On October 17, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Toronto Innovation Acceleration Partners ("TIAP") reported that the two companies have expanded LAB150, their translational BRIDGE partnership, to include Amgen as a strategic partner (Press release, Evotec, OCT 17, 2022, View Source [SID1234622057]). The expansion goes along with a combined investment of US$ 14 m to expedite LAB150 programmes towards the formation of new companies.

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LAB150 was created by Evotec and TIAP in 2017 to accelerate Toronto’s academic research into market-ready products. The expanded agreement builds upon existing partnerships between Evotec, TIAP, and Amgen to support the development of disruptive therapeutics by TIAP’s member base and draws upon Evotec’s industrialised drug discovery platforms. Amgen will provide financial support for chosen LAB150 projects along with significant mentorship from their drug discovery and development teams. In addition, Amgen Ventures will evaluate LAB150-derived companies for venture investment. These combined efforts will amplify the efficiency and translational potential of academic research to develop Canadian intellectual property, novel therapies, and accelerate commercialisation by Canada’s next generation of life science companies.

"As our strategic partner since 2019, Amgen has worked closely with TIAP, and we are thankful for their continued support as we drive the commercialisation of breakthrough Canadian innovations. Together with Evotec, we look forward to collaborating with Amgen to bring enhanced expertise and capital to LAB150 to enable life science company creation," said Parimal Nathwani, President and CEO of TIAP. "To have two globally recognised industry leaders, Amgen and Evotec, come together under the LAB150 umbrella bodes very well for the life science community in Canada and improving global health."

According to Philip Tagari, Vice President of Research at Amgen, "Amgen’s ongoing four-year partnership with TIAP to support very early innovation in the Greater Toronto biotechnology ecosystem has revealed both the unique expertise within TIAP to curate novel projects with significant future medical and commercial potential, as well as the outstanding quality of the biomedical research performed in the network of world-class institutions that LAB150 accesses. This multi-year investment, in partnership with the long-term collaborators at Evotec, will provide a streamlined path for cutting-edge academic science in Ontario to transition into early-stage company formation and identification of novel candidates for clinical development, with the intent of providing meaningful medicines for patients with grievous illness."

Dr Thomas Hanke, EVP Head of Academic Partnerships at Evotec, added: "The LAB150 BRIDGE partnership has demonstrated its ability to successfully identify and validate high-potential therapeutic projects and drive them towards the formation of new companies. We very much look forward to accelerating our efforts further by leveraging Amgen’s impressive track record in the drug development space across therapeutic areas as well as in the formation of successful life science companies."

With over $ 7 m invested, more than 150 projects evaluated, and ten projects currently being supported, LAB150 has established a strong track record. Having Amgen as a new partner in this programme will ensure a robust 360-degree selection process and scale up LAB150’s capital-efficient investments to fast-track therapeutics. Moreover, the symbiotic partnership between the three partners around LAB150 will bring crucial expertise to the development and financing of emerging technologies.

On October 17, 2022 Gilead Sciences, Inc. (NASDAQ: GILD) and MacroGenics (NASDAQ: MGNX) reported an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART platform, and two additional bispecific research programs (Press release, MacroGenics, OCT 17, 2022, View Source [SID1234622055]). The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

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A leader in the bispecific antibody space, MacroGenics has extensive experience applying its proprietary DART platform to develop novel therapeutics. MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimize cytokine-release syndrome (CRS), a potentially life-threatening toxicity, while increasing the magnitude of antitumor activity with a longer half-life to permit intermittent dosing.

"MacroGenics’ bispecific expertise naturally complements Gilead’s portfolio strengths in immuno-oncology and our growing hematology franchise," said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Development, Gilead Sciences. "We believe MGD024, with its potential to reduce CRS and permit intermittent dosing through a longer half-life, could translate to more patient-friendly dosing and enhanced clinical outcomes for people living with AML and MDS. This partnership is the latest in our efforts to develop and advance transformative new cancer therapies as we deepen our portfolio across oncology indications."

Scott Koenig, MD, PhD, President, and CEO, MacroGenics said, "Rapid advances over the last decade have made CD123 a very promising target in oncology research. Advancing our bispecific DART molecule, MGD024, through a strategic collaboration with the team at Gilead will accelerate our ability to drive further development of MGD024 to the potential benefit of people living with blood cancers."

