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ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Second Quarter Ended March 31, 2023

On May 9, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported a corporate update and announced financial results for the fiscal second quarter ended March 31, 2023 (Press release, ESSA, MAY 9, 2023, View Source [SID1234631310]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"ESSA is in a strong cash position as we execute our clinical strategy to advance our lead candidate, EPI-7386, with our cash runway expected to fund operations and programs through 2025," stated David Parkinson, MD, President and CEO of ESSA. "This quarter, we continued to enroll patients into our Phase 1 study of EPI-7386 in combination with Xtandi (enzalutamide), and we are working with clinical sites to prepare for initiation of the randomized Phase 2 portion of the study as soon we complete Phase 1 and select a recommended Phase 2 dose. Our Phase 1 EPI-7386 monotherapy expansion study is progressing as planned with two doses of EPI-7386 currently being tested in advanced metastatic castration-resistant prostate cancer ("mCRPC") patients. We also advanced an additional EPI-7386 combination therapy program through an agreement with Janssen, under which Janssen will supply Erleada (apalutamide) and Zytiga (abiraterone acetate) for an ESSA-sponsored and conducted Phase 1 clinical study in multiple prostate cancer patient populations including metastatic hormone-sensitive prostate cancer patients and non-metastatic castration-sensitive prostate cancer patients. We plan to begin testing these new antiandrogen combinations with EPI-7386 in the second half of 2023."

Clinical and Corporate Highlights for the Second Quarter Ended March 31, 2023

EPI-7386 Clinical Collaborations

The Company continues to enroll patients into the fourth cohort of the Phase 1/2 study of EPI-7386 in combination with enzalutamide in patients with mCRPC naïve to second generation antiandrogens. The Company expects to complete the Phase 1 portion of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the third quarter of 2023, followed by initiation of the Phase 2 part of the study. The open-label, randomized Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended phase 2 doses versus single agent enzalutamide at the standard of care dose. The Phase 2 study is expected to enroll approximately 120 patients.
In April 2023, the Company entered into a clinical trial support agreement with Janssen Research & Development, LLC ("Janssen") under which Janssen will supply apalutamide and abiraterone acetate for a Phase 1 clinical study sponsored and conducted by ESSA evaluating EPI-7386 combination therapies in two cohorts. The two cohorts will be evaluated as additional cohorts in the Company’s ongoing Phase 1 study of EPI-7386 (Clinical Trials Identifier: NCT04421222). Cohort A will assess EPI-7386 in combination with abiraterone acetate plus prednisone in patients with mCRPC and high-risk metastatic castration-sensitive prostate cancer. Cohort B is a Window of Opportunity study in which patients with non-metastatic castration-resistant prostate cancer ("nmCRPC") will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide. ESSA will retain all rights to EPI-7386. The Company expects enrollment to begin in the second half of 2023.
EPI-7386 Monotherapy

The Phase 1b EPI-7386 monotherapy dose expansion study is ongoing and is evaluating two doses/schedules of single agent EPI-7386 in mCRPC patients with less than three prior lines of therapy, no visceral disease and no prior chemotherapy who have progressed on at least one second-generation antiandrogen. The Company is also enrolling nmCRPC patients in the Window of Opportunity cohort of this study, in which patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard of care therapy.
Summary Financial Results

