On July 25, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported a significant milestone for the Company’s DecisionDx-Melanoma gene expression profile test, surpassing 100,000 tests ordered (Press release, Castle Biosciences, JUL 25, 2022, View Source [SID1234616914]). From the launch of DecisionDx-Melanoma through June 30, 2022, the test has been ordered more than 105,000 times by more than 10,200 providers for patients diagnosed with cutaneous melanoma.

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"Since I founded the Company, a cornerstone of our strategy has been a keen focus on improved patient care and for DecisionDx-Melanoma, transforming the management of cutaneous melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Today, we celebrate reaching this milestone of more than 100,000 clinical orders, which has allowed us the opportunity to make a significant impact in the lives of patients diagnosed with cutaneous melanoma. As we look to tomorrow, we believe that DecisionDx-Melanoma will continue to help clinicians and their patients make improved treatment decisions."

DecisionDx-Melanoma is designed to inform two clinical treatment questions in the management of cutaneous melanoma:

a patient’s individual risk of sentinel lymph node (SLN) positivity and
a patient’s personal risk of recurrence and/or metastasis.
Integrating a patient’s tumor biology and their clinicopathologic features, DecisionDx-Melanoma provides comprehensive and actionable results to guide risk-aligned patient care.

DecisionDx-Melanoma’s clinical utility is supported by more than 35 peer-reviewed publications, including two meta-analyses, which the Company believes represents the largest body of data for a cutaneous melanoma prognostic test. The test has been independently validated and studied in more than 9,000 patient samples, including an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma cases. In a recent study in collaboration with the NCI, patients diagnosed with cutaneous melanoma and tested with DecisionDx-Melanoma had a 27% improvement in melanoma-specific survival compared to untested patients, suggesting that DecisionDx-Melanoma test results can aid in providing more risk-aligned treatment plans for improved patient outcomes.1

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 9,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration resulted in a study to evaluate melanoma-specific survival and overall survival, where patients tested with DecisionDx-Melanoma had better survival rates than untested patients. This data shows that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. DecisionDx-Melanoma has been validated in four archival risk-of-recurrence studies of more than 900 patients and six prospective risk-of-recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

On July 25, 2022 Komodo Health reported that it will join advocacy leaders at Fight Colorectal Cancer (Fight CRC) and 17 other leading public health institutions and industry leaders at the White House to discuss solutions to improve colorectal cancer care standards in the U.S (Press release, Fight CRC, JUL 25, 2022, View Source [SID1234616913]). The meeting is in response to President Biden’s call to action to improve and increase access to colorectal cancer screening, with a special emphasis on reaching underserved communities and closing gaps in care. The group of advocacy and industry experts will explore policy solutions and public-private partnerships that will advance the President’s Cancer Moonshot goals.

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At the event, Komodo will reinforce its commitment to partnering with patient advocacy and public health leaders to democratize access to patient-level insights on colorectal cancer care. Real-world evidence from Komodo’s Healthcare MapTM can help to identify where screening is needed in order to improve early detection in the communities that need it most. Komodo will use its technology platform to advance more proactive research, investment, and public health guidelines that can meaningfully address standards of care and preventive screenings for colorectal cancer. Komodo’s commitment is in response to President Biden’s renewed Cancer Moonshot initiative, which calls for ambitious goals and solutions to "end cancer as we know it."

"We’re proud to support the President’s Cancer Moonshot Initiative, and deepen the industry’s understanding of exactly when, where, and how patients experience disparities in care," said Arif Nathoo, MD, CEO and Co-Founder, Komodo Health. "We must take a data-driven approach to developing policies that improve healthcare equality and drive better outcomes for all."

Komodo has been working with Fight CRC and other advocacy and industry leaders in the colorectal cancer community for the past several years, leveraging Komodo’s data-driven intelligence to improve earlier detection, identify barriers to screenings, and help patients identify colorectal cancer specialists in their region. Earlier this year, Fight CRC launched its digital tool, the Fight CRC Provider Finder, a user-friendly resource built on Komodo’s Healthcare Map that allows patients and caregivers to more quickly find healthcare providers experienced in colorectal cancer.

Although colorectal cancer is preventable with timely screening and highly treatable if caught early, one in three people are not up to date with colorectal cancer screening. This was exacerbated by the COVID-19 pandemic; a recent analysis by Komodo Health found new CRC diagnoses were down more than 32%. Despite the availability of several safe and effective CRC screening options, CRC remains the No. 2 overall cancer killer in the U.S. Early detection and treatment play a particularly vital role in reducing racial health inequities and improving outcomes for those with CRC.

