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Takeda Emphasizes Strategy for Delivering Sustainable Growth Over Next Decade at the 40th Annual J.P. Morgan Healthcare Conference

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

Arcus Biosciences Provides Update on Clinical Programs, Including Key 2022 Milestones

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]).

"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

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

Vaxiion Therapeutics Announces Clearance of IND Application for the Intralesional Administration of VAX014 to Subjects with Treatment Refractory Solid Tumors

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]).

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.

GRAIL and Premier’s PINC AI™ Partner to Support Patient Access to Galleri® Multi-Cancer Early Detection Blood Test

On January 10, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a collaboration with Premier, Inc.’s PINC AI, an advanced technology and services platform that provides artificial intelligence-enabled clinical performance improvement technologies, to support patient access to Galleri, GRAIL’s groundbreaking multi-cancer early detection blood test (Press release, Grail, JAN 10, 2022, View Source [SID1234598540]).

Under the partnership, Premier’s PINC AI will augment its AI-enabled clinical decision support technology to alert clinicians to patients who present an elevated risk of cancer and may benefit from early detection with the Galleri test. The alert will be evidence-based, integrated in the workflow and is expected to be compatible with existing electronic medical record systems. Indianapolis-based Community Health Network is expected to be the first health system to pilot candidate alerts.

"At GRAIL, we are steadfast in our mission to detect cancer early. We are committed to making Galleri available to healthcare providers and eligible patients as a complement to guideline recommended cancer screenings, because we know that most cancers are diagnosed too late, when outcomes are poor," said Dr. Joshua Ofman, president and chief medical officer at GRAIL. "The partnership with Premier’s PINC AI, a trusted leader in healthcare technology, will support a key pillar of new early cancer detection technology – the identification of eligible patients through healthcare providers’ existing workflows."

"PINC AI augments clinical intelligence and helps ensure patients receive evidence-based care," said Leigh Anderson, president of Premier’s PINC AI. "Our goal with the new candidate alerts is to ensure more patients who need a cancer screening get one. We believe that Galleri is a game-changing screening tool that has the potential to increase early detection and treatment that can save lives, improve quality and reduce unnecessary costs."

More than 600,000 people die from cancer each year in the U.S., according to the American Cancer Society. This is in large part because the majority of cancers are found in later stages when treatment options are limited. Recommended screening tests only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and, in high-risk smokers, lung. More than 70 percent of cancer deaths are from cancers that lack recommended early detection screening.

In addition, studies have demonstrated that stage at diagnosis has the greatest impact on costs, with decreased costs for patients diagnosed early in the disease compared to those diagnosed at later stages.

"Galleri is a validated and transformational test that can detect more than 50 cancers with a single blood draw and predict the origin with a high degree of accuracy and a low rate of false positives," said Patrick McGill, M.D., executive vice president and chief transformation officer at Community Health Network. "With this collaboration between PINC AI and GRAIL, our clinicians will be alerted when patients meet certain criteria for the ordering of a Galleri test. We believe this will make Community Health Network much more effective in our efforts to detect cancers early, when treatments are more effective, giving our patients the best chances of a successful outcome. Thanks to Community Health Network’s Foundation sponsorship and funding, we are proud to be the first health system taking advantage of this collaboration."

Galleri is available in the U.S. by prescription only to complement existing single cancer screening tests.

About Galleri

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.

For more information about Galleri, visit www.galleri.com.

Knight Cancer Institute at Oregon Health & Science University to Offer the Galleri® Multi-Cancer Early Detection Test

On January 10, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early, reported a collaboration with the Knight Cancer Institute at Oregon Health & Science University (OHSU) to offer Galleri, GRAIL’s multi-cancer early detection (MCED) blood test (Press release, Grail, JAN 10, 2022, View Source [SID1234598539]). OHSU will provide patients access to Galleri via a pilot program to help find signals of cancer in earlier stages and advance the delivery of cancer care.

Beginning this month, the Galleri test will be offered to eligible patients through the OHSU Knight Cancer Institute. The OHSU Knight Cancer Institute is at the forefront of multi-cancer early detection, including serving as a founding member of the MCED consortium, a group of leading cancer-focused organizations evaluating technologies that have the potential to reduce cancer mortality through earlier detection and providing guidance for their clinical use.

"At GRAIL, we are focused on detecting cancer early, when treatments are more effective and there is potential for cure," said Dr. Josh Ofman, president and chief medical officer at GRAIL. "We are honored to work alongside the preeminent team of researchers and clinicians at the OHSU Knight Cancer Institute who share our vision and are committed to bringing their patients the benefits of earlier cancer detection."

More than 600,000 people die from cancer each year in the U.S., according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and, in high-risk smokers, lung. In fact, 71% of cancer deaths have no recommended early detection screening at all.

"Multi-cancer early detection is a true game-changing technology in how we detect and treat cancer," said Tom Beer, M.D., deputy director of the OHSU Knight Cancer Institute and chief medical officer of the Knight Cancer Institute’s Cancer Early Detection Advanced Research (CEDAR) Program. "After evaluating how the Galleri test worked in the clinical trial setting, we are now able to offer eligible patients access to the test."

In a clinical study, Galleri demonstrated the ability to detect more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.

OHSU is also a leading partner in the interventional PATHFINDER 2 study evaluating the implementation and performance of Galleri in a clinical care setting. Initial results from the first PATHFINDER study were presented by Dr. Beer at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting and demonstrated Galleri’s performance was consistent with findings from previous observational studies, underscoring the potential real-world ability of Galleri to find deadly cancers earlier.

About Galleri

For more information about Galleri, visit www.galleri.com.