Formosa Pharmaceuticals Files Clinical Trial Application for TSY-110, an Antibody-Drug Conjugate Biosimilar Targeting HER2-Positive Breast Cancers

On August 28, 2026 Formosa Pharmaceuticals, Inc. (TWSE: 6838), reported the submission of a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial for TSY-110. TSY-110 is a biosimilar candidate referencing Roche’s antibody-drug conjugate (ADC) Kadcyla (ado-trastuzumab emtansine), indicated for HER2-positive metastatic and early-stage breast cancer.

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Designed following regulatory guidance from both US and EU authorities, the upcoming trial will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of TSY-110 compared with the reference product. This milestone advances Formosa Pharmaceuticals’ and EirGenix’s shared goal of providing cost-effective biosimilar ADC treatments to patients across regulated global markets.

"Filing this CTA marks a significant achievement for Formosa Pharmaceuticals and underscores our strategic alliance with EirGenix," said Erick Co, Ph.D., President and Chief Executive Officer of Formosa Pharmaceuticals. "Antibody-drug conjugates have established themselves as mainstays in oncology, including HER2-positive breast cancer care, but patient access remains constrained by high treatment costs. Advancing TSY-110 into clinical evaluation is a momentous step toward fulfilling our goal of delivering world-class, accessible ADC options to oncologists and patients."

About TSY-110

TSY-110, also designated as EG12043, is an antibody-drug conjugate (ADC) biosimilar co-developed by Formosa Pharmaceuticals and EirGenix, Inc. (TWSE: 6589). The conjugate links HER2 monoclonal antibody, trastuzumab, with a cytotoxic payload (mertansine) to selectively eradicate HER2-overexpressing cancer cells while minimizing systemic toxicity. Comprehensive preclinical assessments demonstrate high biosimilarity, drug-antibody ratio (DAR) consistency, and comparable plasma kinetics to the reference product.

About HER2-Positive Breast Cancer Market

HER2-positive breast cancer accounts for a significant portion of all breast cancer diagnoses globally. Approximately 2.4 million breast cancer cases were diagnosed in 2024, with HER2+ disease affecting roughly 360,000 to 480,000 of these patients based on the standard 15–20% prevalence rate. HER2-targeted therapies continue to be a prominent tool in modern oncological care. Kadcyla, approved by the FDA in 2013, generated approximately $2.5 billion in global sales in 2025.

(Press release, Formosa Pharmaceuticals, AUG 28, 2026, View Source [SID1234670411])

Aprea Therapeutics Announces Expansion of Intellectual Property Portfolio for Precision Oncology Programs

On August 28, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported an update on its existing patent portfolio.

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"Our expanding patent portfolio reflects Aprea’s commitment to innovation and building a differentiated leadership position in precision medicine," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "A strong global intellectual property portfolio is a critical component of our strategy, supporting the advancement of potentially best in class oncology therapies while protecting the long-term value of our programs. We remain focused on strengthening our intellectual property position as we advance our pipeline and pursue new treatment options for patients with difficult-to-treat cancers."

The intellectual property covering Aprea’s WEE1 kinase inhibitor program includes two pending U.S. patent applications, one pending U.S. provisional application, two granted non-U.S. patents (Australia and Korea), and 12 pending non-U.S. patent applications. The WEE1 family of applications, if granted, will expire in 2047, not including any regulatory exclusivities that may be awarded. The WEE1-portfolio covers key aspects of the program, including proprietary compounds, pharmaceutical compositions, and methods of use. The Company’s lead WEE1 inhibitor, APR-1051, is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial in advanced/metastatic solid tumors harboring certain cancer-associated gene alterations.

