Industry Insights: Converging modalities drive the next wave of bioconjugate therapies

Summary

This month’s updates highlighted continued momentum across ADCs, radioconjugates, and emerging conjugate modalities, underpinned by strategic partnerships, regulatory progress, and continued capital deployment.

Collaborations remained a central theme, as companies prioritized access to differentiated targets, payloads, and supply chains. Strategic alliances around radionuclide-drug conjugates and long-term isotope sourcing highlighted growing confidence in targeted radiotherapy and theranostics, while multiple ADC discovery and licensing deals emphasized bispecific formats, novel payloads, and tumor-penetrant designs.

Regulatory momentum was notable across the globe, with China advancing several next-generation ADC programs with IND clearances, while the US FDA supported innovation through Fast Track and Orphan Drug designations and continued rollout of its National Priority Voucher pilot. A major clinical inflection point came with the FDA’s approval of trastuzumab deruxtecan plus pertuzumab as a first-line regimen in HER2-positive metastatic breast cancer, reinforcing ADCs as frontline standards. RNA interference also progressed, with multi-target GalNAc–siRNAs entering early clinical evaluation for cardiometabolic disease.

Market activity reflected sustained investor appetite for conjugate technologies. Financing rounds supported DAC, surfaceome-driven ADC pipelines, and late-stage registrational studies, complemented by creative funding structures such as single-asset SPVs. Corporate rebranding, leadership appointments, and platform-focused pivots further signaled long-term commitment to conjugate-based innovation.

Clinically, the field saw a steady cadence of first-patient dosing and expansion decisions across HER2, HER3, ROR2, and Trop2 programs, alongside encouraging early efficacy signals in hard-to-treat solid tumors. Late-stage data continued to validate ADC–IO combinations, while preclinical research highlighted advances in tumor-activated delivery, precision radioconjugates, and selective targeting strategies. Collectively, these developments point to a rapidly diversifying and increasingly integrated bioconjugation ecosystem entering 2026.

COLLABORATION AND PARTNERSHIPS

Harbour BioMed entered strategic collaboration with Lannacheng to develop radionuclide drug conjugates [1]

Harbour BioMed announced a long-term strategic collaboration with Yantai Lannacheng Biotechnology to jointly advance the development of next-generation radionuclide-drug conjugates for oncology. The partnership combines Harbour BioMed’s fully human antibody discovery capabilities, including its Harbour Mice^® platform and heavy chain-only antibody technology, with Lannacheng’s expertise in radiopharmaceutical research, radioisotope supply, linker design, and GMP manufacturing. The collaboration aims to develop targeted radiotherapies with potential theranostic applications, leveraging tumor-specific delivery of radionuclides to improve efficacy while limiting off-target toxicity. Lannacheng’s integrated platform and infrastructure are expected to support scalable development and commercialization of radionuclide-drug conjugates candidates emerging from the collaboration.

Akari Therapeutics initiated GMP manufacturing for lead ADC AKTX-101 [2]

Akari Therapeutics announced the initiation of GMP manufacturing activities to support IND-enabling development of AKTX-101, its lead ADC program. The company selected WuXi XDC as its contract development and manufacturing organization to produce GMP-grade material for upcoming clinical studies. AKTX-101 incorporates Akari’s proprietary PH1 payload, which is designed to modulate RNA splicing and provide combined cytotoxic and immuno-oncology (I-O) activity. The manufacturing campaign is intended to support a planned Phase 1 first-in-human trial, which Akari expects to initiate in late 2026 or early 2027, pending regulatory clearance. The collaboration establishes a strategic partnership between Akari and WuXi XDC for current and potential future ADC programs.

Ipsen licensed LRRC15-targeted ADC rights from Simcere Zaiming [3]

Ipsen announced a licensing agreement with Simcere Zaiming for rights outside Greater China to SIM0613, an investigational ADC targeting LRRC15. Under the terms of the deal, Simcere Zaiming is eligible to receive up to $1.06 billion in upfront, development, regulatory, and commercial milestone payments, along with tiered royalties on net sales. SIM0613 is designed to target LRRC15, a protein highly expressed on multiple tumor types and cancer-associated fibroblasts, with limited expression on normal tissues, and is engineered for enhanced tumor penetration. Ipsen will assume responsibility for manufacturing, clinical development, and regulatory activities outside Greater China. SIM0613 is expected to enter Phase 1 development in the second half of 2026.

Nona Biosciences and Valink Therapeutics formed bispecific antibody and ADC discovery alliance [4]

Nona Biosciences and Valink Therapeutics announced a strategic biologics discovery alliance to accelerate the development of bispecific antibodies and bispecific ADCs. The collaboration, branded ‘Biology to Bispecific’ (B2B)™, combines Nona’s Harbour Mice^® fully human antibody platforms, including heavy chain-only antibodies, with Valink’s LiliumX™ discovery and screening technology. The alliance will initially focus on generating bispecific ADC candidates for solid tumors, with plans to expand Valink’s internal pipeline and support future co-development and licensing opportunities. By integrating complementary antibody repertoires and high-throughput functional screening, the collaboration aims to enable rapid identification of novel target combinations and differentiated complex biologics.

