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.

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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]).

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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.

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"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

On January 10, 2022 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that updates on clinical programs and key milestones anticipated in 2022 (Press release, Arcus Biosciences, JAN 10, 2022, View Source [SID1234598542]).

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"Our priorities for 2022 are clear and unambiguous—to flawlessly execute on the expansion of our global clinical programs which will include more than 10 randomized Phase 2 and 3 studies. We also expect to present randomized datasets from ARC-7 and ARC-8 at medical meetings and generate early data for AB521 that will clarify its potential as a best-in-class molecule," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus Biosciences. "Our strong cash position and the support from our partner Gilead Sciences enable earlier investment to intelligently advance a broad development plan for our novel and potentially practice-changing combinations to treat cancer."

Program Updates and 2022 Milestones

Anti-TIGIT program (domvanalimab and AB308)

Recent Updates:

Taiho Pharmaceutical Co., Ltd., exercised its option for domvanalimab and AB308 in Japan and certain other territories in Asia (excluding China). In exchange for the exclusive license, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.
Anticipated 2022 Milestones:

Data from ARC-7, an ongoing randomized 150-patient three-arm study in first-line PD-L1≥50% NSCLC, including progression-free survival data, are expected to be presented in 2H22.
In addition to ARC-10, an ongoing registrational study in 1L PD-L1≥50% NSCLC, we and Gilead plan to initiate two new Phase 3 studies in lung and gastrointestinal (GI) cancers, as well as additional clinical studies of domvanalimab-based combinations, in 2022.
AstraZeneca and Arcus will initiate the PACIFIC-8 registrational Phase 3 study in January to evaluate domvanalimab plus durvalumab, an anti-PD-L1 antibody, in unresectable Stage 3 NSCLC with curative intent, where durvalumab is standard of care.
Data from the Phase 1/1b ARC-12 study evaluating AB308, an Fc-enabled anti-TIGIT antibody, plus zimberelimab in advanced malignancies will inform future development plans.
Etrumadenant (A2a/A2b adenosine receptor antagonist)

ARC-4 Update:

The randomized Phase 1/1b study ARC-4 did not show differentiated clinical activity for etrumadenant plus zimberelimab and pemetrexed/carboplatin compared to that of zimberelimab and pemetrexed/carboplatin in patients with metastatic, EGFRm+ NSCLC who progressed after one or more TKI therapies. Arcus is conducting exploratory biomarker analyses to assess whether sub-populations of patients in the study derive benefit from etrumadenant-based treatment, such as those with PD-L1 high tumors. Final data from the study will be presented when available.
All ongoing studies for etrumadenant will continue unchanged. These studies are in settings where encouraging clinical activity has been observed, such as PD-L1≥50% NSCLC (ARC-7), castrate-resistant prostate cancer (CRPC; ARC-6), and colorectal cancer (CRC; ARC-9). Patients whose tumors harbor EGFRm+ characteristics are excluded from the ARC-7 and ARC-10 studies.
Anticipated 2022 Milestones:

Data from the etrumadenant-containing arm of ARC-7 are anticipated to be presented in 2H22, as noted above.
Data from the randomized cohort of ARC-6 evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in second-line (2L) metastatic CRPC are anticipated in 2H22.
Additional clinical studies for etrumadenant-based combinations, including the "triplet" of etrumadenant plus domvanalimab and zimberelimab, are being planned for 2022.
Quemliclustat (small molecule CD73 inhibitor)

Recent Updates:

Completed enrollment of 90 patients into the randomized portion of ARC-8, a Phase 1 study evaluating quemliclustat plus zimberelimab and gemcitabine/nab-paclitaxel vs quemliclustat plus gemcitabine/nab-paclitaxel in 1L pancreatic cancer.
Anticipated 2022 Milestones:

Results from the randomized portion of ARC-8, including data on progression-free survival, are expected to be presented in 2H22.
Enrollment of the cohort in 2L pancreatic cancer, an area of high unmet need, is on track to be completed in 1H22.
Additional clinical studies for quemliclustat are being planned for 2022.
AB521 (HIF-2a inhibitor)

Recent Updates:

Initiated ARC-14, a study to investigate the safety, tolerability, and pharmacokinetic profile of AB521 in healthy volunteers.
Anticipated 2022 Milestones

