On April 20, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported updates from its EphA2 pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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"EphA2 is a potentially high value target that is widely expressed in cancer and has been considered undruggable following the failure of multiple antibody-based approaches due to toxicity or insufficient efficacy. Encouraging results presented at AACR (Free AACR Whitepaper) demonstrate the potential of our Bicycle platform to drug this target with a generally well tolerated and differentiated safety profile and enhances our understanding of how best to deploy EphA2-targeted therapeutics," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "Nuzefatide pevedotin has demonstrated an emerging differentiated safety profile as a monotherapy and in combination with a checkpoint inhibitor, in over 150 patients to date. Consequently, using a combination of expression analysis, preclinical patient-derived xenograft efficacy studies, and human patient imaging, we have identified significant opportunities for this molecule in a number of cancers, including pancreatic cancer."

Dr. Lee added: "We have now identified 8mg/m2 Q2W as the preferred dose for monotherapy. Our strategy is to initially develop nuzefatide in pancreatic cancer where patients have limited available treatment options, and in parallel, to bring forward the next generation of EphA2-targeted radiotherapeutics to build on our foundational work in bladder and other EphA2-expressing tumors. Following this strategy, I am very pleased to announce that the first patient in our 2L+ pancreatic ductal adenocarcinoma Phase 2 study has been successfully dosed."

AACR Annual Meeting 2026 Data Highlights

Nuzefatide pevedotin (nuzefatide), formerly BT5528, a potentially first-in-class EphA2 targeting Bicycle Drug Conjugate (BDC), Phase 1/2 data in combination with nivolumab in metastatic urothelial cancer (mUC) patients. As of the February 9, 2026 data cutoff, results from the Phase 1/2 trial evaluating nuzefatide 6.5mg/m2 once every two weeks (Q2W) plus nivolumab 480mg once every four weeks (Q4W) in 14 patients with mUC who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed:
40% confirmed overall response rate (ORR) (4/10) among patients with EphA2+ tumors and 100% confirmed ORR (3/3) among patients with EphA2+ tumors that were monomethyl auristatin E (MMAE)-naïve.
Patients who achieved a partial response (PR) or at least 16 weeks of stable disease (SD) were on treatment for a minimum of 56 weeks and most continued on treatment at the time of the data cut-off.
Nuzefatide in combination with nivolumab was generally well tolerated with no Grade ≥3 treatment-related adverse events (TRAEs) of clinical interest and no TRAEs of haemorrhage observed. Only one dose-limiting toxicity of Grade 3 fatigue that lasted for five days was reported and improved to Grade 1 without dose reduction.
In contrast to other EphA2-targeted agents, nuzefatide has demonstrated a positive emerging efficacy and safety profile in over 150 patients with hard-to-treat tumors to date. Further work has led Bicycle Therapeutics to determine 8mg/m2 Q2W as the preferred dose for the Phase 2 trial in patients with recurrent pancreatic ductal adenocarcinoma (PDAC).

Additional human imaging data of a Bicycle Imaging Agent (BIA) targeting EphA2 in patients with PDAC. The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA). Seven patients with histologically confirmed PDAC underwent PET/CT imaging up to three hours post injection of the EphA2 BIA. Data demonstrated rapid tumor uptake and excretion primarily via the kidneys in six out of seven patients. EphA2 BIA PET imaging successfully detected multiple liver, bone, lymph node, and peritoneal metastases.

These data are representative of the results seen in 15 out of 18 patients with PDAC who have undergone EphA2 BIA imaging to date. Bicycle Therapeutics believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical data and highlight the potential of Bicycle molecules for targeted radioligand therapies and radiopharmaceutical imaging.
Preclinical assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of PDAC. Expression of EphA2 was found in all 16 PDAC PDX models. Of the 14 PDAC PDX models assessed for anti-tumor activity, 10 models were sensitive to nuzefatide, six of which showed high sensitivity. These data support the potential for nuzefatide to offer a novel option for the treatment of patients with PDAC.

