Alivexis to Present MOD-D Program at the 85th Annual Meeting of the Japanese Cancer Association

On September 9, 2026 Alivexis, Inc. ("Alivexis"), a preclinical-stage computation-driven drug discovery company, reported it will present our recent data from MOD-D, one of our drug discovery programs, at the 85th Annual Meeting of the Japanese Cancer Association, to be held September 24th-26th in Kyoto, Japan.

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Our presentation will focus on the pharmacological profile of AL003626, Alivexis’ highly potent novel WDR5 inhibitor, and its therapeutic activity in various MYC-driven cancers, in the session entitled "Novel Therapeutic Strategies Targeting Cancer Vulnerabilities".

Alivexis’ presentation details are as follows:
Title: Development of AL003626, a Novel WDR5 Inhibitor Targeting the WDR5–MYC Axis for the Treatment of MYC-Driven Cancers
Presentation Number: E-1063
Authers: Masahiro Matsuki, Takafumi Shimizu, Taisuke Takahashi, Blake Mertz, William Sinko, and Yoh Terada
Presentation Date/Time: Thursday, September 24th, 12:50-14:05 (JST)
Venue: Kyoto International Conference Center, Room 12 (2F Room J)

(Press release, Alivexis, SEP 9, 2026, View Source [SID1234670666])

AIM ImmunoTech Highlights Scientific Rationale, Supportive Data and Continued Advancement of Ampligen® in Pancreatic Cancer in New CEO Corner Video

On September 9, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the release of a new installment of its CEO Corner series featuring Chief Executive Officer Thomas K. Equels discussing the Company’s scientific strategy and continued advancement of Ampligen (rintatolimod) in pancreatic cancer.

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In the CEO Corner, Equels discusses the significant challenges associated with pancreatic cancer, including its highly immunosuppressive – or "cold" – tumor microenvironment, which can prevent the immune system from mounting an effective response and has historically limited the effectiveness of many immunotherapy approaches.

Ampligen, AIM’s investigational TLR3 agonist, is designed to activate innate immunity and help reshape the tumor microenvironment, potentially making tumors more responsive to checkpoint inhibition. Based on existing data, AIM believes Ampligen may have a broad-spectrum synergistic effect with both PD-1 checkpoint inhibitors such as pembrolizumab, and PD-L1 checkpoint inhibitors such as durvalumab.

This scientific rationale is being evaluated through the Company’s ongoing Phase 2 DURIPANC study, which is assessing Ampligen in combination with AstraZeneca’s durvalumab as maintenance therapy following standard-of-care treatment in patients with pancreatic cancer. AIM believes the study has the potential to provide important insights into patient selection, biomarker identification and the characteristics of patients who may derive the greatest clinical benefit, helping inform the design of a potential future pivotal development program.

"Pancreatic cancer remains one of oncology’s most difficult diseases, in large part because its immunosuppressive tumor microenvironment creates significant barriers to effective immune responses," said Equels. "Our strategy with Ampligen is designed to address that underlying biology by activating innate immunity and potentially making these tumors more responsive to checkpoint inhibition. As we continue to advance DURIPANC, biomarker research and our broader clinical development strategy, we believe the data generated can further strengthen our understanding of Ampligen’s mechanism of action and its potential role in addressing this significant unmet medical need."

Beyond DURIPANC, AIM continues to build a broader body of scientific and clinical evidence supporting Ampligen through collaborations with leading institutions, ongoing biomarker research, expansion of its intellectual property portfolio and continued regulatory engagement.

Looking ahead in DURIPANC, the Company expects primary endpoint analyses, continued biomarker evaluations and overall survival follow-up. It also plans future regulatory interactions to provide additional opportunities to evaluate Ampligen’s potential and refine AIM’s long-term pancreatic cancer development strategy.

The latest CEO Corner segment is now available on the Company’s website here.

(Press release, AIM ImmunoTech, SEP 9, 2026, View Source [SID1234670665])

Adagene Achieves Milestone in Collaboration with Exelixis for Advancement of SAFEbody® Antibody-Drug Conjugate Candidates

On September 9, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported the achievement of a milestone in its ongoing collaboration and license agreement with Exelixis, Inc. ("Exelixis").

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The milestone achievement is related to a preclinical milestone event for XB404 and resulted in a $2.0 million milestone payment from Exelixis. XB404, built with Adagene’s SAFEbody masking technology, is designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. An additional payment to Adagene was triggered by the selection of candidates for another SAFEbody antibody-drug conjugate (ADC) program. Exelixis has the right to utilize Adagene’s SAFEbody technology platform to generate masked monoclonal antibodies for the development of masked ADC candidates.

Adagene is eligible to receive development and commercialization milestones and royalties on net sales of products developed.