Aprea’s ATR inhibitor program is protected by a strong patent estate, including four granted U.S. patents, one pending U.S. application, and one pending international application. There are 22 granted non-U.S. patents and 13 pending non-U.S. patent applications. The granted patents will expire 2035-2037 and the pending applications, if granted, could extend exclusivity into 2045. Additional regulatory exclusivities up to five years may also be available. This portfolio comprehensively covers the program’s proprietary compounds, pharmaceutical compositions, and methods of use. During 2025, Aprea determined the recommended Phase 2 monotherapy dose (RP2D) of 1,100 mg once daily for ATRN-119 in the ABOYA-119 Phase 1/2a dose-escalation study and subsequently closed this study to focus resources on the clinical development of APR-1051. Building on the completion of dose escalation, the Company is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. Aprea believes ATRN-119’s mechanism of action, potentially favorable safety profile, and pharmacologic characteristics could make it an ideal candidate for combination with other anti-cancer therapies, including radiation therapy, chemotherapy, antibody-drug conjugates (ADCs) and immune checkpoint inhibitors.

(Press release, Aprea, AUG 28, 2026, View Source [SID1234670409])

DualityBio Enters a Global Collaboration and License Agreement with Genentech to Develop Next-Generation ADCs Built on DualityBio’s DUPAC Novel-Payload Platform

On August 28, 2026 DUALITYBIO Inc. (HKEX: 09606; "DualityBio" or the "Company") reported that it has entered into a collaboration and license agreement with Genentech, a member of the Roche Group, to develop next-generation antibody-drug conjugates ("ADCs") built on the Company’s proprietary DualityBio Unique Payload Antibody Conjugate ("DUPAC") platform.

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DUPAC is one of DualityBio’s four proprietary ADC platforms and is dedicated to payloads with novel mechanisms of action. It comprises multiple distinct payloads, each built on a unique antitumor mechanism, paired with optimized and compatible linker technologies designed for systemic stability and tumor-specific release. DUPAC payloads are engineered based on a common set of criteria: high potency, broad-spectrum activity across tumor types, a short systemic half-life permitting rapid clearance, and a bystander effect suited to heterogeneous solid tumors.

As topoisomerase inhibitor–based ADCs move into earlier lines of therapy across major solid tumor indications, patients who progress on this payload class represent a large and growing area of unmet medical need. The DUPAC platform is designed to retain antitumor activity in that setting and in tumors that are less responsive to topoisomerase inhibitor–based ADCs.

Under the terms of the agreement, Duality will generate and develop ADCs against Genentech defined oncology targets using payloads from the DUPAC platform. For the collaboration programs, DualityBio will lead discovery and early global clinical development. Genentech receives an exclusive, worldwide license to the collaboration ADCs, and will assume sole responsibility for further clinical development and commercialization after Phase 1a.

Under the agreement, DualityBio will receive an upfront payment of US$45 million and is eligible to receive more than US$1 billion in aggregate development, regulatory and commercial milestone payments across all programs, together with tiered royalties on annual net sales of approved products.

"As topoisomerase inhibitor–based ADCs achieve broad clinical success and move into earlier lines of therapy, a growing unmet medical need is emerging for patients whose tumors are resistant or refractory to this payload class. We built DUPAC to help address this challenge with a family of next-generation payloads designed to overcome resistance and enable each ADC program to expand the breadth of the underlying tumor biology. By combining DualityBio’s payload innovation and early-stage global clinical development capabilities with Genentech’s deep oncology expertise and worldwide development reach, we can advance these programs with greater speed and scale and bring differentiated medicines to more patients around the world," said Dr. John Zhu, Founder and Chief Executive Officer of DualityBio.

"By further enhancing targeted medicines like ADCs, we focus our innovation where the need is highest," said Boris L. Zaïtra, head of Roche Corporate Business Development. "Backed by Roche’s decades-long legacy in oncology, collaborating with partners such as DualityBio enables us to identify novel treatment options, such that we can tackle patients’ unmet needs in cancer care."

About DUPAC

DUPAC (DualityBio Unique Payload Antibody Conjugate) is DualityBio’s proprietary platform for ADC payloads with novel mechanisms of action, and one of four ADC technology platforms developed by the Company alongside DITAC, DIMAC and DIBAC. DUPAC encompasses several payloads, including DUP5, DUP9 and DUP10, each acting through a distinct antitumor mechanism. Preclinical data on DUP5-based ADCs and DUP9-based ADCs, including activity in tumor models relatively insensitive to topoisomerase inhibitor payloads and non-human primate tolerability, have been presented at multiple medical conferences, including AACR (Free AACR Whitepaper) 2025 (Abstract 5454), AACR (Free AACR Whitepaper)-NCI-EORTC International Conference 2025 (Abstract B129 and Abstract B130), and AACR (Free AACR Whitepaper) 2026 (Abstract 2657).

