On November 2, 2020 AIVITA Biomedical, Inc., a private biotechnology company specializing in innovative stem cell applications, reported that treatment has been completed for all 57 patients in the Phase 2 clinical trial of AV-GBM-1 in patients with glioblastoma (Press release, AIVITA Biomedical, NOV 2, 2020, View Source [SID1234569640]). The company was able to manufacture final product at a notable 94% success rate, showing strong commercial and clinical viability.

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The eight-site, single-arm study investigates AV-GBM-1, AIVITA’s novel immunotherapy for the treatment of glioblastoma that targets the autologous tumor-initiating cells responsible for the rapid growth and proliferation of the disease. AIVITA achieved a 97% success rate in both growing tumor-initiating cells from each patient and in collecting sufficient monocytes from the peripheral blood from which to derive dendritic cells, resulting in a 94% overall success rate for manufacturing a final treatment given to patients. AV-GBM-1 was well-tolerated, and no patients experienced severe adverse events attributed to the treatment, and no patients discontinued treatment because of side-effects.

"This milestone brings us closer to having a better understanding of the potential for AV-GBM-1 to effectively treat patients with glioblastoma," said Bob Dillman, M.D., chief medical officer of AIVITA. "With such a high manufacturing success rate and no significant side effects, we are hoping this technology will chart a new path forward in immunotherapy."

Out of the 57 patients who participated in the study, the average number of doses injected was 6.9 out of a possible 8. The study’s primary endpoint is overall survival (OS) from enrollment date of patients treated with AV-GBM-1, with secondary endpoints including progression free survival from enrollment date and OS and PFS from date of surgical resection. AIVITA expects new interim findings to be presented at future medical meetings in November.

AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with glioblastoma, ovarian cancer and melanoma. AIVITA is also seeking conditional commercial approval of its melanoma treatment in Japan.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy, AV-OVA-1, or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and completed treating 57 with the tumor-initiating cell-targeting immunotherapy, AV-GBM-1.

The primary endpoint of the trial is overall survival (OS) and secondary endpoints include progression-free survival (PFS) and OS measured from date of enrollment, OS/PFS measured from date of diagnosis and OS/PFS from date of enrollment based on Karnofsky Performance Status, age, and extent of surgical resection. Tertiary endpoints will include OS/PFS from date of first injection and OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On November 2, 2020 Targovax ASA, reported that Magnus Jäderberg, CMO of Targovax, will present the company at the World Immunotherapy Congress today, Monday 2 November, at 11:20 CET (Press release, Targovax, NOV 2, 2020, View Source [SID1234569639]).

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The presentation will be available to download at www.targovax.com after the event.

About the event

The World Immunotherapy Congress is part of the Festival of Biologics. The Festival of Biologics is the meeting place for the life science community to bridge the gap between academia and industry.

On November 1, 2020 LifeArc reported that it initiated a new strategic collaboration with Cleveland Clinic that aims to accelerate the translation of promising scientific discoveries into new tests and treatments for patients (Press release, LifeArc, NOV 1, 2020, View Source [SID1234573196]).

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The relationship begins with LifeArc sponsoring two new post-doctoral fellowships at Cleveland Clinic’s centre for Therapeutics Discovery located on the main campus within the Lerner Research Institute in Cleveland, Ohio. LifeArc will provide funding for the researchers’ salaries and laboratory supplies over two years.

The fellows will carry out investigative research on early-stage innovative projects in therapeutic areas that closely align with the strategic priorities of both organisations. These include infectious disease; cancer, with a focus on early detection and precision medicine; and neurological disorders, including epilepsy and neuropathic pain. Other key shared areas of interest include diagnostics and biomarker development, to create new tests that enable doctors to tailor treatments to patients.

The Fellows program will be led by Dr. Andy Merritt, director for medicinal chemistry at LifeArc, and Dr. Shaun Stauffer, director of Cleveland Clinic’s Centre for Therapeutics Discovery.

"We are delighted to kick-off this new long-term collaboration with Cleveland Clinic with our shared goal of advancing the translation of early-stage innovative discoveries into new life-changing medicines and diagnostics," said Dr. Merritt.

