Joey Man

🚨 Presentation Alert: Overview of Proposed Changes to GMO Therapy Regulation in Australia 🚨 Australia's Gene Technology Act 2000 has been the cornerstone of GMO (Genetically Modified Organism) regulation for over two decades. However, with rapid advancements in genetic therapies, it’s time for an update. These proposed changes aim to modernize our approach to GMO regulation and align with international best practices while ensuring robust safety standards. BPR's latest presentation: "Overview of Proposed Changes to GMO Therapy Regulation in Australia", outlines the first significant revisions to the Act since its inception. The information presented focuses on the main changes to the gene technology scheme that affect regulation of GMO medicinal therapies and licence applications for these therapies.

1

📢 NEWS: Today AusBiotech and MTPConnect have released a discussion paper on critical life science growth issues ahead of our upcoming National Biotech and Medtech Development and Commercialisation Summit, on 19 November 2024 in Canberra.   Australia's life sciences sector is an essential part of Australia’s economy, supporting high-paying and skilled jobs, manufacturing exports, and underpinning the health and wellbeing of Australians. It is rightly recognised by the Australian Government as a critical sector that is essential for Australia’s future. Yet while we are in the top ten globally for research, we slip down to 30th for the translation and commercialisation of that research. The upcoming Summit will see AusBiotech and MTPConnect gather some of the country’s most senior leaders from a cross-section of the biotech and medtech sector to tackle these issues.    The joint discussion paper launched today unpacks Australian and global policy contexts, stubborn industry challenges, and barriers to achieving robust “Development and Commercialisation” outcomes. MTPConnect CEO Stuart Dignam said the discussion paper and 19 November Summit aim to harness industry insights and create a united voice to government ahead of the 2025 election. “Medical products are one of Australia’s most significant value-add exports, but gaps in biomedical and medical technology product development limit our ability to fully realise the commercial potential of our innovation prowess,” Mr Dignam said. Add your voice to the discussion The Summit is one part of the conversation, and your insights are crucial to ensuring the discussions and any outputs reflect the diverse perspectives of the industry. If you aren’t attending the Summit, we invite you to complete the survey to share your views. Check out the discussion paper and survey below: https://lnkd.in/gmAjHbFp Stuart Dignam, Hon. Jaala Pulford, Rebekah Cassidy, Erin McAllum, Duncan Macinnis, Lisa Dubé, Amelia Vom, Andrew Bowskill, Tracey Wilkinson, Dana Bell

49

Learn about the growth issues that lie ahead for the Aus biotech sector with this new discussion paper by AusBiotech and MTPConnect.

2

🎙️ In this episode of Med Tech Talks, we sit down with Dr Amir Zalcenstein, Managing Director of SYNthesis BioVentures. Amir shares his fascinating journey through venture capital and biotech, highlighting the differences between overseas and the Australian medtech landscapes, and why he loves the ASX. He also discusses SYNthesis’ unique approach to early-stage investment in Australian innovations, and says that there’s opportunities to leverage our nation’s wealth, saying: “There is a disconnect between early-stage science, early-stage financing, venture financing, and the ginormous pool of capital that is the Australian capital markets and powered by superannuation savings… you have this gigantic pool of money and you have great science. For whatever reason, there is no organic connection between them. And so what we are hoping to do is to be the ones who provide that continuity of capital.” If you're passionate about the future of med tech, biotech and venture capital, or want insights on global med tech trends, this episode is a must-listen! https://lnkd.in/gTBkj5my #MedTech #Biotech #VentureCapital #Innovation #MedTechTalks #ASX

