On March 16, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the fourth quarter and year ended December 31, 2021 and provides a corporate update (Press release, BioLineRx, MAR 16, 2022, View Source [SID1234610165]).

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Significant events and achievements during the fourth quarter 2021 and subsequent period:

Commissioned a comprehensive third-party market assessment of the US stem cell mobilization market, which identified a commercial opportunity in the US of ~$360 million;
Completed a successful pre-NDA meeting with the FDA, at which the FDA agreed that the Company’s proposed regulatory data package is sufficient to support an NDA submission in stem cell mobilization. To that end, the Company intends to submit its NDA in this indication in mid-2022;
Announced significantly positive and commercially relevant results from a pharmacoeconomic cost effectiveness study comparing Motixafortide + G-CSF versus G-CSF alone and indirectly comparing Motixafortide + G-CSF versus plerixafor + G-CSF. Both analyses demonstrated substantial cost savings from using Motixafortide and further strengthened the case for use of Motixafortide as a primary mobilization agent for all multiple myeloma patients undergoing autologous stem cell transplantation (ASCT);
Versus plerixafor + G-CSF, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$30,000 per patient (not including the cost of Motixafortide).
Versus G-CSF alone, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$19,000 per patient (not including the cost of Motixafortide).
Delivered one oral and three poster presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which was held December 11-14, 2021. The oral presentation highlighted the successful GENESIS Phase 3 pivotal trial;
Announced formation of Immuno-Oncology Scientific Advisory Board comprised of recognized leaders in the fields of cancer immunology, intra-tumoral injections and clinical development. The SAB will provide guidance on the Company’s ongoing AGI-134 anti-cancer vaccine program and other potential immuno-oncology initiatives;
Completed recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors;
Ended the fourth quarter on solid financial footing, with cash and cash equivalents of $57.1 million.
"The opportunity for Motixafortide in stem-cell mobilization is significant," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We recently commissioned a comprehensive third-party market assessment which identified a $360 million addressable annual opportunity in the US. We continue to maintain optionality among a number of commercialization alternatives, as we believe the very concentrated end market, where approximately 80 transplant centers in the US conduct the vast majority of stem cell transplant procedures, would require a limited commercialization footprint. In the meantime, in order to ensure that Motixafortide is well positioned for a timely and robust US launch that will maximize the value of the asset, we have initiated a number of pre-commercialization launch activities.

At the same time, we are very pleased with the additional results of our pharmacoeconomic study, which demonstrate a significant cost benefit for Motixafotide plus G-CSF as compared to plerixafor plus G-CSF, one of the main current treatment options. These results, together with the overwhelmingly positive results from our GENESIS Phase 3 study, give us tremendous optimism for the potential of Motixafortide to become the new standard of care mobilization agent for multiple myeloma patients – the first true advancement in stem cell mobilization since the approval of plerixafor in 2008.

Following our very productive pre-NDA meeting with FDA that we completed in December, we are diligently working to submit the NDA and position the product for commercialization. We anticipate the NDA submission will occur in mid-2022."

"With over $57 million in cash, we believe we are well financed to extract maximum value from Motixafortide in SCM while at the same time advancing our other pipeline programs," concluded Mr. Serlin.

Upcoming Expected Milestones:

Submission of NDA to FDA for Motixafortide as novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022;
Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in H2 2022;
Initiate Phase 2 study of AGI-134 in 2023;
Potential FDA approval of Motixafortide in 2023;
Potential US launch of Motixafortide in SCM in 2023.
Financial Results for the Year Ended December 31, 2021:

Research and development expenses for the year ended December 31, 2021 were $19.5 million, an increase of $1.3 million, or 7.1%, compared to $18.2 million for the year ended December 31, 2020. The increase resulted primarily from an increase in expenses associated with the AGI-134 phase 1/2a study, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the year ended December 31, 2021 were $1.0 million, an increase of $0.2 million, or 19.4% compared to $0.8 million for the year ended December 31, 2020. The increase resulted primarily from an increase in consultancy services related to Motixafortide.

General and administrative expenses for the year ended December 31, 2021 were $4.3 million, an increase of $0.4, or 10.0% compared to $3.9 million for the year ended December 31, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance expenses.

The Company’s operating loss for the year ended December 31, 2021 amounted to $24.8 million, compared to an operating loss of $22.9 million for the year ended December 31, 2020.

