On January 25, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), reported that the first patient has been dosed in its Phase I clinical trial evaluating BMF-219, the company’s irreversible covalent menin inhibitor, in patients with relapsed/refractory (r/r) acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations (Press release, Biomea Fusion, JAN 25, 2022, View Source [SID1234606765]).

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!

"We are honored and deeply humbled by this significant milestone, which marks our successful transition to a clinical stage company. Just over four years ago, we took the concept of designing a small molecule that targets menin and brought forward BMF-219 to the clinic to significantly improve the lives of patients," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "I’m incredibly proud of our team for their ability to execute on this aggressive timeline. This signals how we intend to operate as a drug discovery and development organization – advancing world-class science with rapid momentum and driven by an unwavering mission to improve patient outcomes and save lives. We are pursuing a novel approach to developing best-in-class molecules with our FUSION System across multiple indications and anticipate announcing our next pipeline candidate in the first half of 2022."

"Since 2017, we have focused on building a world-class discovery and development team at Biomea Fusion. We have internally developed our FUSION System, which allows us to expeditiously target validated cancer biology with breakthrough covalent chemistry. Our pipeline assets are designed to achieve higher selectivity, deeper target inactivation and thereby afford patients a greater therapeutic window. BMF-219 is just our first asset graduating now into clinical development. Our team has evolved significantly and is set up today not only to explore the full potential of BMF-219 and the inhibition of the menin pathway but also to advance several other programs into the clinic," said Ramses Erdtmann, President of Biomea Fusion. "We are an integrated biotech company engaged in all phases of drug discovery and clinical development. We have come a long way and are now set up to fully explore pre-clinically and clinically innovative therapies for the benefit of patients."

The current Phase I, open-label, multi-center, dose escalation and dose expansion study is designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of once daily oral dosing of BMF-219 in patients with r/r acute leukemias, including subpopulations where menin inhibition is expected to provide a therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). Additional information about the Phase I trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

Acute Myeloid Leukemia (AML) and Acute Lymphocytic Leukemia (ALL)

AML is the most common form of acute leukemia in adults and is responsible for the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 20,000 people in the U.S. are diagnosed with AML each year, and the five-year overall survival rate in adults is roughly 29% (Source: NCI SEER Data). Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (e.g., MLL1/KMT2A gene rearrangements or NPM1 mutations). ALL is a less common leukemia, with approximately 6,000 new cases in the U.S. each year and a higher five-year survival rate of nearly 70% (Source: NCI SEER Data). Between 10-15% of adult ALL patients and 60-70% of pediatric ALL patients have MLL1/KMT2A gene rearrangements.

On January 25, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that the first patient has been treated in its second pivotal phase III clinical trial, COMPOSE (NCT04919226), evaluating the company’s lead radiopharmaceutical candidate, ITM-11 (n.c.a. 177Lu-edotreotide), for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (Press release, ITM Isotopen Technologien Munchen, JAN 25, 2022, View Source [SID1234606781]). ITM-11 is a Targeted Radionuclide Therapeutic consisting of the high-quality radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) fused with a somatostatin analogue to specifically target somatostatin receptor-positive (SSTR+) GEP-NETs. While COMPOSE is evaluating ITM-11 for the treatment of well-differentiated high grade 2 and grade 3 GEP-NETs, the radiopharmaceutical is also being investigated in ITM’s ongoing pivotal phase III trial, COMPETE (NCT03049189), in patients with grade 1 and 2 GEP-NETs. GEP-NETs are rare types of tumors that can occur in the pancreas or in other parts of the gastrointestinal tract. Due to their frequent asymptomatic and progressive nature, GEP‑NETs often present late with advanced disease requiring innovative therapeutic measures. The trial design of COMPOSE was recently presented at the 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) and the 2021 North American Neuroendocrine Tumor Society (NANETS) annual symposium.

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!

"We are committed to providing urgently needed solutions for the treatment of GEP-NETs which are often diagnosed with advanced disease," commented Steffen Schuster, Chief Executive Officer of ITM. "As such, we hope to build upon previous promising data to demonstrate in COMPETE and COMPOSE that Targeted Radionuclide Therapy with ITM-11 has the potential to improve treatment outcomes and quality of life for a broad patient population."

"Targeted Radionuclide Therapy is a promising therapeutic concept that enables a precise intervention both for the primary tumor as well as for metastases. N.c.a. 177Lu-edotreotide has demonstrated potential in earlier stage GEP-NET patients, and I look forward to evaluating it in a more advanced late-stage population with higher tumor grade in high need of better therapeutic options," added Prof. Walter, Principal Investigator of COMPOSE at Hospices civils de Lyon, France.

COMPOSE (NCT04919226) is an international, prospective, randomized, controlled, open-label, multi-center phase III clinical trial to evaluate the efficacy, safety, and patient-reported outcomes of first- or second-line treatment with ITM-11 (n.c.a. 177Lu-edotreotide) compared to best standard of care in patients with well-differentiated high grade 2 and grade 3 (Ki-67 index 15-55), SSTR+, GEP-NETs. The study aims to randomize 202 patients 1:1 to ITM-11 or to best standard of care — either chemotherapy (CAPTEM or FOLFOX) or everolimus — according to the investigator’s choice. The primary endpoint of the study is progression-free survival, which will be assessed every 12 weeks from randomization onwards. Secondary outcome measures include overall survival up to two years after disease progression. Sponsor of the COMPOSE trial is ITM Solucin GmbH, a subsidiary of ITM Isotope Technologies Munich SE.

