On January 24, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that its partners Bruce Power and Isogen (a partnership between Kinectrics and Framatome) have completed the installation of a groundbreaking Isotope Production System (IPS), becoming the first power reactor in the world with the installed capability to produce Lutetium-177 (Lu-177), a medical isotope used in the treatment of various cancers, such as neuroendocrine tumors and prostate cancer (Press release, ITM Isotopen Technologien Munchen, JAN 24, 2022, View Source [SID1234606741]). This system will also have the ability to produce other isotopes for medical uses over the long term.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This installation of the IPS is an exciting milestone on our journey to becoming the first power reactor in the world to provide a scalable, game-changing solution in the supply of life-saving medical isotopes for the global medical community," said James Scongack, Bruce Power’s Chief Development Officer and Executive Vice President, Operational Services. "Our medical Isotope Program and the IPS installation are a result of years of innovation and development in partnership with Isogen (a Framatome and Kinectrics company), Saugeen Ojibway Nation, and ITM; and will provide large-scale capacity to help produce medical isotopes, which will be used across the world in new treatments to fight cancer."

With the new system installed, activities will now shift to planned commissioning along with preparation activities for commercial production that will follow once these activities and regulatory submissions are successfully completed.

"Ontario is leading the way in the production and supply of medical isotopes around the world," said Hon. Todd Smith, Ontario’s Minister of Energy. "I’m proud of the innovative work being done by Bruce Power and its partners in the supply chain, including Framatome and Kinectrics. Their efforts are helping to further cement our position as an international isotope superpower, while providing critical medical tools to help meet the needs of patients battling cancer."

Lu-177 offers doctors an alternative to traditional chemotherapy by deploying a "seek-and-destroy" dose to target cancer cells while limiting damage to surrounding healthy tissues and organs.

The IPS was developed and manufactured by Isogen, a joint venture between Framatome and Kinectrics, that is focused on developing innovative isotope production technologies.

"The installation and successful transfer of the first target marks a major accomplishment and successful implementation of Framatome Healthcare technology; the first Isotope Production System (IPS) in a power reactor for commercial production of therapeutic medical isotopes," said Curtis Van Cleve, President and CEO of Framatome Canada Ltd. "We applaud the dedication and efforts of our partners, at Bruce Power, Saugeen Ojibway Nation, Kinectrics, ITM and our team, and the support of their families that allowed them to see this installation through."

"The installation of the IPS is the result of countless hours of support from many people at Bruce Power, Framatome, Kinectrics, Saugeen Ojibway Nation and our suppliers. The entire team demonstrated tremendous dedication, especially during the pandemic." said David Harris, CEO of Kinectrics. "This was a critical step to enable the production of Lutetium-177 for our partner, ITM, and to fortifying a strong, reliable, and large-scale global supply chain of life-saving isotopes, that both physicians and patients can depend on."

With its new IPS system, Bruce Power will conduct the irradiation of Ytterbium-176 (176Yb) as a first step in the production of no-carrier-added Lutetium-177 (n.c.a. 177Lu). Processing of the irradiated Ytterbium-176 for the production of n.c.a. Lutetium-177 as well as the global supply of n.c.a. 177Lu will be handled by ITM.

"The successful installation of this production site builds an important milestone in our partnership with Bruce Power and Isogen to scale-up the production of high-quality medical radioisotopes," said Steffen Schuster, CEO at ITM. "We look forward to the upcoming launch of the IPS system and are proud to contribute with our unique manufacturing methodology to yield high-quality n.c.a. 177Lu and to make it accessible for cancer patients worldwide."

The installation of the IPS is a significant step in the landmark isotope project, which is a partnership that began more than three years ago with over 400 dedicated professionals working on various stages of the project.

In November 2021, Bill Walker, MPP of Bruce-Grey-Owen Sound, introduced a Private Member’s motion – which passed with all party support – to assert Ontario’s leadership role in the production and supply of medical isotopes as a strategic priority for the province. Today’s announcement exemplifies that Ontario continues to be at the forefront of medical isotope technology.

"I want to congratulate Bruce Power, Framatome and Kinectrics on this important accomplishment," said MPP Walker. "Ontario has long been looked to as a leader in the medical isotope space, and these partners are playing an important role in the global supply chain to provide patients around the world with life-saving cancer treatments and diagnostic tools."

Bruce Power will market the new isotope supply in an historic collaboration partnership with Saugeen Ojibway Nation (SON). The partnership project with SON, named "Gamzook’aamin Aakoziwin," includes an equity stake for SON and a revenue-sharing program that directly benefits the SON.