Cellectar Biosciences entered multi-year radioisotope supply agreement with Ionetix [5]

Cellectar Biosciences announced a multi-year supply agreement with Ionetix Corporation to secure clinical- and commercial-scale supplies of the alpha-emitting radioisotopes actinium-225 and astatine-211. Under the agreement, Ionetix will provide cGMP-grade isotopes to support Cellectar’s targeted alpha therapy programs through clinical development and potential commercialization. The supply will support expansion of Cellectar’s radiotherapeutic pipeline, including its proprietary Phospholipid Drug Conjugate™ delivery platform, and advancement of CLR-225 into clinical trials for solid tumors such as pancreatic cancer.

Bicycle Therapeutics entered long-term agreements to secure lead-212 supply for radioconjugate development [6]

Bicycle Therapeutics announced a 15-year agreement with the UK Nuclear Decommissioning Authority for access to up to 400 tonnes of reprocessed uranium to support production of lead-212 for its radioconjugate programs. The company also entered a collaboration with the UK National Nuclear Laboratory to extract thorium-228 from the material, which will be further processed into radium-224 and used to generate lead-212 via a bespoke generator being developed with SpectronRx. The arrangements are intended to enable end-to-end discovery, development, and commercial supply of Bicycle^® Radioconjugates incorporating lead-212 as a targeted alpha therapy payload. Bicycle is advancing a radioconjugate pipeline including programs targeting EphA2 and MT1-MMP.

Oxford BioTherapeutics entered a strategic oncology target discovery collaboration with GSK [7]

Oxford BioTherapeutics (OBT) announced a multi-year, multi-target strategic collaboration with GSK focused on discovering novel antibody-based therapeutics for cancer. The collaboration will leverage OBT’s proprietary OGAP^®-Verify platform to identify and validate oncology targets, with joint research activities supporting target validation. Subsequent research, development, and commercialization efforts will be led by GSK. Under the terms of the agreement, OBT will receive an undisclosed upfront payment and is eligible for downstream milestone payments and royalties on net sales of resulting products. OBT’s pipeline includes I-O programs and ADCs, and the agreement represents the company’s second major pharmaceutical collaboration announced this year.

GV20 Therapeutics reported milestone payment under ADC collaboration with Mitsubishi Tanabe Pharma [8]

GV20 Therapeutics announced receipt of a milestone payment from Mitsubishi Tanabe Pharma Corporation under a collaboration agreement established in early 2025. The collaboration focuses on the development of ADCs using GV20’s antibodies directed against novel tumor antigens identified through its proprietary STEAD AI platform. Under the terms of the agreement, GV20 received an upfront payment and is eligible for additional milestone payments, while Mitsubishi Tanabe Pharma holds an exclusive right to negotiate a license to the antibodies during the collaboration period. The partnership aims to generate potentially first-in-class ADC candidates for oncology applications.

REGULATORY CHANGES AND UPDATES

Kelun-Biotech received China IND approval for ITGB6-targeted ADC [9]

Kelun-Biotech announced that China’s National Medical Products Administration has approved the IND application for SKB105 (CR-003), an integrin beta-6 (ITGB6)–targeted ADC, for the treatment of advanced solid tumors. SKB105 features a fully human anti-ITGB6 IgG1 antibody conjugated to a topoisomerase I inhibitor payload using the company’s proprietary Kthiol^® irreversible conjugation technology. ITGB6 is highly expressed across multiple solid tumors with limited expression in normal tissues, supporting a differentiated safety profile. The approval follows Kelun-Biotech’s recent strategic collaboration with Crescent Biopharma, under which Crescent holds ex-China rights to SKB105 while Kelun-Biotech retains development and commercialization rights in Greater China.

US FDA awarded national priority vouchers to TROP2 ADC and oral PCSK9 inhibitor [10]

The US FDA announced the award of Commissioner’s National Priority Vouchers under its pilot program to two investigational products, citing their potential to improve patient access through affordability. The awarded products were enlicitide decanoate, an oral PCSK9 inhibitor for lowering LDL cholesterol, and sacituzumab tirumotecan, a TROP2-directed ADC. The voucher program, launched in June 2025, is intended to incentivize development of therapies that may enhance access to care while enabling expedited FDA review timelines. With these awards, a total of 18 products have received vouchers under the pilot program. The FDA recently reported its first completed review under the program, noting substantial time savings compared with standard review processes.

