On June 23, 2022 GTC reported that it is honored to participate in a webinar hosted by RUNX1 and the MDS Foundation: Get Free Access to Genetic Testing for Underserved MDS and Hematologic Malignancy Patients (Press release, Genomic Testing Cooperative, JUN 23, 2022, View Source [SID1234618944])

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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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The event will take place on June 23rd at 12:00 PM PST or 3 PM EST.

Register link: https://bit.ly/WebinarJune23

Agenda:

Intro:

Tracey Iraca, Executive Director – MDS Foundation

Katrin Erickson, Executive Director – RUNX1

Making Diagnosis of Hematologic Neoplasms in the Era of Genomics Available to All by Dr. Maher Albitar, CEO/CMO of Genomic Testing Cooperative

Value of Molecular Profiling for MDS by Dr. Rafael Bejar, UCSD Moores Cancer Center

Q&A

Please register by Tuesday, June 22nd. Upon registering, you will receive an email with a webinar link and a PASSWORD to connect through Zoom.

On June 23, 2022 Minomic International Ltd reported that it has taken a step forward to bring the MiCheck Prostate test to Australians (Press release, Minomic, JUN 23, 2022, View Source [SID1234616197]).

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MiCheck Prostate detects aggressive prostate cancer overcoming the low accuracy of conventional screening tests, reducing unnecessary intervention such as painful biopsies and improving overall management of the patient.

The performance of MiCheck Prostate is supported by numerous clinical studies, including a recent one at Macquarie University Hospital, that found that MiCheck Prostate has a sensitivity of 93% and a specificity of 45%.

With testing available now at selected Sonic Healthcare Australia Pathology laboratories, Minomic can offer MiCheck Prostate to many more Australian men.

Minomic CEO Dr Brad Walsh says the availability of the test will help Australia’s urologists to provide better patient care; "The use of MRI for the detection of prostate cancer, in Australia, has been a revolutionary step forward in the early and accurate detection of this cancer. MRI, when combined with results from MiCheck Prostate provide urologists with an additional aid in clinical decision-making before proceeding to more invasive investigations such as biopsy."

"The test is now market ready in both Australia and the US, while China and other markets such as Europe are also in our sights."

An estimated 25,000 Australian men and two million American men undergo biopsies each year to diagnose prostate cancer after an elevated Prostate-Specific Antigen (PSA) test result. Approximately 50% of these biopsies are unnecessary as the patient does not have cancer or has a low-grade cancer that requires monitoring rather than intervention. In addition, 1-3% of these biopsies can lead to sepsis and death. These unnecessary biopsies lead to patient anxiety and pain that should be avoided.

Prostate cancer remains an ongoing global challenge. Each year around 250,000 men in the US and 20,000 men in Australia are diagnosed with prostate cancer. It is estimated that 1 in 8 males will be diagnosed with a prostate cancer in their lifetime.

Minomic opened a capital raise earlier this year to take the test to market in both Australia and the US ahead of a planned stock market listing in 2023. Last year it received a $400,000 co-investment from the Advanced Manufacturing Growth Centre’s (AMGC) Commercialisation Fund and the Federal Government’s Modern Manufacturing Initiative.

Minomic has established a US based marketing team and obtained a CLIA license enabling availability of MiCheck Prostate in the world’s largest healthcare market.

On June 23, 2022 McKesson Corporation (NYSE: MCK) and HCA Healthcare, Inc. (NYSE: HCA) reported an agreement to form a joint venture combining McKesson’s US Oncology Research (USOR) and HCA Healthcare’s Sarah Cannon Research Institute (SCRI) (Press release, McKesson, JUN 23, 2022, View Source [SID1234616213]). USOR is the research arm of McKesson’s The US Oncology Network and draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. SCRI, which is the research arm of Sarah Cannon, HCA Healthcare’s Cancer Institute, offers end-to-end clinical trial site support services with a deep expertise in early-phase oncology research and drug development as well as a specialized contract research organization (CRO).

