Black Diamond Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 11, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 11, 2022, View Source [SID1234614260]).

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"We continue to build a pipeline of novel MasterKey therapies with our product candidates, including BDTX-1535 and BDTX-4933, and we are focused on delivering development candidates generated from our MAP drug discovery engine as we work to address major unmet needs of oncology patients. With our recently announced pipeline prioritization and realignment of resources to strengthen our financial position, we believe Black Diamond is well-positioned for strong execution across our upcoming clinical and preclinical milestones into the third quarter of 2024," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are incredibly pleased with the pace at which our BDTX-1535 Phase 1 study has been advancing with the recently announced first patient dosed. This next generation brain-penetrant inhibitor of oncogenic EGFR represents a unique opportunity to potentially address existing gaps in the treatment landscape for patients with EGFR mutant NSCLC and GBM and we look forward to providing a clinical update for the program in 2023."

Recent Developments

BDTX-1535:

BDTX-1535 is designed as a potent, selective, irreversible and brain-penetrant MasterKey inhibitor of epidermal growth factor receptor (EGFR) mutations expressed in GBM and of intrinsic and acquired resistance EGFR mutations to third generation EGFR inhibitors in NSCLC.
In April 2022, the first patient was dosed in the Phase 1, global study of BDTX-1535.
The Company expects to provide a clinical update on BDTX-1535 in 2023.
BDTX-4933:

BDTX-4933 is a brain-penetrant BRAF inhibitor against families of Class I, II, III canonical and non-canonical mutations being developed for the treatment of patients with or without brain tumors. BDTX-4933 is designed to be highly selective and potent, with the ability to avoid paradoxical activation.
Black Diamond initiated investigational new drug (IND)-enabling studies in the first quarter of 2022 and expects to submit an IND application for BDTX-4933 with the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Discovery-Stage Pipeline:

Black Diamond continues to leverage its Mutation-Allostery-Pharmacology, or MAP, drug discovery engine to advance its discovery-stage pipeline and anticipates progressing its fibroblast growth factor receptor (FGFR) program towards a development candidate nomination in 2022, in addition to disclosing a development candidate against a new target in 2023.
Corporate:

In April 2022, Black Diamond announced plans to realign its resources to prioritize research and development programs for BDTX-1535, BDTX-4933 and discovery efforts, and decided to discontinue the development of BDTX-189 and reduce its workforce by approximately 30% to extend its cash runway into the third quarter of 2024.
In March 2022, Black Diamond appointed Wendy L. Dixon, Ph.D. to its Board of Directors, who joined the Board with over 40 years of biopharmaceutical industry experience, including service as a member of the board of several publicly traded biopharmaceutical companies.
In February 2022, Black Diamond appointed Elizabeth Montgomery as its Chief People Officer, who joined the Company with nearly 20 years of expertise and experience in developing strong corporate culture at a number of life sciences organizations.
Financial Highlights

Cash Position: Black Diamond ended the first quarter of 2022 with approximately $179.7 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $28.6 million for the first quarter of 2022 compared to $100.1 million for the year ended December 31, 2021.
Research and Development Expenses: Research and development (R&D) expenses were $17.8 million for the first quarter of 2022 compared to $22.8 million for the first quarter of 2021. The decrease in R&D expenses was primarily due to reduced activities on the BDTX-189 program and reduced spending on early discovery projects.
General and Administrative Expenses: General and administrative (G&A) expenses were $7.9 million for the first quarter of both 2022 and 2021.
Net Loss: Net loss for the first quarter of 2022 was $25.5 million, as compared to $30.3 million for the same period in 2021.
Financial Guidance

Following the Company’s pipeline prioritization and workforce realignment announcement in April 2022, Black Diamond has extended its cash runway which is expected to be sufficient to fund its anticipated operating expenses and expenditure requirements into the third quarter of 2024.

Biodesix Announces First Quarter 2022 Results and Highlights

On May 11, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for first quarter ended March 31, 2022 and provided a corporate update (Press release, Biodesix, MAY 11, 2022, View Source [SID1234614221]).

