Dominic Wall

📣 Weekly Highlights 📣 a.  Doma Biopharmaceutical (Suzhou) Co., Ltd has received FDA clearance of Investigational New Drug (IND) application for its first bispecific ADC DM001. On June 26, 2024, it also obtained Australia's CTN approval and is set to commence a Phase 1 clinical study. DM001 is a bispecific ADC designed to treat solid tumors by targeting both TROP2 and EGFR receptors. The bispecific antibody was assembled using common light chain antibodies produced by Renlite. Payload-linker of DM001 is named as BLD1102. b.  Huadong Medicine announced that the IND application for HDM2005 targeting the ROR1 receptor has received approval from the US FDA. This approval allows for Phase 1 clinical trials in the United States, with indications for advanced malignant tumor. Source: Doma & Huadong Medicine websites AsymBio is a leading CDMO with comprehensive solutions for Novel Drug Conjugates (NDCs). Contact us for more information: https://www.asymbio.com/ #ADC  #payload  #linker  #IND  #BLA  #FDA #NMPA  #bioconjugation  #innovation  #DS  #DP

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Leukaemia & Blood Cancer New Zealand agree with the proposal to expand access to generic lenalidomide and pomalidomide. This decision will bring New Zealanders one step closer to the international standard of care and will enable New Zealand haematologists to practice in closer alignment with internationally recognised clinical treatment pathways. It is important to recognise that – despite this proposal – an urgent unmet need persists for myeloma patients, who have not seen a new mode of action funded in the last decade. Myeloma is a relapsing and remitting disease, meaning that access to several treatment options with different mechanisms of action is required to keep people living. Daratumumab represents a new mode of treatment, and both daratumumab and carfilzomib are clinically and cost-effective therapies that form part of the established standard of care internationally. Not having access to these medications means that New Zealanders are ineligible for some clinical trials. These modern medicines continue to await funding on Pharmac’s Options for Investment list and highlight a broader issue where New Zealanders have to wait for the patent life of medicines to expire before they are publicly funded. This is unacceptable for blood cancer patients whose survival is wholly reliant on access to innovative medicines and who cannot afford to wait. LBC will continue to lobby for improved decision-making and faster access to standard of care therapies. For all the details in this proposal, please visit the Pharmac site https://lnkd.in/gcSdvNkP This is your opportunity to have your say. Email your feedback to: [email protected] by 4 pm, Friday 17 May 2024

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Are you a medical device or IVD manufacturer based in Australia? The Cisema team looks forward to meeting you at ARCS Australia 2024 Annual Conference next week where our CEO Hamish King will be presenting about "China & Hong Kong medical device & IVD registrations: top tips and latest updates." #medtech #biotech #regulatory #quality #clinical #compliance

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FivepHusion is excited to announce a deal with the University of Wollongong for the innovative #ResectAssist™ Platform. ResectAssist™ is a next-generation #drugdelivery #technology that enables targeted delivery of #cancer medicines directly into solid tumours via standard endoscopy, facilitating focused high dose #therapy, maximising anti-cancer efficacy and minimising side effects. The first therapy in development from the ResectAssist™ Platform is the optimised delivery of the most efficacious drugs for #pancreatic cancer, which is projected to become the 2nd leading cause of cancer-related deaths by 2030 and is a US$4B global market opportunity. ResectAssist™ is an exciting pipeline development opportunity aligned with FivepHusion's strategy of optimising cancer therapeutics to improve #patient treatment outcomes and quality of life. #innovation #biotech #pharma #investor Kara Vine-Perrow Morteza Aghmesheh Jef Pennings Bethany Pons

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Thanks to FirstWord Pharma for covering our announcement yesterday of $35.5M in funding from Advanced Research Projects Agency for Health (ARPA-H) and The National Institutes of Health to advance our first-in-class engineered IgA moncolonal antibodies for #cancer and #infectiousdiseases. Article link: https://lnkd.in/drHgtDyr Press release link: https://lnkd.in/e-2EgrsM