Non-operating expenses amounted to $1.8 million for the year ended December 31, 2021, compared to non-operating expenses of $5.7 million for the year ended December 31, 2020. Non-operating expenses for both periods primarily relate to fair-value adjustments of warrant liabilities and issuance expenses related to the ATM.

Net financial expenses amounted to $0.4 million for the year ended December 31, 2021, compared to net financial expenses of $1.4 million for the year ended December 31, 2020. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the year ended December 31, 2021 amounted to $27.1 million, compared with a net loss of $30.0 million for the year ended December 31, 2020.

The Company held $57.1 million in cash, cash equivalents and short-term bank deposits as of December 31, 2021.

Net cash used in operating activities for the year ended December 31, 2021 was $23.6 million, compared to $23.2 million for the year ended December 31, 2020. The $0.4 million increase in 2021 was primarily the result of an increase in research and development expenses.

Net cash used in investing activities for the year ended December 31, 2021 was $38.2 million, compared to net cash provided by investing activities of $16.7 million for the year ended December 31, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits during the respective periods.

Net cash provided by financing activities for the year ended December 31, 2021 was $57.7 million, compared to $17.9 million for the year ended December 31, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of the Company’s ADSs in January 2021, warrant exercises, and net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital. The cash flows in 2020 primarily reflect the registered direct offerings of ADSs in May and June 2020, as well as net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, March 16 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 18, 2022; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2021 has been filed with the U.S. Securities and Exchange Commission at View Source and posted on the Company’s investor relations website at View Source The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Mali Ze’evi, Chief Financial Officer, at [email protected].

On March 16, 2022 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that the company will participate in the KeyBanc Capital Markets Life Sciences & MedTech Forum. Nick Green, president and chief executive officer of Avid Bioservices, will be the featured speaker in a fireside chat at the conference, which will take place March 22-23, 2022 in a virtual format (Press release, Avid Bioservices, MAR 16, 2022, View Source [SID1234610164]).

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Details of the company’s participation are as follows:

KeyBanc Capital Markets Life Sciences & MedTech Forum
Conference Date: March 22-23, 2022
Fireside Chat Time/Date: 1:30 – 2:05 p.m. Eastern on Wednesday, March 23, 2022
Format: Virtual Conference; webcast available
To listen to the live webcast of the KeyBanc fireside chat, or access the archived webcast, please visit: View Source

On March 16, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the fourth quarter and full year ended December 31, 2021 (Press release, Athenex, MAR 16, 2022, View Source [SID1234610163]).

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"We are pleased to announce our new vision for the future of Athenex, by deploying our resources and harnessing our expertise toward the advancement of our promising cell therapy programs. The encouraging data that we have generated so far, along with our belief that cell therapy is driving the next major innovation cycle in cancer treatment, give us confidence in our new strategy," said Johnson Lau, Chief Executive Officer of Athenex. "We are taking action to swiftly redirect our resources and have begun executing on cost savings measures to right-size the company and support our transformation to a lean, focused cell therapy company."

Corporate Developments

Key Program and Business Updates

Focus R&D resources on developing cell therapy programs
Discontinue oral discovery program apart from oral paclitaxel
Reducing operating expenses: With the objective of extending its cash runway, the Company is implementing cost cutting initiatives and workforce reduction to lower operating expenses by over 50%
Plan to monetize non-core assets consistent with new focus and strategy of company
Key Anticipated Milestones

Update on ANCHOR data previously presented at ASH (Free ASH Whitepaper) in 2021 at ASTCT on April 23-26, 2022
Update from KUR-501, our autologous program in pediatric neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting on May 16-19, 2022
Preclinical data presentation of allogeneic GPC3 CAR-NKT cell program in liver cancer at ASCO (Free ASCO Whitepaper) on June 3-7, 2022
Expand CD19 CAR-NKT ANCHOR study to a multi-center study under the newly allowed IND
Data update from KUR-502 at American Society of Hematology (ASH) (Free ASH Whitepaper) on December 10-13, 2022
Potential regulatory update from MHRA for Oral Paclitaxel in metastatic breast cancer (mBC) in UK
Data from I-SPY 2 trial of Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H22
IND filing for KUR-503, our allogeneic CAR-NKT program in liver cancer in 1H23
Fourth Quarter 2021 and Recent Business Highlights

