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.

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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.

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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.

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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]

On January 25, 2022 Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, reported that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma (Press release, Cartesian Therapeutics, JAN 25, 2022, View Source [SID1234606767]). To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years. Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory cell manufacturing platform. This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.

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Descartes-25 is designed to deliver two complementary antitumor proteins directly to the tumor: a novel three-arm bispecific antibody that binds B-cell Maturation Antigen (BCMA) with femtomolar avidity and the potent antitumor cytokine interleukin-12 (IL-12). Descartes-25 cells are further engineered with a membrane-bound homing protein that directs the cells to the tumor microenvironment for local delivery of their antitumor cargo. In preclinical models, Descartes-25’s IL-12 synergistically potentiates its BCMA bispecific antibody to eliminate myeloma with unprecedented activity.

"Patients with relapsed and/or refractory multiple myeloma have few treatment options remaining," said Kenneth Anderson, M.D., Kraft Family Professor of Medicine at Harvard Medical School and Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics. "A cell therapy that locally delivers a combination of a BCMA-bispecific antibody and IL-12, without using lymphodepleting chemotherapy, is an elegant and highly innovative approach. If approved, it will be a welcome addition to our toolkit for treating this currently incurable disease."

"We designed Descartes-25 to be highly potent and well tolerated by focusing on creating the ideal pharmacokinetic profile: continuous, measured, and local delivery of a synergistic combination of antitumor agents," said Murat Kalayoglu, M.D., Ph.D., President and Chief Executive Officer at Cartesian. "I am proud of our integrated team of scientists and physicians for their hard work and rapid clinical translation of this first-in-class therapy."

"With Descartes-25, Cartesian scientists used RNA Armory technology to convert stem cells into a targeted combination therapy," said Chief Scientific Officer Michael Singer, M.D., Ph.D. "Therefore Descartes-25 is not just a potent antitumor therapy. It’s also a blueprint for future RNA cell therapies to deliver three or more rationally selected and spatially targeted combination therapeutics for a diverse array of diseases."

About the Phase 1/2a Clinical Trial

The Phase 1/2a study (NCT05113342) is an open-label, multicenter, dose escalation trial for Descartes 25 in patients with relapsed and/or refractory multiple myeloma. The study aims to enroll twenty patients who have previously failed two or more lines of treatment to determine the safety and preliminary efficacy of Descartes-25. For more information visit View Source

About RNA Armory

The RNA Armory is Cartesian’s proprietary cell engineering platform that generates large-scale, potent RNA cell therapies with extended protein expression. The RNA Armory is currently focused on RNA engineering two types of cells, T-cells and Mesenchymal Stem Cells (MSCs). Our CAR T-cell programs harness the safety of RNA and autologous engineering to target autoimmune diseases and frontline cancer – without lymphodepletion. Our off-the-shelf MSC programs leverage these cells’ clinical safety record and excellent capacity for protein secretion to deliver synergistic combinations of therapies. For more information visit View Source

On January 25, 2022 Lineberger Comprehensive Cancer Center reported An anonymous donor has made a $25 million gift to establish the UNC Lineberger Center for Triple Negative Breast Cancer and to support other key UNC Lineberger initiatives (Press release, Lineberger Comprehensive Cancer Center, JAN 25, 2022, View Source [SID1234606783]). This is the largest donation in UNC Lineberger’s history, and it enables the cancer center to advance its groundbreaking research on diagnosing and treating a highly aggressive breast cancer that disproportionately affects Black, Latina and young women and historically has limited research funding.

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The gift was made in gratitude for the care a family member received while being treated for cancer at UNC, and to help expand and expedite the cutting-edge cancer research being conducted at UNC Lineberger. Specifically, the donor designated their investment to help women and men with all types of breast cancer, especially triple negative breast cancer because of its poor prognosis. In addition, the gift will support research directed toward developing more effective treatments for metastatic disease, improving pediatric cancer care, and eliminating racial disparities in cancer treatment outcomes.