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Genomic profiling PrOSPeCT achieves a significant patient milestone (BiotechDispatch 6.6.2024): Australia's largest cancer genomics initiative has achieved a significant milestone. Over 5,000 Australians diagnosed with hard-to-treat cancers with minimal treatment options have received referrals for free comprehensive genomic profiling. Precision Oncology Screening Platform Enabling Clinical Trials (PrOSPeCT) is led by not-for-profit cancer genomics pioneer Omico. PrOSPeCT was established in 2023 to provide 23,000 Australians with advanced or incurable cancers, or earlier diagnoses of cancers with poor prognoses, comprehensive genomic profiling (CGP) of their cancer at no cost. Ian Black #AusBioNSW https://lnkd.in/gNS6dqqt

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🚨 Australia's PBAC decision for cancer care: stays within-tumour types 🚨 MSD and Bristol Myers Squibb recently proposed a shift in how PD-(L)1 therapies are funded to ensure faster access for #cancerpatients. However, PBAC’s decision to keep funding ‘within tumour types’ instead of #genomic expression raises concerns. We look forward to discussions and collaboration between industry and government to shift the paradigm of precision medicine healthcare for Australians As Rare Cancers Australia's CEO, Christine Cockburn, highlights: "This is another example of arguing about the life-jacket while the patient is drowning." 🆘 MSD Australia & New Zealand and RCA expressed deep disappointment at PBAC’s outcome, reminiscent of a similar decision six years ago. So, is Australia’s #HTA process keeping up with scientific advances? Should PBAC think differently, or is the risk of change too great? We believe the risk of not changing is too great and are acting for the health of Australians 🧬 With cancer increasingly understood as driven by genomic malfunctions rather than its anatomical origin, a paradigm shift towards truly personalised medicine is essential. The ‘within tumour types’ model risks sidelining innovations that could significantly improve patient lives. 📢 Let’s push for forward-thinking and ensure we are supporting access to healthcare Thanks MedNews Aust/NZ and Megan Brodie for covering these stories that matter #CancerCare #PersonalisedMedicine #HealthInnovation #Genomics #PBAC #HealthcareReform https://lnkd.in/gpjPmuAN

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Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF), an Australian biotech committed to developing the next generation of synthetic anti-infectives, has successfully wrapped up dosing of its latest cohort in the Phase 1/2 UTI/Urosepsis clinical trial. The trial, which is evaluating RECCE® 327 (R327) at rapid infusion rates, achieved its highest dosage to date, administering 4,000mg of R327 over 20 minutes to six human subjects. Administering antibiotics through rapid intravenous infusions has proven to be a safe and effective method, significantly impacting patient treatment, reducing wait times, and alleviating nursing workloads worldwide. An independent safety committee will review the cohort data, with preliminary results expected in the coming weeks. More at #Proactive #ProactiveInvestors #ASX #RCE #Biotech #AntiInfectives #AMR #AntibioticResistance http://ow.ly/mwBu105wktu

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🎙️ ASX Briefs Podcast    #Amplia CEO and MD Dr. Chris Burns spoke with ASX Briefs host Andrew Musgrave this week to discuss the Company's progress on the ACCENT trial investigating FAK-inhibitor narmafotinib in pancreatic cancer.     Dr. Burns discussed the growing prevalence of pancreatic cancer globally, and the urgent need for safe and efficacious treatments. He also shared the Company’s latest results from the Phase 2a trial, and the Company’s plans for the year ahead.     "We've just started recruiting our next 24 patients, and we'll finish that recruitment near the end of Q1 2025. At that point, we'll be releasing some early data from that clinical trial, that we think that will be quite interesting. Top line data will come out mid-year, and then a more complete data set by the end of 2025."     Listen here 👉 https://lnkd.in/gGeDHCjQ     $ATX #Amplia #innovation #biotech #pancreaticcancer #clinicaltrial #pharma