In March 2026, Bicycle Therapeutics began enrolling patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC, and the first patient was successfully dosed in April 2026.
Preclinical assessment of nuzefatide anti-tumor activity in cell-line-derived xenograft (CDX) models of head and neck squamous cell carcinoma (HNSCC). Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing CDX models of HNSCC.
The presentations are available in the Publications section of the Bicycle Therapeutics website.

(Press release, Bicycle Therapeutics, APR 20, 2026, View Source [SID1234664536])

On April 20, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported will webcast management participation as follows:

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• BofA Securities Health Care Conference 2026 at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 12, 2026

• Goldman Sachs 47th Annual Global Healthcare Conference at 2:00 p.m. ET on Monday, June 8, 2026

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, APR 20, 2026, View Source [SID1234664552])

On April 20, 2026 Independent biopharmaceutical company Specialised Therapeutics (ST) reported the approval of ZEPZELCA (lurbinectedin), in combination with atezolizumab (Tecentriq), as a new first-line maintenance treatment option for adult patients in Australia and Singapore, who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), an aggressive form of lung cancer.[1],[2] This follows the recent decision by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to issue a positive opinion recommending the approval of ZEPZELCA in Europe.[10]

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In combination with atezolizumab, ZEPZELCA has been approved for use in Australia and Singapore as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.[1],[2]

Both approvals for ZEPZELCA in ES-SCLC were obtained under Project Orbis — an initiative of the United States Food and Drug Administration’s (US FDA’s) Oncology Center of Excellence. These ZEPZELCA approvals represent the eighth time ST has successfully navigated the Project Orbis process since 2021.

Lung cancer remains a significant health challenge in the region, with an estimated 15,000 diagnoses and 9,000 deaths from the disease each year in Australia.[7],[8] In Singapore, lung cancer is the third most common cancer, with 9,732 new cases diagnosed between 2019-2023.[11] Small cell lung cancer (SCLC) is a highly aggressive cancer that has often already spread to other organs when first diagnosed.[6] It accounts for approximately 10-15% of all lung cancer cases and has a low 5-year survival rate of under 7%.[6]

Professor Nick Pavlakis, Medical Oncologist from Royal North Shore Hospital in Sydney, acknowledged the approval of the new combination therapy as an important step in helping to improve outcomes for patients with ES-SCLC.

"Most patients with small cell lung cancer typically present with extensive-stage disease at diagnosis, meaning they are often faced with experiencing high rates of relapse or recurrence, limited treatment options and a poor prognosis," said Professor Pavlakis.

"While outcomes for patients have improved over the past five years with the addition of immunotherapy to chemotherapy, there continues to be a significant clinical need to improve on first-line therapies used to treat extensive-stage small cell lung cancer to prolong disease control and enhance survival. Today’s announcement is welcome news for the medical and patient community."

ZEPZELCA is being made available in Australia, New Zealand, Singapore, Malaysia, Thailand and Vietnam by Specialised Therapeutics (ST), under exclusive license from European biopharmaceutical company PharmaMar, which has pioneered the development of marine-based oncology medicines.

ST Chief Executive Officer, Mr Carlo Montagner, said the approval of ZEPZELCA for ES-SCLC in the first-line setting would provide clinicians and patients with an important new therapeutic option for this difficult to treat cancer.

"We are delighted to have secured regulatory approvals for ZEPZELCA in combination with atezolizumab as a first-line maintenance therapy for adults diagnosed with ES-SCLC in Australia and Singapore," said Mr Montagner.

"Despite the improved efficacy of first-line therapies for ES-SCLC that have been available since 2019, survival outcomes remain suboptimal, with an estimated 40% of patients experiencing a relapse and requiring second-line treatment. The availability of additional first-line treatment options will enable eligible patients and their clinicians to find the therapy that is right for them, can help to improve their quality of life and importantly, give them more time to spend with their families and loved ones."

