On August 12, 2020 MANA RBM and CUSP reported the randomization of the first subject in ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide with Radium-223 vs Enzalutamide or Darolutamide with Placebo and the Effect upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients, clinicaltrials.gov #NCT04237584] (Press release, MANA RBM, AUG 12, 2020, View Source [SID1234563545]).

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Enrolment is planned for patients with metastatic prostate cancer which progressed with initial androgen deprivation therapy (mCRPC). Patients will be randomized to either darolutamide or enzalutamide, focusing upon detailed safety and tolerability analyses, in addition to clinical outcome assessments, with subsequent addition of radium-223 dichloride or placebo. This phase 3 trial plans to accrue approximately 500 subjects.

Dr. Neal Shore of Carolina Urologic Research Center, the Principal Investigator for the trial, designed the treatment paradigm in collaboration with Dr. Oliver Sartor, Professor at Tulane University School of Medicine. Dr. Shore stated, "The eventual outcome analytics may potentially enhance treatment options for mCRPC as patients as well as augment our understanding of advanced prostate cancer sequencing strategies. We are honored to have enrolled and randomized the first subject and are very appreciative of our trial site organization’s ongoing commitment."

The CUSP Group is a Clinical Research Consortium composed of 24 large tertiary uro-oncology community research practices. As a trial management organization, CUSP supported ESCALATE protocol development, constituted the study network and conducted preliminary protocol education as well as rapid budget and CTA harmonization. As a research advocacy group, CUSP endeavors to bring scientifically interesting and operationally well-crafted trials to its members. These CUSP consortium exclusive studies allow for the early adoption and rapid diffusion of new technologies, medicines, and procedures into the affiliated clinical practices. Additionally, as part of this CUSP advocacy mission, Thomas Paivanas, Executive Director of CUSP, said, "We are excited to be testing a complete digital research ePlatform developed by our colleagues at MANA RBM to conduct overall trial management and remote oversite. These endeavors promise to provide an integrated, potentially paperless system that works well for our research sites, saving them time and enhancing quality."

MANA RBM, the study sponsor, is a clinical trials institute and research laboratory. It is a leader in designing, testing, publishing, and pioneering enhanced methods for remote trial management and quality risk- based monitoring oversight for clinical trials. "For nearly a decade, we have continually enhanced our systems for remote trial management. We are excited to work with Drs. Shore and Sartor in collaboration with the CUSP Clinical Research Consortium to conduct this critical study and to enhance the way sites are able to conduct clinical research," said Penelope Manasco, M.D., CEO of MANA RBM. "We are also excited to announce another unique aspect of this Trial – the launch of REACHERTM. It is the first clinical trial quality management system, based on patent pending software, designed to automatically identify critical, protocol specific errors and systematic errors in near real time across all of the myriad of clnical trial technology systems."

On August 12, 2020 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the second quarter ended June 30, 2020 and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, AUG 12, 2020, View Source [SID1234563544]).

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"With the benefit of having completed our first Phase 3 clinical trial and a clear and efficient registration path defined for etripamil in paroxysmal supraventricular tachycardia (PSVT), we remain fully committed to bringing this therapy to PSVT patients highly in need of better treatment options," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are on track to reopen the RAPID study later this year and believe the updated study design will allow us to best maximize the potential clinical utility of etripamil, including in patients with more persistent supraventricular tachycardia (SVT) events. With our recent $25 million private placement, we believe we are well positioned to execute on the remainder of the PSVT program and look forward to providing updates on our progress in the coming months."

Recent Updates

Announced Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT. In July 2020, Milestone announced a clinical and regulatory update for its pivotal program with etripamil in PSVT following interactions with the U.S. Food and Drug Administration (FDA).

