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Exact Sciences Advances Breast Cancer Care with the Oncotype DX® test and Genomic Profiling Research at SABCS 2024

On November 25, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present 10 abstracts demonstrating the breadth of its Precision Oncology portfolio at the 2024 annual San Antonio Breast Cancer Symposium (SABCS ) from December 10-13 in San Antonio, Texas (Press release, Exact Sciences, NOV 25, 2024, View Source [SID1234648606]).

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"Exact Sciences is committed to improving breast cancer care by providing actionable insights that support informed treatment decisions and help achieve the best outcomes for patients across all backgrounds," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at Exact Sciences. "For 20 years, the Oncotype DX test has led the way in personalized treatment planning, and the new findings presented at SABCS reinforce its trusted role among clinicians, research institutions, and patients alike. With the addition of our OncoExTra test and our anticipated molecular residual disease monitoring test, we’re equipping clinicians with innovative solutions to support patient needs throughout every stage of cancer care."

In collaboration with leading breast cancer experts and research groups, Exact Sciences will share data highlighting how the Oncotype DX test helps guide effective chemotherapy use in everyday practice and clinical trials. New findings from Japan will show how the test supports decision making in breast cancer treatment and can help manage costs. Additionally, retrospective findings reveal African American women are more likely to have higher Recurrence Score results than non-Hispanic White women, with similar survival outcomes. These insights emphasize how the Oncotype DX test can support more equitable breast cancer care across diverse populations and the need for further research to better understand factors behind racial disparities that currently exist.

Data presentations across Exact Sciences’ Precision Oncology portfolio include:

Title : (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER- early breast cancer according to ET-response: Final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial
Session: Late breaking oral presentation GS3-04. Friday, December 13, 9:00-11:45 AM CST; General Session 3, Hall 1

Title: Correlation between the Oncotype DX Recurrence Score categories and progression-free survival of patients with primary metastatic estrogen-receptor positive and HER2-negative breast cancer
Session: Poster P4-12-01. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: The Oncotype DX test to guide adjuvant chemotherapy treatment decisions for early node-negative HR+/HER2- breast cancer patients in Japan: a cost-effectiveness analysis
Session: Poster P4-11-07. December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: Comparative analysis of the Oncotype DX Breast Recurrence Score assay for neoadjuvant letrozole/abemaciclib versus chemotherapy in Stage II-III, Ki67≥20%, HR+/HER2- breast cancer: insights from the GEICAM/CARABELA trial
Session: Poster P1-09-12. Wednesday, December 11, 12:30-2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Genomic risk score distribution and outcomes of patients with early-stage breast cancer diagnosed during pregnancy
Session: Poster P1-03-30. Wednesday, December 11, 12:30-2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Oncotype DX Breast Recurrence Score distribution and prognostic value according to prior pregnancy status in young women with breast cancer
Session: Poster P1-01-23. Wednesday, December 11, 12:30 – 2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Oncotype DX assay association with breast cancer outcomes in different racial and ethnic groups: a retrospective analysis
Session: Poster P2-07-06. Wednesday, December 11, 5:30-7:00 PM CST; Poster Session 2, Halls 2 and 3

Title: Actionable gene alterations affecting the PI3K/AKT and MAPK signaling pathways in breast cancer
Session: Poster P4-03-25. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: Molecular landscape of breast cancer in pre- and postmenopausal women
Session: Poster P3-03-30. Thursday, December 12, 12:00-2:00 PM CST; Poster Session 3, Section Row 3 & Poster 30

Title: Economic analysis of germline genetic testing to assess for hereditary breast cancer: a systematic review
Session: Poster P4-04-14. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Boston Scientific Announces Agreement to Acquire Intera Oncology® Inc.

On November 25, 2024 Boston Scientific Corporation (NYSE: BSX) reported it has entered into a definitive agreement to acquire Intera Oncology Inc., a privately held medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine – a chemotherapy drug – both of which are approved by the U.S. Food and Drug Administration (Press release, Boston Scientific, NOV 25, 2024, View Source [SID1234648605]). The Intera 3000 pump is used to administer hepatic artery infusion (HAI) therapy to treat tumors in the liver primarily caused by metastatic colorectal cancer.