"We commend the bold vision to fight cancer by President Biden and the Moonshot program," said Anjee Davis, President of Fight CRC. "It is our hope as catalysts for the colorectal cancer community that with this meeting, we can address inequities within colorectal cancer screening and make progress toward our Path to a Cure. Prevention plays a huge role in ending colorectal cancer. The White House asked for a plan to get more people screened, and we are here to deliver — leading with the power of the patient voice."

Participants who will be attending the White House Meeting:

Carolyn "Bo" Aldigé — Prevent Cancer Foundation, Founder
Alexey Aleshin, MD, MBA — Natera, General Manager, Early Cancer Detection
Andrew Barnell, MBA — Geneoscopy Inc., CEO and Co-Founder
Danielle Carnival, PhD — White House Cancer Moonshot, Coordinator
Austin Chiang, MD, MPH — Medtronic, CMO Gastrointestinal
Kevin Conroy — Exact Sciences, Chairman and CEO
Erin Darbouze, MPH — Fight Colorectal Cancer, Health Policy Manager
Anjee Davis, MPPA — Fight Colorectal Cancer, President
Richard Goldberg, MD — Fight Colorectal Cancer, Board Member
Greg Hamilton, MBA — Epigenomics, CEO
Lisa Lacasse, MBA — American Cancer Society Cancer Action Network (ACS CAN), President
David Lieberman, MD, AGAF — American Gastroenterological Association, Former President
Molly McDonnell — Fight Colorectal Cancer, Director of Advocacy
Arif Nathoo, MD, MPA — Komodo Health, Co-Founder and CEO
Angela Nicholas, MD — Fight Colorectal Cancer, Board Chair
Mike Nolan, MBA — Freenome, CEO
AmirAli Talasaz, PhD — Guardant Health, Co-Founder and Co-CEO
Catharine Young, PhD — Assistant Director for Cancer Moonshot Engagement and Policy

On July 25, 2022 AstraZeneca and Daiichi Sankyo reported that they have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative) breast cancer who have received a prior therapy in the metastatic setting (Press release, AstraZeneca, JUL 25, 2022, View Source [SID1234616911]). The application has been granted Priority Review.

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Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the fourth quarter of 2022.

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The data from DESTINY-Breast04 represent the first time a HER2-targeted therapy has shown a survival benefit in patients with HER2-low metastatic breast cancer. For more than two decades, only patients with HER2-positive breast cancer have been able to benefit from HER2-targeted therapies. If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumours have lower levels of HER2 expression the opportunity to benefit from a HER2-directed therapy."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "The results seen in the DESTINY-Breast04 trial represent a significant advance and reinforce the potential for Enhertu to become a new standard of care for patients with previously treated HER2-low metastatic breast cancer. The prioritisation of this application by the FDA and inclusion in both the Real-Time Oncology Review and Project Orbis initiatives support the importance of these data, and we look forward to working with the FDA to potentially bring Enhertu to patients with HER2-low metastatic breast cancer as quickly as possible."

The sBLA is based on data from the DESTINY-Breast04 Phase III trial that were presented at the presidential plenary session of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.1

In the trial, Enhertu demonstrated superior and clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease versus standard of care physician’s choice of chemotherapy.

The safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified. Interstitial lung disease or pneumonitis rates were consistent with that observed in late-line HER2-positive breast cancer trials of Enhertu, as determined by an independent adjudication committee. The majority (10%) were primarily low Grade (Grade 1 or 2) with five Grade 3 (1.3%), no Grade 4 and three Grade 5 (0.8%) events reported.

This Priority Review follows receipt of Breakthrough Therapy Designation (BTD) in the US in April 2022 in metastatic HER2-low breast cancer, the fifth BTD in the US for Enhertu.

Regulatory reviews for Enhertu in the HER2-low patient population are also underway in the European Union (EU) and Japan, and Enhertu is already approved in the US, the EU and many other countries across the globe for patients with previously treated HER2-positive (IHC 3+ or IHC 2+/ISH-positive) metastatic breast cancer.