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Avion’s highlights from AusBiotech – Here are some of our highlights from the #AusBiotech Conference in Melbourne, Australia last week: 🧬 Radioligand Therapies: There was an increased focus on radiopharmaceutical development in Australia, with it being noted as one of the fastest growing sectors in precision oncology! Discussions centred around how Australia is at the forefront of the new wave of radiopharmaceutical development and that there is significant opportunity for Australia to solidify its global leadership in radiopharmaceutical research and development. The team at Avion fully agree with these sentiments and  already have the expertise required for precision radiopharmaceutical development and have multiple ongoing clinical trials in this space. 👩‍🔬 Female leadership in biotech: The underrepresentation of women in biotech leadership roles was highlighted and robust discussion were held around how to rectify this. Avion are already ahead of the game here, with our Founder and CEO, Sam Vohra, leading the way for gender diversity! 🔬 Cell & Gene Therapies: With a specific Cell & Gene Therapy Summit, AusBiotech highlighted that cell & gene therapies are helping to revolutionise modern medicine and Australia is experiencing significant growth in this area. With discussion around the emerging challenges and opportunities for Australia’s clinical development industry, Avion is well placed to assist in ensuring these promising technologies successfully progress through the pipeline. Dr Sam Vohra and Jerome Barley attended the conference, catching up with many like-minded professionals and industry leaders. #Avion is based in Melbourne – the Biotech capital! Let’s connect to discuss how Avion can help your biotech trials and research for discovery, regulatory approvals and highlighting difference in molecules. Let’s discuss: [email protected] #Avion #AvionMedical #AvionCRO #CRO #iCRO #ContractResearchOrganisation #ResearchImaging #ClinicalTrials #TrialManagement #ClinicalResearch #MedicalResearch #HealthcareInnovation #PharmaInnovation #LifeSciences #Biotech #Pharmaceuticals #PrecisionMedicine #RegulatoryAffairs #PatientSafety #DataManagement #DrugDevelopment #ResearchExcellence #Therapeutics #AusBio2024

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Our portfolio company Epigenic Therapeutics announced that it has received approval of clinical trial application (CTA) from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and The Health and Disability Ethics Committees (HDEC) to initiate a clinical trial for EPI-003, which is an investigational, liver-targeting antiviral therapy for chronic hepatitis B (CHB) virus infection. EPI-003 is set to become the world's first epigenetic therapy to reach clinical trials for this widespread infectious disease. This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EPI-003 in nucleos(t)ide analogue-treated, chronic hepatitis B patients. #ClinicalTrials #EpigeneticTherapy #HepatitisB #AntiviralTherapy #MedTechInnovation #PharmaceuticalResearch #LiverHealth #FDAApproval #HealthcareInnovation #ChronicHepatitisB #EPI003 #GlobalHealth #MedicalAdvancements #QimingPortfolio #QimingHealthcare Read More: https://lnkd.in/gMtCmgSB

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The first off-the-shelf in vivo CAR cell therapy will enter into Phase I clinical trial. Congratulations to Interius BioTherapeutics! Interius BioTherapeutics announced that it has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to commence a first-in-human Phase 1 clinical trial of INT2104, its lead in vivo CAR candidate for treatment of B-cell malignancies. INT2104 is a wholly-owned investigational gene therapy candidate, which specifically targets CD7-positive T and NK cells and delivers a CAR transgene to create effector CAR-T and CAR-NK cells in vivo. The CAR cells target CD20-positive B cells for the treatment of B cell malignancies. Unlike ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single dose treatment, administered systemically through intravenous infusion without the need for lymphodepletion or for any special equipment or training. Chinese Antibody Society is an independent non-profit, non-government global professional organization with focus upon antibody-based therapeutics. Our society’s official journal, Antibody Therapeutics (2023 CiteScore: 8.7), is an international peer-reviewed, open access journal published by Oxford University Press. You are welcome to visit the official website of the journal (see link below) and submit your therapeutic antibody related manuscripts to our journal. https://lnkd.in/gsTu_U2 https://lnkd.in/eXSJ6y-5 #CART, #Celltherapy,#InvivoCAR, #FIC, #FIH, #antibody, #antibodies, #mAb, #mAbs