Rona Therapeutics submitted bi-valent GalNAc–siRNA RN5681 for Phase 1 clinical evaluation [11]

Rona Therapeutics announced the submission of RN5681 to the Australian Human Research Ethics Committee, advancing its first bi-valent small interfering RNA (siRNA) into clinical development, with Phase 1 dosing expected to begin in Q1 2026. RN5681 is a GalNAc-conjugated, dual-targeting siRNA designed to simultaneously silence PCSK9 and LPA, two genetically validated drivers of atherosclerotic cardiovascular disease. The unimolecular design aims to achieve durable reductions in LDL cholesterol and lipoprotein(a) with infrequent dosing. The submission represents the first clinical program derived from Rona’s bi- and multi-target siRNA platform and marks a regulatory milestone for the company’s cardiovascular RNA interference pipeline.

US FDA expanded label for Enhertu plus pertuzumab in first-line HER2-positive metastatic breast cancer [12]

The US FDA approved a label expansion for fam-trastuzumab deruxtecan-nxki (Enhertu), a HER2-targeted ADC, in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. The decision was based on Phase 3 DESTINY-Breast09 data showing that Enhertu plus pertuzumab significantly improved progression-free survival compared with standard-of-care taxane, trastuzumab, and pertuzumab therapy. Median progression-free survival was 40.7 months for the combination versus 26.9 months for standard therapy, with a 44% reduction in the risk of disease progression or death. Overall survival data were immature at the time of approval.

Avenzo Therapeutics reported Fast Track designation for AVZO-103 in urothelial cancer [13]

Avenzo Therapeutics announced that the US FDA granted Fast Track designation to AVZO-103, a Nectin4/TROP2 bispecific ADC, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously been treated with enfortumab vedotin. The company stated that there are currently no approved ADCs for this patient population. AVZO-103 is being evaluated in a Phase 1/2 first-in-human, open-label study assessing safety, tolerability, and preliminary clinical activity as both a monotherapy and in combination regimens in patients with advanced solid tumors. The Fast Track designation enables increased regulatory interaction and potential eligibility for expedited review pathways.

GSK reported US FDA Orphan Drug Designation for B7-H3-targeted ADC risvutatug rezetecan in small-cell lung cancer [14]

GSK announced that risvutatug rezetecan, a B7-H3-targeted ADC, received Orphan Drug Designation from the US FDA for the treatment of small-cell lung cancer (SCLC). The designation was supported by preliminary clinical data from the Phase 1 ARTEMIS-001 study showing durable responses in patients with extensive-stage SCLC. Risvutatug rezetecan comprises a fully human anti-B7-H3 monoclonal antibody linked to a topoisomerase inhibitor payload. The program has previously received multiple regulatory designations in the USA and Europe across several indications. A global Phase 3 trial evaluating risvutatug rezetecan in relapsed extensive-stage SCLC was initiated in August 2025.

MARKET TRENDS

BioAtla and GATC Health formed special purpose vehicle to advance ROR2-targeted ADC into Phase 3 [15]

BioAtla announced a special purpose vehicle (SPV) transaction with GATC Health to advance ozuriftamab vedotin (Oz-V), a ROR2-targeted conditionally active ADC, into a Phase 3 trial for second-line or later oropharyngeal squamous cell carcinoma. Under the agreement, BioAtla will receive up to $40 million to support clinical development, beginning with an initial $5 million payment, with additional funding expected in Q1 2026. Following the transaction, BioAtla will retain 65% ownership of Oz-V across solid tumor indications, while Inversagen AI will hold 35%. Oz-V has received FDA Fast Track designation and is being developed for patients previously treated with PD-1/L1 inhibitors.

Salarius Pharmaceuticals announced a planned name and ticker change [16]

Salarius Pharmaceuticals announced plans to change its corporate name to Decoy Therapeutics Inc. and its Nasdaq ticker symbol to DCOY following its recent combination with Decoy Therapeutics. The changes are expected to become effective in early January 2026, with the company continuing to trade under the SLRX symbol until that time. The rebranding reflects the company’s transition into a platform-focused biotechnology company centered on peptide-conjugate therapeutics for viral diseases and oncology. The name and ticker change will not affect operations, governance, or the company’s transfer agent, and stockholder approval was not required. The combined company will be led by Decoy’s senior management team alongside Salarius’s finance leadership.

Orum Therapeutics secured $100 million financing to advance degrader–antibody conjugate pipeline [17]

Orum Therapeutics announced an approximately $100 million financing round to advance its degrader–antibody conjugate (DAC) pipeline. The round was led by returning investor KB Investment, with participation from existing investors and new backers including Weiss Asset Management and Korea Investment Partners. Proceeds will support development of Orum’s lead internal program, ORM-1153, an anti-CD123 GSPT1 DAC being developed for acute myeloid leukemia and other hematologic malignancies, with an IND filing planned for the second half of 2026. Funding will also be used to advance additional programs and expand payload classes beyond GSPT1, leveraging the company’s dual-precision targeted protein degradation platform.

