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.

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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.

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]).

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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.

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).

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"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

On September 29, 2025 Aarvik Therapeutics, an innovative, ADC-focused biotechnology company dedicated to engineering precision medicines for cancer therapy, reported that it has successfully closed a Series Seed 2 financing round (Press release, Aarvik Therapeutics, SEP 29, 2025, View Source [SID1234656332]).

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Following its launch in 2021, Aarvik closed an initial Series Seed financing round and signed a research collaboration agreement. Aarvik established laboratories in Hayward and developed its proprietary MUTTA (MUlti-epitope Targeting Tetravalent Antibody; pronounced MOO-TA) platform with a focus on developing next generation antibody drug conjugates (ADCs) that can expand the success of ADCs beyond a limited number of targets. Aarvik’s comprehensive approach facilitates the lowering of the minimum effective dose (MED) while maintaining or improving the maximum tolerated dose (MTD), thereby significantly improving the therapeutic window. In August 2024, the option was exercised to exclusively license the research collaboration program.

Aarvik’s new round of funding further validates the substantial progress made by Aarvik on the MUTTA platform. The funding comes from a diverse set of investors that includes original Series Seed investors as well as a new group of pharma and tech professionals, and contract research and contract development and manufacturing organizations. This funding will allow Aarvik to reach targeted research milestones and further advance its pipeline of ADC assets.

"We are delighted to see Aarvik reach this new milestone," said Ram K. Reddy, serial entrepreneur, venture partner and Independent Board Member of Aarvik Therapeutics. "The support from new as well as existing investors is a reflection of the progress achieved by Aarvik and the potential of Aarvik’s pipeline."

"Aarvik continues to demonstrate that it can combine its deep ADC drug development expertise with its next-generation MUTTA platform to enable powerful oncology therapies," said Jagath Reddy Junutula, PhD, Co-founder, President and CEO of Aarvik Therapeutics. "Aarvik relentlessly pursues novel therapies for hard-to-treat cancer indications through research and innovation."

On September 29, 2025 TAE Life Sciences (TLS) reported preclinical results from its collaboration with Kyoto University, demonstrating that its next-generation boron drugs, when combined with immune checkpoint inhibitors, significantly inhibited tumor growth in certain conditions compared with either immunotherapy alone or BNCT alone (Press release, TAE Life Sciences, SEP 29, 2025, View Source [SID1234656331]). Based on the ongoing success of this collaboration and the exciting data being generated, TLS and Kyoto University have extended their BNCT research partnership through December 2026.

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TLS’s findings are consistent with recent third-party publications highlighting the unique synergy between BNCT and checkpoint inhibitors. Both independent 2024 studies from Japan reported that combining BNCT with PD-1/PD-L1 blockade enhanced tumor control and survival, reinforcing TLS’s own observations of synergistic immune activation. This alignment underscores the translational potential of TLS’s BNCT-immunotherapy strategy.

"These preclinical results with TLS proprietary boronated compounds confirm the potential to not only deliver targeted BNCT but also amplify the effects of immunotherapy," said Rob Hill, CEO of TAE Life Sciences. "This in turn expands our clinical opportunity and strengthens our position in both oncology and the fast-growing immunotherapy markets."

"Our partnership with Kyoto University has been critical in driving novel drug development for BNCT," added Kendall Morrison, Chief Scientific Officer at TLS. "By extending this partnership through 2026, we ensure continuity in preclinical testing, combination optimization, and translational research that supports our IND-enabling path."

Strategic outlook

These results reinforce the potential for TLS’s novel boronated drugs to transform BNCT from a targeted radiation therapy into a powerful immuno-oncology strategy. By combining the precision of BNCT with the systemic effects of checkpoint inhibition, these drugs may help overcome resistance, broaden patient benefit, and establish a new standard for difficult-to-treat cancers. The extension of TLS’s partnership with Kyoto University provides a strong foundation to advance this program toward IND-enabling studies, first-in-human trials and upcoming scientific milestones.