There are approximately 1.4 million people in the U.S. living with primary colorectal cancer, and more than 150,000 new cases are diagnosed each year.i For nearly 25% of these patients, the cancer will spread to the liver during their illness.ii In patients who receive HAI therapy to treat their cancer, the Intera 3000 pump is implanted under the skin and a connected catheter is placed in the hepatic artery, which supplies the liver with oxygenated blood. The pump then provides a continuous flow of floxuridine directly into the liver to treat tumors that have metastasized, most commonly from the colon.

"Liver cancer is a leading cause of cancer-related death, and we are committed to providing meaningful solutions to safely and effectively treat various forms of this disease with minimal systemic side effects and improved outcomes for patients," said Peter Pattison, president, Interventional Oncology and Embolization, Boston Scientific. "Interest in HAI therapy has grown in the oncology community given improved techniques, positive clinical results and ongoing trials. We believe this acquisition will enable us to provide a more comprehensive set of solutions to physicians and their patients to treat both primary and metastatic forms of liver cancer."

The Intera 3000 pump is the only constant flow implantable pump for HAI therapy approved in the United States. The safety and effectiveness of the Intera 3000 pump is supported by data from randomized controlled trials demonstrating the clinical benefits of HAI therapy for patients with unresectable colorectal metastases to the liver, both prior to and following resection. Data from these trials have highlighted that HAI therapy significantly improves tumor response, time to progression and overall survival compared to systemic chemotherapy,iii,iv,v and that combining HAI with systemic chemotherapy may lead to extended survival and higher conversion-to-resection rates in both chemotherapy-naïve and previously treated patients.vi,vii Current Phase II and III studies are exploring HAI therapy use in larger patient groups for first-line, second-line and post-surgery adjuvant treatments.

Boston Scientific expects to complete the transaction in the first half of 2025, subject to closing conditions. The transaction is expected to have an immaterial impact on adjusted earnings per share in 2025 and is expected to be more dilutive on a GAAP basis due to acquisition-related net charges and amortization expense. Specific terms of the transaction have not been disclosed.

BioLineRx Reports Third Quarter 2024 Financial Results and Provides Update on Transformation to Drive Shareholder Value

On November 25, 2024 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the third quarter ended September 30, 2024, and provided updates on strategic actions designed to drive shareholder value (Press release, BioLineRx, NOV 25, 2024, View Source [SID1234648603]).

"The license agreement for APHEXDA that we announced last week was made possible by the tremendous work of our commercial team, who through their hard work proved the significant value that APHEXDA can bring to transplant centers and patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "Our launch progress attracted Ayrmid, who will now, through Gamida Cell, continue to build on the strong commercial foundation that has been laid. We would like to thank our employees for their outstanding contributions to APHEXDA growth and expect this innovative product to reach even more patients with the additional resources from Ayrmid.

"Looking forward, our streamlined and nimble company has a new financial foundation supported by sales royalties and potential milestone payments, which will allow our experienced team to develop important new therapies in rare disease and oncology that address areas with high unmet need. We will also focus on advancing our motixafortide PDAC program through existing collaborations that require de-minimis investment. Through this strategy, we anticipate delivering near- and long-term value for our shareholders," Mr. Serlin concluded.

Corporate Updates

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Executed license agreement with Ayrmid Ltd. to develop and commercialize APHEXDA (motixafortide) in all indications except solid tumors, and across all territories except Asia

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License agreement included a $10 million upfront payment, up to $87 million in potential commercial milestones, and royalties on net sales ranging from 18% to 23%

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BioLineRx will supply motixafortide on a cost-plus basis, for both commercial and development supply

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Certain members of the BioLineRx U.S.-based commercial organization will be transitioned to Ayrmid Pharma Ltd.