Share pharmacokinetic and safety data from ARC-14 in 1H22, which may demonstrate competitive advantages to other HIF-2a inhibitors.
Initiate Phase 1/1b study in oncology patients in mid-2022.
Discovery Programs:

Added a research collaboration to the existing agreement with Gilead under which Arcus will lead the discovery and early development of drug candidates against two novel research targets jointly selected by the parties.
Selected AB598 (CD39 antibody) as a development candidate, which is advancing into IND-enabling studies; several other oncology discovery programs continue to progress.
In 1H22, expect to select the first development candidate for a non-oncology target. This small molecule may have first-in-class potential in several inflammatory diseases.
Financial Guidance

Arcus’s cash position will nearly double to $1.4 billion, upon receiving the option payment totaling $725 million for three programs from Gilead. With this cash position and 50/50 cost sharing with Gilead for the joint development programs, Arcus plans to expand its clinical development programs and anticipates cash utilization of $275-325 million in 2022.

Arcus Clinical Study Overview

Trial

Name

Arms

Setting

Status

NCT No.

ARC-4

etruma + zim + carbo/pem vs.

zim + carbo/pem

TKI R/R EGFRmut NSCLC

Ongoing

Randomized

Phase 1/2

NCT03846310

ARC-6

etruma + zim + SOC vs. SOC

2L/3L CRPC

Ongoing

Randomized

Phase 2

NCT04381832

ARC-7

zim vs. zim + dom vs. zim +

dom + etruma

1L NSCLC (PD-L1 ≥ 50%)

Ongoing

Randomized

Phase 2

NCT04262856

ARC-8

quemli + zim + gem/nab-pac

vs. quemli + gem/nab-pac

1L PDAC

Ongoing

Randomized

Phase 1/1b

NCT04104672

ARC-9

etruma + zim + mFOLFOX

vs. SOC

2L/3L/3L+ CRC

Ongoing

Randomized

Phase 2

NCT04660812

ARC-10

chemo vs. zim vs. zim + dom

1L NSCLC (PD-L1 ≥ 50%)

Ongoing

Registrational

NCT04736173

ARC-12

AB308 + zim

Advanced Malignancies

Ongoing

Phase 1/1b

NCT04772989

ARC-14

AB521

Healthy Volunteer

Ongoing

NCT05117554

PACIFIC-8

durva ± dom

Curative-Intent Stage 3 NSCLC

Planned

Registrational

NA

Carbo/pem: carboplatin/pemetrexed; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; quemli: quemliclustat; R/R: relapsed/refractory; SOC: standard of care; zim: zimberelimab CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma

On January 10, 2022 Vaxiion Therapeutics, the industry leader in bacterial-minicell based cancer immunotherapies, reported the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options. VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy (Press release, Vaxiion Therapeutics, JAN 10, 2022, View Source [SID1234598541]).

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Vaxiion will soon initiate a multi-center, open label Phase 1 dose escalation study to evaluate the safety, tolerability, and initial antitumor activity in both treated and untreated lesions following intralesional administration of VAX014. The upcoming Phase 1 study is not restricted by indication, allowing for assessment of safety and activity of VAX014 across multiple injectable solid tumor types.

"Expanding the clinical footprint of VAX014 to treat a more diverse range of solid tumor types is a logical next step and a major milestone in the development plan for VAX014," said Vaxiion CEO, Matt Giacalone. "But most importantly, we are now in a position where we can explore treating patients with intractable disease. Our strong preclinical data suggest VAX014 has certain immunologic advantages over existing viral-based oncolytic therapies which could translate to better treatment outcomes for eligible patients."

Intralesional administration of VAX014 in preclinical models utilizing immunologically "cold" and "immune excluded" solid tumors consistently demonstrates durable, immune-dependent clearance of treated tumors. These studies have also demonstrated systemic immune-dependent activity against untreated secondary tumors (abscopal effect) coinciding with development of antitumor immunologic memory.

VAX014 is the first clinical product candidate generated from Vaxiion’s proprietary recombinant bacterial-minicell delivery platform. An ongoing Phase 1 study of VAX014 for the intravesical treatment of non-muscle invasive bladder cancer has demonstrated VAX014 to be safe and well tolerated with early indications of antitumor activity.