On May 23, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA)’s Medical Devices Advisory Committee has strongly recommended FDA approval of the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease (Press release, Guardant Health, MAY 23, 2024, View Source [SID1234643674]).

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The recommendation signals the advisory committee panel’s consensus on Shield’s safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions. The FDA is expected to decide whether to approve Shield later this year.

"The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk," said AmirAli Talasaz, co-CEO of Guardant Health. "Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths."

The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S.2 yet has a 91% five-year survival rate when caught at stage I (localized).3 Despite this, one out of three eligible Americans – 50 million people – are not being screened for CRC.4 Current primary non-invasive screening options include stool-based tests which have proven efficacy in detecting CRC; however, studies have consistently found that barriers such as handling stool and challenges performing the test impact adherence.5,6,7,8 Shield offers patients a choice that can be completed with a simple blood draw during a routine office visit.

"Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,"9 said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. "Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion."

The panel’s recommendation is based on Guardant’s premarket approval (PMA) application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study, published in the March 2024 issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.10

For more information about Shield for CRC screening, visit BloodBasedScreening.com.

About the Shield test

The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. Shield is intended for colorectal cancer screening in individuals at average risk of the disease, age 45 years or older. Patients with an "Abnormal Signal Detected" may have colorectal cancer or advanced adenomas and should be referred for colonoscopy evaluation. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. The test is performed at Guardant Health, Inc.

On May 23, 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 has entered into a securities purchase agreement with certain existing and new accredited investors to issue and sell an aggregate of 25,933,706 American Depositary Shares ("ADSs"), each representing one ordinary share, and in lieu of ADSs to investors that so choose, non-voting ordinary shares, each at a price of $21.42 per share, through a private investment in public equity ("PIPE") financing (Press release, Bicycle Therapeutics, MAY 23, 2024, View Source [SID1234643580]). Bicycle anticipates the gross proceeds from the PIPE to be approximately $555 million. The financing is expected to close on May 28, 2024, subject to customary closing conditions.

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The financing was led by a U.S.-based healthcare focused investor with participation from Deep Track Capital, EcoR1 Capital, Fairmount, Forbion, Perceptive Advisors and RA Capital Management. Bicycle plans to use the net proceeds to fund the continued development of its proprietary pipeline and for other research and development, as well as for general corporate purposes.

"We are excited to announce today’s financing as it underscores the increasing conviction that our investors have in the Bicycle platform and team to create novel precision-guided therapeutics, which we believe have the potential to offer patients a significantly improved quality of life over other treatments," said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. "This financing will support our progress across multiple high-value programs and earlier discovery pipeline, both of which have multiple catalysts in the second half of 2024, as we develop innovative medicines that could help patients with cancer and other diseases live longer and live well."

Subsequent to the closing of this financing, Bicycle expects its pro forma cash and cash equivalents will be approximately $1.0 billion as of May 23, 2024. This cash estimate is a preliminary estimate and based on information currently available to management, and these estimates could change.

Jefferies is acting as sole placement agent for the financing.

The offer and sale of the securities to be sold in the PIPE are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and will be sold in a private placement pursuant to Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission ("SEC") under the Securities Act. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Pursuant to the securities purchase agreement, Bicycle has agreed to file a registration statement with the SEC registering the resale of the ADSs and ordinary shares or ADSs issued upon the re-designation of the non-voting ordinary shares issued in the PIPE.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 23, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that mature Phase 2 results describing the positive impact of trilaciclib administered in combination with the TROP2 antibody-drug conjugate (ADC) sacituzumab govitecan (SG) on overall survival (OS) and tolerability compared to SG alone based on historical data from the ASCENT trial will be presented in a poster session during the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting (Press release, G1 Therapeutics, MAY 23, 2024, View Source [SID1234643595]). ASCO (Free ASCO Whitepaper) will be held May 31 to June 4, 2024, in Chicago, IL. A copy of the poster will be made available on the G1 Therapeutics website following the presentation here.

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The abstract was made available by ASCO (Free ASCO Whitepaper) today and includes the initial Phase 2 trial results originally provided by the Company in January 2024. The poster that will be presented at ASCO (Free ASCO Whitepaper) will describe the mature results of the Phase 2 trial as an update to the initial results.

Poster Presentation Details:
Trilaciclib Combined with Sacituzumab Govitecan (SG) in Metastatic Triple Negative Breast Cancer (mTNBC): Updated Phase 2 Safety and Efficacy Results
Seneviratne, L. et al.
Poster and abstract number 1091
Poster session: Breast Cancer-Metastatic
Sunday, June 2, 2024. 9:00 AM-12:00 PM CDT

On May 23, 2024 Blueprint Medicines Corporation (Nasdaq: BPMC) reported updated data from the ongoing Phase 1 dose escalation portion of the VELA clinical trial of BLU-222, an investigational, highly selective and potent CDK2 inhibitor, in combination with ribociclib and fulvestrant in patients with hormone-receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer (Press release, Blueprint Medicines, MAY 23, 2024, View Source [SID1234643628]). The data, which mark the first promising clinical results for a CDK2 inhibitor in combination with an approved CDK4/6 inhibitor, will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2024.