"Our new funding will help accelerate the fruition of exciting innovative ideas that are currently stuck at the lab bench but have huge potential to make a difference to patients.

"We hope this will help projects to reach a key tipping point, creating new opportunities to collaborate on future research programs where we can contribute our expertise in medicinal chemistry, antibody engineering or diagnostics within LifeArc laboratories."

This new funding aims to foster early-stage research that has high potential to benefit patients but requires further validation before it can be taken into larger research programs. LifeArc will be given the first option to initiate new collaborations with the Cleveland Clinic to advance the most promising discoveries and move them closer towards the clinic.

Cleveland Clinic’s Centre for Therapeutics Discovery, established in 2018, promotes the translation of basic science discoveries by Cleveland Clinic researchers into new therapeutics. Under Dr. Stauffer’s leadership, the centre’s team has established a pipeline of innovative drug discovery research programs directed toward improving patient care with a true bench-to-bedside vision.

"We are extremely excited to work with LifeArc," said Dr. Stauffer. "Their vision for how we discover innovative therapies in the future recognizes that this vision starts with discovery teams truly putting patients first with an emphasis on diagnostics and detection.

"It is our shared goal that by establishing this long-term relationship we will empower translational teams, investigators and clinicians to ask the most compelling questions between basic science and human investigation." (Press release, LifeArc, NOV 1, 2020, View Source [SID1234573196])

On November 1, 2020 China Grand Pharmaceutical and Healthcare Holdings Limited ("GP (HK)" or the "Company", together with its subsidiaries, the "Group", stock code: 00512) reported that the Group has entered into several agreements with Telix Pharmaceuticals Limited (ASX:TLX) ("Telix", together with its wholly owned subsidiaries, the "Telix Group"), Jiangsu Institute of Nuclear Medicine, and Beijing Puer Weiye Biotechnology Co., Ltd. ("Puer Weiye") in the field of radionuclide-drug conjugates ("RDC"), focusing on highly innovative and high-barrier radiological diagnostic and therapeutic drugs (Press release, China Grand Pharmaceutical, NOV 1, 2020, View Source [SID1234569743]).

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The Group has entered into a share Subscription Agreement with Telix Group, pursuant to which the Group will invest US$25 million to subscribe approximately 7.6% equity interests of Telix after fulfilling the relevant conditions stipulated in the Subscription Agreement. Furthermore, the Group has entered into a Licensing Agreement with Telix Group, with upfront prepayment and milestones payments of up to US$225 million in aggregate, and a royalty fee for each licensed product as a percentage of annual net sales amount in the licensed region, pursuant to which the Group will obtain the exclusive development, manufacturing and commercialization rights in Mainland China, Hong Kong SAR, Macau SAR and Taiwan (the "Greater China Region") for Telix Group’s innovative RDC TLX591, TLX250 and TLX101 that have the potential to become First in Class therapy for prostate cancer, clear cell renal cell carcinoma ("ccRCC") and glioblastoma. Lastly, the Group has entered into a Partnership Agreement with Telix Group, pursuant to which the Group will obtain the exclusive commercialization rights in the Greater China Region for Telix Group’s innovative RDC TLX591-CDx, TLX250-CDx and TLX599-CDx ("Licensed Products") that have the potential to become First in Class diagnostic method for cancer detection, and the Group will purchase related products from Telix Group pursuant to the Partnership Agreement. In addition, within a certain future period, the Group will have the first right of negotiating exclusive development, manufacturing and commercialization rights in the Greater China Region for future pipeline products of Telix Group.

Headquartered in Melbourne, Australia, Telix is a biopharmaceutical company focused on the development of innovative cancer diagnostic and therapeutic RDC, using Molecularly Targeted Radiation (MTR) and conjugation technology platform to carry out the development and application of RDC. Telix Group’s pipeline covers a variety of cancer types with high morbidity and mortality. At present, Telix Group is conducting over ten clinical trials globally. Three of its pipeline products (TLX101, TLX101-CDx and TLX102) have been granted orphan drug designation, and one product (TLX250-CDx) has been granted breakthrough therapy designation by the United States Food and Drug Administration ("FDA").