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"We are pleased by the progress we continue to make with our core lung diagnostic sales revenue, which grew 17% over the first quarter 2021 despite significant disruption from the COVID-19 Omicron variant during the first half of the quarter," said Scott Hutton, CEO of Biodesix. "We recovered quickly from the Omicron wave, and March was an all-time high in core lung diagnostic test results delivered. We also added to our therapeutic guidance portfolio with a full commercial launch of the 72-hour blood based GeneStrat NGS test, introducing flexibility in addressing individual patient and physician needs when considering the most appropriate treatment options for cancer. In addition, we successfully executed several strategic fundraising efforts to further support our growth and recovery resulting in an additional $27.4 million in debt and equity funding subsequent to quarter end, including a restructuring of our milestone payments to Integrated Diagnostics to provide further financial flexibility."

First Quarter 2022 Financial Results

For the three-month period ended March 31, 2022, as compared to the same period of 2021 (where applicable):

Total revenue of $6.5 million, an expected decrease of 77%, driven primarily by an expected year-over-year decline in COVID-19 diagnostic testing due to lower rate of testing compared to the first quarter of 2021:

Core lung diagnostic revenue of $4.6 million, an increase of 17% driven primarily by growth in the Nodify lung nodule management tests;

COVID-19 testing revenue of $1.0 million, a decrease of 96% in line with expectations as the pandemic recedes and COVID testing trends continue to move to at-home testing;

BioPharma Services revenue of $0.9 million, a decrease of 45% driven by disruptions in clinical trials world-wide by the spike in the Omicron COVID-19 variant;

First quarter 2022 gross margin of $3.3 million, or 51% as a percentage of revenue as compared to 37% in the comparable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing partially offset by costs related to the commercial launch of our GeneStrat NGS test in January;

Operating expenses (excluding direct costs and expenses) of $17.8 million, an increase of 10% driven primarily by growth in sales and marketing to fund our growth in sales and recent GeneStrat NGS commercial launch;

Includes non-cash stock compensation expense of $1.3 million as compared to $1.8 million in the prior year quarter;

Net loss of $15.6 million, an increase of 124%;

Cash and cash equivalents of $16.4 million as of March 31;

Included payment of $4.625 million for scheduled milestone payment in January 2022 to Integrated Diagnostics (Indi);

Liquidity and capital improvements subsequent to March 31, 2022:

Equity proceeds of $11.7 million from a private placement;

Equity proceeds of approximately $2.7 million through the at-the-market facility;

Completion of $25.0 million debt facility of which $15.0 million (approximately $13.0 million, net, after deducting estimated debt issuance costs and original issue discounts) funded in May 2022 and remaining amount contingently available based on contract terms;

Repayment of $3.0 million in outstanding principal balance on Term Loan;

Restructuring of Indi milestone payments reducing required payments by approximately $7.5 million and $7.2 million in 2022 and 2023, respectively.
2022 Financial Outlook

The Company reaffirms our 2022 financial outlook and expects to generate between $37.5 million and $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, May 11, 2022 at 8:00 a.m. Eastern Time.

Takeda Delivers Strong FY2021 Results; Continued Growth Momentum Expected in FY2022

On May 11, 2022 Takeda (TOKYO:4502/NYSE:TAK) reported strong financial results for fiscal year 2021 (period ended March 31, 2022), driven by the performance of its growth products, new product launches and strength across its key business areas (Press release, Takeda, MAY 11, 2022, View Source [SID1234614239]).

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Takeda president and chief executive officer, Christophe Weber, commented: "We are pleased to report another year of strong performance, driven by our growth products. I am energized by the impact we are making for patients and by our continued momentum. We are seeing the potential of our innovative pipeline of approximately 40 clinical stage assets come to life, as demonstrated by the approval and launch of EXKIVITY and LIVTENCITY.