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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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Together, USOR and SCRI will create a fully integrated oncology research organization aimed at expanding clinical research, accelerating drug development and increasing availability and access to clinical trials for community oncology providers and patients, including those in underserved communities. The joint venture plans to offer an expanded clinical research network, a broader portfolio of clinical trials, and enhanced data and analytics capabilities to better match patients with clinical trials.

"McKesson and HCA Healthcare share a commitment to advancing the next generation of cancer care," said Brian Tyler, chief executive officer, McKesson. "This new joint venture is an important step forward in increasing access to clinical trials, particularly within the community setting, where the majority of all cancer patients are initially treated. Additionally, the joint venture directly aligns with McKesson’s strategic growth priorities by further expanding our differentiated oncology ecosystem and improving the value proposition for provider and biopharma partners."

"Clinical research and partnerships are fundamental to how we address our communities’ most pressing healthcare needs," said Sam Hazen, chief executive officer of HCA Healthcare. "We believe this joint venture with McKesson, which unifies our oncology research experts, will promote the development of individualized therapies and provide more opportunities for cancer patients to receive new treatments."

The transaction is expected to close in 2022. Following the close of the transaction, McKesson will own 51% of the joint venture and have operating control. The joint venture will be governed by a Board of Directors with representation from both McKesson and HCA Healthcare. The new company will be led by SCRI’s Dee Anna Smith, who will serve as chief executive officer, and SCRI’s Howard A. "Skip" Burris, III, MD, who will serve as president. Additionally, USOR’s Robert Coleman, MD will become the new organization’s chief medical officer and SCRI’s David Spigel, MD will be its chief scientific officer.

"When it comes to the fight against cancer, building a network of collaborators is essential. Our impact on patients is evident through our longstanding partnerships with experts from Tennessee Oncology, Florida Cancer Specialists and many other valued oncology programs," said Dee Anna Smith, chief executive officer of Sarah Cannon. "In the last three decades, our collaborations have led to advancing treatment standards for the majority of new cancer therapies that are available to patients today. We believe that coming together with US Oncology Research will complement and strengthen our network so that we can continue to make a greater impact for people living with cancer."

Separately, McKesson will acquire Genospace, SCRI’s personalized medicine platform. Genospace is a leading innovator in precision medicine and clinical trial matching. By becoming a part of McKesson, Genospace will power the oncology data and analytics capabilities for the joint venture as well as enhance the ability of its provider partners to more efficiently identify the most appropriate therapies or clinical trials for their patients.

Research is essential to advancing cancer care from diagnosis through survivorship, and as such, the joint venture will enhance both companies’ cancer care offerings. McKesson’s The US Oncology Network and HCA Healthcare’s cancer network, Sarah Cannon Cancer Institute, are not part of the transaction and will continue to operate independently of the joint venture.

Financial terms of the agreement were not disclosed. The transaction is subject to necessary regulatory approvals and other customary closing conditions.

On June 23, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported its unaudited financial results for the six months ended 31 March 2022 (Press release, Redx Pharma, JUN 23, 2022, View Source [SID1234616229]).

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Lisa Anson, Chief Executive Officer, Redx Pharma, said: "We have made strong progress across all aspects of our pipeline. Importantly, we have moved our lead oncology asset, RXC004, into Phase 2 clinical studies; reported encouraging Phase 1 clinical results for our lead fibrosis asset, RXC007; and nominated our next development candidate, RXC008. We expect RXC008, a GI targeted ROCK inhibitor with the potential to be a first-in-class treatment for fibrostenotic Crohn’s disease, to be ready to enter the clinic by the end of 2023. Together with the recent acceptance of the IND submission for the pan-RAF inhibitor, JZP815, by our partner, Jazz Pharmaceuticals, Redx has demonstrated strong progress across all aspects of our pipeline-a testament to the world class abilities of our drug discovery team."

"In addition to our strong pipeline progress, we were particularly pleased, post-period, to have completed a £34.3 million (gross) placing of our shares. These proceeds will fund our development plans through the end of 2023. We were delighted to receive strong support from all our existing investors as well as welcoming a new specialist healthcare investor, Invus."