MacroGenics will be responsible for the ongoing Phase 1 study for MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points. The Phase 1 study will include a dose escalation segment and an expansion segment that is intended to evaluate MGD024 as monotherapy and in combination with other therapies across multiple indications.

Financial Considerations

As part of the agreement, Gilead will pay MacroGenics an upfront payment of $60 million and MacroGenics will be eligible to receive up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones. MacroGenics will also be eligible to receive tiered, double-digit royalties on worldwide net sales of MGD024 and a flat royalty on worldwide net sales of products under the two research programs.

Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures and expects the transaction with MacroGenics to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.04.

On October 17, 2022 Kineta, Inc. ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada) (Press release, Kineta, OCT 17, 2022, View Source;utm_medium=rss&utm_campaign=kineta-announces-clinical-collaboration-with-merck-to-evaluate-kva12123-in-combination-with-keytruda-pembrolizumab-in-cancer-patients-with-advanced-solid-tumors [SID1234622054]). Under this collaboration, Kineta will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KVA12123 (formerly KVA12.1), its novel anti-VISTA monoclonal antibody, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced solid tumors.

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VISTA is a key driver of immunosuppression in the tumor microenvironment. VISTA is up-regulated after checkpoint inhibitor therapy that has been associated with treatment failure and poor outcomes in cancer patients. KVA12123 is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope and at physiologic and acidic pH levels. In preclinical studies, KVA12123 demonstrated promising anti-tumor activity both as a single agent and in combination with PD-1 checkpoint inhibitor therapy.

"Treatment with PD-1 inhibitors as a monotherapy or in combination with other treatments has become a recommended first-line treatment and has dramatically improved outcomes for many cancer patients. However, for patients who failed to achieve a response or who relapse, treatment options are limited. We believe that KVA12123 is a potential best-in-class VISTA blocking immunotherapy that may drive strong anti-tumor efficacy and deliver a highly differentiated product profile across a range of solid tumors," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We are excited to enter into this collaboration with Merck to evaluate KVA12123 in combination with KEYTRUDA in cancer patients later this year."

Kineta is planning to conduct a Phase 1/2 clinical study evaluating KVA12123 as a single agent and in combination with KEYTRUDA in patients with advanced solid tumors. The objectives of the study are to evaluate the safety, tolerability, pharmacokinetics and anti-tumor responses of KVA12123 alone and in combination with KEYTRUDA with interim results anticipated in late 2023. Kineta is responsible for conducting this study, which it expects to initiate in the fourth quarter of 2022.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On October 12, 2022 ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for cancer reported that it will present its technology for treating lung cancer patients at a clinical provider conference (Press release, Andarix Pharmaceuticals, OCT 12, 2022, View Source [SID1234622053]). The conference will focus on the broad array of clinical trial technologies and provider capabilities. The technology will be presented at the OCT New England Conference in Boston, Massachusetts on October 12-13, 2022.

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About Tozaride
Tozaride is a novel, best-in-class cancer therapy based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for both lung cancer (SCLC, NSCLC), and pancreatic cancer patients. Along with its companion diagnostic that helps identify patients most likely to respond – those with sufficient expression of the peptide’s target – Tozaride could provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.

On October 17, 2022 Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) reported that the company has filed an application for partial change of approved indication for its antineoplastic Mitomycin C agent (Mitomycin Injection 2mg and Mitomycin Injection 10mg), which is licensed from Intas Pharmaceuticals Ltd. (Intas), in Japan (Press release, Kyowa Hakko Kirin, OCT 17, 2022, View Source [SID1234622050]).

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Kyowa Kirin voluntarily recalled its Mitomycin C agent from October 2019 due to the discovery of facts that could affect the assurance of sterility in the API manufacturing process. Since then, Kyowa Kirin has been taking all possible actions to resume the supply of this product. Following the NDA filing for topical ophthalmic use early this year in January, Kyowa Kirin also submitted an application to seek approval of Intas-licensed mitomycin C agent for use as an antineoplastic agent in Japan. To file this application, some of the current approval indications and routes of administration were changed.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.