Looking ahead, our goal is to continue to grow Takeda into the most trusted, science-driven, digital biopharmaceutical company, and our strong performance against our strategy in FY2021 reinforces my confidence about the path we are on."

Takeda chief financial officer, Costa Saroukos, commented: "Takeda’s strong FY2021 performance against our management guidance provides a solid foundation for our FY2022 outlook for continued topline growth and robust cash flow generation. This will allow us to allocate capital to maximize value for patients and shareholders as we invest in our R&D engine, new product launches and other growth drivers while continuing to rapidly reduce debt and return cash to shareholders."

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source

(b) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, amortization and impairment of intangible assets, other operating income and expenses, certain JV-related accounting adjustments, non-recurring items, purchase accounting effects and transaction related costs.

(c) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.

(d) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS

– Gastroenterology (GI), with 875.7 billion yen in reported revenue, grew +7% on an underlying basis driven by gut-selective ENTYVIO and anti-acid therapy TAKECAB. Following a review of assumptions regarding ENTYVIO biosimilars, Takeda is no longer expecting entry of biosimilars upon loss of data exclusivity.

– Rare Diseases, with 611.2 billion yen in reported revenue, declined -1% on an underlying basis, impacted by a decline in line with expectations in Rare Hematology due to intensified competition. Hereditary Angioedema (HAE) had underlying growth of +4% driven by the strong growth of global market leader TAKHZYRO, which continued its geographic expansion with approval in Japan in March 2022. Post-transplant antiviral infection treatment LIVTENCITY, which launched in the U.S. in December 2021, has been well received by U.S. transplant centers. Additionally, in a recent exploratory data analysis LIVTENCITY showed reductions in hospitalization rates and length of hospital stay.

– Plasma Derived Therapy (PDT) Immunology, with 507.0 billion yen in reported revenue, delivered exceptional growth of +14% on an underlying basis. This was driven by continued strong growing global demand for our Immunoglobulin portfolio and increasing demand for FLEXBUMIN in China and the U.S., both enabled by improved supply. FY2021 plasma donation volume grew 16% compared to COVID-19-impacted FY2020 and was up 3% over pre-pandemic levels.

– Oncology, with 468.7 billion yen in reported revenue, grew +8% on an underlying basis driven by increased market penetration and strong demand increases in Growth and Emerging Markets, particularly China. Non-small cell lung cancer (NSCLC) treatment EXKIVITY, which launched in the U.S. in September 2021, continued its global expansion with recent conditional approval in the U.K.

– Neuroscience, with 482.3 billion yen in reported revenue, grew +10% on an underlying basis driven by increased demand for VYVANSE following the impact of COVID-19 in FY2020.

PIPELINE UPDATE

Takeda strives to advance a steady stream of potential first-in-class or best-in-class therapies through a pipeline of approximately 40 molecules in clinical development – 90 percent of which did not exist six years ago. Leveraging its development strength, robust partnerships and innovative research engine, Takeda is focused on providing transformative treatments for targeted populations with high unmet needs across its core therapeutic areas.

In FY2021, Takeda further demonstrated its ability to bring new therapies to patients, receiving its highest total number of approvals in a fiscal year across Japan (4 NMEs), China (3 NMEs), the U.S. (2 NMEs), and Europe (1 NME) and leading the industry in drug approvals in Japan in calendar year 2021. Significant pipeline updates in Q4 FY2021 and since include:

Approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for NUVAXOVID Intramuscular Injection, a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. (Press Release)
VONVENDI received approval from the U.S. FDA for adult patients living with severe type 3 von Willebrand Disease (VWD), making it the first and only treatment approved for routine prophylaxis to reduce the frequency of bleeding episodes in adults living with severe type 3 VWD receiving on-demand therapy. (Press Release)
TAKHZYRO was approved by Japan’s MHLW for adult and pediatric patients 12 years of age and older for prophylaxis against acute attacks of hereditary angioedema (HAE) (Press Release). In February, the U.S. FDA approved a single-dose prefilled syringe injection for adult and pediatric patients 12 years and older (Press Release). Studies investigating TAKHZYRO for pediatric patients aged 2 to up to 12 years of age are ongoing and global regulatory filings for this patient population are planned to begin in FY2022. (Press Release)
ALOFISEL showed clinical remission rate at six-months in the real-world INSPIRE study interim analysis consistent with the pivotal clinical ADMIRE-CD Study. ALOFISEL offers a potential cell-mediated closure option for patients with complex Crohn’s perianal fistulas who have shown an inadequate response to at least one conventional or biologic therapy. (Press Release)
First Phase 2 study of TAK-755 was completed. TAK-755 is the first and only ADAMTS-13 replacement therapy in clinical development to address congenital thrombotic thrombocytopenic purpura (cTTP) and immune mediated thrombotic thrombocytopenic purpura (iTTP), life-threatening thrombotic disorders caused by ADAMTS-13 deficiency. Takeda expects Phase 3 data for TAK-755 in cTTP in FY2022 and potential filing for approval in FY2022.
After years of extensive regulatory discussions, Takeda has decided to discontinue development of TAK-609 as data are not sufficient for filing. Takeda remains committed to developing therapies for Hunter syndrome and other lysosomal storage disorders.
Regulatory filings in Europe and endemic countries are ongoing for TAK-003, Takeda’s dengue vaccine candidate, and U.S. regulatory filings are planned for later this year. (Press Release). Additional clinical data (the DEN-301 4.5 year analysis) will be presented at a scientific congress in June 2022.
Expanded collaboration with JCR Pharmaceuticals to develop gene therapies that apply JCR’s J-Brain Cargo blood-brain barrier (BBB) penetration technology for lysosomal storage disorders​.
Entered into a strategic collaboration and license agreement with Evozyne to develop proteins for gene therapies for genetic disorders within the inborn errors of metabolism and lysosomal storage disease areas of research.
FY2022 GUIDANCE

CER: Constant Exchange Rate

Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, discipline in operating expenses, and FX favorability.

In FY2022, Takeda expects continued revenue growth driven by an acceleration of our Growth and Launch Products, alongside FX tailwinds, to fully offset the impact from loss of exclusivity of VELCADE in the U.S. and the non-recurrence of 133.0 billion JPY from the sale of a diabetes portfolio in Japan recorded in FY2021. Core operating profit is expected to reach 1.1 trillion JPY, mainly driven by business momentum.

Key Assumptions in FY2022 Forecast and Management Guidance

Based on currently available information, Takeda expects that its financial results for FY2022 will not be materially affected by COVID-19 or the crisis in Ukraine and Russia and, accordingly, Takeda’s FY2022 reported forecast and management guidance reflect this expectation.

The FY2022 reported forecast and management guidance include approximately 50.0 billion JPY revenue contribution from COVID-19 vaccines.

VolitionRx Limited Announces First Quarter 2022 Financial Results and Business Update

On May 11, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2022 (Press release, VolitionRX, MAY 11, 2022, View Source [SID1234614261]). Volition management will host a conference call tomorrow, May 12 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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"I am delighted with the progress we are making, and in particular could not be prouder of the team’s achievement in securing a global licensing and supply agreement for our Nu.Q Vet Cancer Screening Test with Heska Corporation, one of the industry’s leading companies," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "In April, we expanded our geographic footprint with the launch of the Nu.Q Vet Cancer Test in Singapore through SAGE Healthcare. We have also made good progress in other key areas including our Nu.Q NETs and Nu.Q Capture programs as we shift gears towards our goal of becoming a commercial company with a wide range of world class products."

Volition is hosting a Capital Markets Day at the New York Stock Exchange, in a hybrid format, on Friday, May 13, 2022, at 10 a.m. U.S. Eastern Time. Volition’s executive team will provide strategic updates and discuss the Company’s key short-term growth drivers. Details for this event can be found below.

An interview with Cameron Reynolds, President and Group Chief Executive Officer of Volition.

