On June 06, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported an equity investment of €188 million led by Temasek with participation from funds managed by BlackRock1, Qatar Investment Authority (QIA), ATHOS and Carbyne. The new capital will be used to advance and expand ITM’s innovative radiopharmaceutical pipeline, foster its leading development platform and prepare commercial readiness for the potential market launch of the company’s phase III lead candidate, ITM-11 (n.c.a. 177Lu-edotreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Further solidifying its current position in radioisotope supply, ITM will also apply the new funds together with its expertise as the globally leading manufacturer of n.c.a. Lutetium-177 (177Lu) to increase its in-house manufacturing capacities for 177Lu and expand them to new, high-value medical radioisotopes including Actinium-225 (225Ac). The company will provide these sought-after medical radioisotopes to its global supply network and apply them to broaden its own Radiopharmaceutical Therapy (RPT) pipeline designed to address an array of hard-to-treat cancer indications.

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"ITM is an industry-leading expert in the manufacturing and supply of high-quality medical radioisotopes with a groundbreaking pipeline on the cusp of an exciting data inflection point," said Udo J. Vetter, Chairman of the Supervisory Board at ITM and Chairman of the Advisory Board of Vetter Pharma. "This financing furthers our position as a driver and partner for the radiopharmaceutical industry by supporting commercial readiness efforts for ITM-11 and the expansion of our pipeline with new medical isotopes capable of addressing various cancer indications, all while increasing our robust manufacturing capacities."

"The additional equity and continued collaboration with our existing, industry-specialized investors emphasizes their confidence in our ability to drive value for the radiopharmaceutical field through our unmatched manufacturing capabilities and innovative precision oncology pipeline," noted Steffen Schuster, CEO of ITM. "We have reached key milestones since our last financing round including advancing our pipeline with novel targets in multiple oncology indications, opening our NOVA facility, launching Actineer with CNL for the joint production of Actinium-225 and entering several high-value supply agreements for Lutetium-177. As we continue growing as an organization, our focus remains on bringing the significant therapeutic benefits of Radiopharmaceutical Therapy to as many patients worldwide as possible and we are thankful for the additional financing which will support us on this path."

ITM is built on longstanding experience in the production and supply of high-quality medical radioisotopes for the precise diagnosis and treatment of cancer with an established global supply network. As a fully vertically integrated radiopharmaceutical company, ITM is applying its in-house expertise to develop a broad pipeline of targeted radiopharmaceuticals designed to provide medical benefit for patients living with a range of hard-to-treat cancer indications. ITM-11 (n.c.a.177Lu-edotreotide), the company’s lead candidate, is being evaluated for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in two phase III clinical trials, COMPETE for grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. ITM’s global leadership position in the manufacturing of radioisotopes is a critical value driver for its expanding pipeline programs and is also central to the global radiopharmaceutical industry overall.

About Radiopharmaceutical Therapy (RPT)
Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope such as Lutetium-177 or Actinium-225 to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.

(Press release, ITM Isotopen Technologien Munchen, JUN 6, 2024, View Source [SID1234661158])

On June 6, 2024 Alphamab Oncology (stock code: 9966.HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Alphamab"), a wholly-owned subsidiary of the Company, entered into a research and collaboration agreement (the "Collaboration Agreement") with ArriVent BioPharma, Inc., the shares of which are listed on the Nasdaq Global Market (ticker symbol: AVBP) ("ArriVent"), pursuant to which, Alphamab and ArriVent will collaborate to use Alphamab’s proprietary linker-payload (Alphatecan) and glycan-conjugation platforms to discover and develop novel antibody drug conjugates ("ADC").

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Alphamab will retain the rights to develop and commercialize the related ADC products under the Collaboration Agreement, in mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan Region (collectively, the "Greater China Region"). ArriVent will have exclusive rights to develop and commercialize the ADC products in the field of oncology in countries and regions outside of the Greater China Region and will be responsible for and bear the cost of the corresponding development of the ADC products.

According to the Collaboration Agreement, Alphamab is entitled to receive a one-time, non-refundable upfront payment and potential milestone payments based on the achievement of certain regulatory, development, and sales milestones of up to US$615.5 million in aggregate for the programs. In addition, Alphamab is also entitled to receive tiered sales royalties from ArriVent for each ADC product.

Dr. Ting Xu, Chairman, and CEO of Alphamab Oncology, remarked, "ArriVent shares our passion for developing differentiated, clinically valuable, and globally competitive new drugs. This collaboration, based on Alphamab’s proprietary and clinically validated glycan-conjugation platform, combined with ArriVent’s deep knowledge in oncology and extensive development experience, provides us with the opportunity to work together to deliver important new oncology therapeutics to patients."

Bing Yao, Chairman and Chief Executive Officer of ArriVent, remarked, "This exciting collaboration strengthens and complements our pipeline with the potential to add multiple innovative new ADC programs and exemplifies our strategic model of identifying and developing potential first-and best-in-class product candidates from across the globe. We look forward to complementing the research and discovery capabilities of Alphamab with our global drug development and commercialization expertise to address the unmet needs of cancer patients."

(Press release, Alphamab, JUN 6, 2024, View Source [SID1234657012])

On June 6, 2024 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), reported that China’s National Medical Products Administration (NMPA) approved the investigational new drug application (IND) for oral lasofoxifene (HLX78 in China) submitted with the assistance of Chinese development partner Shanghai Henlius Biotech, Inc. (2696.HK) (Press release, Sermonix Pharmaceuticals, JUN 6, 2024, View Source [SID1234644226]).