"From the initial concept in 2019 to production expected in 2022, our Gamzook’aamin Aakoziwin project is on track to meet an ambitious timeline to have isotope supply ready to meet the increasing demand from doctors and cancer patients around the world," said Chief Lester Anoquot, Chippewas of Saugeen First Nation. "Saugeen Ojibway Nation is proud of the part we have played and will continue to play in this project."

"Short-lived medical isotopes are essential tools for doctors and researchers in the fight against cancer, and this project will provide a much-needed source of these isotopes for patients close to home, in our communities, and around the world," added Chief Veronica Smith, Chippewas of Nawash Unceded First Nation.

"Thanks to the investments being made into the Bruce Power site today we can look to the future and realize a vital role in providing life-saving medical isotopes to the world, while also supplying clean, reliable and low-cost electricity to Ontario, growing the economy and fostering innovation for decades to come," said Hon. Lisa Thompson, Minister of Agriculture, Food and Rural Affairs, and MPP for Huron-Bruce.

On January 24, 2022 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported that the first patients have been enrolled in both of the Phase 2 studies of OBI-999, an antibody drug conjugate (ADC) cancer therapy targeting Globo H, and OBI-3424, a prodrug targeting the enzyme aldo-keto reductase 1C3 (AKR1C3) (Press release, OBI Pharma, JAN 24, 2022, View Source [SID1234606757]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Phase 2 cohort expansion part of the OBI-999-001 (ClinicalTrials.gov Identifier: NCT04084366) entitled "A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors" has now begun enrollment. The Phase 2 part of the study will enroll Globo H expressing patients with pancreatic, colorectal and other high Globo H expression solid tumors in more than ten medical centers in the United States and Taiwan.

The Phase 2 cohort expansion part of the OBI-3424-001 (ClinicalTrials.gov Identifier: NCT03592264) entitled "A Phase 1/2 Study of OBI-3424 in Subjects with Advanced Solid Tumors" has also begun enrollment. This study will enroll AKR1C3 expressing patients with pancreatic and other high AKR1C3 expressing solid tumors in select oncology medical centers in the United States.

OBI’s Chairman and Chief Executive Officer, Michael Chang, PhD, noted "OBI Pharma strives to develop novel therapeutics for cancer patients worldwide. Based upon the impressive Phase 1 safety study and preclinical data of OBI-999 and OBI-3424, we are excited to commence our Phase 2 efficacy and safety study in patients with high Globo H or AKR1C3 antigen expression in solid tumors. We would like to thank the commitment of our international investigators to bring these 1st-in-class cancer therapeutic products to potential patients in our ongoing study."

OBI anticipates completing the enrollment of both Phase 2 studies in the second half of 2023.

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. In pre-clinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In human Phase 1 study, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI-999 is currently in a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) in medical centers in the US and Taiwan. OBI Pharma owns global rights to OBI-999.

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.

OBI-3424 is currently in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT03592264) in medical centers in the US. OBI owns global rights to OBI-3424 except the Asia Pacific region.

On January 24, 2022 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported an upcoming presentation at the 6th Tumor Models for Immuno-Oncology Summit 2022 (Press release, Kineta, JAN 24, 2022, View Source;utm_medium=rss&utm_campaign=kineta-to-present-on-the-companys-piioneer-platform-at-the-6th-annual-tumor-models-for-immuno-oncology-summit [SID1234607393]). Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, will be presenting an overview of the company’s proprietary PiiONEER Platform and the use of human knock-in models for selecting next generation immunotherapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Kineta’s immuno-oncology PiiONEER Platform was designed for the discovery and development of first or best-in-class immunotherapies that address the major challenges with cancer resistance to current therapies. Utilization of the innate immunity focused PiiONEER Platform has resulted in the development of novel, well characterized fully human antibody therapeutics that are being advanced into formal IND enabling and clinical studies.

"We have developed a world-class innate immunity-focused platform for developing important new immunotherapies to treat patients with cancer" said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. "A core component of our PiiONEER Platform is our in vivo knock in models which are the foundation for the development of our novel VISTA and CD27 antibody programs."