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Received $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC, to support BioLineRx’s pipeline expansion

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Operating expense run-rate expected to decrease by more than 70% beginning January 1, 2025 through APHEXDA commercial program transfer and additional headcount reductions

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Company intends to evaluate additional asset opportunities in 2025, with a focus on early-stage clinical programs in oncology or rare diseases that address major areas of unmet need

Financial Updates

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Executed repayment and restructuring agreement with BlackRock EMEA Venture and Growth Lending to repay $16.5 million of approximately $29 million in total debt due; remaining balance will be paid over the next three years at the existing fixed annual interest rate of 9.5 percent

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As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million

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Following the out-license to Ayrmid, the equity investment from Highbridge and the debt repayment to Blackrock, the Company’s cash, cash equivalents and short-term bank deposits are expected to be approximately $20 million, which management believes will be sufficient to fund operations into 2026, as currently planned

APHEXDA Launch Updates

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Aphexda achieved 10 percent market share milestone of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded MOZOBIL and generic plerixafor in all indications

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Institutions ordering APHEXDA increased by 40 percent in the third quarter

Clinical Portfolio Updates
Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

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Continued enrollment in the CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University. In addition to Columbia, patient enrollment has begun at Brown University, and three additional sites are anticipated to begin enrollment over the next two quarters. Full enrollment in the randomized trial targeting 108 patients is anticipated in 2027, with a prespecified interim futility analysis planned when 40% of PFS events are observed

Multiple Myeloma

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Collaboration partner Gloria Biosciences’ stem cell mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical trial in 1H 2025

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Gloria Biosciences has received regulatory approval to commercialize APHEXDA in the Boao Region of China and Macao, areas in Asia that do not require a bridging study

Sickle Cell Disease (SCD) & Gene Therapy

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Announced oral presentation at ASH (Free ASH Whitepaper) 2024 on initial results from a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). Sponsored by investigators at Washington University in St. Louis, the findings from this proof-of-concept study suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle. The presentation will occur at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition taking place December 7-10, 2024, in San Diego, California

Third Quarter 2024 Financial Results

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Total revenue for the three months ended September 30, 2024 was $4.9 million. The Company did not record any revenue during the third quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.2 million, as well as $1.7 million of net revenue from product sales of APHEXDA in the U.S.

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Cost of revenue for the three months ended September 30, 2024 was $0.8 million. The Company did not record any cost of revenue during the third quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales

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Research and development expenses for the three months ended September 30, 2024 were $2.6 million, compared to $2.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to the termination of the development of AGI-134 and a decrease in payroll and share-based compensation

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Sales and marketing expenses for the three months ended September 30, 2024 were $5.5 million, compared to $8.1 million for the same period in 2023. The decrease resulted primarily from lower expenses of commercialization activities related to motixafortide. The higher expenses in the corresponding period of 2023 reflect the ramp-up of pre-commercialization activities related to motixafortide

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General and administrative expenses for the three months ended September 30, 2024 were $1.4 million, compared to $1.5 million for the same period in 2023. The decrease resulted primarily from small decreases in a number of G&A expenses

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Net loss for the three months ended September 30, 2024 was $5.8 million, compared to net loss of $16.0 million for the same period in 2023. The net loss for the 2024 period included $0.8 million in non-operating income, compared to non-operating expenses of $3.1 million for the same period in 2023, both primarily related to non-cash revaluation of warrants

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As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million.

Third Quarter Results Conference Call and Webcast
BioLineRx will report its third quarter 2024 results on November 25, 2024. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 27, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

Bicycle Therapeutics to Present Data for Zelenectide Pevedotin at 2024 San Antonio Breast Cancer Symposium and Provide Program Update

On November 25, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that the company will present data showing the enhanced anti-tumor activity of zelenectide pevedotin monotherapy in triple-negative breast cancer (TNBC) patients with NECTIN4 gene amplification at the 2024 San Antonio Breast Cancer Symposium (SABCS) taking place December 10-13 in San Antonio, Texas (Press release, Bicycle Therapeutics, NOV 25, 2024, View Source [SID1234648602]).

In conjunction with the SABCS poster presentation, Bicycle Therapeutics will also announce topline combination data for zelenectide pevedotin plus pembrolizumab in previously untreated (first-line) cisplatin-ineligible patients with metastatic urothelial cancer, and topline monotherapy data for zelenectide pevedotin in non-small cell lung cancer patients with NECTIN4 gene amplification. The company will host a conference call and webcast for analysts and investors to review the updated data for zelenectide pevedotin.