Clinical Programs

Cell Therapy

Observed ORR of 80% with 3 CRs and 1 PR out of 5 evaluable patients in data presented from Phase 1 ANCHOR trial of KUR-502 in relapsed/refractory CD19-positive leukemia and lymphoma at the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December.
Announced agreement with the National Cancer Institute (NCI) to license TCRs targeting KRAS, TP53, and EGFR to combine with our allogeneic platform for application in solid tumors
Received IND clearance from the FDA to expand Phase 1 ANCHOR study of KUR-502 to up to 12 clinical sites
Orascovery

Initiated the expansion portion of Phase 1/2 trial of Oral Paclitaxel in combination with pembrolizumab in (Non-small Cell Lung Cancer) NSCLC
Commercial Update

Klisyri (tirbanibulin)

Commercial Partner Almirall reported 3% market share the U.S. and expects gains to continue
Over 2,000 HCPs have prescribed Klisyri since its launch, and it has access to over 70 million covered lives within the commercial space
Almirall expects Medicare Part D coverage in 2022
Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 29 products with 54 SKUs.
Athenex Pharma Solutions (APS) currently markets 5 products with 16 SKUs
Fourth Quarter and Full Year 2021 Financial Highlights

Revenues from product sales increased to $23.5 million for the three months ended December 31, 2021, from $21.8 million for the three months ended December 31, 2020, an increase of $1.7 million or 8%. Product sales for the full year 2021 were $92.3 million, down from $105.3 million in 2020, which represents a 12% decrease. This decrease was primarily attributable to non-recurring COVID-related sales in 2020 and international supply chain disruptions caused by COVID-19.

License fees and other revenue for three months and year ended December 31, 2021 were $1.5 million and $27.9 million, respectively, compared to $28.0 thousand and $39.1 million, respectively, for the same periods in 2020.

Cost of sales for the three months ended December 31, 2021 totaled $20.7 million, an increase of $2.4 million, or 13%, as compared to $18.3 million for the three months ended December 31, 2020. Cost of sales totaled $82.4 million for the full year in 2021, a decrease of 14% as compared to $95.4 million for the full year in 2020. The decrease in our cost of specialty product sales was in-line with the decrease in revenue partially offset by corresponding increases in 503B, Contract Manufacturing, and API product sales.

R&D expenses totaled $18.3 million for the three months ended December 31, 2021, in-line with expenses for the three months ended December 31, 2020. R&D expenses totaled $80.2 million for the full year in 2021, an increase of 6% as compared to $75.9 million for the full year in 2020. This increase is primarily due to an increase in costs related to Oral Paclitaxel, drug licensing costs, and cell therapy costs.

SG&A expenses totaled $13.4 million for the three months ended December 31, 2021, a decrease of 57% as compared to $31.4 million for the three months ended December 31, 2020. SG&A expenses totaled $72.6 million for the full year in 2021, a decrease of 22%, as compared to $92.9 million for the full year in 2020. This was primarily due to a $24.8 million decrease of costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the Complete Response Letter in February 2021, offset by increased operating costs, professional fees and compensation expense.

The Company recorded impairment of $69.4 million, including goodwill impairment of $67.7 million, during the year ended December 31, 2021, based on the results of a quantitative goodwill impairment test for our reporting units.

Interest expense totaled $5.1 million and $4.4 million for the three months ended December 31, 2021 and 2020, respectively. Interest expense for the year ended December 31, 2021 totaled $20.7 million, an increase of $9.5 million, as compared to $11.2 million for the year ended December 31, 2020, primarily due to increased borrowings. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree, while interest expense in the prior period was primarily incurred from debt under a former credit agreement with Perceptive Advisors LLC and its affiliates.

Income tax benefit (expense) for the three months ended December 31, 2021 amounted to ($15.0) thousand, compared to income tax expense of ($8.0) thousand for the same period in 2020. Income tax benefit totaled $10.6 million and income tax expense totaled ($4.1) million for the full year in 2021 and 2020, respectively. The income tax benefit in the current year is primarily the result of taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s in-process research and development. This taxable temporary difference is considered a source of taxable income to support the realization of deferred tax assets from the acquirer which resulted in a reversal of our valuation allowance. The income tax expense in the prior year was primarily attributable to foreign income tax withholdings on our revenue earned under our out-license arrangements.

