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Bayer Opens New Research & Innovation Center in Boston-Cambridge Demonstrating Its Commitment to Precision Oncology

On June 29, 2022 Bayer AG reported the opening of its new Research and Innovation Center at Kendall Square in Boston-Cambridge, Massachusetts (U.S.A.), expanding the company’s footprint into one of the world’s most innovative pharmaceutical research and development locations (Press release, Bayer, JUN 29, 2022, View Source [SID1234616381]). Representing a total $140M USD investment into the area, Bayer’s 62,100-square-foot facility houses a new center of precision molecular oncology research equipped with state-of-the-art laboratories and offices for the development of novel targeted cancer therapies for patients. In addition, the center comprises a newly established research team focused on leveraging chemical biology techniques to further propel the company’s oncology drug development process.

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"Our new Bayer research and innovation center at Kendall Square is part of our strategy to be at the forefront of scientific discovery and breakthrough innovation for better patient healthcare," said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division. "Being part of this unique innovation ecosystem will support our teams in creating breakthrough innovations for patients together with the experts here."

"Bayer is undergoing significant growth in the United States in both research and development and our commercial operations," said Sebastian Guth, Ph.D., President of Bayer Pharmaceuticals, Americas Region. "The opening of our new precision molecular oncology research center in Kendall Square reflects the deep commitment Bayer is making to scale our oncology presence in the United States. It also builds on collaborations already in place in Boston in cardiovascular, another key area of focus for Bayer, with our with joint laboratories in precision cardiology with the Broad Institute of MIT and Harvard."

Spanning across two floors, the new center currently provides space for 100 employees, while the company is prepared to fill an additional 50 roles in the coming months. It is designed to enhance the collaboration between Bayer research and development, its internal partners such as BlueRock Therapeutics, Asklepios BioPharmaceutical (AskBio) and Vividion Therapeutics, as well as external partners to accelerate the development of transformative treatments for patients. In addition to the new center at Kendall Square in Cambridge, Bayer has also established strategic research collaborations with top scientific partners in Boston, including joint laboratories in the areas of lung disease with Brigham and Women’s Hospital and Massachusetts General Hospital and precision cardiology with the Broad Institute of MIT and Harvard.

The Research and Innovation Center also marks a strategic investment into Bayer’s oncology innovation to transform healthcare for people living with cancer worldwide, and at the same time to, ensure sustainable long-term growth for the company. Striving to become a top 10 oncology company by 2030, Bayer is investing a significant portion of its global R&D budget toward oncology. The new precision molecular oncology research center will drive the development of targeted next-generation cancer therapies, including efforts to help people living with cancer benefit from molecular tests and targeted treatments through biomarker testing.

Bayer has a 160-year track record of delivering scientific innovation for patients in areas of high medical need and has long embraced external innovation and partnering. Since 2020, Bayer has secured more than 40 transactions in business development and licensing and has invested $1.2B USD in innovative healthcare companies through Leaps by Bayer. The new center is expected to play a role for future partnering investments and collaborations.

With this new center, Bayer is expanding its operations in the leading life sciences cluster worldwide. Boston-Cambridge is home to approximately 1,000 biotechnology companies, with Kendall Square being the center of pharmaceutical innovation on the East Coast of the USA. The company is now present in four of the largest biotechnology hubs in the United States – Boston, San Francisco, San Diego and Research Triangle Park, NC.

Fuzionaire Diagnostics Enters Agreement with McMaster University to Expand Capabilities in Developing Theranostic Radiopharmaceuticals

On June 29, 2022 Fuzionaire Diagnostics, Inc. ("Fuzionaire Dx") reported a collaborative research agreement with McMaster University ("McMaster") under which theranostic radiopharmaceuticals developed with Fuzionaire Dx’s HetSiFA platform will be evaluated at McMaster’s comprehensive preclinical nuclear medicine facilities (Press release, Fuzionaire Diagnostics, JUN 29, 2022, View Source [SID1234616380]).

The collaboration expands Fuzionaire Dx’s capabilities to evaluate oncologic theranostics made from its HetSiFA platform. The collaboration will begin with the biological and preclinical evaluation of multiple theranostic candidates targeting an undisclosed type of cancer and selection of promising candidates for further development.

Fuzionaire Dx creates theranostic candidates by combining its HetSiFAs, or heteroaromatic silicon-fluoride acceptors, with cancer-targeting peptides and other ligands. With the HetSiFA library, new theranostic candidates are created within weeks. The HetSiFA platform is compatible with fluorine-18, the leading radionuclide used in positron-emission-tomography (PET) imaging, and leading alpha- and beta-emitting radionuclides used for therapy, providing unique flexibility in creating new candidates.

Theranostics is a term that describes a "see it, treat it" approach to cancer that uses one radioactive drug to reveal tumor locations and a second radioactive drug to deliver therapy that kills cancer cells.

Primary leadership for the scientific collaboration includes Christopher Waldmann, PhD, Chief Scientific Officer of Fuzionaire Dx, and Saman Sadeghi, PhD, Associate Professor, Chemistry & Chemical Biology, and Principal Investigator, Radiochemistry & Radiopharmaceuticals, at McMaster University.

