On November 24, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that multiple abstracts on vepdegestrant (ARV-471) have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12, 2025 in San Antonio, Texas. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.* Ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation details are as follows:

Title: Subgroup analyses of VERITAC-2: A phase 3 trial of vepdegestrant, a PROTAC estrogen receptor (ER) degrader, versus fulvestrant in ER-positive/ human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)
Presenting Author: Erika P. Hamilton
Presentation Number: PD10-03
Presentation Type: Poster Spotlight Presentation
Session: Poster Spotlight 10: Novel Combinations with Endocrine Therapy
Date: Friday, December 12, 2025
Session Time: 7:00–8:30 AM CT
Presentation Time: 7:36–7:39 AM CT

Title: Circulating tumor DNA (ctDNA) biomarker analyses of a phase 1/2 study evaluating vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)
Presenting Author: Seth A. Wander
Presentation Number: PS2-07-24
Presentation Type: Poster Presentation
Session: Poster Session 2
Date: Wednesday, December 10, 2025
Session Time: 5:00–6:30 PM CT

Title: Real-world prevalence of ESR1 mutations (ESR1m) among patients with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) after first-line (1L) treatment with endocrine therapy (ET) and/or a cyclin dependent kinase 4/6 inhibitor (CDK4/6i)
Presenting Author: David Chandiwana
Presentation Number: PS1-11-09
Presentation Type: Poster Presentation
Session: Poster Session 1
Date: Wednesday, December 10, 2025
Session Time: 12:30–2:00 PM CT

Title: I-SPY2 Endocrine Optimization Pilot (EOP): Neoadjuvant vepdegestrant monotherapy or in combination with letrozole or abemaciclib in molecularly selected patients with stage 2/3 HR+ HER2-negative breast cancer (BC)
Presenting Author: Jo Chien
Presentation Number: PD10-02
Presentation Type: Poster Spotlight Presentation
Session: Poster Spotlight 10: Novel Combinations with Endocrine Therapy
Date: Friday, December 12, 2025
Session Time: 7:00–8:30 AM CT
Presentation Time: 7:33–7:36 AM CT

The I-SPY2 EOP trial is sponsored by Quantum Leap.

Title: A phase 1/2 trial evaluating the safety, tolerability, and efficacy of the KAT6 inhibitor, PF-07248144, in combination with vepdegestrant in patients with ER+/HER2− locally advanced or metastatic breast cancer
Presenting Author: Fengting Yan
Presentation Number: PS5-09-30
Presentation Type: Poster Presentation (Trial in Progress Poster)
Session: Poster Session 5
Date: Friday, December 12, 2025
Session Time: 12:30–2:00 PM CT

The full abstracts can be accessed via the SABCS online program.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC estrogen receptor degrader. In the VERITAC-2 Phase 3 study, vepdegestrant demonstrated statistically significant and clinically meaningful improvement in progression free survival compared to fulvestrant in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The U.S. Food and Drug Administration (FDA) is reviewing the filed New Drug Application (NDA) for vepdegestrant. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer share worldwide development costs, commercialization expenses, and profits.

*In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the commercialization and potential further development of vepdegestrant.

(Press release, Arvinas, NOV 24, 2025, View Source [SID1234660887])

On November 24, 2025 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that Bob Jahr, Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 10:00 AM ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition to the fireside chat, management will be available to participate in one-on-one in-person meetings with qualified members of the investor community who are registered to attend the conference.

A live webcast of the fireside chat will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

(Press release, Outlook Therapeutics, NOV 24, 2025, View Source [SID1234660903])

On November 24, 2025 Pin Therapeutics, a clinical-stage biotechnology company specializing in targeted protein degradation, reported that it has administered the first dose of its CK1α-selective degrader PIN-5018 in a Phase 1 clinical trial. The first patient enrolled has adenoid cystic carcinoma (ACC), a rare malignancy with limited treatment options.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PIN-5018 is an oral CK1α degrader developed based on the novel hypothesis of "synthetic activation of p53." The company is evaluating PIN-5018 as both a monotherapy and in multiple combination regimens. The Phase 1 study employs a dose-escalation design to assess safety, pharmacokinetics (PK), and target engagement/pharmacodynamics (PD). Pin Therapeutics also plans to expand development into additional indications.

