On January 10, 2022 BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported that it has entered into a clinical collaboration with Bristol Myers Squibb (NYSE: BMY) to investigate BioAtla’s two lead CAB-ADC candidates, BA3011 and BA3021, in combination with Bristol Myers Squibb’s anti-PD-1 therapy Opdivo (nivolumab) (Press release, BioAtla, JAN 10, 2022, View Source [SID1234598547]).

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 terms of the agreement, BioAtla and Bristol Myers Squibb will collaborate on clinical trials of separate combination therapies using two of BioAtla’s Conditionally Active Biologic Antibody Drug Conjugates, BA3011 and BA3021, each in combination with Opdvio. BioAtla will serve as the study sponsor and will be responsible for costs associated with the trial execution. Bristol Myers Squibb will provide Opdivo clinical drug supply for the study.

BA3011 (CAB-AXL-ADC) and BA3021 (CAB-ROR2-ADC) are CAB antibody drug conjugates that target receptor tyrosine kinase AXL and ROR2, respectively. AXL and ROR2 are important targets as they are expressed in many solid tumors with higher frequency of expression observed in tumors previously treated with anti-PD-1 therapy. This, coupled with the therapeutic index advantages provided by BioAtla’s proprietary CAB technology, lends strong rationale for investigating BA3011 and BA3021 in combination with Opdivo.

"BioAtla is very pleased to enter into this collaboration with Bristol Myers Squibb. Identification of optimal combination regimens holds significant promise for cancer patients, and we look forward to expanding investigation of our CAB-ADCs in combination with Opdivo," stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc.

"This collaboration supports our strategy to aggressively drive development of therapeutics in areas of high unmet medical need and underscores the potential broad applicability of our CABADCs to provide benefit to many patients across a wide range of tumor types," added Scott Smith, President of BioAtla.

Opdivo is a trademark of Bristol-Myers Squibb Company.

About Mecbotamab Vedotin (BA3011)
BA3011, CAB-AXL-ADC, is a CAB antibody drug conjugate targeting the receptor tyrosine kinase AXL that is overexpressed across multiple different solid tumors. We are developing BA3011 as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, nonsmall cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future. We are enrolling a potentially registration-enabling Phase 2 clinical trial (NCT03425279) of BA3011 given as monotherapy or in combination with a PD-1 inhibitor in soft tissue and primary bone sarcoma patients 12 years and older that are high AXL tumor membrane expressors (AXL high). We also are conducting a Phase 2 study (NCT04681131) in AXL high NSCLC patients who have previously progressed on PD-1/L1, EGFR, or ALK inhibitor therapy. In addition, a multicenter investigator-initiated Phase 2 clinical trial of BA3011 in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer has been initiated in Canada and in the US (NCT04918186).

About Ozuriftamab Vedotin (BA3021)
BA3021, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma, and breast. We are developing BA3021 as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SCCHN) and ovarian cancer. We are enrolling a Phase 2 trial (NCT03504488) of BA3021 monotherapy or in combination with a PD-1 inhibitor in patients with ROR2 high melanoma who have previously progressed on PD-1/L1 inhibitor and patients with ROR2 high NSCLC who have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapy. A Phase 2 study in patients with ROR2 high SCCHN will be initiated in early 2022. In addition, a multi-center investigator-initiated Phase 2 clinical trial of BA3021 in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer has been initiated in Canada and in the US (NCT04918186).

On January 10, 2022 Illumina Inc. (NASDAQ: ILMN) reported a partnership with Boehringer Ingelheim to develop companion diagnostics (CDx) for several programs in Boehringer Ingelheim’s oncology pipeline (Press release, Illumina, JAN 10, 2022, View Source [SID1234598546]). The partnership aims to accelerate the development of therapy selection and precision medicines for patients with advanced cancer.

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 delighted that Boehringer Ingelheim has chosen Illumina to be its long-term partner in the development of companion diagnostics for the treatment of cancers
We are delighted that Boehringer Ingelheim has chosen Illumina to be its long-term partner in the development of companion diagnostics for the treatment of cancers
The partnership spans current and future CDx programs, with plans to add CDx claims to an in vitro diagnostic test Illumina is developing that is based on the content of TruSight Oncology 500 (TSO 500). The first program will co-develop a CDx for a Boehringer Ingelheim investigational medicine.

"We are delighted that Boehringer Ingelheim has chosen Illumina to be its long-term partner in the development of companion diagnostics for the treatment of cancers," said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. "Illumina continues to provide the leading distributable assay enabling comprehensive genomic profiling for both tissue and liquid biopsy and together we will unlock the potential of new biomarkers to identify patients most likely to benefit from new precision medicines."

About TruSight Oncology 500
TSO 500 is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500. To learn more about TSO 500, click here.

