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Hanmi’s Oral Delivery Platform Compound Licensed to Gilead

On September 29, 2025 Hanmi Pharm reported that it has entered into a global licensing and collaboration agreement with Gilead Sciences, Inc. ("Gilead") and Health Hope Pharma ("HHP") granting Gilead the exclusive rights to develop and commercialize encequidar.

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Orascovery is an innovative oral drug delivery proprietary platform owned by Hanmi that enables the conversion of injectable medicines into oral formulations. Encequidar is a P-gp inhibitor that was discovered through Hanmi’s Orascovery platform and originally developed by Hanmi.

Under this agreement, Hanmi and HHP will grant Gilead exclusive global rights to Encequidar within the field of virology. Hanmi and HHP will also provide drug supply, share technical know-how, and participate as key project partners. Hanmi and HHP will each receive an upfront payment and remain eligible for development, regulatory and sales milestones in addition to low single digit royalties on net sales.

Dr. Dennis Lam, founder of HHP said: "We are pleased to announce the licensing agreement with Gilead and Hanmi. This demonstrates the potential of Encequidar as a first-in-class P-gp inhibitor to create more oral formulations in multiple fields. This agreement is also a milestone of successful innovation for both the Hong Kong biotech industry and HHP as a biotech company headquartered in Hong Kong. We will build on this momentum to accelerate HHP’s development of Oraxol and explore other applications of Encequidar in oral formulations."

Jae-Hyun Park, CEO of Hanmi Pharm, said: "This agreement validates Hanmi’s formulation technology and R&D capabilities, while also opening the door to new growth opportunities through collaboration with a leading global partner. We will continue to expand strategic partnerships that can accelerate innovation and patient access worldwide."

Hanmi originally out-licensed Encequidar along with the oral anticancer drug Oraxol to Athenex in 2011. However, following Athenex’s insolvency, rights were transferred to HHP and others. HHP is currently conducting clinical trials of Oraxol in the U.S., Hong Kong, and New Zealand since June 2025, with plans to sequentially launch the product in Europe, Asia, and the U.S.

(Press release, Hanmi, SEP 29, 2025, View Source,Europe%2C%20Asia%2C%20and%20the%20U.S [SID1234660988])

NANOBIOTIX Announces Updated Phase 1 Results Continuing to Support JNJ-1900 (NBTXR3) Plus Anti-PD-1 as a Potential New 1L or 2L+ Option in Anti-PD-1 Naïve or Resistant R/M-HNSCC

On September 29, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported updated data from cohorts 1 and 2 of Study 1100, a multicenter Phase 1 dose escalation and expansion trial evaluating JNJ-1900 (NBTXR3) activated by radiation therapy ("RT") followed by anti-PD-1 immune checkpoint inhibitors (pembrolizumab or nivolumab; "ICIs") in patients with recurrent and/or metastatic head and neck squamous cell carcinoma ("R/M-HNSCC") that is naïve (cohort 1) or resistant (cohort 2) to prior anti-PD-1 therapy (Press release, Nanobiotix, SEP 29, 2025, View Source [SID1234656347]). Study results were presented as a "Top-rated Abstract in Head and Neck Cancer" by Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, at the 2025 Annual Meeting of the American Society of Radiation Oncology (ASTRO).

ABSTRACT #245: PHASE 1 DOSE ESCALATION/DOSE EXPANSION TRIAL OF NBTXR3/SBRT IN COMBINATION WITH NIVOLUMAB OR PEMBROLIZUMAB FOR TREATMENT OF ANTI-PD-1 NAÏVE OR RESISTANT PATIENTS WITH RECURRENT/METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA
Colette Shen1, Ammar Sukari2, William A. Stokes3, George Yang4, Nabil F. Saba3, Jared Weiss1, Jessica Frakes4, Jimmy Caudell4, Paul Chang5, Septimiu Murgu5, Michele Lohr6, Jason Chan7, Kedar Kirtane4, David Rolando8, Omar I. Vivar8, Zhen Gooi5, Aditya Juloori5, Trevor Hackman1, Ari Rosenberg5
1University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA; 2Karmanos Cancer Institute, Detroit, MI, USA; 3Emory Winship Cancer Institute, Atlanta, Georgia, USA; 4Moffitt Cancer Center, Tampa, Florida, USA; 5The University of Chicago, Chicago, Illinois, USA; 6Sanford Cancer Center, Sioux Falls, South Dakota, USA; 7UCSF, San Francisco, CA, USA; 8Nanobiotix, SA, Paris, France