Poster Presentation:
Title: Enhanced anti-tumor activity of zelenectide pevedotin in triple negative breast cancer (TNBC) patients (pts) with NECTIN4 gene amplification (amp)
Session Number: 4
Date and Time: Thursday, Dec. 12, at 5:30-7 p.m. CT
Presentation Number: P4-10-21
Lead Author: Niklas Klümper, M.D., University Hospital Bonn

Conference Call and Webcast Information
Bicycle Therapeutics will host a conference call and webcast on Friday, Dec. 13, at 7 a.m. CT to review the data updates for zelenectide pevedotin. To access the call, please dial +1-833-816-1408 (U.S.) or +1-412-317-0501 (international) and ask to join the Bicycle Therapeutics call. A live webcast and replay of the conference call will be available in the Investor section of the company’s website, www.bicycletherapeutics.com.

Truqap combination in PTEN-deficient metastatic hormone-sensitive
prostate cancer demonstrated statistically significant and clinically meaningful improvement in radiographic progression-free survival in CAPItello-281 Phase III trial

On November 25, 2024 Astrazeneca reported that positive high-level results from the CAPItello-281 Phase III trial showed Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, AstraZeneca, NOV 25, 2024, View Source [SID1234648601]).

Overall survival (OS) data were immature at the time of this analysis; however, the Truqap combination showed an early trend towards an OS improvement versus abiraterone and ADT with placebo. The trial will continue as planned to further assess OS as a key secondary endpoint.

Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally.1 Only one third of patients with metastatic prostate cancer survive five years after diagnosis.2 Newly diagnosed mHSPC is an aggressive form of the disease associated with poor outcomes and survival.3,4 Approximately 200,000 patients are diagnosed with mHSPC each year, and one in four have PTEN-deficient tumours.5 Patients with a tumour biomarker of PTEN deficiency have a particularly poor prognosis.6

Karim Fizazi, MD, PhD, Institut Gustave Roussy, and University of Paris Saclay in Villejuif, France, and principal investigator for the trial said: "Patients with this aggressive form of prostate cancer with tumour PTEN deficiency currently face a particularly poor prognosis, and there is an urgent need for new treatments that improve upon current therapies. The results seen with capivasertib in combination with abiraterone-prednisone and androgen deprivation therapy in the CAPItello-281 trial represent a step forward for these patients."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These results show for the first time, that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient metastatic hormone-sensitive prostate cancer. By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need. It will be important to see greater maturity in key secondary endpoints including overall survival."

The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine.

Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Notes

Prostate cancer
Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with an incidence of more than 1.4 million and approximately 397,000 deaths in 2022.1

Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.2 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.7

Metastatic hormone-sensitive prostate cancer
In patients with mHSPC, also known as metastatic castration-sensitive prostate cancer (mCSPC), prostate cancer cells need high levels of androgens to drive cancer growth.4,7 Hormone therapies, such as ADT, are widely used to block the action of male sex hormones and lower the levels of androgens in the body.4,8 However, resistance to these therapies is common and there is a need to extend their use to delay disease progression and castration resistance, where the prostate cancer grows and spreads to other parts of the body despite the use of these therapies.3,4,8

In patients with de novo mHSPC, the cancer has spread to distant parts of the body at the time of first diagnosis.9

PTEN-loss or deficiency fuels the growth of cancer cells, leading to dysregulation of the PI3K/AKT pathway, and is associated with poor outcomes in patients with prostate cancer.6,10

CAPItello-281
CAPItello-281 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Truqap in combination with abiraterone and ADT versus abiraterone and ADT in combination with placebo in the treatment of patients with PTEN-deficient de novo mHSPC.

The global trial enrolled 1,012 adult patients with histologically confirmed de novo hormone-sensitive prostate adenocarcinoma and PTEN deficiency as confirmed by central testing. The primary endpoint of the CAPItello-281 trial is rPFS as assessed by investigator, with OS as a secondary endpoint.

Truqap
Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.

Truqap is approved in the US, EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results.

Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.

Truqap 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).