On January 10, 2022 Agendia, Inc., a commercial stage company focused on precision oncology for breast cancer, reported a multi-year partnership with Illumina, Inc. (NASDAQ: ILMN), to co-develop in vitro diagnostic (IVD) tests for oncology testing (Press release, Agendia, JAN 10, 2022, View Source [SID1234598545]). The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina’s approach to IVD partnerships in oncology. Agendia joins Illumina’s growing portfolio of more than 30 IVD partners developing over 40 sequencing-based solutions for cancer prognosis, therapy selection, and other applications.

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!

Illumina and Agendia plan to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeqDx sequencing platform to expand the range of gene panels available for solid tumor analysis. The company expects its flagship test, MammaPrint, which is FDA-cleared and currently offered via Agendia’s central laboratory, will be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA.

"This partnership represents a major step in Agendia’s integration of NGS technologies and brings us even closer to our promise of providing crucial genomic information to physicians and their patients to guide care at every single step in a patient’s treatment journey," said Mark Straley, Chief Executive Officer of Agendia. "We believe our current FDA-cleared, broadly reimbursed MammaPrint test provides the perfect foundation for incorporation with Illumina’s MiSeqDx platform. Together, we plan to expand what is possible in breast cancer care and ensure that the essential insights that come from genomic testing are delivered to patients around the world."

Illumina’s robust diagnostic NGS product portfolio, including the MiSeqDx platform, covers a broad range of clinical applications designed for a variety of clinical lab settings. As NGS testing becomes more integrated in routine patient care, Illumina is committed to providing clinical solutions, through both products and partnerships, that enable the diagnosis and management of human diseases.

Agendia’s proprietary testing solutions empower physicians to more accurately diagnose the disease drivers and predict the progression of a woman’s breast cancer. The company’s scientific approach provides a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to personalize treatment. The company believes the decentralized MammaPrint NGS test, developed on the Illumina MiSeqDx platform, will enable major clinical hospitals worldwide to offer the clinical utility and benefits of MammaPrint to their physicians and patients in-house. In addition, the MammaPrint NGS test will leverage nearly two decades of clinical evidence drawn from 30 clinical studies featuring over 30,000 patients with breast cancer, as well as a 15-year history of FDA clearance, top tier medical society guideline inclusion, and well-established and unique CPT codes for broad reimbursement.

"We are pleased to partner with Agendia, with its deep expertise in genomic testing in breast cancer, to expand the reach of NGS-based genomic testing in cancer care," said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. "We believe enabling in-house clinical testing will strengthen the knowledge of the healthcare network, reduce turnaround times, and ultimately better support more patients with improved guidance on care pathways."

On January 10, 2022 Nashville Biosciences, a wholly-owned subsidiary of Vanderbilt University Medical Center (VUMC), reported an agreement with Illumina, a leading genomic technology company, to realize the full potential of VUMC’s DNA databank, BioVU (Press release, Nashville Biosciences, JAN 10, 2022, View Source [SID1234598544]).

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!

The agreement is a continuation of Vanderbilt’s long-term effort around BioVU and will accelerate genomic sequencing, resulting in new discoveries to advance new methods for diagnosing, preventing and treating an array of human diseases.

Under the terms of the agreement, Nashville Biosciences and Illumina will seek to establish an alliance with multiple pharmaceutical industry partners to perform whole genome sequencing on approximately 250,000 de-identified DNA samples collected under an Institutional Review Board (IRB)-approved process over the past 15 years.

The resulting library of de-identified health and genomic data, collected from patients diverse in gender, race, age and clinical conditions will be available to industry partners and researchers at Vanderbilt to discover and advance new methods for diagnosing and treating an array of human diseases.

"Through BioVU and other initiatives by talented individuals from across our campus, Vanderbilt holds a special place at the forefront of personalized medicine. This agreement with Illumina is a next step, allowing us to utilize their global presence and technology to join with industry partners, realizing our vision to achieve the full promise of clinical and genomic data we have developed," said Jeff Balser, MD, PhD, President and Chief Executive Officer for Vanderbilt University Medical Center and Dean of Vanderbilt University School of Medicine.

"Nashville Biosciences’ enriched biobank data, coupled with Illumina’s extensive genomics and bioinformatics expertise will enable scientists and researchers to generate new insights into disease and develop new medicines," said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. "Together, we will be able to identify potential targets that could lower costs, improve development timelines, and make therapies more effective for patients."

BioVU is the most comprehensive collection of human DNA and other biological materials stored at a single site. DNA samples are extracted from discarded blood collected at VUMC during routine clinical testing and linked to a "synthetic derivative" – a copy of VUMC’s electronic medical records from which patients’ personal identifying information has been removed while still preserving the clinical information generated in the ongoing delivery of healthcare.

The linking of specific DNA sequences to clinical information has enabled researchers to understand a wide range of health conditions, from cancer to heart disease, as well as genetic factors that increase the risk for severe illness following infections, including COVID-19.