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https://lnkd.in/gWWrpkVF We recently came across an excellent series of articles on cell therapies published by the team at Fierce Biotech which help make sense of a dynamic and highly competitive landscape. From cancer to auto-immunity, cell therapy continues to make inroads across diseases like cancer, but not all approaches will succeed in all indications. Autologous CAR-T products have demonstrated approvability in liquid tumors, but even these face challenges in manufacturing and commercial pressures. Conversely, Allogeneic and in vivo CAR-T approaches remain to be proven. The future of cell therapy is bright, with research exploring different cell types such as TILs, macrophages, B and NK cells. SUPLEXA, a unique autologous immune cell therapy from Alloplex derived from PBMCs, remains in a class of its own and focuses on treating solid tumors. Alloplex boasts a robust and scalable manufacturing process for SUPLEXA cells. Look for a future article by Alloplex CEO, Dr. Frank Borriello, who will delve deeper into how Alloplex is navigating the issues raised in this series and the shifting competitive landscape. #Alloplex #celltherapies #SUPLEXA #SUPLEXAtherapy #oncologyresearch #cancerresearch #immunotherapy #autologoustherapy #CarT #fiercebiotech #AlloplexBiotherapeutics

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TIA's Director of Strategic Development for Cell & Gene Therapies, Dr Heather Donaghy participated to the ISCT, International Society for Cell & Gene Therapy (#ISCT) meeting in August 2024 in Queenstown, New Zealand. She joined Helen Wray, Darja Nelson and Janet Macpherson to discuss the complex topic of therapy commercialisation, how can we improve the processes underpinning the CGT path to market and facilitate awareness of these considerations early in the scientific process. Despite a challenging commercialisation landscape, the session highlighted the single driving force that continues to unite ISCTers – better, safer therapies for more patients.

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The Victorian Cancer Biobank (VCB) has signed a collaboration agreement with the Singapore Translational Cancer Consortium (STCC) to bolster the biobanking and cancer research capabilities of Victoria and Singapore. The partnership will establish a catalogue where authorised researchers from Victoria and Singapore can co-list and co-access vital and anonymised biospecimens for their cancer research projects. Dr Wayne Ng, General Manager of the VCB, said the partnership will enhance cancer research capabilities in both countries: “Cancer touches everyone no matter where you live so it’s really important that we form partnerships with other biobanks around the world in our joint efforts to find better treatments for cancer.” Prof Chng Wee Joo, Executive Director of the STCC, said the partnership with VCB is a significant milestone in unlocking the value of specimens for impactful translational research in both countries: “The patient specimens at our biobanks are not just samples; they hold the key to personalised oncology treatments. This partnership with VCB expands access and diversity to this vital resource, ensuring that research discoveries translate into real-world impact for our patients.” Consortium for Clinical Research and Innovation, Singapore (CRIS) Pictured (L-R): Tim Richardson MP, Todd Harper - CEO, Cancer Council Victoria, Samantha Higgins - VCB, Dr Eng Chon Boon, and Kiraely Adam Wong. #Biobanking #CancerResearch #Partnerships