Notes

Breast cancer and HER2 expression
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide and in the US.2,3 More than two million cases of breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.2 In the US, more than 290,000 new cases are expected to be diagnosed in 2022, resulting in more than 43,000 deaths.4

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers, and is one of many biomarkers expressed in breast cancer tumours.5 HER2 expression is currently defined as either positive or negative, and is determined by an IHC test which estimates the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.5,6

HER2-positive cancers are defined as IHC 3+, IHC 2+/ISH+, and HER2-negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.5 Approximately half of all patients with breast cancer have tumours with low HER2 expression, with a HER2 IHC score of 1+, or a HER2 IHC score of 2+ in combination with a negative ISH test, an expression level not currently eligible for HER2-targeted therapy.7-10 Low HER2 expression occurs in both HR-positive and HR-negative disease.11

DESTINY-Breast04
DESTINY-Breast04 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive or HR-negative, HER2-low unresectable and/or metastatic breast cancer previously treated with one or two prior lines of chemotherapy. Patients were randomised 2:1 to receive either Enhertu or chemotherapy.

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR-positive disease based on blinded independent central review (BICR). Key secondary endpoints include PFS based on BICR in all randomised patients (HR-positive and HR-negative disease), OS in patients with HR-positive disease and OS in all randomised patients (HR-positive and HR-negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety.

DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy, based on results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in several countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Regulatory applications for Enhertu are currently under review in China, Japan and several other countries for the treatment of adult patients with HER2-positive unresectable or metastatic breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.

Enhertu is under review in Europe and Japan for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, based on the results from the DESTINY-Breast04 trial. Patients with HR-positive breast cancer must additionally have received or be ineligible for endocrine therapy.

Enhertu is under review in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy based on the results from the DESTINY-Lung01 trial, and in Europe for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging and redefining the current clinical paradigm for how breast cancer is classified and treated to deliver even more 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 (fulvestrant) and Zoladex (goserelin) and the next-generation oral selective oestrogen receptor degrader (SERD) and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in HER2-negative early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed 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 (durvalumab) 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 July 25, 2022 CLINUVEL PHARMACEUTICALS LTD reported its Appendix 4C – Quarterly Cashflow Report and Activity Report for the period 01 April to 30 June 2022 (Press release, Clinuvel, JUL 25, 2022, View Source [SID1234616910]).

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STRONG OPERATING CASH FLOW
CLINUVEL’s customer receipts were strong in the final quarter of the 2022 financial year (ended 30 June), driven by rising clinical demand for SCENESSE (afamelanotide 16mg) treatment. 1 The Company continued active management of expenditures across the Group, resulting in a considerable increase in net cash from operating activities. During the quarter ended 30 June 2022, more treatment centres facilitated access to SCENESSE for a larger pool of patients, as CLINUVEL personnel worked closely with insurers and government agencies enabling wider reimbursement for treatment.

"Our operating systems are getting to an optimum level following years of building the foundations for self-distribution and commercial market access," CLINUVEL’s Chief Financial Officer, Darren Keamy said. "Of course we are pleased with the strong financial result, placing the Company in an ideal position to realise its growth plans: increasing access to SCENESSE in response to demand, expanding our product portfolio, and seizing value-adding opportunities." HIGHLIGHTS CASH FLOW Q4 FY2022¹ Cash receipts2 $24,053,000 Operating cash expenditures $5,624,000 Net operating cash flow3 +$18,478,000 Cash reserves4 +19.3% Debt-free 1. Period 01 April to 30 June 2022. All dollar figures in this release are rounded and reported in Australian dollars. 2. Excludes interest income. 3. Operating cash flow excludes non-cash items. 4. % increase in cash reserves compared to previous quarter. Page 2 Appendix 4C & Activity Report In 2021, CLINUVEL outlined a growth strategy which would see the Group spend $175m over five years (to 30 June 2025). The Company is nigh on track against this forecast and is steadily increasing expenditure in its Pharmaceutical and Healthcare Solutions Divisions with the aim to expand clinical use of SCENESSE and add new products. All of CLINUVEL’s cash receipts are generated from its operations, without reliance on debt or equity funding. "CLINUVEL is one of the few life sciences companies on the ASX to generate positive cash flows and profit and seeks to set an example of prudent financial management. Part of this approach is ensuring we can protect the Company from environmental and market pressures, while we execute our longterm plans," Mr Keamy said.

