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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

HUTCHMED Announces NMPA Approval for ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma

On August 28, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective, oral inhibitor targeting FGFR 1/2/3, has been granted conditional approval by the China National Medical Products Administration ("NMPA") for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma ("ICC") with fibroblast growth factor receptor ("FGFR") 2 fusion or rearrangement who have previously received systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver cancers, and consequently it is the second most common type after hepatocellular carcinoma. In recent years, the incidence of ICC has continued to rise, with a 5-year overall survival rate of approximately 9%.[1] Approximately 10-15% of ICC patients globally have tumors harboring FGFR2 fusions or rearrangements.[2],[3]

The approval is supported by data from the Phase II registration cohort of the single-arm, multi-center, open‑label, pivotal Phase II/IIIb clinical trial of ATLED in China (NCT04353375). The results were recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2026. The study met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%) in pretreated advanced ICC patients harboring FGFR2‑fusions/rearrangements, representing a strong, clinically meaningful response.

Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

"As a major and with historically limited targeted options. We are thrilled by the NMPA approval of ATLED, which directly addresses this critical therapeutic gap in China," said Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. "This approval unlocks an important new treatment alternative for a substantial population of pretreated advanced ICC patients. We are fully prepared to leverage our established commercial infrastructure to bring this precision medicine to patients as rapidly as possible."

The Phase IIIb portion of the trial will serve as the confirmatory study to further validate the clinical benefits and safety of ATLED in this setting. Enrollment for this confirmatory cohort was initiated in January 2026.

About ATLED
ATLED (fanregratinib, HMPL‑453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, AUG 28, 2026, View Source [SID1234670387])

INTERIM RESULTS ANNOUNCEMENT FOR THE SIX MONTHS ENDED JUNE 30, 2026

On August 27, 2026 JW Therapeutics reported interim results for the six months ended June 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, JW Therapeutics, AUG 27, 2026, View Source [SID1234671257])

Oncopeptides publishes Q2 report 2026

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Redx Announces Close of Series A Financing of $36 Million and Strengthened Board Composition

On August 27, 2026 Redx Pharma Ltd ("Redx") the clinical-stage, biotechnology company focused on developing novel, small molecule, targeted medicines for fibrotic disease reported completion of its Series A financing of $36 million. The Company is also pleased to confirm a new Board composition, with Andrew Sinclair, Managing Director of Abingworth joining as Investor Director and Bernard Coulie, M.D, joining as an Independent Director.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Series A financing was led by Abingworth, with participation from other new investors including British Business Bank1 , as well as the Company’s current major shareholder, Redmile. As detailed in the Company’s joint announcement with Skye Bioscience, Inc. ("Skye") (Nasdaq: SKYE) on 14 August, 2026, this Series A financing was announced as part of a larger financing and transaction between the companies. In connection with the transaction, it is proposed that Skye will acquire the entire issued share capital of Redx via a scheme of arrangement under Part 26 of the U.K. Companies Act 2006 (the "Transaction"). Upon completion of the Transaction, the combined company will be led by Redx’s current management team and Board and plans to operate under the name Fibrx Therapeutics, Inc. and trade on Nasdaq.

The British Business Bank is helping to anchor Redx and its world-class drug discovery and talent to the UK’s leading scientific ecosystem. While the Nasdaq listing will provide access to a deep pool of global capital, the company will retain its UK roots, and its headquarters and research will continue to be led from its base in Alderley Park, Cheshire, the UK’s largest single-site life sciences campus.

The Series A financing, together with the concurrent private placement ("PIPE financing") entered into by Skye with Abingworth, British Business Bank and Redmile, each of whom invested in both the Series A and PIPE financing, as well as a syndicate of new investors, including NEXTBio and 5AM Ventures, will provide the combined company with an aggregate total financing of approximately $125 million in gross proceeds. The proceeds of the financing will support the advancement of Redx’s lead asset, RXC008, a gut-restricted pan-ROCK inhibitor for fibrostenotic Crohn’s disease (FSCD) into a Phase 2 clinical study.

Andrew Sinclair, Managing Director, Abingworth commented: "At Abingworth, we look to back exceptional teams and truly differentiated biology that can fundamentally reshape patient care. Fibrostenotic Crohn’s disease is one of the largest areas of unmet need in IBD. The data generated by Redx with RXC008 to date, suggest that this novel pan-ROCK inhibitor could have a significant impact in mitigating FSCD pathology and we are delighted to partner with the Company and the other members of the investment syndicate to fully explore this drug candidate’s potential."