Presentation Details:
Title: Use of Human Knock-in Models for Selecting New Generation of Immune Checkpoint Inhibitors
Date: January 26, 7:30AM Pacific Time
Presenter: Thierry Guillaudeux, PhD

On January 24, 2022 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, reported that the Company has completed enrollment of the Phase 1/2a study of its innovative intratumoral cancer vaccine candidate, AGI-134, designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumors (Press release, BioLineRx, JAN 24, 2022, View Source [SID1234606705]). Results of AGI-134’s safety and proof of mechanism are anticipated in the first half of 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The completion of enrollment of the AGI-134 first-in-man study is a very significant milestone for our Company, especially taking into account the difficulties caused by the COVID-19 pandemic on patient recruitment," stated Philip Serlin, Chief Executive Officer of BioLineRx. "AGI-134, our second clinical-stage oncology asset, has a unique mode of action, applicable to all injectable tumor types. In preclinical models, AGI-134 led to regression of primary tumors, prevented growth of secondary tumors via an abscopal effect, and triggered a vaccine effect that we believe may prevent the development of metastases. This clinical study aims to confirm the proposed mechanism of action and safety profile of AGI-134 in humans, based on which we also plan to explore potential combinations as part of its future clinical development program."

The Phase 1/2a study is a multicenter, open-label study, which recruited a total of 38 patients in the UK, Spain and Israel, and is comprised of two parts. Part 1 was completed, and was an accelerated dose-escalation study in five patients, to determine the maximum tolerated dose and the recommended dose for part 2 of the study. Part 2 is a dose expansion study at the recommended dose in 33 patients, designed to evaluate the safety and tolerability of AGI-134, and to validate AGI-134’s mechanism of action using a wide array of biomarkers. For more information on this Phase 1/2a study, see NCT03593226.

On December 15, BioLineRx announced the formation of an Immuno-Oncology Scientific Advisory Board (SAB) to provide insight and guidance on the Company’s immuno-oncology activities. The SAB, which has provided valuable guidance to the AGI-134 development program, is comprised of recognized key opinion leaders in the fields of cancer immunology, intra-tumoral cancer treatments and clinical development.

About AGI-134
AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

On January 24, 2022 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development reported that the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation and Orphan Drug Designation for the company’s drug candidate LP-184 for the treatment of pediatric patients with ATRT (Press release, Lantern Pharma, JAN 24, 2022, View Source [SID1234606724]). LP-184 is being pursued as a potential new therapy across a range of genetically defined solid tumors, including pancreatic cancer, GBM (Glioblastoma Multiforme) and ATRT (Atypical Teratoid Rhabdoid Tumor).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Historical approaches to treating pediatric ATRT such as surgery, radiation, and chemotherapy have had largely unfavorable long term outcomes for children, and new options are urgently needed," said Kishor Bhatia, Ph.D., chief scientific officer of Lantern Pharma. "The gene SMARCB1 was included among several genes whose expression negatively correlated with LP-184 sensitivity in tumors. This in silico correlation was convincingly confirmed by in vitro and in vivo assessments of LP-184 in ATRT. The highest potency of LP-184 in-vivo has been seen in ATRT xenografts." Dr. Bhatia continued, "Based on both the in-silico and in-vivo observations, LP-184 has the potential to become a critical part of the armamentarium of approved treatment options specifically for these patients. Receiving Rare Pediatric Disease Designation from the FDA underscores the critical value of our growing focus on pediatric oncology indications at Lantern and represents another significant milestone for the LP-184 program."

The National Cancer Institute (NCI) classifies ATRT as Grade IV tumors, meaning they are malignant (cancerous), aggressive and fast-growing. ATRTs are very aggressive childhood malignancies of the central nervous system. The underlying genetic cause are inactivating bi-allelic mutations in SMARCB1 (also called INI1) or in SMARCA4. Nearly 90 percent of pediatric ATRTs are caused by changes in the gene known as SMARCB1.

The FDA grants rare pediatric disease designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless changed by legislation. If issued, a sponsor may redeem a priority review voucher for priority review of a subsequent marketing application for a different product candidate, or the priority review voucher could be sold or transferred to another sponsor.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to investigational treatments that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. The program was developed to encourage the development of medicines for rare diseases, and benefits include tax credits and application fee waivers designed to offset some development costs, as well as eligibility for market exclusivity for seven years post approval.

LP-184 is being developed for multiple targeted oncology indications. Lantern Pharma intends to further advance LP-184 as a new, potent treatment option in genetically defined subsets of patient populations in areas of high unmet clinical need, including pancreatic cancers, GBM, and other cancers that are DNA damage repair deficient. The U.S. Food and Drug Administration (FDA) has previously granted LP-184 Orphan Drug Designation for the treatment of pancreatic cancer, and for the treatment of malignant glioma, including GBM.