On October 26, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it will report third quarter 2022 financial results after the close of the U.S. financial markets on Monday, November 7, 2022 and will hold a conference call that same day beginning at 4:30 p.m. Eastern time (Press release, Ligand, OCT 26, 2022, View Source [SID1234622397]). Speakers on the call will include Ligand’s CEO John Higgins, President and COO Matt Korenberg and CFO Tavo Espinoza.

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On October 26, 2022 AstraZeneca reported that Positive high-level results from the CAPItello-291 Phase III trial showed that it’s capivasertib in combination with Faslodex (fulvestrant) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus Faslodex in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy (with or without a CDK4/6 inhibitor) (Press release, AstraZeneca, OCT 26, 2022, View Source [SID1234622396]).

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The trial met both primary endpoints, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumours had qualifying alterations in the PIK3CA, AKT1 or PTEN genes. Although the overall survival (OS) data were immature at the time of the analysis, early data are encouraging. The trial will continue to assess OS as a key secondary endpoint.

The safety profile of capivasertib plus Faslodex was similar to that observed in previous trials evaluating this combination.

Breast cancer is the most common cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020.1 Approximately 70% of breast cancer tumours are considered HR-positive and HER2-low or negative.2 Endocrine therapies are widely used for the treatment of HR-positive breast cancer, but many patients with advanced disease develop resistance to 1st-line CDK4/6 inhibitors and estrogen receptor-targeting therapies, underscoring the need for additional options.3

Nicholas Turner, MD, PhD, Professor of Molecular Oncology at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, London, UK, and principal investigator in the CAPItello-291 Phase III trial, said: "The CAPItello-291 Phase III trial results show capivasertib offers a clinically meaningful improvement in progression free survival for patients with HR-positive breast cancer. This potential new medicine could give people more time with their cancer under control, which is a priority for patients and their families."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These exciting data in an all-comers population indicate that capivasertib could become a new first-in-class treatment option for patients with HR-positive breast cancer. These patients often experience tumour progression on, or resistance to, available endocrine therapies for advanced disease and urgently need new therapies that extend the effectiveness of endocrine-based treatment approaches."

The data will be presented at a forthcoming medical meeting and shared with global health authorities.

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in development for patients with breast cancer. In addition to these results, the Company is also announcing today results from the SERENA-2 Phase II trial of camizestrant, the next-generation oral selective estrogen receptor degrader (ngSERD) in advanced estrogen receptor (ER)-positive breast cancer.

Notes

HR-positive breast cancer
HR-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype of breast cancer, and the growth of HR-positive breast cancer cells is often driven by ER.2,4,5 Endocrine therapies that target ER-driven disease are widely used as 1st-line treatment for this form of breast cancer in the advanced setting, and often paired with cyclin-dependent kinase (CDK) 4/6 inhibitors. However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease and treatment options are limited.3 Optimising endocrine therapy and overcoming resistance for patients with ER-driven disease at all stages of treatment are active areas of focus for breast cancer research.

CAPItello-291
CAPItello-291 is a Phase III, double-blind, randomised trial that is part of a larger clinical programme focused on capivasertib, an investigational AKT (serine/threonine kinase) inhibitor. CAPItello-291 is evaluating the efficacy of capivasertib in combination with Faslodex versus placebo plus Faslodex for the treatment of locally advanced (inoperable) or metastatic HR-positive, HER2-low or negative breast cancer.

The global trial enrolled 708 adult patients with histologically confirmed HR-positive, HER2-low or negative breast cancer whose disease has recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The trial has dual primary endpoints of PFS in the overall patient population and in a subgroup of patients whose tumours have qualifying alterations in the PIK3CA, AKT1 or PTEN genes. In the trial, approximately 40% of tumours had PI3K/AKT/PTEN alterations.

Capivasertib
Capivasertib is an investigational oral treatment currently in Phase III trials for the treatment of multiple subtypes of breast cancer, prostate cancer and a Phase II trial for haematologic malignancies. A potent, selective adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3), capivasertib is being evaluated in combination with existing therapies in tumours harbouring alterations in the PI3K/AKT/PTEN pathway, and in tumours reliant on signalling via this pathway for survival. Capivasertib is dosed according to an intermittent schedule, which consists of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.

The capivasertib clinical research programme is investigating the safety and efficacy of capivasertib when used in combination with established treatment regimens.

Capivasertib was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited).

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

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

With Enhertu (trastuzumab deruxtecan), a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with ngSERD and potential new medicine camizestrant as well as a potential first-in-class AKT kinase inhibitor, capivasertib. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in 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.