Chief Medical Officer for PharmaMar, Javier Jimenez, welcomed the regulatory approval for ZEPZELCA, saying: "We are very pleased that patients in Australia and Singapore can have access to this new therapy, as it marks an important milestone in the management of this disease, where a significant unmet medical need persists. Building on more than 40 years of commitment to research in diseases with limited treatment options, we will continue to collaborate with our partner in Australia to enable timely and equitable access to this new treatment."

ZEPZELCA belongs to a class of medicines known as alkylating agents, which work by damaging the DNA of cancer cells, helping to slow or stop their growth.[12] The regulatory approvals for ES-SCLC in Australia and Singapore were based on results from the Phase 3 IMforte clinical trial. The study enrolled 660 treatment-naïve patients with ES-SCLC across 13 countries in the induction phase. Following this, 483 patients who responded to induction treatment were randomised to receive either ZEPZELCA with atezolizumab (LU-AT) or atezolizumab monotherapy (AT) as first-line maintenance therapy.[13] The trial results supported the use of LU-AT as a new first-line maintenance treatment option over AT alone in patients with this aggressive cancer, with improvements recorded in both median progression free survival (PFS; 5.4 months vs. 2.1 months) and median overall survival (OS; 13.2 months vs.10.6 months).[13]

Significant variations in treatment-related adverse events (AEs) were noted in the two trial groups (83.5% in patients receiving LU-AT vs. 40% among patients receiving AT monotherapy).[13] Treatment with LU-AT was considered to be generally well tolerated, with no new or unexpected safety signals.[13] The most common adverse reactions (≥ 30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes, decreased platelets, decreased haemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.

For further details on ZEPZELCA, contact your healthcare professional and refer to the approved Australian Consumer Medicine Information, available from the TGA’s website.*

PBS Information: ZEPZELCA is not listed on the Pharmaceutical Benefits Scheme (PBS).

(Press release, Specialised Therapeutics Australia, APR 20, 2026, View Source [SID1234664569])

On April 20, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that new data from the ongoing Phase 0/1 HEAT trial (NCT06824155), evaluating 177Lu-RAD202, a first-in-class HER2-targeted radiopharmaceutical therapy, will be presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, being held April 17–22, 2026 in San Diego, California.

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"These first-in-human results represent an important early milestone for our HER2-targeted radiopharmaceutical program," said Dr. Dimitris Voliotis, Chief Medical Officer of Radiopharm Theranostics. "In a heavily pre-treated patient population with significant unmet need, 177Lu-RAD202 demonstrated encouraging tumor uptake and a favorable safety profile at the lowest dose level. Importantly, the observed dosimetry supports continued dose escalation, which was recently approved by the Data Safety and Monitoring Committee (DSMC) to advance to the third cohort at 130 mCi dosing. We look forward to further evaluating the therapeutic potential of this novel approach and expect to see signs of antitumor activity at higher, more therapeutic dose levels."

The AACR (Free AACR Whitepaper) poster highlights first-in-human safety, biodistribution, dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi.

Key Findings from the AACR (Free AACR Whitepaper) Abstract and Poster

Meaningful tumor uptake of 177Lu-RAD202 was observed at the initial and lowest dose level of 30 mCi, particularly in breast cancer lesions
177Lu-RAD202 was generally well tolerated in the first three treated patients, with predominantly Grade 1–2 treatment-emergent adverse events
No dose-limiting toxicities or treatment discontinuations due to adverse events were observed
Organ-level absorbed radiation doses were within expected and clinically acceptable ranges, supporting continued dose escalation
Poster Presentation Details

Title: A First-in-Class HER2-Targeted Radiopharmaceutical Therapy: Initial Findings from the Phase 0/1 HEAT Trial of 177Lu-RAD202 in HER2+ Advanced Solid Tumors
Abstract Number: CT046
Presenter: Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics
Session: Poster Session
Dates: April 20, 2026 at 9:00 AM PT
The complete poster can be found on the Company’s website here.

On April 8, 2026, Radiopharm Theranostics announced the positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance 177Lu-RAD202 to the third cohort at a dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors1. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.