CASH RECEIPTS AND OPERATING EXPENDITURES – JUNE QUARTER 2022 CLINUVEL recorded Q4 FY2022 cash receipts of $24,503,000, a 64% increase on the same quarter of 2021. Operating expenditures totalled $5,624,000 for the quarter, less than the previous four quarters and largely due to a temporary decline in supply chain and manufacturing costs. Overall costs are expected to trend back to previous levels in the near term to meet ongoing clinical demand. Increase in staff has been required to manage and implement various ongoing programs within the Pharmaceuticals and Healthcare Solutions Divisions. The net operating cash flow for the quarter was $18,478,000.

KEY ACTIVITIES – JUNE QUARTER 2022 Commercial Operations CLINUVEL’s distribution of SCENESSE to the EPP community in Europe, the USA, and Israel continued under commercial and special access programs during the June quarter 2022 to meet ongoing and growing patient demand.-$10-$5 $0 $5 $10 $15 $20 $25 Jun-17 Dec-17 Jun-18 Dec-18 Jun-19 Dec-19 Jun-20 Dec-20 Jun-21 Dec-21 Jun-22 A$m Quarter ended Quarterly Cash Flows-CLINUVEL Receipts Operating Expenditures Net Operating Cash Flows Page 3 Appendix 4C & Activity Report Progress of Clinical Programs CLINUVEL has expanded targeted clinical development programs evaluating safety and efficacy of melanocortins – including afamelanotide – for patients with genetic, metabolic, life-threatening and acute disorders. The last update on the Company’s programs was provided in News Communiqué III, released on 23 June 2022. For ease of reference, a summary is provided below.

Healthcare Solutions CLINUVEL is committed to translating its expertise in the role of melanocortins in the human body from the Pharmaceuticals Division to the general population through its Healthcare Solutions Division. A range of overthe-counter topical products is being developed and commercialised for targeted audiences at the highest risk from exposure to ultraviolet (UV) and high energy visible (HEV) light.

The first product will provide polychromatic protection across a wider spectrum of light. Future dermatocosmetic products will assist in DNA repair of the skin and the stabilisation of melanogenesis, drawing on the technology and learnings from the Pharmaceutical Division programs. Ahead of formal product launch, an extensive digital marketing campaign is being deployed to build a following amongst targeted audiences. New digital platforms, including LightSkinScience.com and dedicated social media channels have been launched, with a team of CLINUVEL Ambassadors (CUVAs) engaged to educate and build connectivity with the targeted audiences. Other Activities and Announcements CLINUVEL announced its Strategic Update IV in May 2022, which can be accessed on the Company’s website.

The Company’s announcements in the June quarter 2022 are available on the CLINUVEL website, with other updates available on the CLINUVEL News website. Although the Company is no longer obligated under ASX Listing Rules to publish quarterly cash flow results, it elects to continue to do so to keep its global investors updated regularly. A copy of the Appendix 4C – Quarterly Cash Flow Report for the final quarter of FY2022 is attached. Pursuant to Listing Rule 4.7C and as disclosed in Item 6.1 to the attached Appendix 4C, $1,065,000 were recorded in respect to Non-Executive Directors’ fees, Managing Director’s fees and non-monetary benefits (inclusive of non-monetary and non-cash benefits and unused and long accrued annual leave entitlement to Managing Director).

On July 25, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that data from the company’s Phase 1 study of zanidatamab zovodotin (ZW49), an investigational novel bispecific HER2 targeted antibody-drug conjugate, were accepted for an oral presentation at the European Society for Medical Oncology Congress 2022 in Paris (Press release, Zymeworks, JUL 25, 2022, View Source [SID1234616909]).

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The abstract, entitled "Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers", will be presented by Komal Jhaveri, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation on Monday, September 12 at 5:25 pm CEST during the ESMO (Free ESMO Whitepaper) meeting being held September 9-13, 2022, at the Paris Expo Porte de Versailles in Paris, France.

"This presentation represents an important milestone for Zymeworks as the first opportunity to share clinical data from our zanidatamab zovodotin development program," said Kenneth Galbraith, Chair and CEO of Zymeworks. "We are especially pleased to present these data at ESMO (Free ESMO Whitepaper), which provides us an opportunity to update many of the global leaders in cancer research from around the world on this important effort."

Zymeworks will host a conference call to further discuss the clinical data presented at ESMO (Free ESMO Whitepaper) and provide an overview on future clinical development plans for zanidatamab zovodotin after the presentation.