On April 23, 2025 Adcendo ApS ("Adcendo"), a biotech company focused on the development of first and best-in-class ADCs for the treatment of cancers with high unmet medical need, reported it will be presenting data on its two novel ADC programs ADCE-T02, targeting Tissue Factor, and ADCE-D01, targeting uPARAP, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in Chicago, Illinois, from April 25th to April 30th, 2025 (Press release, ADCendo, APR 23, 2025, View Source [SID1234652044]).

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ADCE-T02 is a potential best-in-class Topo-1 inhibitor-based ADC targeting Tissue Factor (TF). Tissue Factor is clinically validated target overexpressed in a broad range of solid tumors, with limited expression in normal tissues. ADCE-T02 is composed of a next-generation TF targeting antibody conjugated to an exatecan-based T-1000 payload, a clinically validated linker-payload technology. ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models and is well tolerated in non-human primate toxicology studies with no evidence of toxicity from earlier generation TF ADCs. A phase 1 clinical trial in advanced solid tumors is ongoing in both Australia and the United States. Australian recruitment is underway and enrollment in the United States will be initiated in the near future [NCT06597721].

ADCE-D01 is a first-in-class ADC targeting uPARAP conjugated to the Topo-1 inhibitor payload P-1021. uPARAP is a novel endocytic ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas, while exhibiting restricted expression in normal tissues. ADCE-D01 is composed of a first-in-class uPARAP-targeting antibody conjugated to an optimized, clinically validated linker payload technology, selected for its superior efficacy and tolerability. Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including soft tissue sarcoma and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific toxicity. A phase 1 clinical trial in advanced soft tissue sarcomas is enrolling in the United States and is under regulatory review in the European Union [NCT06797999].

Dominik Mumberg, PhD, Chief Scientific Officer at Adcendo, said: "We are excited to share the promising preclinical data for ADCE-T02 and ADCE-D01 demonstrating strong anti-tumor activity across a broad range of epithelial and mesenchymal tumor models with highly favourable tolerability profiles. We look forward to advancing both programs in our phase 1 Tiffany-01 and ADCElerate1 trials to help cancer patients in need of novel therapeutic options."

Details of the poster presentations are as follows:

Date & Time: April 29th, 9.00am – 12.00pm CT
Session Title: Antibodies and Antibody-Drug Conjugates
Poster Section: 36

Board Number: 14, Abstract number: 4778
Presentation title: ADCE-T02: A first-in-class topoisomerase-1 inhibitor-based antibody drug conjugate against tissue factor demonstrates excellent preclinical efficacy and tolerability
Authors: T. T. Poulsen1, Y. Zhang2, J. Zhang2, H. Shi2, S. Liu3, X. Meng2, M. Gillberg1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 Multitude Therapeutics, Shanghai, China. 3 Multitude Therapeutics, Redwood City, CA, USA

Board Number: 20, Abstract number: 4784
Presentation title: ADCE-D01: a first in class antibody-drug conjugate against urokinase plasminogen activator receptor-associated protein (uPARAP) demonstrates excellent preclinical efficacy and tolerability
Authors: J. Wardman1, A. Bie1, C. Côme1, P. Barkholt1, S. van Putten1, C. Løkke1, I. Gregersen1, J. Lange1, M. Gilberg1, K. Bannister1, M. Krogh-Madsen1, T. T. Poulsen1, C. Nielsen1, L. Engelholm2, N. Behrendt2, C. Lynch1, P. Hemmingsen1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 The Finsen Laboratory, Rigshospitalet/BRIC, Copenhagen University, Copenhagen, Denmark

Abstracts are available in an online itinerary planner (ADCE-T02 abstract; ADCE-D01 abstract), and will be available in an online only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research one month after the conference. Electronic posters will be made available for registered conference participants from April 25th, 2025, through the conference web portal.

About antibody-drug conjugates (ADCs):

ADCs are a class of highly potent biopharmaceutical drug composed of a targeting antibody linked to a biologically active drug or cytotoxic compound. ADCs combine the unique and very sensitive targeting capabilities of antibodies, with the potent effects of the conjugated cytotoxic drugs, allowing sensitive discrimination between healthy and cancer tissues.

On April 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported its results for the first quarter ending March 2025 (Press release, Alligator Bioscience, APR 23, 2025, View Source [SID1234652060]).