About the HEAT Trial

177Lu-RAD202 is a Lutetium-177–labeled single-domain antibody (sdAb) designed to target HER2-expressing tumors. The sdAb format enables deep tumor penetration and rapid systemic clearance, while the beta-emitting isotope 177Lu delivers cytotoxic radiation with potential bystander effects independent of HER2 receptor density.

The HEAT trial (HER2-Antibody Therapy with Lutetium-177; (NCT06824155) is a first-in-human, open-label, multicenter integrated Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally-advanced or metastatic solid tumors.

Phase 0 evaluates biodistribution, pharmacokinetics, and radiation dosimetry using an imaging dose
Phase 1 consists of multiple-dose escalation to assess safety, tolerability, tumor targeting, and to determine the recommended Phase 2 dose
About RAD202:

RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.

(Press release, Radiopharm Theranostics, APR 20, 2026, View Source [SID1234664586])

On April 20, 2026 Eli Lilly and Company (NYSE: LLY) and Kelonia Therapeutics, Inc. ("Kelonia"), a clinical-stage biotechnology company pioneering in vivo gene delivery, reported a definitive agreement for Lilly to acquire Kelonia.

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Kelonia has developed a proprietary in vivo gene placement system (iGPS ) that uses specially engineered lentiviral-based particles designed to efficiently and selectively enter T-cells inside the body, allowing the patient’s own body to generate chimeric antigen receptor T-cell (CAR-T) therapies that can treat underlying disease. Kelonia’s lead program, KLN-1010, is an investigational, one-time intravenous gene therapy that generates anti-B-cell maturation antigen (BCMA) CAR-T cells, targeting the BCMA protein expressed on the surface of multiple myeloma cells. Encouraging early clinical results were presented in the plenary session of the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, providing initial clinical validation and demonstrated promising tolerability. KLN-1010 could represent a transformative advance in the treatment of multiple myeloma by eliminating the complexities of ex vivo patient-specific cell therapy manufacturing, and pre-administration chemotherapy.

"Autologous CAR-T therapies have meaningfully improved outcomes for patients with various cancers, but significant manufacturing, safety, and access barriers mean that only a fraction of eligible patients actually receive them. Kelonia’s in vivo platform has the potential to change that by delivering rapid, durable responses in a far simpler, off-the-shelf format," said Jacob Van Naarden, executive vice president and president of Lilly Oncology and head of corporate business development. "The early clinical data for KLN-1010 are highly encouraging, both as a potential step forward for patients with multiple myeloma and as proof of concept for Kelonia’s platform. We look forward to working together with the Kelonia team to rapidly advance KLN-1010 to address patient need and recognize the full potential of their platform in other conditions where patients may benefit."

"Kelonia’s leadership in advancing the immense promise of in vivo cell therapy is unmatched, extending its reach and impact beyond the traditional boundaries of personalized medicine," said Kevin Friedman, Ph.D., chief executive officer of Kelonia. "We have demonstrated the ability to achieve deep multiple myeloma remissions with significantly reduced complexity and cost relative to ex vivo CAR T-cell approaches. In combination with Lilly’s strengths, our in vivo iGPS platform is positioned to broaden the reach of cell therapy beyond the current CAR-T landscape in hematologic malignancies and to transform treatment across a far wider range of cancers and other serious diseases. It’s been a privilege continuing the journey started by Michael Birnbaum and the Venrock team. I am deeply grateful to our employees, partners, and investigators, and most importantly, the patients who make this progress possible."

Under the terms of the agreement, Lilly will acquire Kelonia, and Kelonia shareholders will receive up to $7.00 billion in cash, inclusive of an upfront payment of $3.25 billion, and subsequent payments upon achievement of certain clinical, regulatory and commercial milestones.

The transaction is subject to customary closing conditions, including customary regulatory approvals, and is expected to close in the second half of 2026. Lilly will determine the accounting treatment of this transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For Kelonia, Jefferies LLC is acting as financial advisor, and Goodwin Procter LLP is acting as legal counsel.

(Press release, Eli Lilly, APR 20, 2026, View Source [SID1234664537])