Charlotte Lawrence, Managing Director and Head of Direct Equity at the British Business Bank, said: "Redx is an example of the pioneering science emerging from North West England. With RXC008, the company has the potential to develop an entirely new category of treatment for a patient population that today has limited options. This investment will support Redx as it advances a potentially transformative treatment, while helping ensure that the company’s innovation, talent and intellectual property remain rooted in the UK."

As a result of the Series A financing closing and following approval by Redx’s shareholders on 14 August 2026, the convertible loan notes issued pursuant to a note purchase agreement entered into on 29 June 2020 and the A1 ordinary shares in Redx were converted into ordinary shares. The convertible bridging loan notes issued on 16 April 2026 were converted into Series A shares. Following the conversion, the current number of Redx shares in issue and the number of total voting rights count is 707,228,330. Redx shareholders should use this number as the denominator for any calculations relating to their holding in Redx.

Changes in Board Composition Reflect Investor Base and Increase Fibrosis Expertise

As the Series A financing has now closed, the following changes to the Redx board of directors (the "Board") have become effective: Andrew Sinclair joins the Board as the Investor Director representing Abingworth, with Natalie Berner of Redmile retaining her seat as an Investor Director. Jeremy Green of Redmile remains as chair of the Board. Claire Catherinet, previously an Investor Director representing Sofinnova, has stepped down from the Board. Bernard Coulie M.D, PhD, the current CEO of Pliant Therapeutics, Inc. joins the Board as an Independent Director, bringing clinical experience as a gastroenterologist together with a wealth of knowledge in clinical development of novel anti-fibrotic therapies. Peter Presland and Dr Bernard Kirschbaum will remain on the Board as Independent Directors, together with Lisa Anson, CEO, who is an Executive Director.

"We are thrilled to have completed this Series A financing and to welcome new investors including Abingworth and British Business Bank as shareholders. We also appreciate the continued strong support from our major shareholder, Redmile. Importantly, the appointment of Bernard Coulie to the Board will provide invaluable clinical and strategic insights as we progress our pipeline of novel anti-fibrotic drug candidates through development" commented Lisa Anson, CEO, Redx. "This financing is an important catalyst for the Company and will allow us to commence our Phase 2 programme for our lead asset, RXC008 for patients living with FSCD, enabling us to drive the next phase of the Company’s growth."

RXC008, A Novel Gut-restricted pan-ROCK Inhibitor

Rho-associated coiled-coil forming protein kinase (ROCK) is well established as an antifibrotic target and is known to consist of two isoforms ROCK 1 and 2. RXC008 is a potent, oral, small molecule non-systemic ROCK1/2 inhibitor that avoids the significant cardiovascular side effects of systemic pan-ROCK inhibitors, including tachycardia and hypotension, by being restricted to the GI-tract via high efflux and low permeability. This results in virtually no systemic breakthrough, with the molecule being rapidly metabolised by paraoxonase enzymes in the plasma should any breakthrough occur. Data from the Phase 1 study showed good tolerability and tissue exposure with no clinically relevant breakthrough or hypotension observed, and a good safety profile with no serious adverse events. RXC008 has an open IND in the US and was granted FDA fast track designation in January 2026. RXC008 is now ready to commence a Phase 2 clinical study, with topline data expected in mid-2028.

About Fibrostenotic Crohn’s Disease (FSCD)

Crohn’s disease affects 1.7m2 people globally and >70,000 new cases are diagnosed each year. More than 50% of patients with Crohn’s disease can develop significant fibrosis and stricture formation within ten years after diagnosis3 ; this fibrosis associated with Crohn’s disease is known as fibrostenotic Crohn’s disease. The current management of fibrotic strictures of the gastrointestinal tract is primarily surgical as no drugs are specifically approved to tackle fibrosis, which can progress despite intervention with current standard of care anti-inflammatory therapies. Once a patient is suffering from FSCD, healthcare costs increase by an additional >$80k4 per patient per year due to additional hospitalizations and treatment versus Crohn’s disease, creating a health economic burden in this area of high unmet need.

(Press release, Redx Pharma, AUG 27, 2026, View Source [SID1234670413])