32

1 Comment

We are grateful to announce the successful first close of $20 million in Proto Axiom's Series B capital raise. This capital, entirely unallocated, is dedicated to fuelling new investments, with a clear mandate: to empower Australia’s leading scientists at the most critical stage—the very beginning. Australia has long been a global leader in research, yet our biotech sector has not lived up to its full potential. Government-subsidised programs have often crowded out private investment, while market power dynamics have led to rent-seeking behaviours. Moreover, exclusivity clauses often lack transparency, stifling innovation and delaying the path from discovery to patient care. As a result, ground-breaking ideas are not reaching the market, and our collective promise to advance public health remains unfulfilled. As such, our mission is to remove the barriers that politics often places in the path of scientific progress. Together, we're committed to transforming the future of Australian biotech, ensuring that the best ideas make it from the lab to the lives of those who need them most. https://lnkd.in/g5b3giSc -- Board: Gavin MacLaren, Kathy Connell, GAICD, Tom Harley, Nicholas von Guionneau, MD, Tristan Edwards Team: Lindsay Wu, Hugh Mc Gonagle, John Roach, Laura Wimberger, Marina Naidion, Nicholas Hunt (Endo) Strategic Advisors: Anand Gautam (Chair), The Hon Gabrielle Upton FAICD FRSN, Lawrence Gozlan, Michelle Burke, Simon Allen, Rob McInnes, Serge Scrofani Scientific Advisors: Brian Ledwith (Chair), Bart Kolodziejczyk OAM, Sara Althari, Swee Kheng Khor, William (Bill) Marshall, Michael Sierra, Russell Basser

328

43 Comments

The VCCC Alliance and Monash Partners Comprehensive Cancer Consortium are proud to unveil a roadmap for advancing equitable access to genomic testing for cancer. A key project under the VCCC Alliance Personalised Cancer Care program, funded by Victorian Government from 2021-2024, the Precision Oncology Roadmap was a collaboration between the Alliance and MPCCC. It included a Precision Oncology Summit, held in 2023, which captured the diverse views of clinicians, researchers and consumers. The Roadmap has been submitted to Cancer Australia to inform its National Framework for Genomics in Cancer Control. Read more and access the Roadmap here: https://lnkd.in/gPatMKmT Tim Richardson Grant McArthur AO Melissa Southey Mark S. Victorian Department of Health Department of Premier and Cabinet (Vic) Australian Government Department of Health and Aged Care

75

3 Comments

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

2

If you’re curious about AI's impact on drug discovery but missed our recent free conference, we’ve got you covered.     NAIC, CSIRO and CSL presented the AI for Drug Discovery and Beyond conference on 20 August. It focused on how we can better leverage AI to advance drug discovery in Australia. We aimed to address unmet medical needs to improve global health quality.      Key takeaways…    Prof Andrew Nash shared that drug R&D is a complex and expensive process and it delays finding the right affordable therapeutics for patients. The future is about re-inventing workflows, using generative AI to break knowledge silos, reduce cost and improve quality of research.      A/Prof Fatemeh Vafaee, UNSW, and Dr Aarathi Sugathan, CSL, showed us what can be done with bringing data from multimodal sources together to identify better targets and repurpose existing drugs faster.     Prof Denis C. Bauer, GAICD, CSIRO, demonstrated a cloud first bioinformatics mindset is critical to leverage the massive amount of data available globally and touched on the importance of federated data sharing to develop impactful AI models.    Dr Lewis Blackman, CSIRO, Dr Sukhvir Kaur (Roop) Bhangu, CSIRO, and Dr Davy Guan, UQ/CSIRO, shared how AI is used in drug discovery and design at CSIRO.    #AIAustralia #ArtificialIntelligence #science #BioMedical 

49

3 Comments

Skyhawk Therapeutics is advancing precision medicine with SKY-0515, a breakthrough drug targeting the root cause of Huntington’s disease. By reducing the harmful huntingtin protein at the RNA level, SKY-0515 offers new hope for Huntington’s and beyond. Now in Phase 1 clinical trials in Australia, SKY-0515 is progressing through key stages to ensure safety and effectiveness. While there’s still a long road ahead, this innovative treatment could pave the way for future therapies for neurodegenerative diseases and cancer. We’ll be following this journey closely and keeping our community informed. 💙 Read more: https://en.hdbuzz.net/373