Net loss attributable to Athenex for the three months and year ended December 31, 2021 were $104.4 million and $199.8 million, respectively, or ($0.95) and ($1.92) per diluted share, respectively, as compared to a net loss of $49.5 million and $146.2 million, or ($0.53) and ($1.72) per diluted share, for the same periods in 2020.

For further details on the Company’s financial results, including the results for the full year ended December 31, 2021, refer to the Form 10K filed with the SEC.

2022 Financial Guidance

Athenex’s product sales in 2021 amounted to $92.3 million, which represents 9% growth over the prior-year period, excluding one-time international sales of $21.0 million relating to the COVID pandemic. The Company expects 2022 year-over-year product sales growth to be in the range of 15-20%. While the Company does not give quarterly guidance, product sales are expected to increase throughout the year, as new products are launched.

Cash Conservation Update

As of December 31, 2021, the company had cash and cash equivalents of $35.2 million, restricted cash of $16.5 million, and short-term investments of $10.2 million, for a total of $61.9 million. The Company is implementing cost saving programs and monetizing non-core assets, resulting in plans to extend cash runway in 2022.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Wednesday, March 16, 2022, at 4:30 p.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source

On March 16, 2022 AstraZeneca reported that Further positive results from the OlympiA Phase III trial showed MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy (Press release, AstraZeneca, MAR 16, 2022, View Source [SID1234610162]).

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These results were presented today at a European Society for Medical Oncology Virtual Plenary. The OlympiA trial is led by the Breast International Group (BIG) in partnership with the Frontier Science & Technology Research Foundation (FSTRF), NRG Oncology, AstraZeneca and MSD.1

In the key secondary endpoint of OS, Lynparza reduced the risk of death by 32% versus placebo (based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). Lynparza improved the three-year survival rate to 92.8% versus 89.1% for those on placebo. At four years, the survival benefit was maintained with 89.8% of patients treated with Lynparza alive versus 86.4% of those on placebo. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.

Primary results from the OlympiA Phase III trial were first presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and are published in The New England Journal of Medicine.2 The OS data and the primary results formed the basis for the recent approval by the US Food and Drug Administration (FDA) of Lynparza in this setting.

Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020.3 Nearly 91% of all breast cancer patients in the US are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5-10% of patients.4,5

Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London, said: "OlympiA’s latest results are great news for patients with a specific inherited form of breast cancer. Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high. OlympiA has now shown that olaparib not only reduced the risk of recurrence but also improved overall survival for women with high risk early-stage breast cancer and a BRCA1/2 mutation and is an exciting demonstration of the benefits of targeting the specific biology of disease for these women."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These exciting results further support how Lynparza could significantly change the way people with germline BRCA-mutated early breast cancer are treated. The OlympiA trial is the first time we’ve seen a PARP inhibitor deliver survival benefit in early breast cancer, highlighting the importance of persistent innovation in tackling cancer early."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "The results from the OlympiA trial highlight that patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer can both live longer and with reduced risk of disease recurrence when treated with Lynparza in the adjuvant setting, compared to placebo. These data further reinforce the importance of germline BRCA testing immediately after diagnosis to help identify patients who may be eligible for treatment with Lynparza."

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. In the EU, this indication also includes patients with locally advanced breast cancer.

Notes

Early breast cancer
Early breast cancer is defined as cancer confined to the breast with or without regional lymph node involvement, and the absence of distant metastatic disease.6 In the US, the 5-year survival is 99% for localised breast cancer (only found in the breast area) and 86% for regional breast cancer (cancer that has spread outside the breast to nearby structures or lymph nodes).4 Despite advancements in the treatment of early breast cancer, up to 30% of patients with high-risk clinical and/or pathologic features recur within the first few years and patients with gBRCA mutations are more likely to be diagnosed at a younger age than those without these mutations.7

Breast cancer is one of the most biologically diverse tumour types with various factors fuelling its development and progression.8 The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease.9

OlympiA
OlympiA is a Phase III, double-blind, parallel group, placebo-controlled, multicentre trial testing the efficacy and safety of Lynparza tablets versus placebo as adjuvant treatment in patients with gBRCAm high-risk HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.1

The primary endpoint of the trial is invasive disease-free survival defined as time from randomisation to date of first loco-regional or distant recurrence or new cancer or death from any cause.1

BIG
The Breast International Group (BIG) is an international not-for-profit organisation for academic breast cancer research groups from around the world, based in Brussels, Belgium.