In terms of project status, Telix Group has completed phase II clinical trial for TLX591 and is currently planning to start phase III clinical trial in Australia and the United States, and it has submitted New Drug Application ("NDA") to the FDA for TLX591-CDx in September of this year. Telix Group is preparing to commence two phase II clinical trials to assess the efficacy of TLX250 in combination with current immuno-oncology therapies for ccRCC. TLX250-CDx has been granted breakthrough therapy designation and is currently being studied in a phase III clinical trial. The combination of TLX101 and external beam radiation is currently being studied in a phase I/II clinical trial at several hospital locations across Europe and Australia.

The Group and Jiangsu Institute of Nuclear Medicine have entered into a memorandum of strategic cooperation to reach an agreement on the development, manufacturing, testing and standard formulation, preclinical research and intellectual property of RDC; the Group and Puer Weiye has entered into a share purchase agreement, pursuant to which the Group will acquire 100% equity interest in Puer Weiye for a consideration of not more than RMB10 million subject to conditions precedent. Upon the completion of this acquisition, the Group will obtain the "Radioactive Pharmaceutical Production License", "Radioactive Pharmaceutical Trading License" and "Permit for Radiation Safety". After the acquisition of Puer Weiye, the Group will become the second Hong Kong listed company permitted to engage in the production, commercialization and development of radioactive pharmaceuticals.

According to data released by Statista, the size of the global nuclear medicine/radiopharmaceuticals market was around US$3.98 billion in 2018 and is expected to reach US$5.06 billion by 2023. Frost & Sullivan’s forecast predicted that the CAGR of China’s radiopharmaceuticals market is about 18.6%, and the total domestic market size is expected to reach RMB9 billion by 2021. Telix Group’s innovative radionuclide conjugation technologies enable molecular targeted drug or antibody to carry radiation, and enhance the imaging diagnostics and treatment for multiple cancer types. By leveraging the radionuclide conjugation technologies of Telix Group, the Group will be able to provide Chinese patients with integrated diagnostic and treatment solutions for multiple cancer types.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "The Group is insightful in the growth opportunities and future development of the radiopharmaceutical industry. Entering into the agreements with well-known companies and institutes to obtain the commercial rights of related products in the Greater China Region and the qualification licenses for trading radioactive pharmaceuticals in China, is another important strategic step for the Group in the expansion of radiopharmaceutical planning. Upon entering the agreements mentioned above, the Group will initiate the clinical trials application of the six licensed products in the Greater China Region. And together with the SIR-Spheres Y-90 resin microsphere that was approved to file NDA in August of this year, in the field of anti-tumor RDC, the Group has owned a total of seven products for the diagnostics and treatment of colorectal liver metastases, prostate cancer, ccRCC and glioblastoma. The Group will continue to increase the investment in RDC and to introduce world-class innovative products, so as to build an integrated supply chain including R&D, production, sales and supervision, and to establish a world-leading RDC platform."

"The Group has been dedicated to the research and development of anti-tumor therapy for many years. It has 11 innovative products globally, of which 10 products are in clinical trials across different locations in the globe, covering 8 major solid tumors (including hepatocellular carcinoma, colorectal cancer, ccRCC, prostate cancer, glioblastoma, metastatic melanoma, triple negative breast cancer and squamous cell carcinoma). The variety and quantity of the Group’s product pipeline are at the leading level in this industry.

"The Group adopts the strategy of ‘global expansion and dual-cycle operation’ and will continue to optimize product structure and enrich the pipeline in anti-tumor field by introducing international advanced products and technologies, in order to provide cancer patients with more treatment options and solutions, forming a new pattern of domestic and international cycles that synergize with each other. In the future, the Group will continue to focus on the R&D of innovative products and be actively involved in activities such as global in-licensing, investment and acquisition of high-quality products and assets in core therapeutic areas, in order to enrich product lines and innovative products pool and to bring better returns for the shareholders of the Company."

On November 1, 2020 Astellas reported financial results for the first six months of the fiscal year 2020 (FY2020) (Presentation, Astellas, NOV 1, 2020, View Source [SID1234569642]).

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