Operational Highlights
· Significant clinical progress on lead oncology asset, RXC004, an oral, potent, selective, small molecule Porcupine inhibitor: o In November 2021, initiated PORCUPINE, a Phase 2 trial in genetically selected MSS metastatic colorectal cancer, with US Investigational New Drug (IND) now open; o In January 2022, initiated PORCUPINE2, a second Phase 2 trial in genetically selected pancreatic cancer and unselected biliary cancer.
· On 10 March 2022, Redx presented encouraging Phase 1 safety data for RXC007, an oral selective Rho Associated Protein Kinase 2 (ROCK2) inhibitor with potential for development in multiple fibrotic conditions: o Data showed an excellent safety and pharmacokinetic profile in both the Single Ascending Dose (SAD) and multiple dose cohorts. 23/06/2022, 10:43 View Source View Source 2/25
· On 30 March 2022 nominated RXC008, a Gastrointestinal (GI) targeted Rho Associated Coiled-Coil Containing Protein Kinase (ROCK) inhibitor, as the Company’s next clinical development candidate: o RXC008 is a potential first-in-class treatment for fibrostenotic Crohn’s disease, which has shown strong anti-fibrotic effects in preclinical models. · Progressed the discovery portfolio with the announcement on 27 January 2022 of the Company’s Discoidin Domain Receptor (DDR) inhibitor fibrosis programme: o Developed potent proprietary DDR inhibitors with drug-like characteristics that are now in the lead optimisation phase.
· Advanced preclinical and clinical collaborations with world-leading institutions to enhance the Company’s research capabilities: o Entered a strategic partnership with Caris Life Sciences in December 2021 to accelerate Phase 2 study recruitment in the US for the RXC004 PORCUPINE clinical trial; o Post-period, in April 2022, expanded our collaboration with the Garvan Institute of Medical Research to investigate novel therapeutic targets in cancer-associated fibrosis.
· Significantly progressed our partnered programmes with AstraZeneca and Jazz Pharmaceuticals, resulting in milestones totalling $19 million during the period: o On 9 December 2021, a $10 million (£7.4 million) milestone was triggered from Jazz Pharmaceuticals for the progress in the oncology research collaboration focused on two cancer targets on the MAPK pathway. Post period, one target under this oncology research collaboration with Jazz Pharmaceuticals is confirmed to continue to progress towards an IND application, whilst a second target has been discontinued due to pipeline prioritisation by Jazz given the evolving competitive landscape; o On 23 December 2021, a $9 million (£6.6 million) milestone was triggered from AstraZeneca as RXC006 entered Phase 1 clinical trials; o Post period, on 15 June 2022, Redx announced a milestone of $5 million from Jazz Pharmaceuticals triggered by the US Food and Drug Administration (FDA) clearance of the IND for pan-RAF inhibitor programme, JZP815, which will represent the fifth clinical programme from Redx’s discovery engine to enter the clinic. · Further strengthened the Board of Directors and management team: o Board appointments of Dr Jane Griffiths as Chair from 1 December 2021 and Dr Rob Scott as Non-Executive Director on 27 January 2022; o Established a Science Committee of the Board on 8 March 2022 to oversee Redx’s progress in achieving its scientific and clinical goals; o Appointed Claire Solk on 17 January 2022 to the newly created position of General Counsel.

Financial Highlights

· Cash balance at 31 March 2022 of £31.6 million (31 March 2021 £39.9 million) which includes $19 million in milestone payments received from partnered programmes during the period;
· Successful placing of £34.3 million (gross) completed post-period in June 2022, which received strong support from existing investors and included a new specialist healthcare investor, Invus, which funds the Company’s operations through calendar year 2023, including important Phase 2 proof of concept data readouts for RXC004 and RXC007;
· Post period, on 15 June 2022, Redx also triggered a further milestone payment of $5 million from Jazz; · Increasing investment, reflecting the strong progress in our pipeline, led to increased research and development expenses of £12.9 million (H1 2021: £10.5 million);
· Loss for the period of £9.8 million (H1 2021 £12.7 million). 23/06/2022, 10:43 View Source View Source 3/25 The person responsible for the release of this announcement on behalf of the Company is Andrew Booth, Company Secretary.

On June 23, 2022 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody- and small molecule-based targeted therapeutics, reported an update regarding recent corporate developments (Press release, Philogen, JUN 23, 2022, View Source [SID1234616198]).