The FDA indicated that two studies, the second part of NODE-301, which the Company has renamed the RAPID study, and the completed NODE-301 study could potentially fulfill the efficacy requirement for Milestone’s New Drug Application for etripamil in patients with PSVT. In addition, the FDA agreed to the following program changes:

An updated statistical analysis plan (SAP) for both the RAPID and NODE-301 studies under which the primary efficacy endpoint will be defined as time to conversion over the first 30 minutes, with a target p-value of less than 0.05 for each study. When employing this updated SAP, results from the NODE-301 study show that 54% of etripamil patients vs. 35% of placebo patients converted within 30 minutes (HR 1.87, p=0.02).
In an effort to maximize the potential treatment effect of etripamil, the RAPID study will allow for an optional repeat administration of study drug (either 70 mg of etripamil or placebo) in patients who have not experienced symptom relief within 10 minutes of the first study drug administration.
Milestone expects to reopen enrollment in the RAPID study later this year, with data anticipated in late 2021 or early 2022.

Raised $25 Million Through Private Placement. In July 2020, Milestone entered into a securities purchase agreement with affiliates of an existing shareholder, RTW Investments, LP, whereby Milestone sold pre-funded warrants to acquire an aggregate 6,655,131 common shares at a purchase price of $3.7465 per pre-funded warrant. Each pre-funded warrant is exercisable for one common share at an exercise price of $0.01 per share, has no expiration date, and is immediately exercisable, subject to certain beneficial ownership limitations. Aggregate proceeds received by the Company were $25 million.
Second Quarter 2020 Financial Results

As of June 30, 2020, Milestone had cash, cash equivalents, and short-term investments of $85.4 million and 24.7 million shares outstanding.
Research and development expenses for the second quarter of 2020 were $8.6 million compared with $10.5 million for the prior year period. For the six months ended June 30, 2020, research and development expenses were $20.5 million compared with $18.3 million for the prior year period. The increase in the first half of 2020 reflects the increased clinical development costs and manufacturing and formulation activities supporting Milestone’s Phase 3 clinical trial and the efforts in developing a clinical pathway for etripamil.
General and administrative expenses for the second quarter of 2020 were $3.0 million compared with $1.6 million for the prior year period. For the six months ended June 30, 2020, general and administrative expenses were $5.7 million compared with $2.6 million for the prior year period. The increase reflects additional increasing insurance costs, professional fees and administrative headcount in the first half of 2020 compared to the same period in 2019 primarily to support the compliance requirements of being a public company.
Commercial expenses for the second quarter of 2020 were $1.5 million compared with $2.2 million for the prior year period. For the six months ended June 30, 2020, commercial expense was $3.7 million compared with $4.4 million for the prior year period. The decrease in the three and six months ended June 30, 2020 reflects the efforts in reducing operating expenses affecting primarily pre-commercialization activities as Milestone focuses its efforts on an optimized clinical development pathway for etripamil.
For the second quarter of 2020, operating loss was $13.1 million compared to $14.3 million in 2019. For the six months ended June 30, 2020, Milestone’s operating loss was $29.9 million compared to $25.3 million in the prior year period.
About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions; however, when calcium channel blockers are used for the termination of SVT episodes, they must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, the Company’s lead investigational product, is designed to be a rapid response therapy for episodic cardiovascular conditions. The novel calcium channel blocker is self-administered via a nasal spray which may shift the current treatment paradigm for many patients with PSVT from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials underway in PSVT, and plans to commence a Phase 2 proof-of-concept trial in patients with atrial fibrillation with a rapid ventricular rate, with subsequent studies expected in other conditions where calcium channel blockers are used.

On August 12, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients, reported financial results for the three and six months ended June 30, 2020 and provides an update on its business progress (Press release, Biocept, AUG 12, 2020, View Source [SID1234563543]).

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"Due to our decision to initiate COVID-19 testing, overall commercial volume during the second quarter increased slightly versus the prior year, even with the impact of the pandemic," said Michael Nall, President and CEO of Biocept. "Commercial volume in our core oncology business was down 16% year-over-year, which is significantly better than the decline of up to 40% we anticipated in our second quarter forecast. We reached a low point in oncology testing early in the second quarter, with subsequent improvement as the quarter progressed. However, with the resurgence of the pandemic, physicians report that patient office visits have not returned to pre-COVID levels, which is continuing to affect our oncology testing volume. In addition to the launch of our COVID-19 testing service, our better-than-expected performance was driven in part by new assays that evaluate the cerebrospinal fluid of patients with breast or lung cancer suspected of brain or central nervous system metastases. Revenues for the quarter decreased 23% year-over-year, as a result of fewer patient visits to physician offices attributed to the concerns about COVID 19. That said, revenues for the first half of 2020 were up 7% over the prior year, driven by our strong first quarter performance before the full impact of the pandemic.