– End –

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy 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 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, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.

About ITM-11 (n.c.a. 177Lu-edotreotide)

ITM-11, ITM’s therapeutic radiopharmaceutical candidate being investigated in the phase III clinical studies COMPETE and COMPOSE, consists of two components: the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) and the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets neuroendocrine tumor-specific receptors. Edotreotide binds to these receptors and places the medical radioisotope n.c.a. lutetium-177 directly onto the diseased neuroendocrine cells so that it accumulates at the tumor site. N.c.a. lutetium-177 is internalized into the tumor cells and decays, releasing medical radiation (ionizing β-radiation) with a maximum radius of 1.7 mm and destroying tumor tissue. The highly precise localization can result in the healthy tissue surrounding the targeted tumor being minimally affected.

On January 25, 2022, Bolt Biotherapeutics, Inc. (the "Company") reported that entered into an amended and restated supply agreement with EirGenix, Inc. (the "Amended Supply Agreement"), which amends the original supply agreement with EirGenix, Inc. ("EirGenix") dated March 10, 2019, pursuant to which EirGenix agreed to supply to the Company, on a non-exclusive basis, bulk drug substance of EG12014, its monoclonal antibody being developed as a biosimilar of trastuzumab, which the Company uses in the manufacture of its BDC-1001 HER2 Boltbody ISAC (Filing, 8-K, Bolt Biotherapeutics, JAN 25, 2022, View Source [SID1234606766]). The Amended Supply Agreement, among other things, requires the constitution of a joint steering committee, amends the forecasting schedules and methods of addressing any order delays or cancellations, and adjusts supply pricing based on the scale of production. The remaining terms and conditions under the Amended Supply Agreement remained substantially the same as the original supply agreement.

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!

Under the Amended Supply Agreement, EirGenix provides the Company with its regulatory data package containing the sections of chemistry, manufacturing and control of drug substance EG12014 to facilitate the Company’s development and commercialization efforts, and the Company is required to make milestone payments to EirGenix up to an aggregate of $2.0 million based upon achievement of certain regulatory milestones by the Company’s HER2 Boltbody ISAC. The agreement will remain in effect as long as the Company, or any of its affiliates or licensees, continue to pursue the development or commercialization of any Boltbody ISAC containing drug substance EG12014, unless earlier terminated in accordance with the terms of the Amended Supply Agreement.

On January 25, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported it has entered into a term loan agreement with Oxford Finance, LLC that is designed to primarily support the commercial preparation and potential launch of momelotinib, an investigational agent for the treatment of myelofibrosis, a rare form of blood cancer (Press release, Sierra Oncology, JAN 25, 2022, View Source [SID1234606782]). The Company estimates it had cash and cash equivalents of $104.7 million as of December 31, 2021.

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!

Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra Oncology, said, "Our strong cash position together with the term loan facility with Oxford create great financial optionality for us as we move towards an NDA filing and potential approval of momelotinib."

Under the terms of the loan agreement with Oxford Finance, LLC, Sierra drew an initial $5 million term loan at closing. The company has the ability to access up to an additional $120 million in a series of tranches, $70 million of which are based on certain pre-determined milestones, including US regulatory approval and financing, and $50 million is at the lender’s discretion. In addition, the Company’s Series B Warrants expire 75 days from today, and if fully exercised, would provide a total of $33.3 million in proceeds to the company.

About Momelotinib

Momelotinib is a potent, selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Sierra Oncology announced topline results of the Pivotal Phase 3 MOMENTUM clinical trial, a global, randomized, double-blind study evaluating momelotinib for the treatment of symptomatic and anemic myelofibrosis patients, on January 25, 2022. The company plans to submit a New Drug Application with the US Food & Drug Administration (FDA) in the second quarter of 2022. The FDA has granted Fast Track designation for momelotinib.

On January 25, 2022 Curium reported a technology license agreement granting access to ECZACIBAŞI MONROL NÜKLEER ÜRÜNLER SANAYİ VE TİCARET A.Ş non carrier added Lutetium 177 (Press release, Curium, JAN 25, 2022, View Source [SID1234606799]). Curium also announced it will be funding the associated capital investment to build a production facility of 15000 Ci per annum on its Petten site in the Netherlands.

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!

Curium’s Petten assets are co-located with the world’s largest research reactor and the site is already a world leader in the production of reactor based isotopes, the addition of Lutetium 177 will build on this leadership.

Earlier in the year Curium announced the initiation of its ECLIPSE phase three registration trial for its proprietary LuPSMA in the treatment of patients with metastatic castration resistant prostate cancer.

John Sylvester CEO of Curium’s SPECT and International businesses commented "this is a major milestone in the Curium’s transformation to an oncology therapy company. It builds on our philosophy of reliability of supply being the secret to success in Nuclear Medicine. In addition to serving our internal needs we have the proven global supply chain and sufficient capacity to serve the rapidly growing market for Lu-177 for therapeutic use".

He went on say "We are delighted with Monrol as a technology partner. After extensive benchmarking this technology gave both the highest quality product with the most efficient process. As it is already proven and ‘plug and play’ in nature, the time to market will be very short".

"Curium’s global reach and scale make them ideal partners for our world leading technology, and we are very pleased to announce them as partners" commented Mr. Aydin Kucuk General Manager of Monrol. Please direct all enquires in the first instance to: [email protected]