(Press release, DualityBio, AUG 28, 2026, View Source [SID1234670391])

Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2026

On August 28, 2026 Elicera Therapeutics AB (publ) reported interim results for 1 January – 30 June 2026.

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Second quarter (January-March 2026)

Operating profit/loss amounted to SEK -6,305,471 (-2,892,341)
Loss for the period amounted to SEK -6,261,763 (-2,732,070)
Cash flow from operating activities totaled SEK -3,950,514 (-5,991,211)
Earnings per share before and after dilution totaled SEK -0.12 (-0.06)

Period (January-June 2026)

Operating profit/loss amounted to SEK -11,422,250 (-10,961,745)
Loss for the period amounted to SEK -11,321,823 (-10,745,532)
Cash flow from operating activities totaled SEK -10,932,926 (-6,736,135)
Earnings per share before and after dilution totaled SEK -0.22 (-0.25)

Key events during the quarter

An extra shareholders meeting May 8 approved the boards proposal for a new rights issue at SEK 72.8 m
Elicera’s CSO takes temporary leave to undergo medical treatment – Di Yu appointed Acting Chief Scientific Officer (CSO)
Elicera Therapeutics announces that the final reporting and final payment (SEK 1.4 m) from the EIC Accelerator for the CARMA study have been approved
Elicera’s new issue subscribed at 75 % and Elicera receive SEK 54.6 m before issuing costs
Elicera receives positive feedback from Swedish MPA on Planned Clinical Study with ELC-401 in glioblastoma
Elicera’s annual general meeting June 25 elects Margareth Jorvid as new chair

Key events during the period

Elicera announces final data from its Phase I/IIa trial demonstrating a favourable safety profile and promising efficacy signals of oncolytic virus ELC-100 in neuroendocrine tumors
Elicera provides update on preclinical CAR T-cell program ELC-401 for glioblastoma: preclinical development concluded and clinical trial planning underway
Elicera reports complete metabolic response (CMR) and well tolerated treatment in first two patients of cohort 3 in CARMA study, bringing total CMR to 6 out of 8 treated patients
Elicera’s CSO Magnus Essand named Cancer Researcher of the Year 2026 by the Swedish Cancer Society (Cancerfonden)
Elicera receives Notice of Allowance for Japanease patent protecting the ELC-401 CAR T-cell candidate
Elicera Announces Swedish Cancer Society’s Senior Investigator Award to Chief Development Officer Di Yu

Key events after the end of the period

Last patient treated in the Phase I part of the CARMA study – tumor responses in 10 of 11 patients evaluated to date
Elicera gathers management in Uppsala – CEO transition begins and recruitment of a new CEO has started
Elicera Therapeutics appoints Johan Liwing as new CEO
No other key events that impact earnings or the financial position occurred after the end of the period.

CEO Comments

Updated results from the CARMA study show tumor response in 91 percent of patients

We are pleased to report continued strong results from our clinical Phase I/IIa study CARMA with ELC-301. The twelfth and final patient in the study’s Phase I portion has

now been treated, and among the eleven patients evaluated so far, all have achieved disease control one month after treatment. As many as 91 percent (10 of 11) have had an objective tumor response, including six patients with a complete metabolic response, meaning no remaining active disease. Of these six, four have maintained a

complete response at the most recent follow-up, with the longest-responding patient now disease-free for at least 18 months and another patient for at least 12 months.

These are early but important signs that the responses may be durable rather than temporary, which strengthens our confidence that both ELC-301 and our iTANK platform, together with other CAR T-cell programs, could be decisive even for patients who have stopped responding to their previous CAR T treatment. Particularly interesting is that three of the eleven evaluated patients had previously been treated with other CAR T therapy but subsequently relapsed, and that all achieved disease control after treatment with ELC-301; two of them obtained an objective tumor response, of which one was a complete metabolic response.