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 capivasertib in combination with chemotherapy, and 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 October 26, 2022 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the third quarter of 2022 after the market closes on Thursday, November 3, 2022 (Press release, MacroGenics, OCT 26, 2022, View Source [SID1234622395]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, November 3, 2022, at 4:30 pm ET.

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Conference Call Information

To participate via telephone, please register in advance via this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On October 26, 2022 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) reported that financial results for the third quarter ended September 30, 2022 (Press release, BioMarin, OCT 26, 2022, View Source [SID1234622394]).

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"As anticipated, BioMarin is on-track to deliver double-digit revenue growth and profitability for the full-year 2022, underscored by our record year-to-date operating results. VOXZOGO demand is driving our financial performance and we expect additional launches in Japan and other global markets to further accelerate sales of this innovative product," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "Our third quarter and year-to-date performance not only showcased the continuing success of our VOXZOGO commercial launch, but also the European regulatory approval of ROCTAVIAN, the world’s first gene therapy approved for the treatment of severe hemophilia A. The launch in the EU is underway and, in the United States, the BLA for ROCTAVIAN was accepted by the FDA with an assigned PDUFA target action date of March 31, 2023. With two key product approvals and commercial launches over the past 12-months, the foundation of our 5-year strategic plan is in place."

Financial Highlights:

Total Revenues for the third quarter of 2022 were $505.3 million, an increase of 24% compared to the same period in 2021 despite continued erosion of the U.S. KUVAN market, and incremental foreign exchange headwinds. The increase in Total Revenues was primarily attributed to the following:
Higher VOXZOGO commercial sales due to new patients initiating therapy globally following regulatory approvals by the European Medicines Agency (EMA) and the FDA in the third and fourth quarters of 2021, respectively and
Higher NAGLAZYME and VIMIZIM product revenues primarily driven by the timing of orders in countries that place large government orders, particularly in Europe and Latin America and new patients initiating therapy in Europe and the Middle East; partially offset by
Lower KUVAN product revenues primarily due to generic competition as a result of the loss of exclusivity in the U.S., consistent with expectations.
GAAP Net Loss decreased to $6.7 million for the third quarter of 2022 compared to GAAP Net Loss of $36.5 million for the same period in 2021. The decrease was primarily related to higher gross profit driven by increased sales volume, partially offset by higher selling, general and administrative (SG&A) expenses and a higher tax provision. The increase in SG&A expenses was largely due to higher costs to support the commercial launch of VOXZOGO and ROCTAVIAN, higher foreign currency exchange losses and severance costs associated with the Company’s organizational redesign announced in October 2022. The increase to the tax provision was primarily attributed to higher year-to-date income driven by increased gross profits and the net gain on the sale of the Priority Review Voucher during the first quarter of 2022.
Non-GAAP Income increased to $82.7 million for the third quarter of 2022 compared to Non-GAAP Income of $33.5 million for the same period in 2021 driven by higher gross profit due to increased sales volume partially offset by higher SG&A expenses largely driven by higher costs to support the commercial launch of VOXZOGO and ROCTAVIAN and higher foreign currency losses.
New Product Approvals and Launches (ROCTAVIAN and VOXZOGO)

Following EMA approval in the quarter, the commercial launch of ROCTAVIAN is now underway. It is estimated that approximately 20,000 adults are affected by severe hemophilia A across more than 70 countries in Europe, the Middle East, and Africa. Of the 8,000 adults with severe hemophilia A in the 24 countries within BioMarin’s footprint covered by the EMA approval, there are an estimated 3,200 patients who are indicated for ROCTAVIAN based on the current label.
To determine eligibility for ROCTAVIAN, treating physicians in countries covered by the EMA approval can use a companion diagnostic (CDx) test to ensure that patients do not have pre-existing antibodies to AAV5. The CDx test is CE-marked and designed to ensure the highest safety standards for use in determining patient eligibility for treatment with ROCTAVIAN.
On October 12, 2022, BioMarin’s resubmission of the BLA for ROCTAVIAN was accepted by the FDA with a PDUFA target action date of March 31, 2023. The FDA recently communicated plans to hold an advisory committee meeting but has yet to provide a date. If approved, ROCTAVIAN would be the first gene therapy in the U.S. for the treatment of severe hemophilia A.
At present, in the U.S. the Premarket Approval (PMA) application is under review at the Center for Devices and Radiological Health to support contemporaneous approval of a CDx along with the ROCTAVIAN BLA.
The global expansion of VOXZOGO is actively underway, with market access and reimbursement progressing as anticipated. As of September 30, 2022, there were 29 active markets contributing to VOXZOGO sales with an estimated 713 children being treated, as compared to an estimated 446 children as of June 30, 2022.
In the quarter, VOXZOGO became commercially available in Japan resulting in meaningful contributions from the early launch. Japan accounts for approximately half of the 1,500 patient opportunity in the Asia-Pacific region.
Mid-stage Product Life Cycle Expansion Opportunities (VOXZOGO and ROCTAVIAN)