(Press release, Adagene, SEP 9, 2026, View Source [SID1234670664])

Elicera Therapeutics Receives Safety Committee Recommendation to Use Highest ELC-301 Dose as CARMA Moves Toward Phase IIa in B-cell Lymphoma

On September 9, 2026 Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on oncolytic viruses and CAR T-cell therapies, armed with immune-activating properties via the company’s commercially available iTANK platform, reported that the Data Safety and Monitoring Board (DSMB) has completed its final assessment of the ongoing Phase I-part of the CARMA clinical study with the CAR T-cell therapy, ELC-301, for the treatment of B-cell lymphoma. The DSMB recommended the highest dose for continuation of the study into Phase IIa.

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The dose-escalation study, conducted in collaboration with Uppsala University as the co-sponsor, consists of two parts: a dose-escalation study (Phase I) with 12 patients, which is now complete, and a dose-expansion study (Phase IIa) with 6 patients. The cell therapy ELC-301 incorporates the iTANK platform technology, which, through its parallel immune activation, aims to provide a broader and more effective attack on cancer cells.

No dose limiting toxicities have been reported in Phase I. The Data Safety and Monitoring Board (DSMB) has, after reviewing the safety data, recommended the highest dose level as the Phase IIa dose. Once approval from the Swedish Medical Products Agency (MPA) has been received, Phase IIa patients will be treated at the highest dose level.

The latest data reported from the CARMA study, press released on August 11, showed that among the eleven patients evaluated, all had achieved disease control (no disease progression) one month after treatment, and 91 percent (10/11) had obtained an objective tumor response, including six patients (55 percent) with complete metabolic response (disease-free status). Of these, four patients remained disease-free, one for at least 18 months and one for at least 12 months. The company will provide an update of preliminary efficacy data from all 12 patients in the Phase I-part of the study when the final patient in Phase I has undergone the one-month evaluation.

"Built on the accumulated efficacy signals we have seen so far in Phase I, the DSMB’s positive recommendation strengthens our confidence in ELC-301. We can now proceed with the Phase IIa part of the CARMA study as soon as possible after MPA approval. This brings us one step closer to offering a new treatment option to patients with limited alternatives. I look forward to sharing the complete Phase I data in due course", says Elicera’s CEO, Johan Liwing.

(Press release, Elicera Therapeutics, SEP 9, 2026, View Source,c4393670 [SID1234670641])

Adlai Nortye Announces First Patient Dosed in Australia and U.S. FDA IND Clearance for AN4035, a First-in-Class Pan-RAS(ON) Inhibitor-Based ADC

On September 8, 2026 Adlai Nortye Group Ltd. (NASDAQ: ANL) ("Adlai Nortye" or the "Company"), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, reported that the first patient has been dosed with AN4035 in Australia, initiating the global Phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors. The Company also received a "Study-May-Proceed" letter from the U.S. Food and Drug Administration (FDA) on its investigational new drug (IND) application, clearing the path to expand the trial into the United States.

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"AN4035 is the first proof-of-concept candidate from our RAS Inhibitor Conjugated Antibody (RASiCA) platform, specifically engineered to address two pressing challenges in oncology. First, the ADC field urgently needs novel payload classes to overcome cross-resistance, as existing options remain largely confined to just topoisomerase I and microtubule inhibitors. Second, systemic pan-RAS(ON) inhibitors have been hampered by on-target, off-tumor toxicities, particularly in the skin and gastrointestinal tract. By conjugating our potent pan-RAS(ON) payload to a CEACAM5-targeting antibody, AN4035 is designed for tumor-selective delivery while sparing normal tissues," said Dr. Archie Tse, President, Head of Research & Development. "Following regulatory clearance to begin the trial in Australia last month, we have dosed the first patient and secured a "Study-May-Proceed" letter from the U.S. FDA. We look forward to advancing this asset globally and remain on track to report full Phase Ia data in the second half of 2027."

This global phase I trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 as monotherapy and in combination with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors. CEACAM5 is highly overexpressed in colorectal, pancreatic, and lung cancers – tumor types that frequently harbor RAS mutations. The Company is also filing an IND application for AN4035 with the China National Medical Products Administration (NMPA).

About AN4035

AN4035 is a first-in-class ADC targeting CEACAM5 and armed with a highly potent pan-RAS(ON) inhibitor payload. In preclinical studies, the ADC demonstrates favorable thermal and plasma stability with desirable pharmacokinetic properties. Strong intracellular payload retention drives nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cancer cell lines, coupled with a potent bystander-killing effect. In vivo, AN4035 has shown robust anti-tumor activity with deep tumor regression in CEACAM5-positive CDX and PDX models. Compared with the payload alone, the ADC exhibits enhanced target-mediated tumor retention and significantly improved tumor selectivity over normal tissues, resulting in an overall favorable therapeutic index. Adlai Nortye is evaluating AN4035 in a global phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors.

(Press release, Adlai Nortye Biopharma, SEP 8, 2026, View Source [SID1234670661])