On June 3, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported initiation of a Phase 1/2 clinical study of its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors (Press release, Avenzo Therapeutics, JUN 3, 2025, View Source [SID1234653666]).

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"HER3 is a key dimerization partner of EGFR, and their interaction is known to drive oncogenic signaling across a range of solid tumors, including non-small cell lung cancer, breast cancer, and head and neck cancer," said Anthony Tolcher, M.D., FRCPC, CEO and Founder, NEXT Oncology. "Based on its preclinical data and differentiated design targeting this pathway, AVZO-1418 offers a promising approach for patients with advanced solid tumors."

The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

"We are excited to have initiated our company’s second clinical trial within 2 weeks of receiving IND clearance," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This is another important milestone in our journey to advance potentially differentiated drug candidates that help fight cancers with high unmet medical needs."

On June 3, 2025 Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported that management will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10, 2024, at 8:40 am ET (Press release, Alector, JUN 3, 2025, View Source [SID1234653665]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

On June 3, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that biomarker data from its OPTIMIZE-1 clinical trial were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Alligator Bioscience, JUN 3, 2025, View Source [SID1234653629]).

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OPTIMIZE-1 is a Phase 1b/2 trial evaluating mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The study has demonstrated strong clinical outcomes to date, including a ~30% survival rate at 24 months and a median overall survival of 14.9 months.

The biomarker analyses highlighted mitazalimab’s immunological mechanism of action, with immune activation in responding patients and gene signatures associated with clinical benefit and improved survival. These results support continued development of mitazalimab, including a planned confirmatory trial in mPDAC.

"ASCO continues to be a cornerstone event for clinical oncology, and it was a privilege to share our OPTIMIZE-1 data with the international community," said Søren Bregenholt, CEO of Alligator Bioscience. "The high level of engagement and many productive meetings we’ve had during the conference further validate the growing interest in mitazalimab and its potential in pancreatic cancer."
The presentation poster is available on Alligator’s website. Alligator’s participation at ASCO (Free ASCO Whitepaper) is part of its broader commitment to scientific collaboration and strategic business development.

On June 2, 2025 AimedBio reported it has successfully secured $38 million in a Pre-IPO funding round. The round was led by existing key investors—InterVest, DS Asset Management, Samsung Life Public Welfare Foundation, and SMB Investment Partners. Mirae Asset Securities joined as the sole new investor.

With the newly secured funding, AimedBio plans to accelerate the development of its next-generation ADC pipeline and advance preparations for global clinical trials. Following the licensing of its lead asset, AMB302, to U.S.-based Biohaven in December 2024, the company is now focusing on the preclinical development of the next candidates AMB303 and AMB304. At the same time, AimedBio aims to significantly expand its pipeline through next-generation ADC platform technologies.

Dr. Nam-Gu Her, CEO of AimedBio stated, "This Pre-IPO round closed earlier than expected, reflecting strong confidence from our existing shareholders. Mirae Asset Securities’ participation signals growing market confidence in AimedBio’s vision and potential."

"Based on our successful licensing deal to date, AimedBio is projected to achieve operating profitability for two consecutive half-years—the second half of 2024 and the first half of 2025. This is a significant milestone, as it demonstrates that the company has moved beyond potential to proving its ability to generate sustainable revenue," he added.

AimedBio also noted, "Additional technology licensing deals are expected within this year, and with the rapid expansion of our preclinical pipeline, we are set to accelerate high-growth momentum. Through the development of globally competitive ADC therapies, we aim to provide meaningful treatment options to patients and continuously enhance corporate value."

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(Press release, AimedBio, JUN 2, 2025, View Source;s_keyword=&s_where=&start=0 [SID1234656917])

On June 2, 2025 RemeGen reported data from phase 1b/2 clinical trial of RC108 in combination with furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on EGFR-TKI treatment, and the results showed obvious synergistic effect between RC108 and furmonertinib (Press release, RemeGen, JUN 2, 2025, View Source;cid=115&id=2661 [SID1234656124]).

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RC108 is a c-mesenchymal-epithelial transition factor (c-MET) targeted ADC developed by RemeGen. It binds to MET with high affinity and precisely delivers cytotoxins into c-MET-expressing tumor cells. Furmonertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed by Allist Pharmaceuticals.

Studies have shown that MET-overexpression is the main resistance mechanism for the progression of EGFR-TKI treatment. RC108 has a good killing effect on tumor cells with different MET expression levels. The results of phase 1 study (NCT04617314) showed that the objective response rate (ORR) of RC108 alone in patients with MET-overexpressing (≥ IHC 1+) locally advanced or metastatic NSCLC who have progressed on EGFR-TKI treatment was 33%.

The study presented at 2025 ASCO (Free ASCO Whitepaper) is an open, single-arm, multicenter phase 1b/2 clinical trial to evaluate the safety, tolerability, efficacy, and pharmacokinetic profile of RC108 in treatment of patients, aiming to provide a reference basis for the development of a rational combination dosing regimen for subsequent studies.

Results of the analysis up to April 11, 2025 showed that RC108 in combination with furmonertinib demonstrated encouraging antitumor activity in patients with MET-overexpressing locally advanced or metastatic NSCLC with a manageable safety profile:

• In patients with ≥1+ tumor cells membrane staining and ≤20% tumor cells with strong (3+) cytoplasmic staining, ORR was 40.5%, and median progression-free survival (PFS) was 7.1 months.

• In patients with ≥3+ tumor cells membrane staining and ≤20% tumor cells with strong (3+) cytoplasmic staining, ORR was 61.1%, and median PFS was 8.2 months.

• Common AEs included: asthenia, nausea, decreased appetite, vomiting, etc.

RemeGen is currently preparing phase 3 clinical study of this combination therapy.