Akari Therapeutics announces $5 million financing to support ADC payload platform development [18]

Akari Therapeutics announced definitive agreements for a registered direct offering and concurrent private placement expected to generate approximately $5 million in gross proceeds. The financing included the issuance of American Depositary Shares and unregistered warrants, with participation from directors, officers, executive management, and institutional investors. In addition, certain noteholders agreed to convert approximately $2.5 million of outstanding debt into equity-linked instruments, reducing company liabilities. Ladenburg Thalmann & Co. acted as the exclusive placement agent. Akari stated that net proceeds will be used to support continued research and development of its oncology ADC payload platform, as well as for working capital and general corporate purposes.

Immunome announces plans for $400 million underwritten public offering [19]

Immunome announced plans to commence an underwritten public offering of $400 million of its common stock, with an option for underwriters to purchase up to an additional $60 million of shares. The offering is subject to market and other conditions and will be conducted in accordance with a previously filed shelf registration statement with the US Securities and Exchange Commission. Leerink Partners, JP Morgan, TD Cowen, Goldman Sachs & Co. LLC, and Guggenheim Securities are serving as joint bookrunning managers. Immunome is a clinical-stage oncology company advancing a portfolio of targeted cancer therapies, including ADCs and radiotherapeutics, with programs spanning late-clinical to early-stage development.

Serina Therapeutics appoints Joshua Thomas as Vice President and Head of Chemistry [20]

Serina Therapeutics announced the appointment of Joshua Thomas, PhD, as Vice President and Head of Chemistry, where he will lead internal and external chemistry activities supporting the company’s POZ Platform™ drug optimization technology. Thomas will oversee chemistry efforts spanning discovery through development, including optimization of POZ-based candidates. He previously held senior scientific leadership roles at Mersana Therapeutics, where he contributed to the development of ADC platforms, including work on the development of cytotoxic payloads and linker chemistries.

TuHURA Bioscience reported portfolio updates following recent financing [21]

TuHURA Biosciences provided a portfolio update highlighting clinical, scientific, and financing milestones across its I-O programs. The company reported progress in its Phase 3 study of IFx-2.0 as an adjunct to pembrolizumab in first-line Merkel cell carcinoma, conducted under a Special Protocol Assessment with the US FDA, with enrollment targeted for completion in Q4 2026. TuHURA also summarized data presented at the 57th ASH Annual Meeting, supporting the delta opioid receptor as a target for its bi-functional ADC platform, as well as discussions from a December 2025 mini-symposium on VISTA targeting in acute myeloid leukemia. The company also announced a $15.6 million equity financing to support upcoming development milestones.

DISCO Pharmaceuticals appointed new CEO and closed €36 million seed financing to advance ADC pipeline [22]

DISCO Pharmaceuticals announced the appointment of Mark Manfredi PhD, as Chief Executive Officer and the final close of a €36 million seed financing round. The financing was co-led by Ackermans & van Haaren and NRW.Bank, with participation from Sofinnova Partners, AbbVie Ventures, M Ventures, and Panakes Partners. Proceeds will be used to advance multiple surfaceome-targeted ADC programs in SCLC and microsatellite-stable colorectal cancer toward IND-enabling studies and to expand the company’s pipeline. Manfredi succeeds founder Roman Thomas MD, who will continue to support DISCO as a strategic advisor. DISCO is developing bispecific ADCs and T-cell engagers based on its proprietary surfaceome-mapping platform.

Samsung Life Science Fund announced equity investment in Phrontline Biopharma [23]

Samsung Life Science Fund announced an equity investment in Phrontline Biopharma, a clinical-stage biotechnology company developing ADCs for solid tumors. The fund is jointly established by Samsung C&T, Samsung Biologics, and Samsung Bioepis, and is managed by Samsung Ventures. Phrontline Biopharma is advancing ADCs based on proprietary bispecific antibody and dual-linker payload platforms designed to enable simultaneous delivery of two payloads with complementary mechanisms of action through a branched-linker architecture. The company aims to address limitations associated with single-payload, single-target ADCs, including resistance, tumor heterogeneity, and durability of response. The investment expands Samsung Life Science Fund’s portfolio of ADC-focused companies.

Ankyra Therapeutics appoints Sailaja Battula as Chief Scientific Officer [24]

Ankyra Therapeutics announced the appointment of Sailaja Battula PhD, as chief scientific officer. Battula brings experience across I-O, drug discovery, inflammation, and autoimmunity, with prior leadership roles at Immuneering Corporation, Bicycle Therapeutics, Forma Therapeutics, and Applied Immunology. She will lead Ankyra’s scientific strategy and pipeline development, including its anchored drug conjugate platform. Ankyra’s lead program, tolododekin alfa (ANK-101), is an interleukin-12–based anchored drug conjugate designed for localized delivery within the TME. ANK-101 is being evaluated in first-in-human clinical studies as monotherapy and in combination with anti-PD-1 therapy, including trials in advanced solid tumors and metastatic NSCLC.