Net Loss. ESSA recorded a comprehensive loss of $7.1 million for the first quarter ended March 31, 2023, compared to a comprehensive loss of $10.9 million for the second quarter ended March 31, 2022. For the second quarter ended March 31, 2023, this included non-cash share-based payments of $1.4 million compared to $1.9 million for the prior year, recognized for stock options granted and vesting. The decrease in the second quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $852,347 in interest income.
Research and Development ("R&D") expenditures. R&D expenditures for the second quarter ended March 31, 2023 were $4.5 million compared to $7.6 million for the second quarter ended March 31, 2022 and include non-cash costs related to share-based payments ($750,159 for the second quarter ended 2023 compared to $1.1 million for the second quarter ended 2022). The decrease in R&D expenditures for the year ended March 31, 2023 is the result of decreased non-cash share-based payments, legal patents and license fees and manufacturing costs related to the Phase 1 clinical trial of EPI-7386.
General and administration ("G&A") expenditures. G&A expenditures for the second quarter ended March 31, 2023 were $3.7 million compared to $3.8 million for the second quarter ended March 31, 2022 and include non-cash costs related to share-based payments of $686,932 for the second quarter ended 2023 compared to $741,494 for the second quarter ended 2022. The decrease in the second quarter is the result of decreased non-cash share-based payments and professional fees.
Liquidity and Outstanding Share Capital

At March 31, 2023, the Company had available cash reserves and short-term investments of $157 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2025.

As of March 31, 2023, the Company had 44,092,374 common shares issued and outstanding.

In addition, as of March 31, 2023 there were 2,927,477 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 7,477 warrants at a weighted average exercise price of $42.80. There were 8,045,274 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.08 per common share.

CytoMed Therapeutics Limited Announces Collaboration with MD Anderson Cancer Center to Advance Allogeneic Off-the-Shelf Gamma Delta T Cells in Oncology

On May 9, 2023 CytoMed Therapeutics Limited (Nasdaq: GDTC) ("CytoMed" or the "Company"), a biopharmaceutical company focused on harnessing its licensed proprietary technologies to create novel allogeneic cell-based immunotherapies for the treatment of human cancers, reported it has entered into a research collaboration agreement with The University of Texas MD Anderson Cancer Center ("MD Anderson") in Houston, Texas, to use gamma-delta T cells (gdTc) for the treatment of acute myeloid leukemia (AML) and breast cancer (Press release, Cytomed Therapeutics, MAY 9, 2023, View Source [SID1234631309]). AML is the most common type of acute leukemia in adults and is likely to worsen quickly if untreated. However, there are not many treatment options available for AML. Similarly, the incidence rate of breast cancer globally is high, and patients may quickly run out of treatment options, especially if they suffer from triple-negative breast cancer. This collaboration aims to develop new treatment modalities for unmet needs of AML and breast cancer patients at an affordable cost.

The study will be led by Venkata Lokesh Battula, Ph.D., associate professor of Leukemia at MD Anderson. Under the terms of the two-year agreement, research teams will evaluate the application of CytoMed’s allogeneic gdTc on various subtypes of AML and breast cancer in vitro and in vivo. The study is expected to use patient-derived AML cells and breast cancer cell lines for investigation. The results of the study are intended to be part of an Investigational New Drug Application with the U.S. Food and Drug Administration for the allogeneic use of gdTc for blood and solid cancers.

CytoMed received approval in January 2023 from Singapore’s Health Science Authority to conduct a first-in-human Phase I clinical trial for the use of its lead allogeneic chimeric antigen receptor T-cell (CAR-T) product candidate (CTM-N2D) against several blood and solid tumor cancers, including colorectal, lung, liver, ovarian, lymphoma and multiple myeloma [ANGELICA Trial, NCT05302037]. This is a single-site, open-label, dose-escalating trial at the National University, Hospital, Singapore, an established major public hospital.

"Interest in the potential of our allogeneic immunotherapy platform to provide additional treatment options has been strong," said Dr Tan Wee Kiat, Chief Operating Officer at CytoMed, "and international collaborations, like the current collaboration with MD Anderson Cancer Center, are a key part of our strategy to maximize our impact."

Menarini Group Announces New Data on Elacestrant at 2023 ESMO Breast Cancer Congress and 2023 ASCO Annual Meeting

On May 9, 2023 The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, reported that they will present new data related to elacestrant in upcoming congresses (Press release, Menarini, MAY 9, 2023, View Source [SID1234631308]).