During the quarter, the Company held discussions with global regulatory health authorities regarding the favorable results from the Phase 2 randomized, double-blind, placebo-controlled VOXZOGO study in infants and young children up to five years of age with achondroplasia. Based on these interactions, BioMarin intends to submit supplemental marketing applications by the end of 2022 in the U.S. and EU to expand access to VOXZOGO treatment for this younger age group.
Product expansion opportunities with ROCTAVIAN are supported by a number of clinical studies currently underway. The Phase 3b study to evaluate ROCTAVIAN with prophylactic corticosteroids has completed enrollment and is expected to read-out in early 2023. Two additional studies, one investigating ROCTAVIAN treatment in those with active or prior inhibitors, as well as one study investigating ROCTAVIAN in people with pre-existing antibodies against AAV5.
Earlier-stage Development Portfolio (BMN 255, BMN 331, BMN 351, BMN 349, BMN 293 (DiNA-001))

BMN 255 for primary hyperoxaluria, a prognostic factor for chronic renal disease: The Company is proceeding with the multi-ascending dose phase of the First-in-Human study with BMN 255. BioMarin believes the availability of a potent, orally bioavailable, small molecule like BMN 255 may be able to significantly reduce disease and treatment burden in certain people with chronic renal disease.
BMN 331 gene therapy product candidate for Hereditary Angioedema (HAE): Dosing continues in the Phase 1/2 HAERMONY study to evaluate BMN 331, an investigational AAV5-mediated gene therapy for people living with HAE, including dose escalation to the 6e13vg/kg dose, which our non-clinical studies project to provide therapeutic levels of C1-inhibitor.
BMN 351 for Duchenne Muscular Dystrophy (DMD): Investigational New Drug application (IND)-enabling studies continue with BMN 351, an antisense oligonucleotide therapy for individuals with exon 51-skip-amenable DMD. BMN 351 was developed using familiar chemistry and superior biology, by targeting a novel, upstream, splice enhancer site demonstrating improved binding affinity and tolerability in preclinical models. Preclinical data suggest that restored expression of near-full-length dystrophin protein at levels of up to 40% will convert phenotypes from rapid loss to durable preservation of strength and ambulation. The IND is expected to be activated in early 2023 to enable initiation of the clinical phase of development.
BMN 349 for alpha-1 antitrypsin deficiency: Preclinical studies have demonstrated that BMN 349 is an orally bioavailable, small molecule that is titratable with rapid onset and high potency and efficacy. Preclinical results have strong implications for potential improvement of current management, particularly for severe liver disease requiring rapid action. IND enabling studies are well-underway and BioMarin’s goal is to file an IND for BMN 349 in the second half of 2023.
BMN 293 (formerly DiNA-001) for MYBPC3 hypertrophic cardiomyopathy (HCM): Preclinical studies are underway with BMN 293 following a collaboration announced in 2020 with DiNAQOR, a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies. Mutations in MYBPC3 are the most common cause of inherited HCM. Early investigations suggest that gene therapy-mediated gene transfer can lead to widespread expression of the gene product, cardiac myosin-binding protein C (MyBP-C), in cardiac tissue, which can normalize cardiac hypertrophy, improve relaxation kinetics and potentially alleviate functional deficits in individuals suffering from cardiomyopathy. BioMarin’s goal is to file an IND for BMN 293 in 2023.

BioMarin will host a conference call and webcast to discuss third quarter and year to date 2022 financial results today, Wednesday, October 26, 2022 at 4:30 p.m. ET. This event can be accessed through this link or on the investor section of the BioMarin website at www.biomarin.com.

On October 26, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported promising initial results from the ongoing dose-escalation stage of JEWEL-101, a phase 1 study evaluating XB002, Exelixis’ next-generation tissue factor-targeting antibody-drug conjugate (Press release, Exelixis, OCT 26, 2022, View Source [SID1234622393]). The data are being presented on Friday, October 28 during the Antibody-drug Conjugates Poster Session (abstract 256) at 10:00 a.m. CEST at the 34th Symposium on Molecular Targets and Cancer Therapeutics hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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"Following promising preclinical data, it is encouraging to see that XB002 was well-tolerated across multiple dose levels with a pharmacokinetic analysis supporting the ability of XB002 to remain stable after infusion and reach its target before releasing its cytotoxic payload," said Susanna Ulahannan, M.D., M.Med., Assistant Professor of Medicine in the Section of Hematology/Oncology, University of Oklahoma College of Medicine and Associate Director of Oklahoma TSET Phase 1 Program, OU Health Stephenson Cancer Center at the OU Health Sciences Center. "As the dose-escalation phase progresses, and we initiate enrollment into tumor specific cohorts, I look forward to learning more about how XB002 may benefit people with advanced solid tumors, in particular in tumor types with high unmet need."