Avacta Therapeutics reported new preclinical pharmacology data for FAP-Exd peptide drug conjugate [25]

Avacta Therapeutics announced new preclinical pharmacology data for FAP-Exd (AVA6103), its second asset derived from the pre|CISION^® tumor-activated delivery platform, which is expected to enter Phase 1 testing in Q1 2026. FAP-Exd is a fibroblast activation protein–cleavable peptide-drug linking a proprietary peptide to a topoisomerase I inhibitor payload. The data demonstrated tumor-specific cytotoxicity, sustained intratumoral release of active exatecan with limited systemic exposure, and robust antitumor activity across multiple patient-derived xenograft models. Avacta also reported that artificial intelligence–guided analysis was used to prioritize clinical indications based on co-expression of FAP and SLFN11.

CLINICAL TRIALS AND RESEARCH

Hummingbird Bioscience dosed first patient in Phase 1 trial of HER3 ADC [26]

Hummingbird Bioscience announced that the first patient has been dosed in a Phase 1 clinical trial evaluating HMBD-501, a next-generation HER3-targeted ADC, in patients with advanced HER3-expressing solid tumors. The multicenter, open-label study is being conducted at sites across the USA and is designed to assess safety, tolerability, and preliminary clinical activity. HMBD-501 incorporates an exatecan payload and has been engineered to optimize efficacy while improving safety relative to earlier HER3 ADC approaches. Initial data from the dose-escalation portion of the trial are expected in the second half of 2026.

Alphamab Oncology received IND clearance in China for Phase 2 study of subcutaneous ADC–PD-L1 co-formulation in cervical cancer [27]

Alphamab Oncology announced that China’s National Medical Products Administration has accepted the IND application for a Phase 2 clinical trial of JSKN033 as a first-line treatment for advanced cervical cancer. JSKN033 is a high-concentration subcutaneous co-formulation combining a HER2 bispecific ADC with a PD-L1 immune checkpoint inhibitor. The open-label, multicenter study will evaluate JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, assessing safety, efficacy, and PK/PD outcomes. JSKN033 integrates targeted cytotoxic delivery with immune modulation and is designed to improve treatment convenience and outcomes in a setting with significant unmet clinical need.

Senhwa initiated Phase Ib study combining CX-5461 with trastuzumab deruxtecan [28]

Senhwa Biosciences announced that its first-in-class investigational agent pidnarulex (CX-5461) will be evaluated in combination with Enhertu in a Phase 1b clinical trial for patients with HER2-positive solid tumors and breast cancer, including HER2-low and metastatic disease. The study is supported by the US National Cancer Institute’s NExT program and marks CX-5461’s first clinical entry into combination strategies with ADCs. CX-5461 is a G-quadruplex stabilizer designed to disrupt cancer-specific transcriptional stress pathways, while Enhertu is a HER2-directed ADC delivering a topoisomerase I inhibitor payload. The combination aims to explore synergistic efficacy in difficult-to-treat HER2-expressing tumors.

First patient dosed in Phase 3 trial of trastuzumab deruxtecan in adjuvant endometrial cancer [29]

The first patient has been dosed in the global Phase 3 DESTINY-Endometrial02 trial evaluating Enhertu, a HER2-directed ADC, as adjuvant therapy in patients with HER2-expressing endometrial cancer following surgery. The randomized, open-label study is comparing Enhertu, with or without radiotherapy, versus standard-of-care chemotherapy with or without radiotherapy. Conducted in collaboration with The GOG Foundation and ENGOT, the trial will enroll ~710 treatment-naïve patients with HER2 IHC 3+ or 2+ disease across multiple regions. The primary endpoint is disease-free survival, with overall survival as a key secondary endpoint.

Phase 3 trial met primary and secondary endpoints for Keytruda plus enfortumab vedotin in muscle-invasive bladder cancer [30]

Merck reported that the Phase 3 KEYNOTE-B15/EV-304 trial evaluating perioperative pembrolizumab (Keytruda^®) in combination with the nectin-4-targeted ADC (enfortumab vedotin) met its primary endpoint of event-free survival in patients with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy. The randomized study enrolled 808 patients and compared the combination plus surgery with neoadjuvant chemotherapy and surgery. The combination also met key secondary endpoints, including overall survival and pathologic complete response rates. Merck stated that the safety profile was consistent with prior studies. The companies plan to present the data at a future medical meeting and discuss the results with regulatory authorities.

HUTCHMED initiated first-in-human study of HER2-targeted antibody-targeted therapy conjugate [31]

HUTCHMED announced the initiation of a global first-in-human Phase 1/2a clinical program evaluating HMPL-A251, a first-in-class PI3K/PIKK–HER2 antibody-targeted therapy conjugate (ATTC), with the first patient dosed in December 2025. HMPL-A251 comprises a humanized anti-HER2 IgG1 antibody linked via a cleavable linker to a highly selective PI3K/PIKK inhibitor payload. The open-label, multicenter study is enrolling adults with unresectable, advanced, or metastatic HER2-expressing solid tumors and includes dose escalation and dose expansion components. Primary objectives include assessment of safety, tolerability, and dose optimization, with secondary endpoints evaluating preliminary antitumor activity, pharmacokinetics, and immunogenicity.