ADC Therapeutics Doses First Patient in Phase 1b Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in Combination with Other Anti-cancer Agents

On June 29, 2022 ADC Therapeutics SA (NYSE: ADCT) reported the first patient has been dosed in LOTIS-7, a Phase 1b clinical trial evaluating ZYNLONTA in combination with other anti-cancer agents in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (Press release, ADC Therapeutics, JUN 29, 2022, View Source [SID1234616379]).

"As ZYNLONTA has been shown in preclinical studies to have synergistic or additive effects when combined with other anti-cancer therapies, we are eager to explore the potential of our differentiated CD19-directed ADC in combination with other established therapies," said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. "We are excited by the opportunity to allow more lymphoma patients to achieve a response and benefit from the new combinations we are evaluating in LOTIS-7."

The first arm of the LOTIS-7 open-label, multi-center, multi-arm Phase 1b trial will evaluate the safety and activity of ZYNLONTA in combination with polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Burkitt lymphoma. The trial will include multiple arms in two parts – a dose escalation part and a dose expansion part. For more information about the LOTIS-7 trial, please visit www.clinicaltrials.gov (identifier NCT04970901).

ZYNLONTA is also being evaluated in the LOTIS clinical trial program as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. For more information about the LOTIS trials, please visit View Source

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

MTTI Doses First Patient in EBTATE Neuroendocrine Tumor Clinical Trial

On June 29, 2022 Molecular Targeting Technologies, Inc. (MTTI), reported that the first patient has been dosed in a clinical trial of EBTATE (177Lu-DOTA-EB-TATE) for the treatment of patients with advanced, well differentiated neuroendocrine tumors. This US based, Phase I clinical trial will evaluate the safety and dosimetry of EBTATE (Press release, Molecular Targeting Technologies, JUN 29, 2022, View Source [SID1234616378]).

EBTATE is a patented peptide targeting radiotherapeutic drug. It selectively targets and binds to somatostatin receptor 2 on neuroendocrine tumors, which are then killed by the radionuclide. EBTATE was designed to bind to serum albumin, extending in vivo residence time, enabling lower, less frequent dosing of the radiopharmaceutical vs. the current standard of care. Early, ex.-US, clinical results in 60 patients showed EBTATE is more effective and safer for neuroendocrine tumor patients*.

Chris Pak, President & CEO of MTTI comments "This is a substantive milestone for MTTI. It marks the advent of safer, more effective, economical targeted radiotherapy drugs for neuroendocrine tumors. Recent clinical data presented at the 2022 SNMMI meeting also suggests that EBTATE treatment without the conventional amino acids infusion is safe and does no harm to kidney function, potentially, significantly improving patient comfort vs current treatments."

Scorpion Therapeutics Nominates STX-721 as EGFR-EXON-20 Development Candidate with a Best-in-Class Profile

On June 29, 2022 Scorpion Therapeutics, Inc. ("Scorpion Therapeutics"), a pioneering biotechnology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, reported that it has selected STX-721 as a development candidate from its STX-EGFR-EXON20 program (Press release, Scorpion Therapeutics, JUN 29, 2022, View Source [SID1234616377]). STX-721 is a next-generation, orally delivered small molecule designed with potentially best-in-class selectivity to target Exon 20 insertion mutations in epidermal growth factor receptors ("EGFR"), a well-known, clinically validated oncogenic driver in non-small cell lung cancer ("NSCLC").

NSCLC is the most common form of lung cancer and EGFR mutations are one of the most common mutations in NSCLC. NSCLC tumors that express EGFR with Exon 20 insertion mutations have an incidence of approximately 3,400 patients per year in the United States. Commercially available therapies for NSCLC patients with EGFR Exon 20 insertion mutations have moderate clinical efficacy and are limited by significant toxicities associated with the inhibition of wild-type EGFR in healthy tissues such as the skin and GI tract. These toxicities can lead to dose reductions or interruptions, which may reduce efficacy and leave a significant unmet need.

"We are delighted to announce STX-721 as our second clinical program," said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion Therapeutics. "While currently marketed agents have transformed the treatment of many EGFR-mutant lung cancers, patients presenting with Exon 20 insertion mutations remain underserved by existing options, which lack sufficient selectivity over wild-type EGFR and therefore carry significant, dose-limiting toxicities that narrow the therapeutic window and attenuate their efficacy. STX-721 was designed as a next-generation molecule to overcome these limitations. We look forward to sharing the detailed preclinical profile for STX-721 later this year and to submitting an IND to the U.S. Food and Drug Administration in 2023."

Leveraging its proprietary drug-hunting platform, Scorpion Therapeutics designed a highly differentiated candidate molecule that provides exquisitely selective inhibition of Exon 20 insertion mutations compared to the wild-type form of the protein. This may allow for maximal inhibition of the mutant protein in cancer cells compared to normal tissues, thereby reducing the toxicities that lead to dose limitations or reductions with existing EGFR Exon 20 inhibitors. In preclinical studies, STX-721 demonstrated best-in-class selectivity versus all other disclosed clinical-phase Exon 20 inhibitors, as well as dose-dependent anti-tumor activity in xenograft models at well-tolerated doses. Scorpion Therapeutics expects to present these preclinical data at a medical meeting in the second half of 2022 and to submit an IND for STX-721 in 2023.