PIN-5018 Achieves Complete Response in ACC PDX Models
The company highlighted compelling preclinical data in ACC, a disease with no approved standard-of-care therapy. In two patient-derived xenograft (PDX) models, treatment with PIN-5018 resulted in a complete response (CR) in one model and marked tumor regression in the other, demonstrating robust antitumor activity and supporting clinical translation.

Expansion Planned into mCRPC, Colorectal Cancer, and Other Rare Tumors
Pin Therapeutics notes that CK1α plays a key biological role in resistance mechanisms that emerge during androgen receptor (AR) inhibitor therapy. Based on this insight, the company is pursuing a strategy aimed at enabling rapid entry into the first-line (1L) setting for metastatic castration-resistant prostate cancer (mCRPC) through combination therapy with an AR signaling inhibitor (ARSI). In colorectal cancer, the company is advancing a clinical program based on the innovative concept of "synthetic activation of WNT signaling."

Advancing Mechanism-Based Precision Oncology
Pin Therapeutics emphasized its commitment to mechanism-based precision oncology across its entire pipeline by applying sophisticated biological mechanisms. Ongoing initiatives include mode-of-action studies, integrated PK/PD analysis, and biomarker development to identify the most appropriate patient populations for each indication.

"Our goal is to leverage our innovative degradation modality and novel biological frameworks to provide meaningful therapeutic options for cancer patients with limited or no existing treatments," Pin Therapeutics CEO Hyunsun Jo said. "We look forward to demonstrating the clinical value of PIN-5018 across multiple tumor types."

(Press release, Pin Therapeutics, NOV 24, 2025, View Source [SID1234660919])

On November 24, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (BsADC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The designation was granted for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. There are no approved antibody-drug conjugates for patients previously treated with enfortumab vedotin.

"Receiving Fast Track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on enfortumab vedotin," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We believe AVZO-103 has the potential to become a promising treatment option for patients and we are committed to rapidly advancing its clinical development."

AVZO-103 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors.

About Fast Track Designation
Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
Rolling Review of a Biologic License Application or New Drug Application by the FDA

(Press release, Avenzo Therapeutics, NOV 24, 2025, View Source [SID1234660888])

On November 24, 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 for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported positive safety, PK and PD data from Cohort 7 (37mg capsules) in its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or in patients who have failed prior BRAF/MEK inhibition (NCT06299839).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea commented, "We are highly encouraged by the initial safety data generated in Cohort 7 (37mg capsules), where zero treatment-related adverse events have been observed during the DLT period. Furthermore, PD data demonstrates the pharmacological profile we believe is necessary to achieve consistent pathway inhibition over the 24-hour dosing period, while avoiding both periods of excessive suppression and periods of insufficient target engagement. We believe this balanced profile will be critical for achieving clinical efficacy while minimizing the most commonly observed adverse events associated with MEK inhibitors. We believe PAS-004 is particularly well suited for the treatment of diseases involving the MAPK pathway that require chronic dosing over long periods of time, where sustained long-term pathway suppression at safe and well-tolerated doses is required."

PAS-004 has demonstrated in Cohort 7 (37mg capsules):

Safety and Tolerability Results:

PAS-004 was safe and well tolerated with no dose limiting toxicities (DLTs), and no treatment-related adverse events observed during the DLT period.

After reviewing cohort 7 data, the Safety Review Committee recommended to proceed to Cohort 8, 45mg capsules, without modification.

Pharmacodynamics (PD) Results:

At steady-state, individual patient plasma data showed PAS-004 inhibiting phosphorylated extracellular signal-regulated kinase (pERK) at a level of 80% near Cmax.

At steady-state, individual patient plasma data showed PAS-004 inhibiting pERK at a level above 60% at Cmin (24-hour postdose).

Pharmacokinetics (PK) Results:

Linear PK and dose-proportionality.

PK curve with Cmax/Cmin ratio <2.

AUC: 6,690 ng*h/mL; Cmax: 313 ng/mL; Cmin: 260 ng/mL.

Graph 1 below represents the complete PAS-004 dose escalation curve at steady state in our ongoing Phase 1 trial in advanced cancer patients.

(Press release, Pasithea Therapeutics, NOV 24, 2025, View Source [SID1234660904])