3

Looking forward to speaking today on the topic of ESG through the lense of early stage Biotech at the AusBiotech conference. Join us on a panel on “Demystifying ESG” as we discuss what investors really want to see in a company’s ESG reporting. Aimed at answering that question for SME directors and executives. And there's a great panel chaired by Melissa McBurnie who will share their expert insights: Join me and Ilona Marchetta, Jacob Elkhishin, and Ali Ukani. We'll explore ESG (Environmental, Social, Governance), focusing on: 🔑 Investor perspectives and why materiality is crucial 💼Tackling compliance challenges for small biotech companies 📊Importance of governance, risk management, and sustainability in early-stage firms Don’t miss the tips on how to start your #ESG journey! 🗓️ Thursday, October 31, 2024 🕐 1:30 PM - 2:15 PM 📍 Room 110, Melbourne Convention and Exhibition Centre #AusBiotech2024 #LifeSciences #IRDepartment #ESG #esginvesting #investment

27

2 Comments

We've dosed the first Australian patient in our Phase 1b azer-cel clinical trial (azercabtagene zapreleucel) at the Royal Prince Alfred Hospital in Sydney. The trial focuses on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), one of the most challenging and aggressive forms of non-Hodgkin’s lymphoma. Azer-cel is one of the few allogeneic CAR T-cell therapies currently being evaluated in Australia, offering an off-the-shelf alternative to traditional autologous CAR T-cell therapies. Recent data from US trial sites showed promising results, including multiple complete responses in patients who had failed multiple prior treatments. Managing Director and CEO Leslie Chong said, “Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease. The trial’s opening at RPAH in Sydney reflects our commitment to accelerating the development of innovative, offthe-shelf immunotherapies that have the potential to improve outcomes for patients with relapsed or refractory DLBCL. We are proud to bring this trial to Australia and look forward to expanding recruitment across multiple sites.” Read the full ASX Announcement here: https://lnkd.in/gexgrGqa #Imugene #IMU #AzerCel #CAR_T #CancerResearch #ClinicalTrials #Biotech

75

3 Comments

𝐓𝐮𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐒𝐞𝐜𝐮𝐫𝐞𝐬 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐟𝐨𝐫 𝐏𝐡𝐚𝐬𝐞 𝟏𝐛 𝐓𝐫𝐢𝐚𝐥 𝐨𝐟 𝐓𝐔𝐍𝐄-𝟒𝟎𝟏 𝐢𝐧 𝐂𝐡𝐫𝐨𝐧𝐢𝐜 𝐇𝐞𝐩𝐚𝐭𝐢𝐭𝐢𝐬 𝐁 Tune Therapeutics Tune Therapeutics has received approval from New Zealand's Medsafe to initiate a Phase 1b clinical trial for TUNE-401, the first epigenetic silencing therapy to target chronic Hepatitis B (HBV). This groundbreaking approach leverages Tune's proprietary lipid nanoparticle (LNP) technology to deliver RNA encoding an epi-silencing protein that inactivates HBV DNA and cccDNA without cutting or editing the genome. Dr. Ed Gane, Principal Investigator for the trial, emphasized, "Epigenetic silencing has the potential to achieve sustained disease remission with a finite course of treatment." Key Highlights: First-in-human trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of TUNE-401. Aims to achieve functional cures by shutting down HBV "viral factories" at the epigenetic level. Trial to begin in Auckland, New Zealand, with results to be presented at the AASLD Liver Meeting on November 18. “TUNE-401’s unique mechanism could deliver long-awaited benefits for HBV patients,” said Derek Jantz Derek Jantz, CSO of Tune Therapeutics. #TuneTherapeutics #Epigenetics #HepatitisB #TUNE401 #LiverDisease #ClinicalTrials #PrecisionMedicine #GeneticMedicine #GlobalHealth #AASLD2024