The efficacy of ICI monotherapy remains limited in R/M-HNSCC, with objective response rates between approximately 13% and 18%, and median Overall Survival ("mOS") between approximately 8 months and 12 months. As approximately 66% of patients with R/M-HNSCC experience disease recurrence locally or loco-regionally, addition of RT to the treatment regimen is often recommended to improve local control and as a potential option for stimulating immune responses. However, to date, the addition of RT has not significantly improved ICI efficacy in R/M-HNSCC. As such, patients with R/M-HNSCC have an unmet need for novel treatment strategies that can improve local tumor control and potentiate systemic immune response.

Safety and Feasibility

JNJ-1900 (NBTXR3) activated by RT followed by anti-PD-1 was consistently well-tolerated and remained feasible in this heavily pre-treated patient population (n=103):

Injection remained consistently feasible at the recommended Phase 2 dose (33% GTV)
Favorable safety profile including no additional toxicities in lesions that were injected after re-irradiation
27 patients experienced treatment-emergent adverse events (TEAEs) of any grade (1, 2, or 3+) related to JNJ-1900 (NBTXR3) and 32 patients experienced TEAEs of any grade related to the injection procedure
Of these patients, 5 experienced grade 3+ TEAEs related to JNJ-1900 (NBTXR3) and 4 experienced grade 3+ TEAEs related to the injection procedure
In total, 71 patients experienced TEAEs of any grade related to the overall therapeutic regimen
Patients were deemed non-evaluable for efficacy (n=12) if more than one RT session was missed and/or a post-treatment tumor response assessment was unavailable
Signals of Efficacy

Potential enhancement of local responses:

Evaluable Anti-PD-1 Naïve Patients (n=41)
Injected-lesion Disease Control Rate ("DCR"): 95% (39/41)
Injected-lesion Overall Response Rate ("ORR"): 66% (27/41)
Local Progression-free Survival ("LPFS"): 34.4 months [95% CI: 12.8; Not Reached]
Evaluable Anti-PD-1 Resistant Patients (n=50)
Injected-lesion DCR: 94% (47/50)
Injected-lesion ORR: 50% (25/50)
LPFS: 7.3 months [95% CI: 5.7; Not Reached]
Systemic responses beyond potential enhanced local control:

Evaluable Anti-PD-1 Naïve Patients
DCR per RECIST 1.1: 63% (26/41)
ORR per RECIST 1.1: 37% (15/41)
Evaluable Anti-PD-1 Resistant Patients
DCR per RECIST 1.1: 74% (37/50)
ORR per RECIST 1.1: 32% (16/50)
Early signals of Overall Survival that is expected to mature with additional follow up:

Evaluable Anti-PD-1 Naïve Patients
Median Overall Survival: 15.5 months [95% CI: 11.0; Not Reached]
Evaluable Anti-PD-1 Resistant Patients
Median Overall Survival: 11.4 months [95% CI: 7.8; 16.7]
Notably, survival data in anti-PD-1 resistant patients suggests JNJ-1900 (NBTXR3) activated by RT followed by anti-PD-1 may overcome prior resistance to immune checkpoint inhibitors. Overall, these results show strong local control, with an aggregate DCR of 95% (86/91) in JNJ-1900 (NBTXR3)-injected lesions in evaluable patients, representing a critical potential outcome for patients with R/M-HNSCC. Moreover, the results suggest that the antitumoral activity of JNJ-1900 (NBTXR3) activated by RT may occur beyond the injected lesion. Investigators concluded that these promising results warrant further exploration in randomized controlled trials.

"Through the evaluation of JNJ-1900 (NBTXR3) cohorts 1 and 2 of Study 1100, we are ensuring that we prioritize the clinical development of innovation that acts both locally and systemically to address the unmet needs of patients with R/M-HNSCC," said Study 1100 Coordinating Investigator Colette Shen, MD, PhD. "Our findings from Study 1100 have consistently supported a well-tolerated safety profile with early efficacy signals, and I look forward to further investigation of JNJ-1900 (NBTXR3) as a potentially new and complementary therapeutic option for patients."

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Johnson & Johnson.