"For the immediate future, COVID-19 testing is an important part of our business and I’m pleased to report that we have received over 11,000 specimens to date," he added. "We have secured components to date for approximately 50,000 COVID-19 specimen collection kits to support current testing and expect to begin shipping our own COVID-19 specimen collection kits to our lab services customers later this year, which will contain our proprietary VEE-SURE viral transport media. These kits will be available for use in our lab or can be sold to other labs. We are excited about our recent development agreement with Aegea Biotechnologies to utilize Switch-Blocker technology to develop tests that could increase sensitivity in detecting SARS-CoV-2, the virus that causes COVID-19, and provide additional information on specific strain types.

"We are proud to support public health efforts by offering COVID-19 testing and plan to develop and offer these critical products and services for as long as they are needed," said Mr. Nall. "As a long-term strategy, we remain focused on oncology and believe we are well positioned to weather the pandemic as we continue to make progress on multiple aspects of our core business and build for a strong future. We are an established leader in liquid biopsy with our Target Selector assays, providing information that is critical to physician decision-making for their patients diagnosed with cancer. We expect that when the pandemic subsides, our commercial oncology volume will return to growth. We believe our recently strengthened balance sheet will support this strategy."

Second Quarter 2020 and Recent Highlights

Commercial Launches

Launched COVID-19 testing and have received over 11,000 specimens to date. The vast majority of results to date have been reported to healthcare providers within 48 hours. The collection kits for RT-PCR SARS-CoV-2 testing have been assembled by Biocept with components sourced from another provider. Specimens are shipped overnight to Biocept’s high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory. The lab is using Thermo Fisher Scientific’s FDA-approved for EUA (Emergency Use Authorization) testing TaqPath molecular diagnostic platform and kit.
Biocept is developing its own COVID-19 specimen collection kits for distribution to clients and expects those kits to be available later in 2020.
Launched research-use-only (RUO) kits that allow molecular laboratories worldwide to detect oncogene mutations in tissue and liquid biopsies through the analysis of Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies, as well as circulating tumor DNA (ctDNA) gained from blood. Our first RUO kit with the ability to use tissue and liquid biopsy samples is designed for the detection of EGFR mutations, which are among the most frequently evaluated biomarkers of lung cancer. RUO kits for other oncogene mutations are planned for future launches.
Awarded CE-IVD Mark for the Target Selector molecular assay EGFR Kit. The CE Mark confirms that Target Selector kits meet the requirements of the European In-Vitro Diagnostic Devices Directive, and allows Biocept to commercialize these kits throughout the European Union and other geographies that recognize the CE Mark. Molecular assay kits detect key oncogene mutations through the analysis of both FFPE tissue and ctDNA. The EGFR pathway can include mutations that are among the most frequently evaluated biomarkers for lung cancer.
Expanded menu of molecular assay kit offerings with the launch of a Target Selector kit to detect BRAF mutations. Similar to the EGFR kit, the BRAF RUO kit detects key oncogene mutations through the analysis of both FFPE tissue gained from surgical biopsies, as well as ctDNA gained from blood. The BRAF mutation is among the most frequently evaluated biomarkers across many solid tumors, including lung cancer and melanoma.
Development Agreement

Entered into a development agreement with Aegea Biotechnologies to develop a new, highly sensitive, next-generation PCR-based COVID-19 assay utilizing the patented Switch-Blocker technology. The test is designed for improved analytical performance in order to better assist healthcare providers in screening and managing patients. The collaboration highlights the potential to apply the Switch-Blocker technology to molecular diagnostics in COVID-19 and other infectious diseases, in addition to oncology applications.
Commercial Agreements