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The IND approval allows Henlius to join the ongoing global registrational ELAINE-3 trial with responsibility in China. ELAINE-3 (NCT05696626), the third Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trial, is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

This month, Henlius expanded its license from Sermonix to add additional Asia territories for upfront, milestone and royalty payments. The agreement also allows Henlius to share with Sermonix expedited co-development of oral lasofoxifene in Japan. Sermonix has completed a Phase 1 Japanese PK study and, together with Henlius, will begin engagement with the Pharmaceuticals and Medical Devices Agency (PMDA) to address a regulatory path to study lasofoxifene in Japan, which is an important region for expanded global access to lasofoxifene investigation.

"With active ELAINE-3 enrollment already underway in the U.S., Canada, EU and Israel, we are pleased to announce that Henlius, our Chinese development partner for oral lasofoxifene, received approval for its investigational new drug application," said Dr. David Portman, Sermonix founder and chief executive officer. "This milestone clears Henlius to enroll patients in ELAINE-3 in China, therefore further diversifying our patient population and potentially helping more people to better confront this terrible disease."

"The collaboration between Henlius and Sermonix started in January 2024," said Ms. Ping Cao, Henlius chief business development officer and SVP of business development. "In mere months from agreement to amendment, our unified dedication shines, turning swift collaboration and full-hearted implementation into tangible success – as underscored by our product’s IND approval in China."

Oral lasofoxifene is an investigational novel targeted endocrine therapy in clinical development that has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations.

In two completed Phase 2 clinical studies (ELAINE-1 and ELAINE-2), lasofoxifene demonstrated anti-tumor activity against tumors with ESR1 mutations as a monotherapy and in combination with abemaciclib, a CDK4/6 inhibitor. Lasofoxifene’s bioavailability and potent activity in mutations of the estrogen receptor, in addition to its potential to improve sexual and urogenital health with a well-tolerated profile, could hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, and, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

Breast cancer is the second most diagnosed cancer in the world, according to GLOBOCAN 2022. There were around 2.3 million new cases of breast cancer in 2022 globally, including more than 357,000 in China.1 ER+ breast cancer comprises 60-70% of all breast cancers.2 Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor (AI) has been recommended by the National Comprehensive Cancer Network (NCCN) and Chinese Society of Clinical Oncology (CSCO) guidelines to be the adjuvant and first-line standard of care for patients with ER+/HER2- breast cancer.3,4 However, almost all patients treated with AIs in the advanced setting develop resistance,5 with ESR1 mutations being one of the most prevalent alterations, present in up to 40% of patients and a significant mechanism of resistance to endocrine therapy.6 Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists.

On June 6, 2024 SpringWorks Therapeutics, Inc. ("SpringWorks") reported to have received notice of termination of the Amended and Restated Collaboration and License Agreement, dated September 6, 2022, between SpringWorks and GlaxoSmithKline Intellectual Property Development Ltd ("GSK") (the "License Agreement"), effective 180 days following the receipt of notice of termination (Filing, 8-K, SpringWorks Therapeutics, JUN 6, 2024, View Source [SID1234644195]).

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In connection with such termination, SpringWorks expects that GSK will continue the ongoing clinical trials under the License Agreement that include nirogacestat in combination with low-dose belamaf, an antibody-drug conjugate targeting BCMA B-cell maturation antigen in multiple myeloma until completed with respect to the 27 patients currently enrolled in such trials. SpringWorks will continue to support the completion of such trials with drug product supply and future publication efforts with respect to the data developed.

Once the termination becomes effective, the non-exclusive licenses granted by SpringWorks to GSK under the License Agreement will terminate. Termination of the License Agreement does not trigger any payment obligations on the part of SpringWorks or any other material wind-down costs. This termination does not affect SpringWorks’ rights to continue developing or commercializing its products or product candidates.

On June 6, 2024 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT" or the "Company"), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that the first patient has been dosed in the ONKORAS-101 trial for its lead program, BBO-8520 (Press release, BridgeBio, JUN 6, 2024, View Source [SID1234644189]). BBO-8520 is a first-in-class orally bioavailable and highly potent small molecule direct inhibitor of KRASG12C (ON) state. BBO-8520 binds covalently to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRASG12C, leading to rapid and sustained inhibition of KRASG12C activity.

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On dosing the first patient, Professor Benjamin Solomon, head of lung medical oncology at the Peter MacCallum Cancer Center, said, "We are excited to partner with BridgeBio Oncology Therapeutics to bring a transformative new therapy to patients. Non-small cell lung cancer is among the most prevalent malignancies globally and there is a significant need for new precision oncology medicines to improve outcomes for patients in the metastatic setting. BBO-8520 promises to have a substantial impact in improving outcomes and prognosis for this group of patients."

BBO-8520 was designed to inhibit the (ON) state to provide optimal target coverage and to address KRASG12C amplification and receptor tyrosine kinase activation – the two key mechanisms of adaptive resistance to current (OFF) state inhibitors. BBO-8520 drives substantial tumor growth inhibition in multiple preclinical models, even after emergence of resistance to sotorasib, an FDA approved (OFF) state inhibitor of KRASG12C. BBO-8520’s discovery was the result of a collaboration between the National Cancer Institute RAS Initiative at Frederick National Laboratory for Cancer Research, Lawrence Livermore National Laboratory, and BridgeBio Oncology Therapeutics.

The ONKORAS-101 study will enroll patients pre-treated with first generation KRASG12C (OFF) inhibitors as well as patients with no prior KRASG12C targeted therapy experience. The trial will enroll across the US, Australia, Canada, and the EU.

BridgeBio Oncology Therapeutics’ CEO, Eli Wallace, PhD, added, "The initiation of the Phase 1 clinical trial of BBO-8520 represents an important advancement for BBOT, as we are now a clinical-stage organization. We are grateful for the opportunity to offer patients with KRASG12C-driven lung cancer a targeted therapy that is expected to provide a significant improvement over current standards of care."