On August 23, 2023 Disruptive Pharma reported positive results from its recent preclinical study for DPH001 (Press release, Disruptive Pharma, AUG 23, 2023, View Source [SID1234649944]). With its innovative MMC technology, researchers at Disruptive Pharma have engineered an improved sorafenib formulation intended for the treatment of hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC). DPH001, confirms its bioequivalent exposure profile at 50% API dose compared to NEXAVAR Our data show that the MMC sorafenib formulation of DPH001 achieved the 2X absorption and reduced inter-animal variability which was the goal of the PK study. The animals were given MMC sorafenib formulation, at 50% API dose, and NEXAVARat standard API dose. CEO Peter Åsberg: "we look forward to continue developing DPH001 which will bring an important improvement for patients with HCC/RCC. We believe it can have a major impact on the market and have a positive impact for the patients in terms of an improved side-effect profile undergoing sorafenib treatment. We’re really excited about our upcoming work and the commercial opportunities we see that DPH001 can bring as well as being a demonstrator on how the patented MMC technology may be utilized to create improved versions of marketed products."

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Furthermore, Åsberg highlighted the broader potential of Disruptive Pharma’s MMC technology, which could pave the way for enhanced versions of existing products, stating, "DPH001 serves as a prime example of how our patented MMC technology can be harnessed to create superior iterations of marketed products. This not only demonstrates our commitment to innovation but also underscores our dedication to improving patients’ lives."

On August 23, 2023 WuXi Biologics reported its Interim results for the six months ended June 30, 2023 (Filing, 3 mnth, JUN 30, WuXi Biologics, 2023, AUG 23, 2023, View Source [SID1234634973]).

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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

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On August 23, 2023 Arcus Biosciences (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that its management team will participate in the following upcoming investor conferences in September (Press release, Arcus Biosciences, AUG 23, 2023, View Source [SID1234634665]):

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2023 Wells Fargo Healthcare Conference
Date: Wednesday, September 6th, 2023 at 10:15 a.m. ET
Location: Boston, MA
Format: Fireside Chat

Citi 18th Annual BioPharma Conference
Date: Wednesday, September 6th, 2023 at 3:30 p.m. ET
Location: Boston, MA
Format: Company Panel — Immuno-Oncology

Morgan Stanley 21st Annual Global Healthcare Conference
Date: Tuesday, September 12th, 2023 at 4:15 p.m. ET
Location: New York, NY
Format: Fireside Chat

2023 Cantor Fitzgerald Global Healthcare Conference
Date: Tuesday, September 26th, 2023 at 10:20 a.m. ET
Location: New York, NY
Format: Fireside Chat

Live webcasts of the fireside chats and panel will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. Replays will be available following the live event.

On August 23, 2023 Australian biotech company Ferronova reported that it has signed a licensing agreement with the Purdue Research Foundation (PRF) for the application of PRF’s patented Fibroblast Activation Protein (FAP) inhibitor in magnetic resonance imaging (MRI) and MRI-guided therapies (Press release, Purdue Research Foundation, AUG 23, 2023, View Source [SID1234634664]).

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The licensing agreement will bring together Ferronova’s patented FerroTrace platform, a super-paramagnetic iron-oxide nanoparticle (SPION) formulation, and PRF’s patented FAP inhibitor in a combination to be applied in targeted radiotherapy of difficult cancers with complicated treatment margins such as glioblastoma, prostate cancer and pancreatic cancer.

"Purdue researchers are the driving force behind world changing innovations, and our partnership with Ferronova serves as yet another testament to our dedication to partnering with companies that can improve the world and save lives with Purdue technologies," said Brooke Beier, senior vice president of Purdue Innovates. "This is an example of intellectual property protection from the laboratory of a world-renowned Purdue innovator, and we are excited about the boundless potential of many more Purdue technologies that will make an impact."

In recent years, FAP has received increasing attention as a cancer treatment target, due to its prominent expression in solid tumours but virtual absence from healthy tissues.1 Led by renowned researcher Philip Low, the Presidential Scholar for Drug Discovery and Ralph C. Corley Distinguished Professor for Chemistry at the Purdue University College of Science’s Department of Chemistry, researchers at Purdue University developed an FAP inhibitor that works by inhibiting a pathway associated with the formation of cancer-associated fibroblasts (CAFs), cells that regulate tumour growth. In addition to reducing CAF formation, the inhibitory agent also reduces collagen I formation, a protein that is associated with tumour growth.2

"This licensing and collaboration agreement is great news as it signals a new approach in targeted radiotherapy for the treatment of glioblastoma," said Associate Professor Hien Le, a radiation oncologist at South Australia (SA) Health, Head of Research at the Department of Radiation Oncology at Royal Adelaide Hospital (RAH), and Associate Professor at the University of South Australia. "We look forward to the collaboration and progressing the new approach to the clinic to see how the combination of FerroTrace and the FAP inhibitor will impact practice in glioblastoma."

