On July 12, 2022 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported that interim clinical data from an ongoing Phase I study of BBT-176 has been selected for a mini oral presentation at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC WCLC 2022), Aug. 6-9 in Vienna (Press release, Bridge Biotherapeutics, JUL 12, 2022, View Source [SID1234616631]).

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The oral presentation, to be delivered by Sun Min Lim, M.D., Ph.D., assistant professor at Yonsei University College of Medicine, will discuss interim clinical data from the Phase I study of BBT-176 in advanced non-small cell lung cancer (NSCLC) patients harboring an EGFR mutation who were previously treated with at least one epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). According to the published abstract, the presentation will cover potent anti-tumor efficacy of BBT-176 explored with radiological improvements in both target and non-target lesions from two patients harboring EGFR triple mutations of exon 19 del/T790M/C797S.

One patient from the 320mg dosing cohort exhibited 30.3 percent shrinkage of the target lesion, according to the abstract. Another patient from the 480mg dosing cohort exhibited 26.3 percent shrinkage of the target lesion. Investigators will explore the recommended Phase 2 dose (RP2D) based on the overall safety, efficacy and tolerability information collected in the Phase 1 clinical study.

The abstract for the presentation (MA07.09) is now available at https://bit.ly/3uv2StQ.

Session and Presentation Information
Title: BBT-176, a 4th-generation EGFR TKI, for Progressed NSCLC after EGFR TKI Therapy: PK, Safety and Efficacy from Phase 1 Study
Session Title: Overcoming Resistance to EGFR Inhibitors
Session Number: MA07.09
Presentation Session: August 8, 2022, 12:52 pm CET
Presenting Author: Sun Min Lim, M.D., Ph.D., Yonsei University College of Medicine
Session Discussant: Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute

On July 12, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that management will host a virtual research forum in which it will unveil the next product candidate, discuss immunostimulatory ADCs (iADCs) as a novel modality, and highlight recent enhancement to its cell-free manufacturing platform (Press release, Sutro Biopharma, JUL 12, 2022, View Source [SID1234616612]).

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Webcast details:

Wednesday, July 20, 2022 at 4:30 pm ET, or 1:30 pm PT
To access and register for the live webcast, please go to View Source
The webcast information will also be available through the News & Events section of the Investor Relations portion of the Company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.

On July 12, 2022 Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, reported the launch of solid tumor assays through its Pharma Assay Development (PAD) services (Press release, Mission Bio, JUL 12, 2022, View Source [SID1234616632]). The availability of this new service offering will help to accelerate the development of cancer therapeutics by reducing the time and cost associated with the characterization of solid tumor cells.

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Precision therapeutics for solid tumors have been historically bottlenecked due to technical challenges associated with the ability to deeply profile thousands of individual cells for a rich characterization of tumor evolution and heterogeneity. This must be done at a much higher resolution compared to bulk next-generation sequencing to enable detection of rare events, at a much earlier stage before progression.

Utilizing Mission Bio’s Tapestri platform, the company’s PAD services for solid tumors partner with researchers to provide high-resolution data to unmask the underlying genetic diversity across cell populations. Insights into the clonal landscape and co-occurrence of mutations enable improved patient stratification for clinical trials and the identification of druggable targets for precision therapeutics. Researchers can also monitor treatment resistance by analyzing the acquisition of rare mutations driving tumor progression over the course of treatment.

The expansion of Mission Bio’s PAD services to solid tumor research comes just three months after the launch of the Solid Tumor Solution on the Tapestri Platform, demonstrating Mission Bio’s commitment to continuously developing innovative single-cell technologies for its pharma customers.

"We have seen tremendous uptake and interest from top-tier pharma companies for our blood cancer Pharma Assay Development program, and we expect the same momentum for our solid tumor services," said Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio. "With our solid tumor services, Mission Bio partners with pharma customers to elucidate the mechanisms of drug resistance through mutation acquisition, determine how cells transform from benign to malignant states, and reveal the genomic changes enabling cancer cells to metastasize – without having to bring single-cell technology or resources in-house. From a customer’s perspective, it is as easy as shipping out samples and getting a fully analyzed report back."

Mission Bio’s PAD services deliver comprehensive support across the therapeutic development process. The company has a dedicated team that works with researchers to develop assays, identify high-impact samples, and analyze the data. As part of the service, pharma partners have access to Mission Bio’s innovative technology, assay development team, R&D organization, and bioinformatics support.

For more on Mission Bio and the Tapestri platform, please visit missionbio.com.

On July 12, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that Genentech, a member of the Roche Group, has exercised its second option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies (Press release, Bicycle Therapeutics, JUL 12, 2022, View Source [SID1234616597]).

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Bicycle and Genentech are collaborating on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Pursuant to the terms of the February 2020 agreement, Genentech was granted two collaboration expansion options, each of which gave Genentech the right to add one additional program to the collaboration in exchange for a $10 million payment to Bicycle. In October 2021, Genentech exercised its first expansion option, and has now exercised its second expansion option, triggering an additional $10 million payment. None of the compounds in Bicycle’s wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration.

"We are pleased both with the ongoing progress in our collaboration with the preeminent immuno-oncology team at Genentech, and that Genentech has once again elected to exercise an option to add a new program," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "This represents the second expansion option exercised by Genentech under the terms of our collaboration agreement, and we believe this highlights the potential of Bicycles across a wide range of targets. We look forward to our continued collaboration to develop potential new cancer treatments based on Bicycles."

On July 12, 2022 -mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported initiation of its first clinical trial with a SADA construct (Press release, Y-mAbs Therapeutics, JUL 12, 2022, View Source [SID1234616613]). This Phase 1 multicenter basket trial targets malignant melanoma, sarcoma and small cell lung cancer. The trial will have three parts: Part A with dose-finding for the SADA molecule and testing of dosing intervals between the protein and the 177Lu-DOTA payload, Part B will determine the optimal dose of 177Lu-DOTA, and Part C will be evaluating safety and initial signals of efficacy using repeated dosing. The Company expects a total of approximately 59 patients at 6-10 U.S. sites to be included in the trial.

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The GD2-SADA construct was created using our SADA technology, which was licensed by the Company from Memorial Sloan Kettering Cancer Center ("MSK") and Massachusetts Institute of Technology ("MIT") in April 2020. The SADA technology utilizes a pre-targeted payload delivery method where antibody constructs assemble in tetramers and bind to the tumor target. Unbound constructs predictably disassemble into smaller antibody fragments and are excreted through the kidneys within hours after administration. In a second infusion, a radioactive payload binds to the antibody constructs attached to the tumor target in order to radiate the tumor. This provides the possibility of targeting tumors with precision while minimizing radiation of normal tissues. We believe that the SADA technology platform can deliver a variety of payloads and could potentially be developed against multiple tumor targets, as well as for theragnostic purposes.

"The FDA acceptance of the IND for GD2-SADA marks an important milestone towards our mission of developing novel SADA treatments as we continue to execute our clinical development strategy for our pipeline of SADA constructs for the treatment of cancers with unmet medical need," said Thomas Gad, founder, President and Interim CEO. "We are seeing significant partnership interest for the SADA technology and we believe we are well-positioned to leverage the SADA platform as we move forward. We are truly excited about the potential of the SADA technology, which has already shown great promise, and we believe that it can further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents."

Researchers at MSK, including Dr. Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and in Y-mAbs.