On November 10, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-1418 (DB-1418), a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate (BsADC).

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The designation was granted for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR tyrosine kinase inhibitor (TKI).

"We are excited to receive this Fast Track designation from the FDA, underscoring the promise of AVZO-1418, especially for patients with EGFR-Mutated TKI-Pretreated NSCLC," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This designation has the potential to help expedite the development of AVZO-1418, which we continue to rapidly advance in Phase 1."

AVZO-1418 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study 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.

About Fast Track Designation
Fast Track is a FDA process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
Rolling Review of a Biologic License Application or New Drug Application by the FDA

(Press release, Avenzo Therapeutics, NOV 10, 2025, View Source [SID1234659706])

On November 10, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the third quarter ended September 30, 2025, and highlighted recent Company progress.

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"Our late-stage firmonertinib program continues to make strong progress across EGFR-mutant NSCLC populations, with two global Phase 3 pivotal studies being conducted in uncommon EGFR mutant non-small cell lung cancer (NSCLC). Backed by compelling data in both PACC and exon 20 insertion mutations, firmonertinib consistently shows the potential to address significant unmet needs in these underserved patient populations," said Bing Yao, CEO of ArriVent. "Following our strong Phase 1b findings, we are advancing to pivotal development with enrollment of the first patient in our global pivotal Phase 3 trial for PACC mutant NSCLC expected in the fourth quarter of this year. Additionally, we project topline pivotal data from our global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026, a patient population for which firmonertinib received FDA Breakthrough Therapy Designation."

Dr. Yao continued, "Our antibody-drug conjugate (ADC) portfolio is also advancing with our lead candidate ARR-217, a CDH17-targeted ADC with best-in-class potential for the treatment of gastrointestinal cancers, in an ongoing Phase 1 trial. We expect additional ADC programs to progress toward the clinic, expanding our ADC portfolio across multiple solid tumor indications. With a strong balance sheet and projected cash runway into mid-2027, we believe we are well-positioned to deliver on multiple near-term catalysts."

Third Quarter 2025 and Recent Highlights

Firmonertinib

● Final Phase 1b data in EGFR PACC mutant NSCLC. In September 2025, ArriVent presented final proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with NSCLC harboring EGFR PACC mutations at the 2025 World Conference on Lung Cancer (WCLC). Firmonertinib demonstrated clinically meaningful progression free survival, central nervous system (CNS) complete responses, and a manageable safety profile consistent with previous trials in what we believe to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.

Pipeline

● Clinical advancement of ADC lead candidate ARR-217 (MRG007). Phase 1 dose escalation continues in the Phase 1 study for ARR-217, a CDH17-targeted ADC, in gastrointestinal malignancies with our partner, Lepu Biopharma Co., Ltd. In addition, ArriVent has received FDA IND clearance for ARR-217.
Upcoming Milestones

● First-line EGFR PACC registrational study. Enrollment of first patient in the randomized, global pivotal ALPACCA Phase 3 study for first-line firmonertinib monotherapy in EGFR PACC mutant NSCLC expected in Q4 2025.

● Firmonertinib Pivotal EGFR exon 20 insertion data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is projected to be in early 2026.
Corporate

● Appointed Brent S. Rice as Chief Commercial Officer. In September 2025, ArriVent appointed Brent S. Rice as Chief Commercial Officer who joins ArriVent with over 25 years of U.S. and global commercial experience in the biotechnology and pharmaceutical industry. Before joining ArriVent, Brent most recently served as the Senior Vice President and global Chief Commercial Officer, and Managing Director U.S. at Autolus Therapeutics Ltd. where he led global commercialization, commercial strategy and business portfolio management of their early and late-stage pipeline, including next generation oncology therapies.
2025 Financial Results

● As of September 30, 2025, the Company had cash and investments of $305.4 million which is expected to fund operations to mid-2027.

● Net cash used in operations was $129.9 million and $54.1 million for the nine months ended September 30, 2025 and 2024, respectively.

● Research and development expenses were $121.2 million and $58.8 million for the nine months ended September 30, 2025 and 2024, respectively. This includes a $40 million one-time upfront payment for the in-licensing of ARR-217 from Lepu Biopharma.

