AstraZeneca has signed a licensing agreement with Pinetree Therapeutics for a preclinical epidermal growth factor receptor (EGFR) degrader candidate, potentially worth more than $545m. AstraZeneca will pay $45m upfront for global developmental and commercialisation rights for the pan-EGFR degrader, and Pinetree will also be in line to receive up to $500m in milestone-based payments along with tiered royalties on sales. “[The] pan-EGFR degrader was developed from AbReptor, our proprietary multispecific antibody platform and has demonstrated promising preclinical anti-tumour activity in drug-resistant and tyrosine kinase inhibitor (TKI)-resistant tumours, as well as enhanced activity when used in combination with current EGFR inhibitors,” said Dr Hojuhn Song, founder and CEO of Pinetree. Targeted protein degraders, often called molecular glues, have been a growing area of interest in recent years. Most of these therapies are developed in oncology. According to GlobalData’s drug database, over 200 therapies in development have been classified as molecular glue ...
BioAtla has received a fast track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) ozuriftamab vedotin (BA3021) to treat a certain type of head and neck cancer. Ozuriftamab vedotin is a conditionally and reversibly active ADC targeted against ROR2, a receptor tyrosine kinase present in many solid tumours. ROR2 is a non-canonical wnt5A signalling receptor, the overexpression of which is associated with poor prognosis and resistance to standard therapies. This fast track designation concerns the use of ozuriftamab vedotin in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) for whom the disease has progressed despite platinum-based chemotherapy and anti-PD-1/PD-L1 antibody treatment. The ADC is the subject of an ongoing multi-centre, open label Phase II trial (NCT05271604) investigating the therapy’s efficacy and safety for this indication. Though a full readout is still pending, interim data from ...
Lupus is the lead autoimmune indication for Artiva Biotherapeutics, which has an early-stage clinical trial underway. Artiva’s allogeneic cell therapies are based on natural killer cells. By Frank VinluanCell therapy first reached patients as treatments for cancer. Artiva Biotherapeutics is part of a growing group of companies working to bring cell therapy to autoimmune disease, and its IPO has raised $167 million for clinical trial plans. Artiva priced the IPO at $12 per share, which was below the $14 to $16 per share price range the biotech set in preliminary terms last week. However, it boosted the deal size by increasing the number of shares in the offering. The 8.7 million shares it initially planned to offer would have raised $130.5 million at the proposed pricing midpoint. The company was able to raise more by selling 13.92 million shares. The shares of San Diego-based Artiva shares debuted on the Nasdaq ...
By Don Tracy, Associate Editor The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors. The FDA has granted Fast Track Designation to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, which is a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.1 “Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are ...
Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
Two months after MSD (Merck & Co) set its eye on acquiring Eyebiotech (EyeBio), the former has closed the deal, making EyeBio its subsidiary. MSD has acquired all outstanding shares of the privately held UK-based biotech through a subsidiary as part of the agreement. EyeBio’s shareholders will receive approximately $0.50 per share, totalling $1.3bn. Following the acquisition, MSD has gained access to EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway. A Phase IIb/III trial investigating Restoret in patients with DME is expected to begin in H2 this year. In February, EyeBio reported positive data from the Phase Ib/IIa AMARONE trial (NCT05919693) in patients with treatment-naïve diabetic macular oedema (DME) and treatment-naive neovascular age-related macular degeneration (AMD). In the study, Restoret improved vision in 26 participants with DME, leading to an improved best-corrected visual acuity by +11.2 letters and a mean ...
Recently, Journal of Translational Medicine, a prestigious medical journal, published a research article describing mechanism of action (MOA) of Henlius’ innovative anti-HER2 monoclonal antibody (mAb), HLX22, in dual HER2 blockade therapy. The research analysed the structure foundation and mechanisms of action associated with HLX22, further validating its potential in combination with trastuzumab in the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer to benefit more patients worldwide. Trastuzumab, the first HER2-targeted cancer therapy, was introduced in clinical practice and revolutionised the treatment of HER2-positive breast cancer and gastric cancer. Trastuzumab in combination with pertuzumab and docetaxel has also verified their synergistic effect in the treatment of HER2-positive metastatic breast cancer, and the combination regimen is now the standard of care in this indication. However, a phase 3 trial that assessed the efficacy of pertuzumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic gastric or G/GEJ cancer ...
England’s National Institute for Health and Care Excellence (Nice) has recommended Almirall’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer, Eli Lilly, and AbbVie, respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of ...
Recently, results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with HANQUYOU (HLX02, trastuzumab, trade name: HERCESSI™️ in the U.S., Zercepac® in Europe) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The leading principal investigator for this study is Professor Jin Li from Shanghai East Hospital, School of Medicine, Tongji University. The results showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. The results of HLX22-GC-201 were first presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The study data and updated results with another 7.8 months of follow-up were accepted for publication on MED ...
The Francis Crick Institute and Imperial College London (ICL) cancer therapy spinout, Myricx Bio, has raised £90m in series A financing to advance its novel cancer treatments into clinical development. The investment will help to develop the company’s therapies to treat a range of different tumour types, including breast, lung and colorectal cancer, to advance into clinical testing. Currently the largest series A round to ever be raised by an EU academic biotech spinout, the round was co-led by life science investors Novo Holdings and Abingworth, with additional investors including British Patient Capital, Cancer Research Horizons and Eli Lilly and Company, as well as founding investors Brandon Capital and Sofinnova Partners. The spinout is focused on the discovery and development of a novel class of payloads for antibody-drug conjugates (ADCs), which involves antibodies that bind to the surface of certain tumour types to deliver a drug to its target. The ...
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