2

Off the back of Celosia’s very exciting funding announcement last week, Celosia Therapeutics is pleased to share a video interview with CEO Dr Kathryn Sunn. Key highlights in this video include:   🌟 Dr Sunn’s career background and joining Celosia 🌟 ALS disease, current treatment landscape and the significance of Celosia’s lead program CTx1000 🌟 Celosia’s Series A fundraising 🌟 Trends and challenges in research commercialisation in recent years   To watch the full interview, please visit Celosia’s website via this link: https://lnkd.in/gzCZJU6i   #ALS #treatment #drugdevelopment #researchcommercialisation  

32

1 Comment

I’ll be attending the Ausbiotech conference and available to meet with companies looking to enhance their clinical trial designs and manage key data assets more effectively. If you're aiming to streamline your data management processes and optimize trial outcomes, let’s connect. #Ausbiotech #ClinicalDataManagement #ClinicalTrialDesign #Biotech #Medtech

27

𝐖𝐡𝐢𝐥𝐞 𝐦𝐨𝐬𝐭 𝐛𝐢𝐨𝐭𝐞𝐜𝐡𝐬 𝐟𝐨𝐜𝐮𝐬 𝐨𝐧 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭, 𝐀𝐮𝐬𝐩𝐞𝐫𝐁𝐢𝐨 𝐭𝐚𝐫𝐠𝐞𝐭𝐬 𝐭𝐡𝐞 𝐮𝐥𝐭𝐢𝐦𝐚𝐭𝐞 𝐩𝐫𝐢𝐳𝐞—𝐚 𝐟𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐚𝐥 𝐜𝐮𝐫𝐞. 𝐇𝐞𝐫𝐞’𝐬 𝐰𝐡𝐲 𝐭𝐡𝐢𝐬 𝐜𝐡𝐚𝐧𝐠𝐞𝐬 𝐞𝐯𝐞𝐫𝐲𝐭𝐡𝐢𝐧𝐠. AusperBio just secured $73M in Series B financing to advance its groundbreaking therapy, AHB-137, aiming for a functional cure for chronic Hepatitis B. Unlike traditional approaches that focus on managing symptoms, AusperBio’s proprietary Med-Oligo™ platform is disrupting the landscape with targeted oligonucleotide therapies. This funding will not only accelerate clinical trials but also enable global-scale operations and expansion of their therapeutic pipeline. AHB-137’s progress signifies a paradigm shift in treating one of the world’s most challenging chronic diseases. 𝐀𝐬 𝐚 𝐥𝐞𝐚𝐝𝐞𝐫 𝐢𝐧 𝐛𝐢𝐨𝐭𝐞𝐜𝐡 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧, 𝐡𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐬𝐞𝐞 𝐭𝐚𝐫𝐠𝐞𝐭𝐞𝐝 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬 𝐥𝐢𝐤𝐞 𝐀𝐇𝐁-137 𝐢𝐧𝐟𝐥𝐮𝐞𝐧𝐜𝐢𝐧𝐠 𝐭𝐡𝐞 𝐛𝐫𝐨𝐚𝐝𝐞𝐫 𝐥𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞 𝐨𝐟 𝐜𝐡𝐫𝐨𝐧𝐢𝐜 𝐝𝐢𝐬𝐞𝐚𝐬𝐞 𝐭𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭? Yiming Yin, Justin Tan, Nan (Alan) Zhao, Ph.D., Yingbin (Jean) Xu, Way Tang, PhD, Jack Ding, Jack Ding, Dr. Hui Wu, Jianyu W., Mingjiu Chen Sam Fan, Sheng Liu, Yoon Pin Lim, Yerriswamy Manchi, Samuel Gan Yong Chang, Yiming Yin, Justin Tan, Leo Liang, 𝐋𝐞𝐚𝐫𝐧 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐮𝐬 ▶️ https://lnkd.in/ed_mKpkF #AusperBio #BiotechInnovation #ChronicHepatitisB #FunctionalCure 

8

1 Comment

#AusBiotech started! Our Principal Data Scientist and Business Development Manager Sebastian Rauschert is representing us there so feel free to reach out for a chat about bioinformatics, biostatistics, data science and drug discovery!

5