Elacestrant has been approved by the FDA for treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. New data will be presented at the upcoming 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress and the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"ER+/HER2- breast cancer constitutes 70% of all breast cancers. ORSERDU (elacestrant) is the first new endocrine therapy in 20 years approved by the FDA addressing ER+, HER2-, ESR1-mutated metastatic breast cancer (mBC), a subgroup that appears in up to 40% of patients in second line mBC and beyond, and who have poor outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "We continue to generate new data for elacestrant in different subgroups, as well as quality of life data, which is important because being able to lead a normal life when under treatment is a vital goal for patients suffering from breast cancer."

See below for details of the Menarini Group/Stemline Therapeutics’ upcoming presentations on elacestrant.

ESMO Breast Cancer Congress 2023
Abstract Title: EMERALD trial analysis of patient-reported outcomes (PROs) in patients with ER+/HER2− advanced or metastatic breast cancer (mBC) comparing oral elacestrant vs standard of care (SoC) endocrine therapy
Abstract #: 1880
Session Title: Proffered Paper session 1 (ID 7)
Session Date and Time: May 11, 2023; 2:00-3:30 PM CEST, Hamburg Hall
Presentation Type: Oral (proffered paper)

2023 ASCO (Free ASCO Whitepaper) Annual Meeting
Abstract Title: Oral elacestrant vs standard-of-care in estrogen receptor-positive, HER2-negative (ER+/HER2-) advanced or metastatic breast cancer (mBC) without detectable ESR1 mutation (EMERALD): Subgroup analysis by prior duration of CDK4/6i plus endocrine therapy (ET)
Abstract #: 1070 | Poster Bd #: 291
Session Title: Breast Cancer – Metastatic
Session Date and Time: June 4, 2023; 8:00AM CDT, Hall A
Presentation Type: Poster

About the EMERALD Phase 3 Study (NCT03778931)
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations.

About ORSERDU (elacestrant)

Indication
ORSERDU (elacestrant), 345 mg tablets, is approved by the U.S. Food & Drug Administration (FDA) for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

The Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA).

Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also planned to be evaluated in early breast cancer disease.

Full prescribing information can be found at www.orserdu.com

Important Safety Information, ORSERDU
Warnings and Precautions

Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.
Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).
Drug Interactions

Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.
Use in Specific Populations

Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or via email at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

China NMPA Approves TYVYT® (sintilimab injection) in Combination with Bevacizumab and Chemotherapy in Patients with EGFR-mutated Non-squamous NSCLC who Progressed after EGFR-TKI Therapy

On May 9, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major diseases, and Eli Lilly and Company ("Lilly", NYSE: LLY), jointly reported that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) in patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor (TKI) therapy (Press release, Innovent Biologics, MAY 9, 2023, View Source [SID1234631307]). It makes TYVYT (sintilimab injection) globally the first PD-1 inhibitor approved for patients with EGFR-mutated non-squamous NSCLC that progressed after EGFR-TKI therapy, which is a breakthrough in the field of immunotherapy.

This is the seventh NMPA-approved indication of TYVYT (sintilimab injection). The first six indications of TYVYT (sintilimab injection) are included in the National Reimbursement Drug List (NRDL), making TYVYT (sintilimab injection) the only PD-1 inhibitor for the first-line treatment of five high-incidence cancer types in the NRDL – including non-squamous NSCLC, squamous NSCLC, hepatocellular carcinoma, esophageal squamous cell carcinoma, and gastric cancer. TYVYT (sintilimab injection) is also the first and the only immunotherapy medicine for gastric cancer in the NRDL. This is also the eighth NMPA-approved indication of BYVASDA (bevacizumab injection).

This new approval in China was based on the results of a randomized, double-blind, multi-center, prospective Phase 3 clinical trial (ORIENT-31, NCT03802240) evaluating TYVYT (sintilimab injection) ± BYVASDA (bevacizumab injection) + chemotherapy (pemetrexed and cisplatin) for the treatment of patients with EGFR-mutated non-squamous NSCLC who progressed after EGFR-TKI therapy.