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" With the continued strengthening of mitazalimab’s clinical profile—including 24-month survival data, further dose validation, and positive regulatory alignment—we are well-positioned for Phase 3 initiation in the second half of 2025. Combined with enhanced financial flexibility following the rights issue and strategic portfolio optimization, we are advancing with confidence toward our goal of delivering transformative immunotherapies for patients with hard-to-treat cancers."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Announcement of encouraging overall survival benefit from the Phase 2 trial OPTIMIZE-1, with 24-month follow-up data showing a 29.4% survival rate for mitazalimab in combination with mFOLFIRINOX—three times higher than estimates for chemotherapy alone.
Top-line data from the 450 µg/kg back-filled cohort in OPTIMIZE-1 further support 900 µg/kg as the recommended Phase 3 dose.
Additional positive survival data for mitazalimab demonstrated through a literature-based indirect comparison, showing an incremental overall survival benefit and further supporting progression to Phase 3.
Successful completion of End-of-Phase 2 meeting with the FDA with positive feedback and alignment on clinical development strategy and Phase 3 trial design.
Company

Approval of rights issue and reverse share split at Extraordinary General Meetings held on 13 January and 27 March 2025, respectively.
Successful completion of rights issue in February 2025 with gross proceeds of SEK 153 million; BTUs converted and units issued to guarantors and Fenja Capital.
Peer-reviewed publication of data for ATOR-1017 (evunzekibart) in the Journal for ImmunoTherapy of Cancer confirming its immunomodulatory effects.
FDA grants Chinese Shanghai Henlius Orphan Drug Designation in gastric cancer for Alligator’s out-licensed candidate HLX22.
Publication of Alligator’s Annual Report for 2024 on 27 March 2025, outlining operational and financial highlights.
FINANCIAL SUMMARY FOR Q1 2025
The financial summaries for the quarterly periods ending 31 March 2025 and 31 March 2024 are presented below.

All amounts in MSEK,
unless specified January – March
2025 January – March
2024
Net sales - 7.0
Operating profit/loss -43.7 -59.6
Profit/loss for the period -8.3 -62.8
Cash flow for the period -34.6 -26.2
Cash and cash equivalents 28.9 40.0
Earnings per share before and after dilution, SEK -1.1 -95.4
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Thursday, April 24 2025, at 2 p.m. CEST/ 8 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the January – March 2025 interim report, which will be followed by a Q&A session.

On April 23, 2025 Incyte (Nasdaq: INCY) reported that multiple abstracts featuring new data from its oncology portfolio will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held May 30 – June 3, 2025, in Chicago (Press release, Incyte, APR 23, 2025, View Source [SID1234652076]).

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"The data featured at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, from both our approved medicines and early-stage pipeline, reflect our ongoing efforts to transform cancer care," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "We are advancing potential therapies across some of the most difficult-to-treat cancers and hematological diseases, including squamous cell anal cancer, ovarian cancer and myelofibrosis, with the hope of making a meaningful difference for these patients."

Key abstracts accepted for presentation:

Oral Presentations

INCB123667

Safety and Preliminary Efficacy from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Advanced Platinum-Resistant and Refractory Ovarian Cancer (OC)
(Abstract #5514. Session: Rapid Oral Abstract – Gynecologic Cancer. June 3, 9:42 a.m. ET (8:42 a.m. CT))

Pemigatinib

A Phase 2 Study of Pemigatinib for Pre-treated Glioblastoma or Other Gliomas with Activating FGFR1-3 Alterations: Results from FIGHT-209
(Abstract #2003. Session: Oral Abstract Session – Central Nervous System Tumors. May 30, 4:21 p.m. ET (3:21 p.m. CT))

Poster Presentations

Retifanlimab

Experience of Patients with HIV and Squamous Cell Carcinoma of the Anal Canal (SCAC) Treated with Retifanlimab
(Abstract #3521. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

POD1UM-303/INTERAACT2 Subgroup Analyses and Impact of Delayed Retifanlimab Treatment on Outcomes in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
(Abstract #3525. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

Final Results of POD1UM-201, a Phase 2 Study of Retifanlimab, a Humanized Anti–PD-1 Antibody, in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC)
(Abstract #9536. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

Long-term Outcomes After Discontinuation of Retifanlimab in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC) in the POD1UM-201 Trial
(Abstract #9538. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