Accendatech’s Phase 3 Trial of ACT001, an Oral Compound with Novel MoA, Begins Enrolling Patients with Small Cell Lung Cancer with Brain Metastasis in a Highly Competitive Research Field

On September 29, 2025 Accendatech Co., Ltd, a clinical-stage biotech company developing natural compound-based small molecule drugs with unique pharmacological properties reported the enrollment of first small cell lung cancer patient with brain metastasis this month for the pivotal phase 3 study in China (CTR20253399) (Press release, Accendatech, SEP 29, 2025, View Source [SID1234656336]). The initiation of phase 3 trial is based on encouraging intracranial tumor response and overall survival signal from a phase 2b ACT001-CN-051 study which were released during 2025 SNO/ASCO conference held in Baltimore, MD in August, 2025. The topline data is expected to be published in a peer-reviewed journal.

ACT001 is the first study drug with the potential to enhance both chemoradiotherapy and immune therapy simultaneously that enters a phase 3 stage. It is also the first pivotal-stage study drug targeting NF-κB and STAT3 pathways since the cloning of gene involved in these two pathways approximately 39 and 33 years ago respectively. There have been numerous pre-clinical publications that proposed the pathways as therapeutic targets.

The kick-off of phase 3 ACT001 study is another evidence to reflect the increasingly dynamic nature of drug study in SCLC space since the approval of immune checkpoint inhibitors in 2019 and more recent approval of tarlatamab in 2024 as the first T cell engager ever approved in any solid tumor. The phase 3 ACT001 trial further diversify the drug development landscape in SCLC space that has now become a hot battle ground due to interesting efficacy data from studies on multiple novel modalities such as ADC and bi-specific antibodies.

bioAffinity Technologies Announces Pricing of $4.8 Million Public Offering

On September 29, 2025 bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW) a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported that it has priced a public offering of securities as described below for aggregate gross proceeds to the Company of $4.8 million, before deducting agent fees and other estimated expenses payable by the company (Press release, BioAffinity Technologies, SEP 29, 2025, View Source [SID1234656335]).

The offering consists of 1,921,799 shares (the "Shares") of our Common Stock (or pre-funded warrants (the "Pre-Funded Warrants") in lieu thereof) at a purchase price of $2.50 per share (or $2.493 per Pre-Funded Warrant). Each Pre-Funded Warrant will be exercisable for one share of our Common Stock and will be immediately exercisable and will expire when exercised in full. The purchase price of each Pre-Funded Warrant will equal the price per share of Common Stock being sold to the public, minus $0.007, and the exercise price of each Pre-Funded Warrant will be $0.007 per share.

The closing of the offering is expected to occur on or about September 30, 2025, subject to the satisfaction of customary closing conditions.

WallachBeth Capital, LLC is acting as sole placement agent for the offering.

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

The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-290480), as amended, previously filed and declared effective by the Securities and Exchange Commission (SEC). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 the registration or qualification under the securities laws of any such state or jurisdiction. The offering is being made only by means of a preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.

FDA Approves Guardant360® CDx as Companion Diagnostic for Eli Lilly and Company’s Inluriyo™ (imlunestrant) for Treatment of ESR1-mutated Advanced Breast Cancer

On September 29, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved its Guardant360 CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and Company’s Inluriyo (imlunestrant) (Press release, Guardant Health, SEP 29, 2025, View Source [SID1234656334]). Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy (ET).

"This FDA approval provides another treatment for breast cancer patients with ESR1 mutations for their specific type of cancer along with expanded access to comprehensive genomic profiling with a simple blood draw," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "Precision testing plays a critical role in helping physicians identify the correct treatment, providing patients and their doctors with the comprehensive genomic profiling needed to see if they are eligible to receive the right treatment and improving outcomes."

Breast cancer remains the second leading cause of cancer death among women in the United States.1 Guardant360 CDx was used to identify patients who had ESR1 mutations in the Phase 3 EMBER-3 trial, in which Inluriyo was found to reduce the risk of progression or death by 38% versus ET.2 Patients with ESR1 E380, V422del, S463, L469, L536, Y537, and D538 mutations detected by Guardant360 CDx are eligible for treatment with Inluriyo.

The Inluriyo approval as a companion diagnostic marks the sixth CDx claim approved by the FDA for Guardant360 CDx, and the second FDA-approved indication in breast cancer treatment, following a similar approval for ORSERDU (elacestrant) granted by the FDA in 2023.

For more information about Inluriyo, please visit View Source