Rona Therapeutics completed Phase 1 of GalNAc-conjugated siRNA [32]

Rona Therapeutics announced completion of Cohort 1 dosing in its Phase 1 first-in-human clinical study of RN3161, a GalNAc-conjugated siRNA targeting INHBE for the treatment of obesity. The randomized, double-blind, placebo-controlled study is evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on body weight in adults with overweight and obesity. Cohort 1 was completed with a favorable initial safety and tolerability profile, representing the first clinical milestone for the program. RN3161 is designed to achieve deep and durable silencing of INHBE with once- or twice-yearly dosing. Additional cohorts in the Phase 1 study are planned for completion in 2026.

OKYO Pharma reported exploratory corneal nerve imaging results from Phase 2 trial [33]

OKYO Pharma announced exploratory corneal nerve imaging analyses from a randomized, placebo-controlled, double-masked Phase 2 trial evaluating urcosimod in patients with neuropathic corneal pain. Using in vivo confocal microscopy, patients treated with 0.05% urcosimod showed directional increases in corneal nerve fiber count and total nerve fiber length, while corresponding measures declined in the placebo group. The analyses were based on an exploratory endpoint in an 18-patient study. Urcosimod is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor. The company reported that the findings suggest a potential effect on corneal nerve structure in addition to previously reported pain reduction, supporting further clinical evaluation of the candidate in neuropathic corneal pain.

CONFERENCES, EVENTS, AND PUBLICATIONS

Iksuda presented early Phase 1 activity of HER2 ADC IKS014 in esophageal cancer [34]

Iksuda Therapeutics presented early clinical activity data from its Phase 1 study of IKS014, a HER2-directed ADC, at the 2026 ASCO Gastrointestinal Cancers Symposium. The open-label, multicenter trial is evaluating IKS014 in patients with advanced HER2-expressing solid tumors. An unplanned analysis of 10 patients with HER2-positive esophageal cancer showed encouraging antitumor activity, with five patients achieving responses, including one complete response, and three additional patients demonstrating durable stable disease beyond 6 months, resulting in an 80% clinical benefit rate. Based on these findings, the ongoing Phase 1 study will include a dedicated expansion cohort for patients with previously treated HER2-expressing esophageal adenocarcinoma.

15 years of progress in radiopharmaceutical drug conjugate research summarized in recent review article [35]

A review published in July 2025 in Medical Journal of Peking Union Medical College Hospital examined 15 years of progress in radiopharmaceutical drug conjugate research. Authored by researchers from Peking Union Medical College Hospital, the review outlined current RDC classifications, including antibody-, peptide-, and small-molecule–based conjugates, and highlighted trends in clinical development and therapeutic targeting. The authors noted increasing clinical trial activity, growing interest in cyclic peptide-based RDCs due to favorable selectivity and toxicity profiles, and the impact of regulatory guidance introduced since 2020 to standardize evaluation and quality control. The review emphasized the role of radiopharmaceutical drug conjugates in theranostics and precision oncology, while identifying isotope supply, radiochemistry, and regulatory harmonization as ongoing challenges.

Johns Hopkins researchers reported TRBC2-targeted ADC for T-cell malignancies [36]

Researchers at the Johns Hopkins Kimmel Cancer Center reported the development of a TRBC2-targeted ADC for the treatment of T-cell lymphomas and leukemias, published in Nature Cancer. The ADC selectively targets the TRBC2 variant of the T-cell receptor, which is expressed in approximately half of T-cell malignancies, while sparing TRBC1-positive normal T cells. The antibody component, JX1.1, was identified using a phage-displayed antibody library and next-generation sequencing, and was conjugated to a pyrrolobenzodiazepine payload. In preclinical cell line and animal models, the ADC demonstrated selective tumor cell killing, durable tumor regression, and minimal toxicity, expanding a previously established TRBC1-based precision targeting strategy.

Actinium Pharmaceuticals presents preclinical data for radioconjugate in breast cancer [37]

Actinium Pharmaceuticals reported new preclinical data for ATNM-400, an Actinium-225-based antibody radioconjugate, at the 2025 San Antonio Breast Cancer Symposium. ATNM-400 demonstrated antitumor activity across multiple breast cancer models, including hormone receptor–positive, triple-negative, and tamoxifen- and trastuzumab-resistant disease. The target antigen was shown to be overexpressed in resistant tumors, supporting enhanced cytotoxicity. Mechanistic studies indicated alpha-particle–induced double-strand DNA damage, consistent with irreversible tumor cell killing. Favorable biodistribution with sustained tumor uptake and rapid clearance from normal tissues was reported, suggesting a differentiated tolerability profile. The data support further development of ATNM-400 as a potential pan-tumor radiotherapeutic, either as monotherapy or in combination regimens.