As soon as the last patient has undergone their follow-up evaluation, the study’s independent Data Safety Monitoring Board (DSMB) will assess the third and final cohort, which will determine the recommended dose for the study’s continued

dose-expansion part (Phase IIa) with an additional six patients.

Magnus Essand and Di Yu receive prestigious awards – the organization stands strong

We are very proud that our co-founder and Chief Scientific Officer, Professor Magnus Essand, was awarded the Swedish Cancer Society’s Cancer Researcher of the Year award during spring 2026 for his pioneering research in immunotherapy targeting cancer — a fine and well-deserved recognition also of the scientific foundation on which Elicera’s development programs rest. At roughly the same time, our Chief Development Officer Di Yu was awarded the Swedish Cancer Society’s prestigious Senior Investigator Award,which provides funding for his research over the next three

years. Together, these awards underscore the scientific quality that permeates the company.

We have previously announced in a press release that Magnus took temporary leave in May from his commitments to the company and the board in order to undergo

medical treatment. We wish him all strength during this time. Di Yu, who has already held the greatest operational responsibility for our scientific and clinical development

in recent years, has, as previously announced, stepped in as Deputy CSO effective immediately to ensure continuity.

In recent years, the company has progressively broadened the team, including by recruiting several senior researchers and an experienced clinical project manager,

in order to reduce dependence on individual key personnel.

Our ongoing operations, including the CARMA study and preparations for our first clinical study in the ELC-401 program, are continuing entirely according to plan.

Strengthened financial position following a successful rights issue

During the second quarter, we carried out a partially guaranteed rights issue of approximately SEK 72.8 million, which after the subscription period ended on May 29 provided the company with approximately SEK 54.6 million before transaction costs. The issue strengthens our financial position and secures capital to complete the recruitment and treatment of all 18 planned patients in the CARMA study.

The capital also enables us to accelerate preparations for the planned first clinical study with ELC-401, including secured funding for process development and tech transfer of the manufacturing process to our chosen manufacturing partner. I want to extend my sincere thanks to our existing shareholders for your continued trust and support in the rights issue, and at the same time warmly welcome our new shareholders.

Important regulatory milestone for ELC-401

In addition to funding the preparatory work, during the quarter we reached an important milestone for ELC-401, our iTANK-armed CAR T-cell candidate targeting IL13Rα2 in the treatment of glioblastoma. We held a scientific advice meeting with the Swedish Medical Products Agency (Läkemedelsverket) regarding the planned first clinical study.

The agency provided supportive and constructive guidance on the clinical protocol, the dose-escalation strategy, and the manufacturing specifications, and confirmed that our preclinical data package is now considered sufficient to initiate our clinical development phase. This guidance gives us a clear framework as we now finalize the study design in parallel with process development and tech transfer, and is an important milestone on the path to starting the first clinical study with ELC-401, which targets solid tumors in the brain. Glioblastoma is a difficult-to-treat disease with a great need for new treatment options. We also had a patent approved in Japan for ELC-401 during the year, further strengthening our intellectual property protection for the program in an important market.

Next step in the development of ELC-100 still under evaluation

In the recently completed clinical Phase I/IIa study of ELC-100 (oncolytic virus) in 12 patients with advanced, metastatic neuroendocrine tumors, a favorable safety

profile was observed with no dose-limiting toxicity. Among the eight evaluable patients, partial response was noted in two, providing early evidence of antitumor activity in a disease with a significant unmet medical need. We are gathering input from Key Opinion Leaders in neuroendocrine tumors. No decision has yet been made regarding the next step in the program’s development.

Margareth Jorvid new Chair of the Board

At the Annual General Meeting, Margareth Jorvid was elected as the new Chair of the Board of Elicera. Margareth has over 30 years of experience in the pharmaceutical industry, with previous roles at international companies such as Hoechst Marion Roussel, including assignments in both Stockholm and Paris. Since 2006 she has run her own life science company focused on regulatory affairs and quality assurance. She holds an MSc in Pharmacy and an MBA, and has previously served as Chair of the international industry organization TOPRA (2005–2006), where she is also a Fellow and honorary member — a role that has given her

broad experience of board and organizational work at an international level.