In the second interim analysis (data cutoff date: March 31st, 2022), in the intent-to-treat (ITT) population, based on the assessment by the Independent Radiographic Review Committee (IRRC), significant and clinically meaningful PFS benefit was sustained with sintilimab plus bevacizumab plus chemotherapy compared with chemotherapy alone (median PFS: 7.2 months vs. 4.3 months; HR=0.51, p<0.0001). Additionally, the key secondary endpoints of objective response rate (ORR) and duration of response (DOR) were improved with sintilimab plus bevacizumab plus chemotherapy, compared with chemotherapy alone.

As of data cutoff date July 4th, 2022, a trend towards overall survival (OS) benefit with sintilimab plus bevacizumab and chemotherapy was observed although the median OS for chemotherapy was prolonged due to crossover after progression in chemotherapy group. The median OS for sintilimab plus bevacizumab plus chemotherapy and chemotherapy alone were 21.1 months vs 19.2 months, HR=0.98. After adjusting for crossover, the OS HR ranged from 0.79 to 0.84. In the exploratory analyses of quality of life, compared with the chemotherapy alone, sintilimab plus bevacizumab and chemotherapy showed longer median time-to-deterioration of the Global Health Status Dimension Score of EORTC Quality of Life Questionnaire Core 30 (QLQ-C30). The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and bevacizumab, without new or unexpected safety signals.

The first interim analysis results of ORIENT-31 were published in The Lancet Oncology on July 28, 2022[i]. The second interim analysis results were published in The Lancet Respiratory Medicine on May 5, 2023[ii].

The principal investigator of the ORIENT-31 Study, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated, "Different from the western population, about half of the Chinese patients with NSCLC have EGFR mutations. EGFR-TKI targeted therapy is the first line treatment choice in NSCLC patients with EGFR sensitive mutation. However, almost all patients will eventually develop TKI-resistance and progression of disease and there are no good treatment options for EGFR-TKI failed NSCLC population[iii]. The ORIENT-31 study is globally the first prospective, randomized and double-blind Phase 3 study that demonstrated that PD-1 inhibitor ± bevacizumab combined with chemotherapy can significantly prolong PFS in EGFR-mutant non-squamous NSCLC population who have failed EGFR-TKI treatment. In addition, compared with standard platinum-based chemotherapy, sintilimab and bevacizumab combined with chemotherapy improved the ORR and DOR, showing survival benefit trend as well as improvement in quality of life. The approval of this indication brings a new treatment option for EGFR-mutated non-squamous NSCLC patients who have failed EGFR-TKI treatment, benefiting more Chinese patients."

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "Despite proven efficacy in broad types of cancer, immunotherapy has rarely made breakthroughs in the treatment of driver gene-positive non-squamous NSCLC patients. We are excited about the results of ORIENT-31 study and this new approval marks the first immunotherapy combination therapy approved for patients with driver gene-positive non-squamous NSCLC in China, and making TYVYT the first PD-1 inhibitor approved for driver gene-positive non-squamous NSCLC globally. Innovent will continue our commitment to innovation and contribute to the ‘Healthy China 2030’ strategy."

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "Lung cancer is a malignant tumor with the highest mortality rate and incidence in China, representing a large unmet medical need[iv]. The new approval of TYVYT is another important clinical development milestone, bringing new hope to the broader lung cancer patients with EGFR mutation. Innovent will continue to develop more novel therapies to address unmet clinical needs and bring more effective treatment options to patients in China and globally. "

Mr. Ben Basil, President and General Manager of Lilly China, stated, "Since its debut in 2018, TYVYT has been approved consecutively six indications including lymphoma, lung cancer, liver cancer, esophageal cancer to gastric cancer, and all six indications have been included in the National Reimbursement Drug List (NRDL), benefiting millions of Chinese patients. I am very excited to see another indication approved today, bringing a brand new treatment option to NSCLC patients who have failed EGFR-TKI treatment in China. TYVYT sets a great example for our partnership with Innovent. We will continually work with our local partners in bringing more innovative drugs to Chinese patients, continuously making contributions to the ‘Healthy China 2030’ blueprint."