Biohaven presents Phase 1 combination data for Trop2 ADC at ESMO [38]

Biohaven presented Phase 1 clinical safety and efficacy data for BHV-1510, a Trop2-targeted ADC incorporating a proprietary TopoIx payload, in combination with the anti-PD-1 antibody cemiplimab at the 2025 European Society for Medical Oncology (ESMO) Congress. In heavily pretreated patients with advanced or metastatic solid tumors, confirmed objective responses were reported in NSCLC, endometrial cancer, and urothelial cancer. At the 2.5 mg/kg Q3W dose, confirmed objective response rates included 60% in NSCLC and 100% in endometrial cancer. Across dose levels, the combination was generally well-tolerated, with low rates of hematologic and gastrointestinal toxicities and no reported cases of interstitial lung disease.

Phase 3 ASCENT-07 results showed similar PFS for sacituzumab govitecan and chemotherapy in HR-positive, HER2-negative breast cancer [39]

Results from the Phase 3 ASCENT-07 trial presented at the San Antonio Breast Cancer Symposium showed that sacituzumab govitecan-hziy, a TROP-2-targeted ADC, achieved similar progression-free survival to standard-of-care chemotherapy when used as first chemotherapy after endocrine therapy in patients with hormone receptor-positive, HER2-negative advanced breast cancer. After a median follow-up of 15.4 months, median progression-free survival was 8.3 months in both arms (hazard ratio 0.85), and the primary endpoint was not met. Objective response rates were numerically higher with sacituzumab govitecan-hziy (37% versus 33%), with a longer median duration of response. Overall survival data were immature at the time of analysis.

Orum Therapeutics presented preclinical data for CD123-targeting DAC ORM-1153 [40]

Orum Therapeutics reported the presentation of preclinical data for ORM-1153, a CD123-targeting DAC, at the 67th American Society of Hematology Annual Meeting. ORM-1153 is designed to deliver a proprietary GSPT1-degrading payload selectively into CD123-positive cancer cells to induce targeted protein degradation. In preclinical acute myeloid leukemia models, including TP53-mutant disease, ORM-1153 demonstrated CD123-dependent internalization, efficient GSPT1 degradation, and durable antitumor activity. The compound showed approximately 1,000-fold higher potency than the unconjugated degrader payload and induced dose-dependent tumor regression in a disseminated xenograft model. Favorable tolerability and minimal effects on normal hematopoietic progenitors were also reported.

References

1. Harbour BioMed. Harbour biomed enters into long-term strategic collaboration with Lannacheng to advance next-generation radionuclide drug conjugates. Dec 29, 2025.

2. Akari Therapeutics. Akari Therapeutics initiates GMP manufacturing of AKTX-101 ADC Program to support Phase 1 first-in-human clinical trial. Dec 23, 2025.

3. Ipsen. Ipsen expands early development pipeline with Simcere Zaiming’s innovative antibody drug conjugate. Dec 22, 2025.

4. Nona Biosciences. Nona Biosciences and Valink Therapeutics form strategic alliance to accelerate novel biologics discovery. Dec 17, 2025.

5. Cellectar Biosciences. Cellectar Biosciences announces strategic supply agreement with Ionetix for actinium-225 and astatine-211 to advance targeted alpha therapies. Dec 16, 2025.

6. Bicycle Therapeutics. Bicycle Therapeutics establishes multiple strategic partnerships to create end-to-end supply chain to support its wholly owned radiopharmaceutical pipeline. Dec 16, 2025.

7. Oxford BioTherapeutics. Oxford BioTherapeutics enters into a strategic collaboration with GSK to discover novel targets for antibody-based therapeutics for the treatment of cancer. Dec 10, 2025.

8. GV20 Therapeutics. GV20 Therapeutics announces achievement of milestone under antibody-drug conjugate collaboration with Mitsubishi Tanabe Pharma Corporation. Nov 25, 2025.

9. Sichuan Kelun-Biotech Biopharmaceutical. Kelun-Biotech receives investigational new drug approval for ITGB6-targeted ADC SKB105 from the NMPA. Jan 5, 2026.

10. US Food & Drug Administration. FDA grants two national priority vouchers. Dec 19, 2025.

11. Rona Therapeutics. Rona Therapeutics unveils the global first bi-valent PCSK9-LPA siRNA into clinical development for cardiovascular risk reduction. Dec 17, 2025.

12. AstraZeneca. Enhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer. Dec 15, 2025.

13. Avenzo Therapeutics. Avenzo therapeutics granted fast track designation for AVZO-103, a potential best-in-class nectin4/TROP2 bispecific antibody-drug conjugate, for the treatment of patients with urothelial cancer previously treated with enfortumab vedotin. Nov 24, 2025.

