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Olema Oncology Announces Palazestrant Dose Selection and Trial-in-Progress Poster at ASCO 2025 Annual Meeting

On May 28, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported it has aligned with the U.S. Food and Drug Administration (FDA) to select 90 mg of palazestrant as the dose for Part 2 of the ongoing registrational Phase 3 OPERA-01 trial in second- and third-line estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer (Press release, Olema Oncology, MAY 28, 2025, View Source [SID1234653446]). This update will be presented as part of the OPERA-01 trial-in-progress poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3 in Chicago, Illinois. The FDA also selected 90 mg of palazestrant in combination with the approved dose of CDK4/6 inhibitor ribociclib for the pivotal Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer.

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"Metastatic breast cancer treatment continues to be challenged by resistance mechanisms resulting in a clear need for innovative new therapies. We believe the clinical results we have achieved to date for palazestrant across ESR1 mutant and wild-type ER+/HER2- tumors, both in the monotherapy and combination treatment settings, support palazestrant’s potential to have a significant positive impact on breast cancer patients," said Naseem Zojwalla, M.D., Chief Medical Officer of Olema Oncology. "We remain steadfast in our commitment to these patients, and with 90 mg of palazestrant confirmed as the selected dose, we are focused on rapidly advancing our OPERA-01 and OPERA-02 pivotal trials with top-line data from OPERA-01 anticipated in 2026 and a potential commercial launch in 2027."

Poster Presentation Details
Title: OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care endocrine therapy for patients with ER+, HER2- advanced breast cancer after endocrine and CDK4/6 inhibitor therapy
Abstract Number: TPS1131
Poster Number: 104b
Poster Session: Breast Cancer – Metastatic
Date/Time: June 2, 2025 from 9:00am–12:00pm CT / 10:00am–1:00pm ET

Additional information can be found on the ASCO (Free ASCO Whitepaper) Annual Meeting website, including abstracts. A copy of the poster will be made available on the Publications page of Olema’s website in alignment with ASCO (Free ASCO Whitepaper)’s embargo policy.

About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01. Learn more at www.opera01study.com. Palazestrant is also being evaluated in multiple Phase 1/2 trials in combination with ribociclib, palbociclib, alpelisib, and everolimus. It will also be evaluated in combination with ribociclib in the planned pivotal Phase 3 trial, OPERA-02.

ykode Therapeutics reports Q1 2025 Financial Results

On May 28, 2025 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported its unaudited financial results for the first quarter of 2025 (Press release, Nykode Therapeutics, MAY 28, 2025, View Source [SID1234653445]).

The financial report can be accessed in the Investors section of the company’s website: View Source

The company will host a webcast presentation at 10 a.m. CET / 4 a.m. ET. A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website and on the following link: View Source;tp_key=4e61cabec4

Neogap receives approval to administer full dose in clinical trial – streamlining development of its personalised cell therapy

On May 28, 2025 Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company developing personalised immunotherapy for cancer treatment, reported to have received approval from the Swedish Medical Products Agency to administer the full dose to all patients in its ongoing phase I/II clinical trial (Press release, Neogap Therapeutics, MAY 28, 2025, View Source;streamlining-development-of-its,c4156253 [SID1234653443]). The decision introduces a more flexible study design and contributes to a faster and more efficient development of the company’s cell therapy.

According to the revised study protocol, the company is now authorised to treat each patient with the full dose, instead of starting with a low dose and gradually increasing it for subsequent patients. The amendment aligns with recently published data from other cell therapy studies and enables earlier analysis of treatment response.

"Being able to give the full dose from the outset is an important step in the development of our personalised cell therapy. It allows us to collect data earlier that may contribute to the evaluation of both the treatment’s safety and efficacy, while supporting a more efficient and flexible study design – to the benefit of both patients and our continued development efforts," says Samuel Svensson, CEO of Neogap Therapeutics.

The company has also received approval to extend the shelf life of both the starting material from the patient’s lymph nodes and the final frozen product. This provides greater flexibility in clinical operations, particularly when treatment needs to be scheduled around standard chemotherapy or temporary infections.

The treatment under evaluation is pTTL (personalised Tumour Trained Lymphocytes), Neogap’s personalised, cell-based immunotherapy designed to strengthen the patient’s own T cells to target solid tumours. It is based on Neogap’s patented technologies PIOR and EpiTCer, and is currently being investigated in a phase I/II clinical trial for advanced colorectal cancer. Patient recruitment is ongoing at several hospitals in Sweden.

iTeos Therapeutics Announces Its Intention to Wind Down Operations

On May 28, 2025 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported the intention to wind down its operations as part of a comprehensive review of strategic alternatives aimed at maximizing shareholder value (Press release, iTeos Therapeutics, MAY 28, 2025, View Source [SID1234653442]).

Following a thorough assessment of the Company’s development pipeline, business prospects, and financial position, the Company’s Board of Directors intends to wind down clinical and operational activities and focus on leveraging the Company’s cash balance to deliver near-term value to shareholders, including any proceeds from the potential sale of the Company’s intellectual property and assets such as EOS-984, EOS-215, and a preclinical obesity program targeting ENT1.

IMUNON Closes Up To $9.75 Million Private Placement Priced At-The-Market Under Nasdaq Rules

On May 28, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported sale of an aggregate of 7,222,223 shares of its common stock (or pre-funded warrants in lieu therof) and short-term warrants to purchase up to an aggregate of 14,444,446 shares of common stock at a purchase price of $0.45 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrants in a private placement priced at-the-market under Nasdaq rules (Press release, IMUNON, MAY 28, 2025, View Source [SID1234653441]). The warrants are exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants at an exercise price of $0.45 per share and will expire three years from the date of stockholder approval.

H.C. Wainwright & Co. acted as the exclusive lead placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agent.

The aggregate gross proceeds to the Company from the private placement was approximately $3.25 million, before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be approximately $6.5 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock, pre-funded warrants and short-term warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and short-term warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the short-term warrants and the shares of common stock underlying the pre-funded warrants and short-term warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the shares of common stock and the shares issuable upon exercise of the pre-funded warrants and short-term warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.