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Oncology One announces new drug discovery project with Children’s Cancer

On August 21, 2021 Oncology One reported a new partnership with Children’s Cancer Institute to develop new drugs for the treatment of childhood solid tumours (Press release, Oncology One, AUG 26, 2021, View Source [SID1234629325]).

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The partnership is focused on the development of novel small molecule drugs to treat neuroblastoma, a type of tumour that forms in the adrenal glands (above the kidney), or near the spine, chest, neck, or pelvis.

The chance of a child developing neuroblastoma is approximately 1 in 100,000 and it is the most prevalent extracranial solid tumour in children under five years old. Neuroblastoma is a serious condition with limited effective treatment options and accounts for 15% of all childhood cancer deaths in Australia. There is an urgent and unmet need for improved therapeutics to treat this cancer.

The project will be run in collaboration with Children’s Cancer Institute’s new childhood disease-focused drug discovery initiative, THerapeutic INnovations for Kids (THINK), and the project is based on the research of Associate Professor Tao Liu, head of the Gene Dysregulation Group also based at the Institute.

Associate Professor Tao Liu’s work has identified a novel protein target that drives tumour growth and is a critical regulator of gene expression in neuroblastoma. The collaboration will initially seek to identify small molecule compounds that inhibit the tumour-driving biological activity of the target. This work involves the screening of hundreds of thousands of compounds using specialised assays developed specifically for this novel target.

Oncology One CEO, Dr Joanne Boag, said: "There is a real lack of funding in Australia to undertake the translational work we are doing in partnership with Children’s Cancer Institute. We are really excited to be working with them on this project, the next step in building on their quality research outcomes towards potential new therapies."

If successful, further work will be needed to develop these compounds towards a ‘lead candidate’ and then a ‘clinical candidate’ that would become an investigational new drug and enter clinical trials.

Chair of the Oncology One Scientific Advisory Board, Dr Ian Street, said: "This project, if successful could dramatically improve treatment outcomes for children with neuroblastoma, and potentially other paediatric and adult cancers as well. This is an early-stage drug discovery project, the first step in the journey of translating a "great Idea" from fundamental research into a new drug for treating patients. This gap is often referred to as the "valley of death" and many commercial investors shy away from early-stage projects. At Oncology One we refer to it as the "Valley of Opportunity" and have developed a unique commercial strategy to partner with research institutions to move these opportunities forward."

Children’s Cancer Institute Executive Director, Professor Michelle Haber AM, said: "We are delighted to be partnering with Oncology One to translate our research from target discovery to drug development. At Children’s Cancer Institute, we are passionate about curing childhood cancer. Cancer kills three children every week in Australia, and of those who survive, 70% will suffer long-term side effects from their non-targeted and aggressive treatments. There is therefore a clear unmet need for new targeted therapies to be specifically designed to treat childhood cancers, and we look forward to working towards this goal with Oncology One."

APS Announces Successful Completion of Pre-IND Meeting With FDA

On August 26, 2021 APS reported that successfully completed the Pre-IND meeting with the US Food and Drug Administration (FDA) (Press release, Applied Pharmaceutical Science, AUG 26, 2021, View Source [SID1234613103]). APS plans to conduct a clinical trial of next-generation RET inhibitor APS03118 in patients not limited by tumor type, under the US IND . The patients with RET-positive non-small cell lung cancer, thyroid cancer or other solid tumors that develop resistance to RET inhibitors will be recruited in the study to investigate the safety and efficacy of APS03118. At the meeting, the FDA provided feedback regarding APS’s planned initiation of clinical trials under a U.S. IND for its lead next-generation RET inhibitor APS03118.

Fourth Indication for Boan Biotech’s Boyounuo (Bevacizumab Injection) Approved in China

On August 26, 2021 Boan Biotech reported that Boyounuo (Bevacizumab Injection), an self-developed anticancer biologic, has been approved by China’s National Medical Products Administration for the treatment of hepatocellular carcinoma (HCC) (Press release, Boan Biotech, AUG 26, 2021, View Source [SID1234595077]). It is the fourth indication approved for Boyounuo, with the first three indications being for advanced, metastatic or recurrent non-small-cell lung cancer, metastatic colorectal cancer, and recurrent glioblastoma. The latest approval gives liver cancer patients a new treatment option and will enable Boyounuo to serve a broader patient population.

Liver cancer is a common malignancy in China, and the disease has a high morbidity and a high mortality rate. HCC is the most common form of liver cancer, accounting for around 90% of all cases . According to data from the World Health Organization’s International Agency for Research, 910,000 new cases of liver cancer were reported worldwide in 2020, of which 410,000 occurred in China, accounting for over 45% of the world total. In China, liver cancer has become the second most deadly form of cancer: 390,000 deaths were reported in 2020, close to the number of new cases the same year . The 5-year survival rate for liver cancer patients in China was only 12.1% , indicating high incidence and low survival. The disease severely affects life and health of China’s population and places a significant healthcare burden on society and patient’s families.

Due to its insidious onset, most liver cancer patients have already reached the middle to late stage of the disease at the time of initial diagnosis, when radical surgery is no longer a treatment option. The prognosis, especially for patients with unresectable HCC, is poor: patients have few options for systemic treatment and the 1-year survival rate after diagnosis is less than 50% . Bevacizumab in combination with atezolizumab is the first first-line treatment for advanced HCC to achieve positive results in more than a decade. The combination therapy overcomes common factors which lead to poor prognosis of HCC by leveraging a unique mechanism of immunotherapy together with the regulatory effects of anti-angiogenic therapy on the immune microenvironment. Compared to first-line therapies for HCC prior to this combination, patients with advanced unresectable HCC who receive the combination therapy are able to live longer and enjoy better quality of life. Bevacizumab in combination with atezolizumab is also the first approved first-line immune combination therapy for unresectable HCC and has been listed as a first-line treatment option for liver cancer by several authoritative guidelines in China and around the world with the best level of evidence and the highest level of recommendation.