Company Highlights

Financial

Cash and cash equivalents as of March 31, 2022, totaled approximately $23.7 million compared with $20.6 million as of December 31, 2021.

On March 30th Volition received a $10 million milestone payment from Heska Corporation.

Net loss for the quarter was $7.7 million dollars compared to $6.1 million for the three-months ended March 31, 2021.

Personnel/ Operational

To support our commercial expansion of Nu.Q Vet we welcomed Daniel Sheres, Product Manager, Devin DeVoue, Marketing Manager and Kristy Valdivia, Global Accounts Manager to the Volition Veterinary Team.

Subsequent to quarter end we appointed Sharon Ballesteros as U.S. Head of Quality and Development Process.

Volition Veterinary

Executed a global licensing and supply agreement with one of the industry’s leading companies, Heska Corporation.

In exchange for granting Heska exclusive worldwide rights to sell the Nu.Q Vet Cancer Screening Test for companion animals at the Point of Care, Volition has received a $10 million upfront payment and is eligible to receive up to a further $18 million based upon the achievement of near/mid-term milestones.

In addition to these milestone payments Volition expects to receive ongoing revenue for the supply of key components for said exclusive point of care product(s).

Volition has also granted Heska non-exclusive rights to sell the Nu.Q Vet Cancer Screening Test in kit format for companion animals, through Heska’s network of central reference laboratories for which Volition will receive ongoing additional revenue for such kit sales.

This is a long-term deal with significant market and revenue potential for Volition through the sale of kits and key components.

Subsequent to the quarter end SAGE Healthcare launched our Nu.Q Vet Cancer Test in Singapore.

We are in advanced negotiations with other potential licensing partners in our efforts to make Nu.Q Vet products as accessible as possible worldwide and anticipate further announcements in 2022.

Nu.Q Capture

Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition’s Nu.Q assays could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery.

The Nu.Q Capture program now has several strands of technology which:

essentially remove background noise, thereby amplifying the signal,

look to identify the signal in a novel way including through mass spectrometry, or

isolate various chromatin fragments, including nucleosomes and transcription factors.

Subsequent to the quarter end Volition sponsored a GenomeWeb webinar entitled "Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes" featuring Professor Axel Imhof. To watch on demand, visit the GenomeWeb website.

Volition is developing a large 1000-plus patient Nu.Q Capture study in lung cancer and colorectal cancer with further announcements expected in 2022.

Upcoming Milestones

Drive near term revenue in the following key areas:

Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet.

Complete Heska Corporation agreement milestones in order to receive further milestone payments.

Sales of key components of Point of Care test with Heska.

Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.

Ongoing and new Nu.Q Discover agreements.

Sales of its disease monitoring tests (e.g. COVID-19, sepsis).

Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis, and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.

Continue to advance its previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the U.S.

Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.

Advance the development of Nu.Q Capture.

Continue to file patents to expand and extend its intellectual property portfolio.

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition. The call will provide an update on important events which have taken place in the first quarter of 2022 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 25, 2022. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 10167203.

The event will be webcast and the presentations will be posted to Volition’s website. A replay will be made available.

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports interim results for phase III SKYSCRAPER-01 study in PD-L1-high metastatic non-small cell lung cancer

On May 11, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from its phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 11, 2022, View Source [SID1234614178]). The study did not meet its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival (OS) was immature, and the study will continue until the next planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting.

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"While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab programme as they emerge."

The tiragolumab programme continues to explore advances in multiple clinical trials to build on Tecentriq, expand into earlier stages of disease, and seeks to provide new treatment options in advanced and difficult-to-treat cancers with high unmet medical need.

About the SKYSCRAPER-01 study
SKYSCRAPER-01 is a global phase III, randomised double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. Co-primary endpoints are overall survival and progression-free survival.

About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer.1 Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq (atezolizumab).2 The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.1

About Tecentriq (atezolizumab)
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma. Tecentriq is also approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted therapies and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as subcutaneous injection to hopefully provide a faster and more convenient option for cancer patients.