing and clinical activities, as well as personnel costs to support these activities. R&D expenses included non-cash stock compensation expense of $1.7 million and $1.2 million for the third quarter of 2025 and 2024, respectively.

G&A Expenses: General and administrative (G&A) expenses for the third quarter of 2025 were $7.9 million, compared to $7.4 million for the third quarter of 2024. The increase of $0.5 million was primarily driven by personnel costs to support business activities. G&A expenses included non-cash stock compensation expense of $1.3 million and $1.3 million for the third quarter of 2025 and 2024, respectively.

Net Loss: Net loss was $35.7 million for the third quarter of 2025, compared to $29.9 million for the third quarter of 2024, and included net interest income of $1.3 million and $2.7 million, respectively.

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2025, were $184.5 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the second half of 2027.

Share Count: As of September 30, 2025, the Company had 56,747,993 shares of common stock outstanding, consisting of 52,471,405 shares of voting common stock and 4,276,588 shares of non-voting common stock. In addition, the Company had 73,087,945 of prefunded warrants outstanding to purchase shares of voting common stock at an exercise price of $0.0001 per share. Pro forma outstanding shares as of September 30, 2025, inclusive of both common stock and prefunded warrants, were 129,835,938.

(Press release, TScan Therapeutics, NOV 12, 2025, View Source [SID1234659832])