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Prof. Dr. Dario Neri, Chief Executive Officer of Philogen commented: "Philogen has made significant progress over the past few months as we continue investing our IPO proceeds to strengthen our GMP manufacturing capacity and speed up patient enrolment in clinical trials. We are particularly pleased with the progress of our Phase III European study investigating Nidlegy treatment of Stage IIIB/C melanoma, of which we have nearly completed patient recruitment.

Fibromun’s trials in soft-tissue sarcoma are also ongoing in the U.S., Germany, Poland, Spain, and Italy (France planned), with the participation of leading clinical centers. We expect to have more than 30 active clinical centers by the end of this year for the European and US pivotal studies.

My thanks go to our investors and to everyone at Philogen for their hard work and unwavering support."

MAIN EVENTS AND RECENT HIGHLIGHTS

Proprietary products

Nidlegy is a pharmaceutical product, proprietary to Philogen, consisting of two active ingredients, L19IL2 and L19TNF. The L19 antibody is specific to the B domain of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are inflammatory cytokines with anti-tumor activities
Phase III European study in Stage IIIB/C melanoma
211 out of 214 patients have been recruited. The trial will read when 95 events (tumor recurrence or patient death) have occurred, as per protocol
21 clinical centers opened in Germany, France, Italy, and Poland
Phase III U.S. study in Stage IIIB/C melanoma
13 clinical sites are currently open. We expect to have more than 25 centers active by the end of 2022 to speed up recruitment
Non-melanoma skin cancer
Progress in Phase II studies ongoing in France, Germany, Poland, and soon in Italy
Fibromun (L19TNF) is a pharmaceutical product, proprietary to Philogen, consisting of the L19 antibody fused to TNF
European Phase III study in metastatic/advanced soft-tissue sarcoma
32 patients have been recruited. The recruitment rate of patients is progressing according to planned timelines
10 clinical centers opened in Germany, Spain, Italy, and Poland. We expect to have more than 20 centers active by the end of 2022
Phase I/II study in glioblastoma at first progression
The Phase I dose escalation part of the study is exploring different doses of Fibromun and Lomustine (3-6 subjects per cohort)
Cohort 1 has been completed with 6 patients.
Recruitment for cohort 2 is ongoing, with 4 out of 6 patients recruited.
The historical objective response rate (ORR) for recurrent glioblastoma treated with Lomustine is 4.3-13.9%. The median progression free survival of these patients with lomustine monotherapy is 6 weeks. In unmethylated MGMT tumors, objective responses are virtually never observed (0% ORR) (Wick et al., J Clin Oncol 2010, 28,1168; Weller and Le Rhun et al., Cancer Treat Rev 2020, 87,102029). In cohort 1, we observed durable major responses in 2 out of 6 patients which are ongoing for more than 12 months. In addition, 3 patients had disease stabilization for over 4.5 months (follow up ongoing), while one patient had Covid-19 and had to exit the study without receiving the combination treatment.
OncoFAP is a small organic molecule ligand with ultra-high affinity for Fibroblast Activation Protein (FAP)
OncoFAP-radio conjugates
Imaging – excellent targeting properties of 68Ga-DOTAGA-OncoFAP confirmed in more than 50 patients with various types of malignancies.
Therapy – 177Lu-DOTAGA-BiOncoFAP, featuring a bivalent OncoFAP ligand, cures cancer in murine models and has been identified as the therapeutic candidate for clinical development.
Signed a contract with Senn Chemicals to manufacture DOTAGA-BiOncoFAP
OncoFAP-drug conjugates – these drugs consist of (i) the OncoFAP ligand, (ii) a cleavable linker and (iii) a cytotoxic payload, which is released selectively at the tumor site. A novel OncoFAP-drug conjugate, featuring an optimized cleavable linker, is being studied in animal models of cancer and may represent a novel potential clinical candidate.
The R&D center in Zürich has recently generated promising novel prototypes, including a highly active small molecule drug conjugate targeting PSMA. The company is well poised for the definition of the clinical candidates to be moved into the clinic in 2023.