Agneta Edberg, who has served as Chair since 2021, stepped down from the chairperson role and was re-elected as an ordinary board member. Her experience and commitment therefore remain part of the board’s work. We want to extend a warm thank you to Agneta for her significant contributions as Chair over the years, and at the same time warmly welcome Margareth to the role.

Johan Liwing is appointed as new CEO

Finally, I want to inform you that the company is entering a new organizational phase, which is a result of Elicera’s successful development and a natural step in the company’s maturation. The board’s and my assessment is that having a unified management team based in the Uppsala region, close to the core operations and the company’s development team, provides the best conditions for building the team that the next phase of program development requires. Since I am based in Gothenburg and, for family reasons, am unable to move to Uppsala, Johan Liwing has been appointed by the Board of Directors as the new CEO effective 1 September 2026. I will remain employed by the company until 31 October 2026 and will also thereafter be available to ensure an orderly handover to my successor. I have great confidence that both the board and the organization are well equipped to lead Elicera forward into the next phase.

(Press release, Elicera Therapeutics, AUG 28, 2026, View Source;30-june-2026 [SID1234670389])

Elicera Therapeutics receives Notice of Allowance for U.S. patent application protecting the ELC-401 CAR T-cell candidate

On August 28, 2026 Elicera Therapeutics AB (publ) ("Elicera"), a clinical stage cell and gene therapy company developing next-generation therapies based on oncolytic viruses and CAR T-cells armed with bystander immune activating properties using the company’s commercially available platform iTANK, reported that it has received a Notice of Allowance from the USPTO (United States Patent and Trademark Office) regarding its patent application for the CAR T-cell candidate ELC-401.

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The patent application protects Elicera’s special antibodies that recognize and bind to the protein IL-13Ra2 (which is often present in large quantities on cancer cells, particularly brain tumors), as well as uses thereof in cancer treatment, such as CAR-T cell therapies.

The patent gives Elicera exclusive rights in U.S. to develop and sell treatments based on these anti-IL-13Ra2 antibodies and related technologies for cancer treatment. This strengthens the company’s protection for ELC-401 (its CAR-T cell candidate against glioblastoma) and other future products based on the same principle.

"Securing patent protection for our anti-IL-13Ra2 antibodies, used in CAR T-cell treatments, is commercially very significant because the United States is the world’s largest and most valuable market for advanced cell and gene therapies. Exclusive protection there strengthens our ability to develop, partner and commercialize ELC-401 and future products based on the same technology", says Elicera’s CEO, Jamal El-Mosleh.

About Glioblastoma and ELC-401
Glioblastoma is the most aggressive primary brain tumor, with a median survival of approximately 15 months despite standard treatments (surgery, radiotherapy, and chemotherapy). ELC-401 is designed to target IL13Ra2-positive tumors while using the iTANK platform to stimulate endogenous immune responses against additional tumor antigens, potentially overcoming heterogeneity and immunosuppression in GBM.

About the iTANK platform
The iTANK technology platform has been developed for arming and enhancing CAR T-cells to meet two of the major challenges CAR T-cell therapies face in the treatment of solid tumors: a very diverse set of tumor antigen targets and a very hostile tumor microenvironment. The technology is used to incorporate a transgene into CAR T-cells encoding a neutrophil activating bacterial protein (NAP). NAP secreted from the CAR(NAP) T-cells has been shown to be able to enhance the function of CAR T-cells and importantly activating a parallel bystander immune response against the cancer via CD8+ killer T-cells. This is expected to lead to a broad attack against most antigen targets on cancer cells. The iTANK platform is used to enhance the company’s own CAR T-cells but can also be universally applied to other CAR T-cell therapies under development. Proof-of-concept data was published in Nature Biomedical Engineering in April 2022. The publication, titled "CAR T cells expressing a bacterial virulence factor triggers potent bystander antitumor responses in solid cancers" (DOI number: 10.1038/s41551-022-00875-5) can be found here: View Source More information about iTANK platform is available here: View Source

(Press release, Elicera Therapeutics, AUG 28, 2026, View Source [SID1234670388])