● General and administrative expenses were $17.5 million and $11.8 million for the nine months ended September 30, 2025 and 2024, respectively.

● Net loss was $130.8 million and $59.9 million for the nine months ended September 30, 2025 and 2024, respectively.

(Press release, ArriVent Biopharma, NOV 10, 2025, View Source [SID1234659705])

On November 10, 2025 Alpha-9 Oncology ("Alpha-9" or "the Company"), a clinical-stage radiopharmaceutical company developing targeted cancer therapies, reported the appointment of Paul Blanchfield as Chief Executive Officer and a member of the Board of Directors. Mr. Blanchfield brings more than 15 years of diverse leadership experience across radiopharmaceuticals, biotechnology, and healthcare – most recently as President of Lantheus, where he oversaw Commercial, R&D, Medical, and Technical Operations.

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"Paul brings exceptional operational experience and deep industry expertise in radiopharma – making him an ideal fit to lead our team at this pivotal moment," said Patrick Heron, Chairman of the Board, Alpha-9 Oncology. "His experience in building and leading commercial and scientific organizations positions him to guide Alpha-9 through its next phase of growth as we advance our clinical programs."

Alpha-9 Oncology is focused on differentiated, highly targeted radiopharmaceuticals that deliver radiation directly to tumor cells while limiting exposure to healthy tissue. The company has developed best-in-class molecules against a range of targets and is currently progressing several drug candidates through early clinical studies.

"Alpha-9 is at the forefront of radiopharmaceutical innovation," said Paul Blanchfield, Chief Executive Officer, Alpha-9 Oncology. "I am honored to join this talented team at such an exciting time for the company, as we accelerate a pipeline of first and best-in-class clinical-stage assets with the potential to meaningfully improve the treatment of people living with cancer."

Mr. Blanchfield joins Alpha-9 during a period of strong momentum following the company’s $175 million Series C financing led by Lightspeed Venture Partners and Ascenta Capital in Q4 2024.

Prior to his time at Lantheus, Mr. Blanchfield held senior roles at Takeda and Shire Pharmaceuticals, including Head of U.S. Immunology, General Manager for Nordics-Baltics, Head of Corporate Strategy, and Chief of Staff to the CEO.

He holds an MBA and MA in Education from Stanford University, and a BA in Economics from Duke University.

(Press release, Alpha9 Oncology, NOV 10, 2025, View Source [SID1234659704])

On November 10, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will participate in three upcoming investor conference in November and December.

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TD Cowen’s Immunology & Inflammation Virtual Summit
Wednesday, November 12
1:30PM PT/4:30PM ET

Jefferies Global Healthcare Conference in London
Tuesday, November 18
2:00AM PT/5:00AM ET/10:00AM GMT

Piper Sandler 37th Annual Healthcare Conference
Tuesday, December 2
9:00AM PT/12:00PM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, NOV 10, 2025, View Source [SID1234659703])

On November 10, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payloads for antibody drug conjugates (ADCs), reported the presentation of immune mechanism-of-action data for its novel ADC payload, PH1. The Company will host a live webcast to discuss the presented data on Tuesday, November 18th (details below).

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The abstract titled,A Novel Splicing-Targeted ADC Payload Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential Beyond Cytotoxicity was presented in oral and poster presentations at the recently held 40th Annual SITC (Free SITC Whitepaper) Meeting by Satyajit Mitra Ph.D., Executive Director, Head of Oncology at Akari Therapeutics.

Dr. Mitra commented, "We were excited to showcase the unique mechanism of action of our novel ADC payload PH1 at the annual meeting for SITC (Free SITC Whitepaper), a premier global immunotherapy conference. It’s not often that one gets to introduce a novel ADC payload class with the unique data we presented. I was thrilled to see our work being received extremely well and the excitement from colleagues to see further clinical development of the PH1 payload as Akari continues to advance its lead ADC molecule, a Trop2 PH1 ADC."