Founded by leading European opinion leaders in 1999, the organisation aims to address fragmentation in breast cancer research and now represents a network of over 50 like-minded research groups affiliated with specialised hospitals, research centres and leading experts across approximately 70 countries on six continents.

BIG’s research is supported in part by its philanthropy unit, known as BIG against breast cancer, which is used to interact with the general public and donors, and to raise funds for BIG’s purely academic breast cancer trials and research programmes.

FSTRF
Frontier Science & Technology Research Foundation (FSTRF) is a non-profit, research organisation which supports research networks, pharmaceutical companies and investigators to conduct scientifically meaningful high-quality clinical trials. The OlympiA trial involved research staff in the US and in the Affiliate office in Scotland.

FSTRF works with scientists and technicians in more than 800 laboratories, universities and medical centres around the world to provide a comprehensive range of research services throughout the clinical trial process including design, analysis and reporting.

Through its work, FSTRF aims to advance the application of statistical science and practice and data management techniques in science, healthcare and education.

NRG Oncology
NRG Oncology is a network group funded by the US National Cancer Institute (NCI), a part of the National Institutes of Health. NRG Oncology brings together the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG), with the mission to improve the lives of cancer patients by conducting practice-changing multi-institutional clinical and translational research. NRG Oncology sponsored OlympiA in the US and collaborated with the other adult cancer clinical trials research groups funded by the NCI, Alliance, ECOG/ACRIN and the Southwest Oncology Group. The NCI and AstraZeneca are collaborating under a Cooperative Research and Development Agreement between the parties.

BRCA
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells.10 When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.10-13

Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents (such as new hormonal agents – NHAs).

Inhibition of PARP proteins with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.

Lynparza is currently approved in a number of countries across PARP-dependent tumour types with defects and dependencies in the DDR pathway including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination repair deficient (HRD)-positive advanced ovarian cancer, respectively; for germline BRCAm, HER2-negative metastatic breast cancer (in the EU and Japan this includes locally advanced breast cancer); for germline BRCAm metastatic pancreatic cancer; and HRR gene-mutated metastatic castration-resistant prostate cancer (BRCAm only in the EU and Japan).

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types.

Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. The companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines independently.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex and Zoladex and the next-generation oral SERD and potential new medicine camizestrant.

The PARP inhibitor, Lynparza, is an approved targeted treatment option for early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD continue to research Lynparza in breast cancer patients with an inherited BRCA mutation.

Building on the first approval of Enhertu, a HER2-directed antibody drug conjugate (ADC), in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings.

To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On March 16, 2022 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported FDA clearance to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with the anti-PD-1 antibody pembrolizumab (Press release, Adagene, MAR 16, 2022, View Source [SID1234610161]). The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).

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ADG126 SAFEbody is designed for conditional activation in the tumor microenvironment (TME), as well as to enhance the efficacy profile by potent Treg depletion and to maintain its physiological function by soft ligand blocking in order to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies.

"The FDA clearance of this trial represents a major step forward in our wholly-owned CTLA-4 program. It builds on a strong safety profile for ADG126 SAFEbody and its parental antibody ADG116, respectively, as a single agent and the ability to achieve doses that may unlock the full potential of CTLA-4 as a proven target for strong ADCC-mediated Treg depletion in the TME. Our goal is to establish the CTLA-4 pathway as the cornerstone of cancer treatment in both single-agent and combination regimens," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "We are excited to initiate our clinical trial evaluating combination therapy with ADG126, which leverages SAFEbody precision masking technology to address toxicity limitations. This multi-regional trial of ADG126 with pembrolizumab also reflects our commitment to bringing highly differentiated therapies to cancer patients globally."

SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the TME, this allows for tumor-specific targeting of antibodies, while minimizing on-target off-tumor toxicity in healthy tissues.

The ADG126-P001 trial is expected to dose the first patients soon. The trial is designed to evaluate safety and tolerability, and to determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab. The trial will begin with dose-escalation (ADG126 at 6 mg/kg) followed by dose expansion at the recommended dose for early efficacy evaluation. A combination cohort of ADG126 with the anti-PD-1 therapy, toripalimab is also being initiated in Australia.