14. GSK. GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA. Dec 10, 2025.

15. BioAtla. BioAtla and GATC Health announce a $40 million special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz-V) into a registrational trial for 2L+ oropharyngeal squamous cell carcinoma (OPSCC). Dec 31, 2025.

16. Salaris Pharmaceuticals. Salarius Pharmaceuticals announces planned corporate name and ticker symbol change to decoy Therapeutics, reflecting strategic pivot to next-generation antiviral and peptide-conjugate platform. Dec 18, 2025.

17. Orum Therapeutics. Orum Therapeutics secures approximately US$100 million to accelerate development of leading degrader antibody conjugate programs to treat serious diseases. Dec 18, 2025.

18. Akari Therapeutics. Akari Therapeutics announces $5 million financing, including concurrent registered direct offering and private placement priced at-market. Dec 16, 2025.

19. Immunome. Immunome announces proposed public offering of common stock. Dec 15, 2025.

20. Serina Therapeutics. Serina Therapeutics strengthens leadership team with appointment of Dr. Joshua Thomas as VP, Head of Chemistry. Dec 11, 2025.

21. TuHURA Bioscience. TuHURA Biosciences provides corporate update following recent financing. Dec 11, 2025.

22. DISCO Pharmaceuticals. DISCO Pharmaceuticals appoints Mark Manfredi as CEO and announces final close of €36 million seed financing. Dec 11, 2025.

23. Samsung Bioepis. Samsung Life Science Fund invests in Phrontline Biopharma to advance antibody-drug conjugate therapeutics in oncology. Nov 25, 2025.

24. Ankyra Therapeutics. Ankyra appoints Sailaja Battula, PhD as Chief Scientific Officer (CSO). Dec 16, 2025.

25. Avacta Therapeutics. Avacta reports new pharmacology data for FAP-Exd (AVA6103). Dec 18, 2025.

26. Hummingbird Bioscience. Hummingbird Bioscience announces first patient dosed in Phase I clinical trial of HMBD-501 in advanced HER3-expressing solid malignancies. Jan 6, 2025.

27. Alphamab Oncology. Alphamab Oncology announces IND application for a Phase II clinical study of HER2 bispecific ADC subcutaneous co-formulation JSKN033 as first-line treatment of advanced cervical cancer was officially accepted by CDE. Dec 29, 2025.

28. Senhwa Biosciences. Senhwa Biosciences aims at multi-billion dollar global market with CX-5461 combined with ADC “blockbuster” therapy. Dec 29, 2025.

29. Daiichi Sankyo. DESTINY-Endometrial02 Phase 3 Trial of ENHERTU^® initiated as adjuvant therapy in patients with HER2 expressing endometrial cancer. Dec 22, 2025.

30. Merck & Co. KEYTRUDA^® (pembrolizumab) Plus Padcev^® (enfortumab vedotin-ejfv) significantly improved event-free survival, overall survival and pathologic complete response rates for cisplatin-eligible patients with MIBC when given before and after surgery. Dec 17, 2025.

31. HUTCHMED. HUTCHMED initiates global clinical development of ATTC candidate HMPL-A251 in patients with solid tumors. Dec 17, 2025.

32. Rona Therapeutics. Rona Therapeutics advances INHBE siRNA into Phase 1 clinical development. Dec 15, 2025.

33. OKYO Pharma. OKYO Pharma announces new data showing favorable corneal nerve outcomes in Phase 2 study for neuropathic corneal pain. Dec 11, 2025.

34. Iksuda Therapeutics. Iksuda to present preliminary analysis of oesophageal cancer data from Phase 1 study of IKS014 at ASCO Gastrointestinal Cancer Symposium. Jan 6, 2025.

35. Xijing L, Cheng B. Recent advances in radionuclide drug conjugates (RDCs) for cancer theranostics: from targeted design to clinical translation. Bioorg. Chem. 2025; 167, 109240. Link

36. John Hopkins Medicine. Johns Hopkins scientists develop targeted therapy for T-cell lymphomas and leukemias. Dec 22, 2025.

37. Actinium Pharmaceuticals. Actinium Pharmaceuticals presents new preclinical data demonstrating potent anti-tumor activity of ATNM-400 across multiple breast cancer subtypes including hormone receptor-positive, triple-negative, and tamoxifen- and HER2 therapy-resistant breast cancer models at SABCS 2025. Dec 12, 2025.

38. Biohaven. Biohaven presents clinical safety and efficacy data for BHV-1510, a next-generation Trop2 antibody drug conjugate in combination with cemiplimab at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress. Dec 11, 2025.

39. American Association for Cancer Research. Sacituzumab govitecan-hziy led to similar progression-free survival as standard of care for certain endocrine therapy-refractory advanced breast cancers. Dec 10, 2025.

40. Orum Therapeutics. Orum Therapeutics presents preclinical data at ASH 2025 demonstrating potent and selective antitumor activity of ORM-1153, a CD123-targeting degrader antibody conjugate for acute myeloid leukemia. Dec 8, 2025.