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 13, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it has signed a definitive merger agreement for Day One to acquire Mersana Therapeutics, Inc. ("Mersana").

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The transaction positions the Company for continued success and expansion of its oncology portfolio, adding Emi-Le, a potential first-in-class monotherapy for patients with ACC, an aggressive cancer with a well-defined patient population and high unmet need, most often arising from the salivary gland. The early anti-tumor activity observed with Emi-Le in an ongoing Phase 1 study, in a disease with a clear unmet medical need, may support a fast path to registration. Emi-Le represents an innovative and differentiated ADC directed against B7-H4, a well-characterized target in certain cancers. B7-H4 is highly expressed in ACC as well as in other adult and pediatric cancers. As a novel targeted investigational agent with monotherapy anti-tumor activity intended for a well-defined patient population without any approved therapies or a clear standard of care, the Company believes that Emi-Le is well positioned for potential rapid development and commercialization.

"This acquisition will add a potential game-changing new medicine to the Day One portfolio and, if approved, will broaden our opportunities for patient impact and for continued growth and value creation," said Jeremy Bender, Ph.D., chief executive officer of Day One. "The addition of the Emi-Le program to our portfolio allows us to leverage the research and development expertise, and the commercial capabilities, that already exist within Day One to address underserved, rare and life-threatening cancers in patients of all ages."

Terms of the Agreement

Under the terms of the definitive merger agreement, Day One will promptly commence a tender offer to acquire all of the outstanding shares of Mersana common stock at a price of $25 per share in cash at closing plus one non-tradable CVR per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash, for total consideration of up to $55.25 per share in cash, representing a total equity value of approximately $129 million at closing and representing a total deal value of up to approximately $285 million. The CVR is payable subject to certain terms and conditions of achievement of the following milestones:

Clinical Milestones

· A development milestone related to an existing partnership agreement: $1.25 per share

· Breakthrough Therapy Designation for ACC granted by FDA: $1.00 per share

· First dosing of a participant in a registrational trial of Emi-Le for ACC-1: $4.00 per share

Regulatory/Sales Milestones

· Regulatory approval granted by FDA in Emi-Le for ACC-1: $9.00 per share

· First commercial sale of Emi-Le in a major EMA market: $2.00 per share

· First commercial sale of Emi-Le in Japan: $1.00 per share

· Annual net sales of Emi-Le exceed $100 million by 2032: $2.00 per share

· Annual net sales of Emi-Le exceed $200 million by 2035: $4.00 per share

· Annual net sales of Emi-Le exceed $300 million by 2037: $6.00 per share

Day One expects to finance the acquisition with existing cash resources. Day One’s strong cash position and financial profile is expected to enable development of Emi-Le through potential approval with no additional financing required.

The transaction is expected to close by the end of January 2026, subject to receipt of applicable regulatory approvals and the satisfaction of other customary conditions.

Advisors

Gordon Dyal & Co., LLC is acting as the exclusive financial advisor to Day One, with Fenwick & West LLP serving as legal counsel. TD Cowen is acting as financial advisor to Mersana, with Wilmer Cutler Pickering Hale and Dorr LLP serving as legal counsel.

Conference Call

Day One will host a conference call and webcast today, Nov. 13 at 8:00 am Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13757215. Live audio webcast will be accessible from the Events page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Media & Investors page for 30 days following the event.

(Press release, Day One, NOV 13, 2025, View Source [SID1234659896])

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 financial results and provided clinical and operational updates for the quarter ended September 30, 2025.

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"In the first nine months of 2025, we continued to advance toward the potential initiation of Phase 3 trials for ORIC-944 in prostate cancer and enozertinib in lung cancer. The ORIC-944 Phase 1b data announced today further support its potential best-in-class efficacy and safety profile, and we look forward to sharing clinical data for enozertinib later this year that will highlight its best-in-class potential," said Jacob M. Chacko, M.D., president and chief executive officer. "Backed by compelling clinical data and a strong cash position, we remain focused on rapidly advancing these programs to registrational studies and, ultimately, commercialization."