Dr. Li Wang, Lilly Corporate Senior Vice President, Head of China Drug Development & Medical Affairs Center, stated, "The ORIENT-31 study is globally the first study in immunotherapy to confirm benefits in EGFR positive lung cancer patients who have failed EGFR-TKI treatment. The two interim analyses have demonstrated encouraging clinical results, breaking the dilemma of EGFR-TKI resistance. With the newly approved indication, TYVYT provides a new treatment option and brings new hope to patients with EGFR-mutated non-squamous NSCLC who progressed after EGFR-TKI therapy in China."

About the ORIENT-31 Study

ORIENT-31 is a randomized, double-blind, multi-center Phase 3 clinical study conducted in China evaluating sintilimab, with or without bevacizumab, combined with chemotherapy (pemetrexed and cisplatin) in patients with EGFR-mutated locally advanced or metastatic nsqNSCLC who have progressed following EGFR TKI treatment (ClinicalTrials.gov, NCT03802240). The primary endpoint is PFS as assessed by IRRC based on RECIST v1.1. The secondary endpoints include overall survival (OS), PFS as assessed by investigators, ORR and safety.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[v]. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for seven indications and included in the National Reimbursement Drug List (NRDL) for six indications. The updated NRDL reimbursement scope of TYVYT (sintilimab injection) include:

For the treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
For the treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
For the treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
For the treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
For the treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy.
Additionally, sintilimab has been approved in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) for the treatment of patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy.

Besides, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.
About BYVASDA (bevacizumab injection)

BYVASDA is a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells[vi]. In China, BYVASDA is approved for eight indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, advanced or unresectable hepatocellular carcinoma, epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer, seven of which are included in the NRDL.

Gilead Strengthens Early Pipeline In Oncology And Inflammation Through The Acquisition Of XinThera

On May 9, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported the acquisition of all outstanding shares of XinThera, a privately held biotech company in San Diego (Press release, Gilead Sciences, MAY 9, 2023, View Source [SID1234631305]). The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation.

Through the acquisition, Gilead gains rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

"The team at XinThera has developed research assets with the potential to target the DNA damage repair pathway in treating cancer and direct the body’s immune response in inflammatory diseases, both of which may improve outcomes for people living with these diseases," said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. "Guided by our scientific framework, this acquisition will allow us to further expand our early pipeline of diverse assets that will continue to fuel our durable late-phase portfolio."

"Gilead and XinThera share similar missions to discover new therapies to treat cancer and inflammatory diseases, which drive our determination to unlock the body’s ability to better respond to these diseases," said Chris LeMasters, who served as XinThera CEO. "We are eager to join Gilead and together explore the potential of our precision medicines as critical components of the next generation of therapies targeting diseases with high unmet need."

First-generation, dual PARP1/2 inhibitors have been shown to be highly efficacious in the treatment of patients with homologous recombination deficiency (HRD) tumors with BRCA-mutations such as breast, ovarian, prostate, and pancreatic cancers, but their use is limited due to hematological toxicities. PARP1 selective inhibitors have the potential to mitigate the hematological toxicities seen in first-generation, dual PARP1/2 inhibitors and enable combination with a wide variety of DNA-damaging agents, including systemic chemotherapy and targeted agents such as Trodelvy (sacituzumab govitecan-hziy). For important safety information, including boxed warning, for Trodelvy, please see full Prescribing Information.

The financial terms of the agreement were not disclosed. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with XinThera to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.12 – $0.15.