On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025.

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In a head-to-head comparison with standard-of-care therapies Tamoxifen and Abemaciclib (i.e., Verzenio), a single intratumoral injection of Zeta-BC-007 significantly outperformed both agents. Mice treated with Zeta-BC-007 containing NME + NaN + ABE showed a 66% reduction in tumor volume and complete absence of tumor activity by day 60, while all mice in the TAM and ABE groups succumbed to disease.

"Zeta-BC-007 represents a significant leap forward in intratumoral cancer therapy. By combining a novel molecular entity with synergistic therapeutics in a lipid-based hydrogel, we’ve demonstrated not only superior tumoricidal activity but also extended survival in preclinical models. These results reinforce our commitment to developing localized, non-systemic treatments that challenge the limitations of conventional cancer care."

— Bryan S. Margulies, PhD, Co-founder and CSO, Zetagen Therapeutics

"These results mark a pivotal moment in our journey to redefine primary breast cancer treatment," said Joe C. Loy, CEO of Zetagen Therapeutics. "the ability of Zeta-BC-007 to deliver potent tumoricidal effects through a single localized injection — without systemic toxicity — represents a new frontier in oncology. We believe this platform has the potential to transform how solid tumors are treated."

Presentation Details:

Abstract Number: 3638
Presentation Number: PSA-06-30
Presentation Title: Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)
Poster Presentation: Thursday, December 11, 2025, 5:00-6:30pm CST
About ZetaPrime (Zeta-PBC-007)
ZetaPrime is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, the novel formulation enables controlled release of multiple small molecules — with one being our novel molecular entity coupled with any other fat-soluble drugs; including other companies CDK4 or CDK4/6 protein inhibitors or any anticancer therapeutic. Designed for solubility within adipose tissue, ZetaPrime is a paradigm-shifting intratumoral approach to adjuvant therapy that targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659380])

On November 4, 2025 Radiant Biotherapeutics, a biotechnology company committed to advancing a breakthrough antibody approach, the Multabody, for a broad range of therapeutic areas, including cancer and infectious diseases, reported new data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting demonstrating its lead oncology candidate, RBT-101, exhibited robust, durable and complete tumor regression while avoiding liver toxicity, in a MC38 colorectal mouse tumor model.

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Radiant’s proprietary Multabody technology uniquely harnesses natural mechanisms to effectively engage multiple disease targets with unmatched strength, precise tunability, and exceptional breadth. 4-1BB is a clinically validated immune checkpoint target that elicits potent anti-tumor immunity and enhanced T cell responses but has eluded safe and effective therapeutic targeting by traditional 4-1BB agonists due to systemic and Fc-mediated liver toxicity. Radiant has leveraged its Multabody platform to develop RBT-101, a multivalent 4-1BB agonist that does not rely on traditional antibody methods to enhance potency, binding strength or durability.

Key Highlights from SITC (Free SITC Whitepaper) 2025 Poster Presentation:

RBT-101 achieved sustained complete tumor regression in MC38 colorectal mouse tumor model
RBT-101 demonstrated long-lived anti-tumor immunological memory; no detectable tumor growth was observed in mice that were re-challenged with MC38 tumor cells after previous successful treatment
RBT-101 demonstrated no signs of liver toxicity, in contrast to benchmark 4-1BB agonist urelumab
"Our data to be presented at SITC (Free SITC Whitepaper) demonstrates that RBT-101 achieves what first-generation 4-1BB agonists could not – delivering robust anti-tumor activity without liver toxicity," said Jo Hulme, Ph.D., CSO of Radiant. "This validates our Multabody platform’s potential to address a broad range of therapeutic targets while avoiding the inherent limitations of conventional antibody-based approaches, as RBT-101 drove potent, tunable and safe agonism of 4-1BB that more closely mimicked natural ligand biology. We look forward to the continued development of Multabodies as promising therapeutics in oncology and other disease areas."