INCB123667

Interim Safety and Antitumor Activity Data from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Metastatic Recurrent Endometrial Cancer
(Abstract #5603. Session: Gynecologic Cancer. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

INCB057643

Safety And Efficacy of Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 In Patients (pts) with Relapsed or Refractory Myelofibrosis (r/r-MF) and Other Advanced Myeloid Neoplasms: A Phase (Ph) 1 Study
(Abstract #6574. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

More information regarding the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at: View Source

About Pemazyre (pemigatinib)
Pemazyre (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a FGFR2 fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

In Canada, Pemazyre is approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe, Japan and Canada.

Pemazyre and the Pemazyre logo are registered trademarks of Incyte.

* Pemazyre (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.

About Zynyz (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Zynyz (retifanlimab) is approved as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

In Canada, Zynyz (retifanlimab) is approved as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

Zynyz is marketed by Incyte in the U.S., Europe and Canada, in 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

On April 23, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported it will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3, 2025) in Chicago, IL (Press release, Adcentrx Therapeutics, APR 23, 2025, View Source [SID1234652045]).

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Adcentrx will deliver a poster presentation on ADRX-0706, a clinical-stage Nectin-4 ADC. The presentation will include interim clinical data from the Phase 1a portion of the ongoing trial (NCT06036121), demonstrating the best-in-class potential for ADRX-0706. The findings indicate a differentiated safety and pharmacokinetic profile, including a significantly lower incidence of critically meaningful adverse events such as peripheral neuropathy. Additionally, preliminary efficacy signals across different dose levels and tumor types provide strong clinical validation of Adcentrx’s ADC platform, including the i-Conjugation technology and novel auristatin payload AP052.

The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The completed Phase 1a portion consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706’s safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers.

Details of the poster presentation at the ASCO (Free ASCO Whitepaper) Meeting are as follows:

Title: Preliminary results from a first-in-human phase 1 dose escalation trial of ADRX-0706, a next generation Nectin-4 ADC, in subjects with advanced solid tumors
Abstract Number: 3018
Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CST
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

The full abstract will be published by ASCO (Free ASCO Whitepaper) in conjunction with the Meeting.

About i-Conjugation Technology

Adcentrx’s proprietary i-Conjugation technology platform is a core component in the design of the company’s ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload.

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.

The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.

ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.
For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On April 23, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it will be delivering a rapid oral presentation of randomized Phase I trial data of individualized neoantigen therapeutic cancer vaccine TG4050 in head and neck cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Transgene, APR 23, 2025, View Source [SID1234652061]).

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A rapid oral presentation is part of a formal session, with a six-minute oral presentation format. It aims at sharing clinical data that stood out among many submissions.

The company will also present a poster on randomized Phase II data of TG4001 in combination with avelumab in the cervical cancer subgroup.

The 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), annual meeting will take place in Chicago from May 30 to June 3, 2025.

TG4050— Rapid oral presentation details:

Title: "Randomized Phase I trial of adjuvant personalized cancer vaccine TG4050 in resected locally advanced head and neck squamous cell carcinoma (HNSCC) patients."

· Session title: Rapid Oral Abstract Session

· Date and Time: Sunday, June 1, 12:06 p.m. CDT

· First Author: Prof. C. Le Tourneau

· Abstract Number: 6016

TG4050 is an individualized neoantigen therapeutic cancer vaccine being developed for solid tumors which is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence and machine learning expertise. TG4050 is being evaluated in a randomized multicenter Phase I/II clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Transgene intends to present 24-month follow-up data from patients enrolled in the Phase I part of the trial. Patients are currently being enrolled in the Phase II part of this trial.

TG4001— Poster presentation details:

Title: "Randomized Phase II trial evaluating the combination of TG4001, an HPV16 therapeutic cancer vaccine and avelumab in patients with immunotherapy-naïve recurrent and/or metastatic (R/M) HPV16-positive cervical or anogenital cancer."

· Session title: Developmental Therapeutics ̶ Immunotherapy

· Date and Time: Monday, June 2, 1:30 p.m. CDT

· First author: Prof. C. Le Tourneau

· Abstract number: 2638

The abstracts will be available on the ASCO (Free ASCO Whitepaper) website on May 22, 2025, at 5 p.m. ET.