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BioCity Biopharma has announced that its #endothelinreceptortypeA (ETA) selective antagonist, #SC0062, has met the primary endpoint of #proteinuria reduction in the 2-SUCCEED trial, a randomized, double-blind, placebo-controlled, dose-ranging #phase2 #clinicaltrial in #chronickidneydisease (CKD). The study is ongoing in the #diabetickidneydisease (DKD) cohort. SC0062 achieved a clinically meaningful and statistically significant reduction in proteinuria, with a clear dose-response relationship and a good safety profile. Importantly, no fluid retention was observed in SC0062-treated patients. Additionally, for patients on SGLT2 inhibitors in the trial, the combination had a favorable safety profile. Trial data will be submitted to upcoming scientific conferences for presentation. SC0062 is a novel, highly selective ETA antagonist designed for CKD, improving renal blood flow, reducing proteinuria, and attenuating inflammatory and fibrotic processes. It aims to enhance safety by mitigating fluid retention, a common adverse effect associated with non or low-selective ET antagonists. For detailed news: https://lnkd.in/d5CHb-Tk For more industry updates: https://lnkd.in/de5zNWmK #BiocityBiopharma #EndothelinReceptorTypeAAgonist #ClinicalTrials #Innovation #Pharma #Healthcare #Proteinuriareduction #CKD #DKD

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Skyhawk Therapeutics, a clinical-stage biotechnology company, announced that the #AustralianHumanResearchEthicsCommittees (HREC) has approved the use of #SKY0515 for up to 12 weeks in its ongoing #Phase1trial for #Huntington’sDisease (HD). The #HREC also approved the inclusion of #VolumetricMRI (vMRI) measurements as an exploratory endpoint in the study. These measurements target brain regions affected by HD, offering additional insights into the impact of SKY-0515 on patients. Skyhawk Therapeutics is thrilled to extend treatment duration for #Huntington’s patients after achieving a 72% reduction in #huntingtinmRNA (HTT) in the healthy volunteer portion of the study. The rigorous evaluation and approval of both the treatment extension and the #vMRI measurements by the HREC are greatly appreciated, as they are seen as enhancing the demonstration of SKY-0515's potential and potentially accelerating the path to pivotal trials. SKY-0515 is an investigational #oralsmallmoleculeRNAsplicing modifier developed using Skyhawk’s proprietary RNA-splicing platform. It is designed to reduce #HTT and #PMS1proteins, the latter being a key driver of #somaticCAGrepeat expansion and #HDpathology. Detailed news: https://lnkd.in/gjDTxeXc Follow our page for more industry updates: https://lnkd.in/de5zNWmK Know more about #RASLSSConsulting: https://lnkd.in/d_daJ5Xv #Skyhawktherapeutics #SKY0515 #Huntingtonsdisease #HREC #VolumetricMRI #Oralsmallmolecule #RASLSSConsulting #MarketIntelligence #MarketResearch #CompetitiveIntelligence #StrategySupport #PortfolioOptimization #MarketExpansion #PartnerIdentification

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Phenomics Australia and Therapeutic Innovation Australia partnership reinforces commitment to address the medical products challenge. In partnership with Therapeutic Innovation Australia (TIA), Phenomics Australia is pleased to announce the successful recipients of the Pipeline Accelerator 2023-24 (Round 2). Through the National Collaborative Research Infrastructure Strategy (NCRIS) program, Phenomics Australia and TIA support a network of national research infrastructure to address the medical products challenge in the 2021 National Research Infrastructure (NRI) Roadmap. We collectively offer academic researchers and SMEs access to a diverse range of Australian translational medical research capabilities, from the molecular basis of health and disease through to clinical trials. 34 projects to share $1,012,068 in voucher awards to access translation national research infrastructure (NRI) to accelerate the translation of therapeutics to improve human health. Research in kidney, heart, skeletal muscle and cardiopulmonary diseases, cancer, and infectious disease, among others, will advance with the support from Phenomics Australia and TIA. These vouchers will subsidise a maximum of $50,000 of the total cost to access these translation NRIs. Eleven recipients were awarded with the Phenomics Australia Pipeline Accelerator 2023-24 (Round 2). Click this link for the full list of recipients and details about their projects: https://lnkd.in/grzgkKid #NCRISImpact Australian Government Department of Education

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