Entered into an agreement with reference-based pricing network Medical Cost Containment Professionals, LLC to process out-of-network claims for Target Selector liquid biopsy testing. Claims will be adjudicated through this network at pre-negotiated pricing in a timely manner, helping to accelerate collections while reducing the length of time receivables remain outstanding.
Expanded Multiplan Health Insurance contract to now include Target Selector NGS panel for breast and lung cancer, as well as coverage for COVID-19 testing. Multiplan is an independent PPO network, with 4,500 acute care hospitals, 110,000 ancillary care facilities and 550,000 healthcare practitioners.
Signed semi-exclusive agreement with skilled nursing facility network with over 50+ sites in multiple states to provide COVID-19 testing to residents and employees. Biocept is one of two laboratories selected.
Industry Conference Presentation

Presented data affirming the ability of the Target Selector platform to identify potentially actionable mutations in the cerebrospinal fluid of patients whose cancer has metastasized to the central nervous system at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. The data were presented in a poster by the study’s principal investigator Kevin Kalinsky, MD, MS, associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons, and an oncologist at New York-Presbyterian/Columbia University Irving Medical Center.
Intellectual Property

Granted patents in Australia and Brazil for the Primer Switch technology, which is useful for ctDNA analysis using RT-PCR and associated methods, including next-generation sequencing (NGS).
Awarded Canadian patent covering the enhanced detection of rare cells, including cancer cells, from a biological fluid sample such as blood or cerebrospinal fluid, expanding the Company’s global patent estate to 40 for use in its molecular diagnostics business.
Corporate Developments

Announced plans to relocate the Company’s corporate offices and laboratory to a new 39,000 square foot facility in San Diego by the end of 2020. The move aligns with the strategy of supporting growth while reducing overhead expense, and is expected to be completed without disruption to workflow.
Raised net proceeds of $9.6 million through a registered direct offering of common stock priced at-the-market.
Second Quarter Financial Results

Revenues for the second quarter of 2020 were $917,000, compared with $1.2 million for the second quarter of 2019, with the decrease attributable to the impact of the COVID-19 pandemic. Revenues for the second quarter of 2020 included $841,000 in commercial test revenue, $38,000 in development services test revenue and $38,000 in revenue for distributed products, Target Selector RUO kits and CEE-Sure blood collection tubes. Revenues for the second quarter of 2019 included $1.1 million in commercial test revenue, $45,000 in development services test revenue and $28,000 from RUO kits and blood collection tubes.

Biocept accessioned 1,399 total samples during the second quarter of 2020, compared with 1,340 total samples during the second quarter of 2019. The Company accessioned 1,184 billable samples during the second quarter of 2020, compared with 1,211 billable samples during the second quarter of 2019. The decline in billable samples was attributable to the impact of the COVID-19 pandemic.

Cost of revenues for the second quarter of 2020 was $2.5 million, compared with $2.7 million for the second quarter of 2019, with the decrease primarily due to lower revenues attributable to the impact of the COVID-19 pandemic.

Research and development (R&D) expenses for the second quarter of 2020 were $1.6 million, compared with $1.1 million for the second quarter of 2019, with the increase primarily due to the launch of COVID-19 PCR testing, laboratory automation projects, and ongoing development and validation of liquid biopsy panels. General and administrative (G&A) expenses for the second quarter of 2020 were $1.9 million, compared with $1.7 million for the second quarter of 2019, with the increase due mainly to higher insurance costs, and higher legal fees primarily related to lease negotiations, warrant exercises and other matters. Sales and marketing expenses for the second quarter of 2020 were $1.3 million, compared with $1.6 million for the second quarter of 2019, with the decrease primarily attributable to lower sales and marketing activities due to pandemic-related travel restrictions.

Other expense, net for the second quarter of 2020 was $56,000, compared with $1.9 million for the second quarter of 2019, which included $1.8 million in warrant inducement expense.

The net loss attributable to common shareholders for the second quarter of 2020 was $6.5 million, or $0.05 per share on 127.2 million weighted-average shares outstanding. The net loss attributable to common shareholders for the second quarter of 2019 was $7.8 million, or $0.38 per share on 20.5 million weighted-average shares outstanding.