JEWEL-101 is enrolling patients with advanced solid tumors for which therapies are unavailable, ineffective or intolerable. A total of 19 patients were enrolled across five initial escalating doses: 0.16 mg/kg (n=3), 0.5 mg/kg (n=3), 1.0 mg/kg (n=6), 1.5 mg/kg (n=3) and 2.0 mg/kg (n=4). The most common types of cancer for patients enrolled were pancreatic cancer, colorectal cancer, cervical cancer and prostate cancer. Median age was 63 years, and 63% of patients had an Eastern Cooperative Oncology Group score of 1. Seventy-nine percent of patients had at least three prior lines of therapy.

"We are pleased to present the first clinical profile of XB002 at ENA 2022, representing an important milestone for our first biologic in clinical development," said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We are eager to proceed to the expansion cohort stage of JEWEL-101 once the recommended dose is determined, as we aim to further understand the activity of this molecule as a potential new treatment for people who have difficult-to-treat tumors with limited treatment options."

The recommended dose and maximum tolerated dose for XB002 have not yet been determined. As of the data cutoff, there were no dose-limiting toxicities. The primary reasons for treatment discontinuation included radiographic progression (47%), treatment-emergent adverse events (AEs; 11%), lack of clinical benefit (11%) and patient request other than AEs (16%).

A pharmacokinetic analysis demonstrated that XB002 exposure increased more than or proportionately to a dose increase from 0.16 mg/kg to 2.0 mg/kg. XB002 total antibody and intact antibody-drug conjugate pharmacokinetics were similar, suggesting XB002 is stable after infusion. Levels of free payload remained low (<1 ng/mL) at all dose levels. At 2.0 mg/kg, mean AUC0-t was 121 μg∙day/mL for intact antibody-drug conjugate and 4.21 ng∙day/mL for free payload; mean Cmax was 46.6 μg/mL and 0.809 ng/mL, respectively.

Grade 3 treatment-emergent AEs were experienced by 42% of patients; there were no grade 4 or 5 treatment-emergent AEs. Treatment-related AEs were experienced by 63% of patients; all were grade 2 or lower, except for one grade 3 event (hypertension), and improved or resolved prior to the next XB002 dose. Serious AEs were experienced by 16% of patients, and all were considered unrelated to XB002; two patients had grade 3 events (COVID-19 pneumonia and diarrhea), and one patient had grade 2 bacteremia. No bleeding events occurred despite the use of anticoagulant agents in 8 patients (42%).

Ocular treatment-emergent AEs were experienced by 42% of patients, with noninfective conjunctivitis (26%) and dry eye (16%) considered related to XB002 treatment. Incidence of ocular events was higher at the 2 mg/kg dose level (75%) than at the other dose levels (33%). No corneal toxicity was observed. All ocular events were reversible with supportive care, which included lubricating, vasoconstrictive, corticosteroid and/or antibiotic eyedrops.

No objective responses were observed. Three patients with stable disease remain on treatment with XB002: one each with metastatic castration-resistant prostate cancer, appendiceal adenocarcinoma and pancreatic adenocarcinoma, at treatment durations of 42 weeks, 10 weeks and 7 weeks, respectively. One additional patient with uterine carcinosarcoma who achieved stable disease as the best response discontinued XB002 at 15 weeks. In the upcoming cohort-expansion stage, the efficacy of XB002 will be further evaluated as a single agent and in combination with nivolumab.

About JEWEL-101

JEWEL-101 is an open-label, multicenter, first-in-human phase 1 study of Exelixis’ next-generation antibody-drug conjugate XB002 in patients with advanced solid tumors. The trial plans to enroll approximately 450 patients and is divided into two parts: a dose-escalation stage and an expansion cohort stage. Expansion cohorts are planned for cervical cancer, ovarian cancer, non-small cell lung cancer, prostate cancer, pancreatic cancer and several other cancers.

More information about the trial is available at ClinicalTrials.gov.

About XB002

XB002 is a next-generation antibody-drug conjugate that targets tissue factor, which is overexpressed in a variety of solid tumors. After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death. XB002 is currently being developed for advanced solid tumors. Preclinical findings demonstrate that XB002 binds tissue factor without affecting the coagulation cascade — a limitation of prior tissue-factor-targeting molecules.