Third Quarter 2025 and Other Recent Highlights

ORIC-944: a potent and selective allosteric inhibitor of PRC2

Announced the completion of the dose exploration portion of the Phase 1b trial and the selection of 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.
Reported preliminary efficacy and safety data from the Phase 1b dose exploration trial of ORIC-944 in combination with androgen receptor (AR) inhibitors in 20 patients with metastatic castration-resistant prostate cancer (mCRPC), which 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. The data reported as of September 22, 2025 demonstrated:
PSA responses and ctDNA reductions across all ORIC-944 dose levels and at comparable rates in combination with apalutamide or with darolutamide.
Broad and deep PSA responses, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed).
Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.
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. 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.
Presented two posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics. In castration-sensitive prostate cancer models, ORIC-944 combined with AR inhibition synergistically suppressed tumor growth, extended survival, and prolonged response duration by limiting cellular plasticity and delaying tumor adaptation. In KRAS G12C-mutant NSCLC and colorectal cancer models, ORIC-944 plus KRAS inhibition improved efficacy and progression-free survival, suggesting PRC2 inhibition may deepen and extend responses by preventing or delaying resistance to KRAS inhibitors.

Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations

The World Health Organization International Nonproprietary Names (INN) expert committee approved "enozertinib" as the nonproprietary (generic) name for ORIC-114.
Announced publication in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), detailing preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain-penetrance, and anti-tumor activity across a broad range of EGFR atypical mutant models, including intracranial lung cancer xenografts.
Continue to enroll Phase 1b trial of enozertinib as a single-agent in patients with advanced NSCLC with EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations, including patients with CNS metastases that are either treated or untreated but asymptomatic, across our 1L expansion cohorts; 2L+ dose optimization cohorts now fully enrolled.
Continue to enroll Phase 1b trial of enozertinib in combination with subcutaneous (SC) amivantamab in 1L NSCLC patients with EGFR exon 20 mutations.

Corporate Highlights:

Announced the appointment of Kevin Brodbeck, PhD, to the newly established role of Chief Technical Officer (CTO).
As previously disclosed, the company raised $108.7 million in net proceeds under the ATM (at-the-market) program in the third quarter, including participation from healthcare specialist funds.

Anticipated Program Milestones:

ORIC anticipates the following upcoming data milestones:

ORIC-944 (mCRPC):
1Q 2026: Combination dose optimization data with AR inhibitor(s)
Enozertinib (NSCLC):
December 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ EGFR atypical, and 2L+ HER2 exon 20 data to be presented at ESMO (Free ESMO Whitepaper) Asia 2025
Mid-2026: 1L EGFR atypical data and 1L EGFR exon 20 combination with SC amivantamab data

Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $413.0 million as of September 30, 2025, which includes proceeds from the $125.0 million private placement financing in May 2025 and $117.6 million in net proceeds raised during the year under the ATM program. The company expects its cash and investments to fund the operating plan into 2H 2028.
R&D Expenses: Research and development (R&D) expenses were $28.8 million for the three months ended September 30, 2025, compared to $31.2 million for the three months ended September 30, 2024, a decrease of $2.4 million. The decrease was due to lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib. For the nine months ended September 30, 2025, R&D expenses were $84.0 million, compared to $82.1 million for the nine months ended September 30, 2024, an increase of $1.9 million. The increase was due to higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib, offset by lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs.
G&A Expenses: General and administrative (G&A) expenses were $7.9 million for the three months ended September 30, 2025, compared to $7.1 million for the three months ended September 30, 2024, an increase of $0.8 million. For the nine months ended September 30, 2025, G&A expenses were $24.5 million, compared to $21.2 million for the nine months ended September 30, 2024, an increase of $3.3 million. The increases were primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation.

(Press release, ORIC Pharmaceuticals, NOV 13, 2025, View Source [SID1234659912])