Nashville Biosciences is a clinical and genomic analytics company providing access to VUMC’s research resources, notably BioVU, and is helping biopharmaceutical, diagnostics, and other life sciences partners accelerate their R&D activities. Since its founding in 2018, Nashville Biosciences has partnered with more than 60 clients to utilize BioVU to identify new disease biomarkers and potential drug targets, optimize clinical trials and conduct other studies using real-world data.

In 2016, for example, VUMC researchers and Illumina collaborated to analyze approximately 100,000 BioVU DNA samples using Illumina’s Multi-Ethnic Genotyping Array (MEGA). At the time, it was the largest single use of the MEGA array and has provided BioVU researchers a rich platform for genetic discovery since its completion.

On January 10, 2022 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the company is positioned for growth in the mid- and long-term with the potential to deliver incremental revenue growth and additional upside potential through FY2030 (Press release, Takeda, JAN 10, 2022, View Source [SID1234598543]). Presenting at the 40th Annual J.P. Morgan Healthcare Conference, Christophe Weber, Takeda’s President and Chief Executive Officer, reinforced the mid-term revenue growth potential of its 14 global brands. In addition to recent FDA approvals, Takeda’s strong pipeline of approximately 40 diverse, clinical-stage assets will provide the potential for a significant number of regulatory approvals over the next several years, further supporting its long-term topline growth outlook. As part of Takeda’s approach to building a robust pipeline, the company also announced today its plans to exercise its option to acquire Adaptate Biotherapeutics after a successful multi-year R&D partnership. This will add a novel antibody-based γδ T-cell engager platform, including pre-clinical candidate and discovery pipeline programs, to Takeda’s immuno-oncology portfolio further demonstrating its commitment to delivering life-transforming medicines to patients.

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!

"Over the past decade, we have reinvented ourselves into a top-tier global company positioned for strong growth through innovation. With our global scale, exciting pipeline and a robust portfolio of brands, together with our investments in data and digital, we aim to revolutionize how we treat disease and improve patients’ experiences," said Christophe Weber, president and chief executive officer, Takeda. "Our growth strategy is clear, and I am confident in our ability to continue delivering on our ambitious vision with several molecules that have significant sales potential in our pipeline and as demonstrated by our two recent FDA approvals of pipeline assets and their launches late last year."

Mid-Term Growth Expected to be Driven by 14 Global Brands

Takeda’s strong commercial execution materializes in the growth of its 14 global brands, which are on track to meet its underlying revenue growth forecast of +14-16% for FY2021 and are expected to continue to help to drive topline acceleration, competitive margins and strong cash flow in the medium term. The company is confident that these global brands, alongside new product launches such as EXKIVITY (mobocertinib) and LIVTENCITY (maribavir), will contribute to forecasted total company incremental revenue growth of approximately JPY 500 billion ($4.5 billion) by FY20251. Incremental revenue is expected to result from continued market penetration, a growing market size in launched countries, and new indications and geographic expansion, including in Japan and emerging markets, such as China. The company also reviewed assumptions for Entyvio (vedolizumab) biosimilars, and is no longer expecting entry of biosimilars when data exclusivity expires.

Pipeline Poised to Deliver Sustained Value

Takeda’s R&D engine has approximately 40 clinical-stage potential therapies in oncology, rare genetics and hematology, neuroscience, gastroenterology, plasma-derived therapies and vaccines, and this diverse pipeline is projected to ensure long-term growth beyond FY2025. Assets expected to be in pivotal trials by the end of FY2022 have more than JPY 1 trillion (~$10B) in non-PTRS adjusted, approximately JPY 500 billion (~$5B) in PTRS adjusted, aggregate peak sales potential2,3. This includes TAK-003, a potential vaccine to treat dengue fever, a global public health threat; TAK-755, the first and only, potentially transformative, targeted ADAMTS13 replacement therapy for thrombotic thrombocytopenic purpura (TTP), a rare and life-threatening clotting disorder; and soticlestat, for the treatment of developmental and epileptic encephalophathies. In addition, five high-potential therapies in earlier stage development, including multiple cell and gene therapies, are expected to have pivotal readouts in the next few years, several of which have significant peak sales potential.

Strong Execution Delivering Value

Throughout its global transformation, Takeda has delivered on its financial commitments. This includes topline acceleration driven by its 14 global brands, which delivered revenue of JPY 1.2 trillion ($11 billion) in FY2020 and are on track to meet Takeda’s underlying revenue growth forecast of +14-16% in FY2021, representing approximately 45% of total core revenue. In addition, Takeda continues to deliver a strong underlying core operating profit margin and free cash flow and is on track towards its deleveraging target of low twos net debt to adjusted EBITDA by FY2023. The company also recently announced its plans to buy back shares, underscoring confidence in its business strategy and commitment to delivering value to shareholders.

Slides from the J.P. Morgan Healthcare Conference presentation and a link to the audio webcast can be accessed on Takeda’s website at: View Source