The poster, titled "Multabodies: A next-generation approach for cancer immunotherapy and 4-1BB agonist therapy," will be presented onsite on Friday, November 7, 2025, and will also be available on the SITC (Free SITC Whitepaper) virtual meeting platform beginning November 7 at 9 a.m. ET.

(Press release, Radiant Biotherapeutics, NOV 4, 2025, View Source [SID1234659398])

On November 4, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"We are advancing the development of our ITK inhibitor, soquelitinib, in both atopic dermatitis and T cell lymphomas. We believe soquelitinib has the potential to be ideally positioned as a well-tolerated treatment for a range of immune diseases and cancers that works through a novel mechanism of action," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We look forward to reporting results from extension cohort 4 of the soquelitinib Phase 1 trial in atopic dermatitis in the coming months, which will provide additional information on the 200 mg twice daily dose and a longer 8-week treatment period. In addition, we remain on track to initiate an atopic dermatitis Phase 2 trial with soquelitinib in early Q1 2026. In oncology, our Phase 3 registration clinical trial in PTCL continues to enroll and we are pleased that the final results from the related Phase 1/1b trial will be presented in an oral session at ASH (Free ASH Whitepaper). These data add to the growing clinical evidence supporting soquelitinib as a safe and active agent with potential in a range of diseases."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

Completed enrollment in extension cohort 4 of the soquelitinib atopic dermatitis Phase 1 clinical trial, which includes 24 patients randomized 1:1 between active (soquelitinib 200 mg twice per day) and placebo. The treatment period for this group is 8 weeks with a 30-day follow-up period with no treatment. The extension cohort 4 is studying the same dose as cohort 3 of the Phase 1 trial, but for a longer treatment period (cohort 3 was 4 weeks). Cohort 3 patients experienced earlier responses and deeper separation from placebo compared to cohorts 1 and 2, which studied a lower dose of 100 mg twice per day or 200 mg once per day. Cohort 3 patients also had a clinically meaningful reduction in itch as early as day 8. Announcement of data from extension cohort 4 is anticipated in January 2026.
On track to initiate atopic dermatitis Phase 2 clinical trial in early Q1 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. The trial is anticipated to enroll four cohorts of 50 patients each, with soquelitinib doses of: 200 mg once per day; 200 mg twice per day; and 400 mg once per day; along with a placebo group. The treatment period is anticipated to be 12 weeks with a 30-day follow-up period with no treatment.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation that is optimized for specific immunology and oncology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

Patient enrollment continues in the Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial, which is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.
Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy.
The final data from the Company’s Phase 1/1b clinical trial evaluating soquelitinib in patients with T cell lymphoma will be reported in an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025. Previously reported interim data from this trial supported the initiation of the ongoing registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL.
Financial Results
As of September 30, 2025, Corvus had cash, cash equivalents and marketable securities of $65.7 million as compared to $52.0 million as of December 31, 2024. Consistent with last quarter, Corvus expects its cash to fund operations into the fourth quarter of 2026.

Research and development expenses for the three months ended September 30, 2025 totaled $8.5 million compared to $5.2 million for the same period in 2024. The increase of approximately $3.3 million was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended September 30, 2025 was $10.2 million compared to a net loss of $40.2 million for the same period in 2024. Included in net loss for the three months ended September 30, 2024 was a non-cash loss of $32.8 million associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended September 30, 2025 was $1.2 million compared to $0.7 million for the same period in 2024, and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.3 million for the three months ended September 30, 2025 compared to a non-cash loss of $0.7 million for the same period in 2024.

Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, November 4, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the third quarter 2025 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

(Press release, Corvus Pharmaceuticals, NOV 4, 2025, View Source [SID1234659349])

On November 4, 2025 Pasithea Therapeutics Corp. (Nasdaq: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, reported activation of a new U.S. clinical trial site at the University of Alabama at Birmingham ("UAB") for its ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patients with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas.

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The UAB site joins the list of clinical centers participating in the Company’s global Phase 1/1b trial, which is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 patients. Enrollment at the UAB site is expected to begin immediately.