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"At ASCO (Free ASCO Whitepaper), we will present highly encouraging clinical data showing that our selective CDK2 inhibitor BLU-222, in combination with ribociclib, a standard of care CDK4/6 inhibitor for HR+ breast cancer, is very well-tolerated and delivers early evidence of clinical activity. This represents a highly significant milestone and holds promise as an important new cornerstone for the treatment of breast cancer, including in the front-line metastatic setting," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "These data validate the potency and selectivity of BLU-222, its potential as a first- and best-in-class CDK2 inhibitor, and its use as the combination partner of choice in breast cancer. With these data in hand, we are advancing ongoing partnering discussions that aim to accelerate development of BLU-222 into registration-directed clinical trials."

Updated Phase 1/2 VELA Trial Results

Based on previously reported positive BLU-222 monotherapy clinical data, a combination dose escalation arm was initiated in the VELA trial to assess the safety and clinical activity of BLU-222 in combination with ribociclib, a CDK4/6 inhibitor approved by the U.S. Food and Drug Administration for advanced or metastatic HR+/HER2- breast cancer, and fulvestrant, a commonly used estrogen receptor antagonist. As of the data cutoff date, 19 patients with HR+/HER2- breast cancer who had progressed on prior CDK4/6 inhibitors were treated with 100 mg to 400 mg twice daily (BID) of BLU-222 plus 400 mg once daily (QD) of ribociclib and combined with fulvestrant.

The combination of BLU-222, ribociclib, and fulvestrant was well-tolerated at all BLU-222 dose levels tested. No dose-limiting toxicities, treatment-related severe adverse events (SAEs), or BLU-222-related treatment discontinuations were reported. Treatment-related hematologic and gastrointestinal AEs were generally mild. The maximum tolerated combination dose has not been identified, and combination dose escalation is ongoing.

Pharmacokinetic data showed dose-proportional exposures of BLU-222, with sustained coverage above the predicted efficacious concentration at the 400 mg BID dose level. In addition, the combination of BLU-222 with ribociclib and fulvestrant had no clinically meaningful impact on individual drug exposures.

Preliminary clinical activity showed compelling reductions in thymidine kinase 1 (TK1) and circulating tumor DNA (ctDNA), biomarkers that have been shown to be predictive of clinical benefit. TK1, a biomarker of tumor proliferation, had the deepest reduction among patients treated with BLU-222 400 mg BID, ribociclib 400 mg QD, and combined with fulvestrant, and was statistically significantly correlated with BLU-222 exposure. All patients with evaluable ctDNA, a biomarker of tumor burden, treated with the BLU-222 400 mg BID combination dose regimen showed ctDNA reductions. Early evidence of clinical benefit includes an unconfirmed partial response in a patient who had previously progressed following six lines of therapy in the metastatic setting, including prior palbociclib and trastuzumab deruxtecan. These data highlight the impact of CDK2 inhibition when BLU-222 is combined with other therapies.

Detailed data will be presented by Dr. Dejan Duric from the Henri and Belinda Termeer Center for Targeted Therapies at Massachusetts General Hospital on June 2, 2024, during the "Breast Cancer – Metastatic" poster session at 9:00 a.m. CT. At the time of presentation, a copy of the poster will be available in the "Science—Publications and Presentations" section of the company’s website at www.BlueprintMedicines.com.

About BLU-222

BLU-222 is a highly selective and potent investigational CDK2 inhibitor with first- and best-in-class potential, designed by scientists at Blueprint Medicines. CDK2 is a cell cycle regulator and an important cancer target, with relevance in HR+/HER2- breast cancer and other malignancies, such as subsets of ovarian and endometrial cancer. Across multiple cancer types, aberrant CCNE1 hyperactivates CDK2, resulting in cell cycle dysregulation and tumor proliferation. Aberrant CCNE1 has been observed as a primary driver of disease, as well as a mechanism of resistance to CDK4/6 inhibitors. In HR+/HER2- breast cancer, the advent of CDK4/6 inhibitors has improved treatment; however, disease progression is nearly universal, and new innovation is needed to improve outcomes and prolong clinical benefit. Historically, CDK2 inhibitor development by others has been challenged due to poor selectivity limiting tolerability and combination potential. Beyond BLU-222, Blueprint Medicines is advancing additional preclinical therapeutic candidates for cell cycle targets including BLU-956, a next-generation CDK2 inhibitor, a CDK2 targeted protein degradation program, and an additional undisclosed research program.

On May 23, 2024 Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, reported that it will showcase data from across its oncology portfolio at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 31-June 4 (Press release, Servier, MAY 23, 2024, View Source [SID1234643643]). New data including two abstracts highlight Servier’s continued leadership in IDH-inhibition.

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Among the data to be presented are preliminary findings from real-world evidence that show trends on treatment patterns in newly diagnosed acute myeloid leukemia (AML) patients. Servier will also share initial results from a Phase 1/2, safety lead-in and dose expansion, open-label, multicenter trial investigating the safety, tolerability, and preliminary activity of ivosidenib in combination with nivolumab and ipilimumab in previously treated subjects with IDH1-mutated nonresectable or metastatic cholangiocarcinoma (CCA).

"Servier is doubling down its conviction to address the unmet needs of patients battling cancer, and our dedication shines through as we prepare to attend and present at ASCO (Free ASCO Whitepaper) this year," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "With over half of our global research & development budget allocated to oncology, our team is committed to advancing scientific studies and being open to innovation both through internal and external means. We’re focused on advancing our reputation of being a key innovator in cancer treatment and are actively seeking partnerships that can expedite access to life-changing therapies for patients."

For more information on Servier’s abstracts for ASCO (Free ASCO Whitepaper), please visit ASCO (Free ASCO Whitepaper)’s website.