Lisa A. Carey, MD, MSc, FASCO, will serve as the inaugural director of the UNC Triple Negative Breast Cancer Center. Carey, the Richardson and Marilyn Jacobs Preyer Distinguished Professor in Breast Cancer Research and a medical oncologist who specializes in treating breast cancer patients, said it is hard to overestimate the gift’s potential impact on advancing triple negative breast cancer research and care.

"While research advances the past 30 years have led to new and more effective treatments for many types of breast cancer, this isn’t the case with triple negative breast cancer," said Carey, who, in addition to her clinical responsibilities, is the deputy director of clinical sciences and co-leader of the breast cancer research program at UNC Lineberger. "The good news is this gift will be a game changer. It provides the cancer center with the resources to expand and speed the pace of our research focused on generating insights that lead to better treatments and outcomes for women with triple negative breast cancer."

Accounting for roughly 10-20% of breast cancer cases in the United States, triple negative breast cancer is so named because it lacks the estrogen, progesterone and HER2 protein receptors commonly associated with other breast cancers. It is an aggressive, fast-growing cancer that has a high risk of spreading beyond the breast and of recurring despite treatment. It has significantly poorer outcomes than other breast cancers, and it disproportionally affects Black, Latina and young women. The only current standard of care involves chemotherapy.

In addition to establishing this new research center, the money will create multiple professorships and accelerate three strategic research initiatives that build on existing UNC Lineberger strengths:

Developing new treatments particularly those that harness a patient’s immune system, including chimeric antigen receptor t-cell (CAR-T) immunotherapy. The objective is more personalized, more effective and less toxic treatment than currently available;
Expanding the genetic understanding and classification of cancer types to improve diagnostics and uncover new targets and modes of therapy;
And creating greater knowledge of nutrition and metabolism and their impact on disease prevention and more holistic treatment options.
"Our world-class researchers at the UNC Lineberger Comprehensive Cancer Center are applying innovative approaches to solving some of the grand challenges of our time," said UNC-Chapel Hill Chancellor Kevin M. Guskiewicz. "Our experts have done foundational work, especially in the space of triple negative breast cancer. Under Lisa Carey’s leadership, they are uniquely positioned to make the most of this generous gift and find life-saving treatments that improve health outcomes for patients in North Carolina and beyond."

Foundational research at UNC Lineberger

UNC Lineberger is internationally recognized for its foundational discoveries that have advanced the field of triple negative breast cancer research.

In 2000, Charles Perou, PhD, the May Goldman Shaw Distinguished Professor of Molecular Oncology and co-leader of the UNC Lineberger breast cancer research program, published a groundbreaking paper identifying the molecular subtypes of breast cancer and demonstrating that breast cancer was not one disease but a collection of diseases with different prognoses. Specifically, the findings defined and characterized the dominant biology underlying triple negative breast cancer.

In 2001, Carey and her UNC Lineberger colleagues launched the first clinical trial in the U.S. that targeted triple negative breast cancers. Through its longstanding population-based study, the Carolina Breast Cancer Study, UNC Lineberger researchers also were the first to demonstrate that triple negative breast cancer disproportionately affected Black women, particularly young black women.

"UNC Lineberger has a world-leading record of advancing understanding of triple negative breast cancer and its therapy," said H. Shelton Earp, MD, UNC Lineberger director. "This remarkable gift will enable us to create an unmatched national hub of research excellence combining and enhancing our expertise in genomics, immunotherapy, and cancer nutrition towards more effective and less toxic therapy for advanced triple negative breast cancer, and with the knowledge gained and our world class community engagement team, better prevention, early detection, and timely therapy for all North Carolina’s rural and urban populations."

"This magnanimous gift is both inspiring and transformative, and it will be life-saving," said A. Wesley Burks, MD, dean of the UNC School of Medicine, vice chancellor for medical affairs, and CEO of UNC Health. "In addition to building on the depth of our expertise in cancer research and care, this gift enables us to focus on uncovering what makes some cancers so difficult to treat and identifying the drivers of racial disparities in cancer treatment outcomes. This is critically important work."