Six Month Financial Results

Revenues for the first six months of 2020 were $2.4 million, a 7% increase from $2.2 million for the first six months of 2019, and included $2.2 million in commercial test revenue, $99,000 in development services test revenue and $107,000 in revenue for Target Selector RUO kits and CEE-Sure blood collection tubes.

Operating expenses for the first six months of 2020 were $15.0 million, and included cost of revenues of $5.5 million, R&D expenses of $2.9 million, G&A expenses of $3.8 million and sales and marketing expenses of $2.8 million.

The net loss for the first six months of 2020 was $14.8 million, or $0.14 per share on 103.1 million weighted-average shares outstanding. This compares with a net loss for the first six months of 2019 of $13.8 million, or $0.83 per share on 16.7 million weighted-average shares outstanding.

Biocept reported cash and cash equivalents as of June 30, 2020 of $24.1 million, compared with $9.3 million as of December 31, 2019. The increase included approximately $27.3 million in net proceeds from three registered direct offerings in 2020, and exercise of overallotment of warrants from the December 2019 financing.

Conference Call and Webcast

Biocept will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions. The conference call can be accessed by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for other international callers. A live webcast of the conference call will be available on the investor relations page of the company’s website at http://ir.biocept.com/events.cfm.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for other international callers. Please use event passcode 10145918. A replay of the webcast will be available for 90 days.

On August 12, 2020 Cellular Biomedicine Group, Inc. (Nasdaq: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported its financial results and business highlights for the second quarter and six months ended June 30, 2020 (Press release, Cellular Biomedicine Group, AUG 12, 2020, View Source [SID1234563541]).

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"We held a virtual research & development day in July to provide an update on the six clinical programs we have in development," said Tony (Bizuo) Liu, Chief Executive Officer of CBMG. "Amid the global pandemic, we continue to enroll patients in investigator-initiated trials (IIT) for our clinical programs in China. This includes C-CAR088 anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T cells (CAR-T) for relapsed or refractory multiple myeloma (MM), C-CAR039 anti-CD19/CD20 bi-specific CAR-T for Non-Hodgkin’s Lymphoma (NHL), and C-TCR055 alpha-fetoprotein (AFP) TCR-T in hepatocellular carcinoma (HCC). We look forward to the completion of our new Rockville facility later this year to support potential U.S. clinical development for C-CAR039 and C-TIL051 tumor-infiltrating lymphocytes (TIL) for non-small cell lung cancer (NSCLC). We also continue to enroll patients in China for our off-the-shelf AlloJoinTM knee osteoarthritis (KOA) Phase II trial. We plan to submit and present the C-CAR088 and C-CAR039 clinical data at a major conference later this year. We are happy to report that we have recently secured borrowings to support our near-term clinical development."

Clinical Highlights for First Half of 2020 and to Date:

C-CAR088 for MM*:
Infused 22 of the 25 enrolled patients; 17 patients with evaluable data for safety and clinical efficacy
No Grade 4 or higher cytokine release syndrome (CRS)
No Grade 2 or higher neurotoxicity and dose limiting toxicities
Cytopenia was mostly related to Cy/Flu lymphodepletion
17 patients with 100% best overall response; comprised of 5 complete response, 9 very good partial response and 3 partial response
C-CAR039 for NHL*:
Infused 10 of the 16 enrolled patients
No Grade 3 or higher CRS was observed
No Grade 2 or higher neurotoxicity
Cytopenia was mostly related to Cy/Flu lymphodepletion
Observed encouraging clinical efficacy with limited number of patients
C-TCR055 in HCC:
Initiated an early dose escalation study to evaluate the safety and efficacy
Conducted a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting: "Selecting Clinical Lead of TCRs Targeting Alpha-Fetoprotein-Positive Liver Cancer on Balance of Risk and Benefit"
On July 13, 2020, the Company hosted a virtual Research & Development Showcase to present an overview and update on the current state of its clinical and pre-clinical programs.
*: As of June 15, 2020

Business Highlights for First Half of 2020 and to Date:

Executed a one-year $25 million convertible bridge loan
Extended the $16 million convertible bridge loan repayment schedule to August, 2021
Obtained $8.6 million lines of credit
Upcoming Milestones:

In the next nine months, present our key clinical assets update at major conferences
In 2021, execute our C-TIL051 to sponsor and initiate an IIT in the U.S. for stage IIIB and IV NSCLC patients refractory to anti-PD1 immunotherapy
Upon completion, qualify our Rockville facility to support U.S. clinical development
Financial Results for the Second Quarter and First Half 2020 as compared to the same periods in 2019:

Net loss allocable to common stockholders for the quarter and six months ended June 30, 2020 was $13.5 million and $25.1 million respectively, compared to $12.1 million and $21.4 million
General and administrative expenses for the quarter and six months ended June 30, 2020 were $3.3 million and $6.7 million, respectively, compared to $3.2 million and $6.6 million
Research and development expenses for the quarter and six months ended June 30, 2020 were $10.1 million and $17.8 million respectively, compared $9.1 million and $15.0 million
Net cash used in operating activities for first half of 2020 was $19.8 million, compared to $18.8 million
Our cash, cash equivalents and restricted cash decreased to $13,581,952 at June 30, 2020 compared to $32,443,649 at December 31, 2019. Subsequent to end of the second quarter, we arranged additional borrowings of $29.3 million to fortify our balance sheet.

On August 12, 2020 Antengene Corporation, a leading innovative hematology and oncology-focused biopharmaceutical company, reported the authorization of the first-in-human trial of ATG-017 (ERASER trial) by the Australian Therapeutic Goods Administration (TGA). ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor (Press release, Antengene, AUG 12, 2020, View Source [SID1234563540]). The study will enroll patients with advanced solid tumors and hematological malignancies. Today’s milestone marks the first TGA trial authorization for Antengene and is the first clinical trial for ATG-017 globally.

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ATG-017 is an oral, potent and highly selective inhibitor of ERK1/2, which are related protein-serine/ threonine kinases that function as the terminal kinases in the RAS-RAF-MEK-ERK signal transduction cascade. This pathway participates in the control of numerous processes which include apoptosis, cell proliferation, and cellular immune response. In preclinical studies, ATG-017 has proven to regulate a large variety of cellular processes by targeting ERK1/2 and has shown to be effective in inhibiting the viability of tumor cell lines in vitro as well as the tumor growth in vivo.

"This first human trial for ATG-017 in Australia is a significant step for our company’s global clinical strategy and we will initiate overseas trials continuously for a number of novel drugs in our pipeline in the near future," said Dr. Jay Mei, M.D., Ph.D., Founder, Chairman and CEO of Antengene. "Our vision is to treat patients beyond borders. For Australian patients with life-threatening diseases and patients around the world, we are passionately working to continue to develop and commercialize more novel therapies to make a difference in patient lives."

"Aberrations in the MAPK pathway are amongst the most common in malignant cancer, so developing effective drugs targeting this pathway remains a high priority. We are excited to begin this trial with the ERK-targeting agent ATG-017, and bring together our group of highly experienced Australian investigators and sites to begin this collaboration with Antengene," said Associate Professor Jayesh Desai, Head of the Phase I/ Early Drug Development Program at the Peter MacCallum Cancer Centre.

"The RAS-MAPK pathway is a major player in a range of largely incurable hematological malignancies, so the potential to effectively target it with ATG-017 represents an exciting opportunity for Australian cancer patients. We very much look forward to collaborating with Antengene on this new trial," said Professor Andrew Spencer, Head of the Malignant Haematology and Stem Cell Transplantation Service at the Alfred Hospital, Melbourne.

In November 2019, Antengene entered into a licensing agreement with AstraZeneca (LSE/STO/NYSE: AZN) under which Antengene has been granted the exclusive global rights to further develop, manufacture and commercialize AZD0364 (ATG-017). ATG-017 is currently being studied in clinical trials for the treatment of various solid tumors and hematological malignancies.

About ATG-017

ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor in clinical development for the treatment of various solid tumors, non-Hodgkin’s lymphoma, acute myeloid leukemia (AML) and multiple myeloma.