"We are pleased to activate UAB as a clinical site for our ongoing Phase 1/1b PAS-004 trial," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "UAB brings deep clinical expertise in NF1 and a strong commitment to advancing care for patients with NF1 neurofibromas. Alongside our continued engagement with the NF community, including our recent platinum sponsorship of the NF Caregivers Symposium, we remain focused on advancing PAS-004 through clinical development with urgency and purpose."

In parallel with the site activation, Pasithea will serve as Platinum Sponsor of the 2025 NF Caregivers Symposium that will be hosted at UAB on November 8, 2025. The symposium gathers caregivers, clinicians, researchers, and advocates to discuss patient care, caregiver support, emerging research, and quality-of-life considerations for families affected by NF1.

"Collaborations between academia, industry, caregivers, and patient advocates improve outcomes and support for NF1 patients," said Dr. Rebecca Brown, Director of NF Clinical Programs at UAB. "We look forward to participating in this clinical trial and supporting other activities that promote resources for the NF community."

About the Phase 1/1b Study of PAS-004

The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose ("RPBD") or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ("QOL") and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology.

The trial will be conducted in two parts. In Part A (dose escalation phase), following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B (expansion phase), approximately 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D).

The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S.

(Press release, Pasithea Therapeutics, NOV 4, 2025, View Source [SID1234659365])

On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Single Intratumoral Drug Injection Yields Complete Response (CR) in Metastatic Breast Cancer (MBC) Bone Lesions", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Wednesday, December 10, 2025.

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The abstract presents preliminary clinical data from a recently completed Phase 2a trial (NCT05280067) performed at the University of British Columbia evaluating ZetaMet (Zeta-BC-003) for safety and efficacy for the treatment of MBC lytic bone lesions in Stage 4 breast cancer patients. Phenotypes treated within the study, TNBC, HR+, HR+/HER2+, and HERS2+/HR-. Each patient underwent a single fluoroscopy-guided injection of ZetaMet while under sedation. All achieved a complete response (CR), ceased tumor activity, with no serious adverse events (SAEs), adverse events (AEs), or skeletal-related events (SREs) and many demonstrated a reconstitution of trabecular bone, which further underscores the potential of ZetaMet to not only halt disease progression but restore skeletal integrity.

The findings build on prior compassionate use cases published in peer-reviewed journals with two-year follow-up, reinforcing ZetaMet’s potential to prevent SREs and improve overall survival. The abstract will be published in SABCS 2025 Proceedings and featured in Clinical Cancer Research.

With the trial now complete and comprehensive analyses underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to Health Canada (HC) and the U.S. Food and Drug Administration (FDA) to inform future planning discussions.

Presentation Details:

Abstract Number: 3549
Presentation Number: PS1-13-18
Presentation Title: Single Intratumoral Drug Injection Yields Complete Response in Metastatic Breast Cancer Bone Lesions: Results from Phase 2a Trial
Poster Presentation: Wednesday, December 10, 2025, 12:30-2:00pm CST
"The promising Phase 2a findings for ZetaMet mirror our earlier peer-reviewed results, reinforcing the strength of our clinically validated strategy in treating metastatic breast cancer." said Joe C. Loy, CEO of Zetagen Therapeutics. "We observed that both treated and adjacent non-treated lesions within the same vertebral body achieved complete response, with no signs of tumor activity and no skeletal-related events—all using the same drug concentration validated in our preclinical studies—strongly affirming the scientific foundation of our approach".

About ZetaMet (Zeta-BC-003)
ZetaMet (Zeta-BC-003) is the first-of-its-kind, synthetic, small-molecule, administered intratumorally to minimize off target toxicity, delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, inhibit pain while regenerating bone, with the potential to increase survival rates.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet.

Zetagen with FDA and Health Canada (HC) approval via the Expanded Access (Compassionate Use) program has treated eight (8) patients with ZetaMet (Zeta-BC-003) with results published multiple peer-reviewed journals.

Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of seven (7) lytic lesions (radiated and non-radiated), reduction in pain, significant attrition of opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.[i] To view this publication via open access, go to: View Source

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659381])