Ferronova is collaborating with the University of South Australia and the University of Sydney on the development of FerroTrace and the FAP inhibitor. The program is funded by a Cooperative Research Centres Project (CRC-P) grant with other partners including Siemens, The Australian Bragg Centre for Proton Therapy and Research, the South Australian Health and Medical Research Institute (SAHMRI) and the University of Sydney.

Glioblastoma is the most common and aggressive primary malignant tumour of the central nervous system, and the current standard of care comprises cytoreductive surgery followed by adjuvant chemoradiotherapy. However, despite aggressive chemoradiotherapy and maximum surgical resection, survival in patients with glioblastoma remains poor with a median overall survival of 13.5 months, and 5-year survival rates of only 5.8%.3

"There is an urgent need for glioblastoma-specific agents to distinguish between glioblastoma and surrounding normal tissue," noted Ferronova CEO, Stewart Bartlett. "We are hopeful that this collaboration will change that, and in future, have a positive impact on the management of patients with this tragic disease."

On August 23, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported its financial results for the half-year ended 30 June 2023 (Press release, Telix Pharmaceuticals, AUG 23, 2023, View Source [SID1234634663]). All figures are in AUD$ unless otherwise stated.

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Financial highlights

Total Group revenue $220.8M – a nine-fold increase on H1 2022 ($24.0M) reflecting continued growth in sales of its prostate cancer imaging agent, Illuccix (kit for the preparation of Ga 68 gozetotide injection), since U.S. commercial launch in April 2022 (H1 2022)
Net loss after tax $14.3M, an 80% reduction on H1 2022 (net loss $70.9M) including a non-cash adjustment of $36.6M (H1 2022: $5.7M) reflecting the strong commercial performance of Illuccix. The contingent consideration liability reflects future variable payments based on percentages of Illuccix sales
Adjusted earnings before interest, tax, depreciation, amortisation and research and development (Adjusted EBITDAR) was $82.4M (H1 2022: loss of $28.0M), demonstrating the profitability of the commercial organisation
Gross margin was 64% (compared to 56% in H1 2022) reflecting normalised operating expenditure
Transition to positive operating cash flow was driven by growth in commercial sales and expenditure control
Closing cash balance was $131.7M at 30 June 2023 (31 December 2022: $116.3M)
Operational highlights

Positive growth outlook for Illuccix in the U.S. and globally as market adoption increases
Supplemental new drug application (sNDA) for Illuccix approved by the U.S. Food and Drug Administration (FDA), label expanded in the U.S. to include selection of patients for PSMA[2]-directed 177Lu radioligand therapy[3]
Operational focus on preparation of regulatory submissions and commercial launch readiness for renal (TLX250-CDx) and glioma (TLX101-CDx) imaging candidates
Completion of the ProstACT SELECT study of TLX591 for prostate cancer therapy,[4] with first data readout expected Q4 2023. ProstACT GLOBAL study on track to begin patient dosing at Australian sites imminently
New studies initiated exploring the carbonic anhydrase IX (CAIX) program in indications beyond kidney cancer, including STARBURST,[5] a ‘basket’ study exploring multiple theranostic targets and STARSTRUCK,[6] a study of TLX250 investigational therapy in combination with a DNA damage repair inhibitor candidate
Multiple studies of TLX101 glioblastoma therapy candidate progressing, including dosing of first patients in IPAX-2 in newly diagnosed patients[7]
Multiple studies progressing with Grand Pharmaceutical Group Limited in China, including bridging studies to support regulatory filings for Illuccix[8] and TLX250-CDx,[9] and approval to commence the Phase I IPAX-China study of TLX101 investigational therapy[10]
Completed stage one of the buildout of Telix Manufacturing Solutions, our European radiopharmaceutical production facility located in Brussels South, Belgium[11]
Agreements to acquire Lightpoint Medical and its SENSEI radio-guided surgery business,[12] and Dedicaid GmbH[13] and its artificial intelligence-based platform enhance Telix’s product offering
Dr Christian Behrenbruch, Managing Director and Group Chief Executive Officer commented on the result: "Telix has delivered an excellent result across all key financial metrics. The business has demonstrated its ability to commercialise successfully, delivering an impressive $218.3M in total revenue from Illuccix sales[14] in H1 2023, with sustained growth in demand since launch.

"Importantly, Telix has transitioned to positive earnings on an adjusted EBITDAR basis signalling the profitability of our commercial organisation.

"We have a positive outlook for continued growth in commercial sales of Illuccix, based on an expanding global PSMA PET imaging market, and expect to see Telix launch two new products in 2024 for brain and kidney cancer imaging, subject to regulatory approval.

"The business is making great progress across its therapeutic programs and, with a number of exciting clinical milestones ahead, will further demonstrate the value and differentiation of its industry-leading pipeline."

Investor Call

An investor webcast will be held at 8.30am AEST on Thursday 24 August 2023 (6.30pm EDT, Wednesday 23 August 2023)

Participants can register for the webcast and find audio call details at the following link: View Source server.com/mmc/p/2sr9bunm