The presented data outlined Akari’s investigation of multiple mechanisms behind preclinical colon tumor regressions induced by a Trastuzumab PH1 ADC as a single agent or in combination with an anti-PD-1 therapy compared to a first-in-class ADC with a microtubule inhibitor payload, Kadcyla, tested also as a monotherapy or in combination with anti-PD1 therapy. A higher rate of complete tumor regressions was seen with Trastuzumab PH1 combined with anti-PD1 therapy (74%) when compared to Kadcyla, combined with anti-PD1 therapy (42%), with statistical significance of p < 0.05. These differentiated results are attributed to a multi-faceted immune response activated by neoantigens induced by the PH1 payload’s ability to disrupt normal RNA splicing. These neoantigens likely trigger the observed multi-modal immune response including a polarization of macrophages to the pro-inflammatory phenotype, an increase in the presence of neutrophils, and importantly, expansion of both B cell clones to produce polyclonal IgM antibodies, and gamma-delta T-cell clones. Notably, these immune system responses were not as prominent in the comparator test arm utilizing Kadcyla, in combination with anti-PD1 therapy. Importantly, these Trastuzumab PH1 results also highlight a synergy between the PH1 ADC payload and the anti-PD1 checkpoint inhibitor. The induction of gamma-delta T-cells by the combination of Trastuzumab PH1 and anti-PD1 is particularly interesting because this subpopulation of T-cells is known to attack cancer through a rapid response and has high cytotoxic activity.

Key Highlights:

Payload diversification is key in the current ADC landscape dominated by 2 ADC payload classes, microtubule inhibitors, and topoisomerase inhibitors.
A payload that disrupts the actions of the spliceosome demonstrates multiple modes of actions to attack cancer, including cytotoxicity and broad immuno-oncology effects.
An ADC of Trastuzumab PH1 induces RNA mis-splicing and subsequently increases neoantigen generation in cancer cells and a subsequent increase in anti-cancer immune cells in the tumor microenvironment.
Trasutuzmab-PH1 in combination with an anti-PD1 agent outperformed Kadcyla in combination with an anti-PD1 agent in complete tumor regressions with statistical significance (74% vs. 42%, p < 0.05) in an immune-competent, HER2-positive colon cancer model.
When combined with anti-PD1 therapy, the MOAs of the two agents complemented each other: Trastuzumab PH1 increased neoantigens, driving an increase in pro-inflammatory macrophages, an increase in pro-inflammatory neutrophils, and the expansion of B cells and resulting IgM antibodies. The anti-PD1 therapy specifically expanded alpha-beta T cell clones as expected, and together, the combination of both therapies drove the unique expansion of gamma-delta T cell clones. The synergy of the Trastuzumab PH1+ anti-PD-1 agent is likely due to each agent’s unique and complementary impact on the immune system.

These unique results seen with both the single agent ADC Trastuzumab-PH1 and the combination therapy with an anti-PD1 agent open up the possibility of creating a new paradigm of an ADC/checkpoint inhibitor therapy that goes beyond today’s regimens using ADCs with traditional payloads. This new potential combination of ADC’s using the PH1 payload with checkpoint inhibitors has the opportunity to set a new standard of care, and the chance to dramatically improve outcomes for cancer patients.

Utilizing its innovative ADC payload platform, Akari is advancing a new class of immuno-oncology ADCs built on the platform of a novel PH1 payload. This payload is designed specifically to target and disrupt the action of the spliceosome and has a unique preclinical efficacy and safety profile with the potential to address an unmet need for oncology patients as a monotherapy or used in combination with checkpoint inhibitors. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells with a proprietary linker and delivers its novel PH1 payload directly into the tumor. Akari is currently initiating IND-enabling studies with the plan to advance this lead ADC into clinical trials in the near future. For more information, visit www.akaritx.com.

Webcast Details

Members from the Akari management team will host a live webcast to discuss the presented data for investors, analysts and other interested parties on Tuesday, November 18, 2025 at 11:00 AM ET.

Interested participants can access the webcast here or on the Presentations page under the Investors section of the Company’s website, akaritx.com. A replay of the webcast will be accessible two hours after the live event and archived for 90 days.

(Press release, Akari Therapeutics, NOV 10, 2025, View Source [SID1234659702])