Boyounuo is an anti-VEGF humanized monoclonal antibody injection developed by Boan Biotech. It is a biosimilar to Avastin. Comparative clinical studies have shown that Boyounuo is highly similar to Avastin in terms of PK characteristics, efficacy, safety and immunogenicity.

Dr. Dou Changlin, R&D President and COO of Boan Biotech, said, "We are delighted to see the approval of another indication for Boyounuo. Bevacizumab is one of the standard therapies used in the treatment of malignant tumors. We anticipate that Boyounuo will help serve more patients and contribute to the better management of cancers in China."

New Studies Published on SDH Models and GIST Research

On August 26, 2021 The Life Raft Group reported that Two new studies were published in July and August 2021 focusing on SDH-deficient tumor models and how location can affect GIST tumor profiles and drug sensitivity (Press release, The Life Raft Group, AUG 26, 2021, View Source [SID1234594778]). Establishment of Patient-derived Succinate Dehydrogenase-deficient Gastrointestinal Stromal Tumor models for predicting therapeutic response was published this week detailing an ongoing study of mutant SDH GIST tumor models focusing on molecular characterization and drug discovery. These patient-derived mSDH GIST models showed recapitulation of the transcriptional and metabolic hallmarks of parent tumors and SDH-deficiency. The study further demonstrated that temozolomide (ClinicalTrials.gov Identifier: NCT03556384), a drug currently in trial, elicits DNA damage and apoptosis in the models. They have successfully translated these discoveries to a cohort of SDH-mutant GIST patients and seen promising results.

"One of the major impediments to treating GIST is the misbelief that this disease is easily curable," said Jason Sicklick, MD, professor of surgery in the Division of Surgical Oncology at University of California San Diego School of Medicine, and a GIST specialist. But in reality, we know this is not the case. Even patients with tumors predicted to be sensitive to certain drugs rarely have complete responses to therapy. There is more to the biology that needs to be discovered."

Among the esteemed team of co-authors are Pediatric & SDH-Deficient Consortium & LRG Medical Advisory Board members Dr. Jason Sicklick, and Dr. Michael Heinrich of the OHSU Knight Cancer Institute, and a frequent speaker at LRG webinars on pathology Christopher Corless (OHSU).

UC San Diego Health published an article with more details about this study and Location of Gastrointestinal Stromal Tumor (GIST) in the Stomach Predicts Tumor Mutation Profile and Drug Sensitivity, published in July 2021.

In this earlier paper, published July 29, 2021, Sicklick and colleagues analyzed where GIST tumors arise in the stomach (the most common site) and their underlying mutations, suggesting that location may be an early clue to mutational type to guide optimal treatment.

Among the co-authors on this study are Dr. Sicklick, Dr. Heinrich, and Dr. Andrew Blakely from National Cancer Institute, who has participated in many LRG Virtual Tumor Boards and written articles for the LRG.

UC San Diego included many details about the scope of the studies and the funding sources in this article.

Cardinal Health™ Nuclear & Precision Health Solutions and IRE ELiT support the growing demand for Ga-68 labeled radiopharmaceuticals

On August 26, 2021 Cardinal Health (NYSE: CAH) and IRE ELiT (the radiopharmaceutical subsidiary of IRE Group) reported that are working to expand patient access to novel radiopharmaceuticals for Positron Emission Tomography (PET) imaging as demand in the United States (U.S.) continues to grow (Press release, Cardinal Health, AUG 26, 2021, View Source [SID1234591440]). Cardinal Health is the preferred U.S. distributor of the IRE ELiT 100 mCi Germanium-68/Gallium-68 radionuclide generator (Ge-68/Ga-68 Galli Eo generator) in support of clinical investigational trials, pre-commercial research and post-approval commercial sales in the U.S. and its territories, including Puerto Rico.

Designed for the on-site preparation of Ga-68 radiolabeled pharmaceuticals, IRE ELiT modified its Ge-68/Ga-68 Galli Eo generator to double its activity from 50 mCi to 100 mCi. This activity enhancement will enable the Nuclear & Precision Health Solutions business of Cardinal Health to increase preparation of Ga-68 radiolabeled pharmaceuticals, which are approved and under investigation for many cancers.

The new, higher-activity 100 mCi generator provides users with more flexibility by increasing the number of daily elutions and the activity in each elution, ultimately increasing the number of patients that can be served. "As a leading U.S. provider of Ga-68 radiopharmaceuticals, Cardinal Health commends IRE ELiT for their efforts to increase the activity of Ge-68/Ga-68 Galli Eo generators," said Mike Pintek, president of Cardinal Health Nuclear & Precision Health Solutions. "Ultimately, this will allow us to better supply medical providers, and their patients, with current and future novel Ga-68 diagnostics."

"Increasing the activity of our Galli Eo generator is a critical part of our plan to meet the exponential demand for Ga-68 radiolabeled pharmaceuticals in the U.S.," said Erich Kollegger, chief executive officer of IRE ELiT. "Combining the expertise of our R&D department with the experience of our production team, IRE ELiT is prepared to produce and supply Cardinal Health with these high-activity generators."

While the activity of the Ge-68/Ga-68 Galli Eo generator has increased, the footprint of each unit will remain the same to ensure Cardinal Health can seamlessly transition to the new 100 mCi Ge-68/Ga-68 Galli Eo generators without impact to the pharmacy.

Cardinal Health currently has the majority of its more than 130 nuclear pharmacies licensed for Gallium-68 and plans to license them all to expand patient access to PET imaging.