On December 6, 2022 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported new study data showing that the Breast Cancer Index test identified which premenopausal patients with early-stage, hormone-receptor positive (HR+) breast cancer benefited from the addition of ovarian function suppression (OFS) to primary adjuvant endocrine therapy (Press release, Hologic, DEC 6, 2022, View Source [SID1234624864]). The Breast Cancer Index test is the first biomarker to be evaluated in a cohort from the landmark Suppression of Ovarian Function Trial (SOFT). The translational study results are featured in the official press program at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022.1 Full study results were presented during the general session #GS1-06 on December 6 at 3:15 p.m. CST.

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"There is a significant need for biomarkers to aid in treatment decisions for premenopausal women with breast cancer. Our study presented at SABCS is the first to examine a biomarker’s ability to determine benefit of ovarian function suppression in these women," said Dr. Ruth O’Regan, Chair of Medicine and Charles A. Dewey Professor at the University of Rochester. "These data found that the Breast Cancer Index test identified women who received benefit from ovarian function suppression as well as those who did not, which is incredibly important given the potential impact of this more intensive treatment approach in young women. While these data are promising, we look forward to further investigating the test’s utility to help inform ovarian function suppression treatment decisions in the future."

The landmark SOFT trial was an international, three-arm, non-blinded, randomized clinical trial of 3,066 premenopausal women with HR+ breast cancer. The trial demonstrated that the addition of OFS to five years of primary adjuvant endocrine therapy (either tamoxifen or exemestane) reduced the risk of recurrence compared to adjuvant tamoxifen alone.2 OFS typically involves hormonal drug injections with a gonadotropin-releasing hormone (GnRH) agonist or surgical removal of the ovaries (bilateral oophorectomy).3 In an effort to evaluate the potential of a biomarker to assist in patient selection for this more intensive approach, the new study presented at SABCS evaluated the predictive and prognostic ability of the Breast Cancer Index test in a cohort of patient tumor samples (n=1,717) from the SOFT trial. Notably, the patient characteristics in this retrospective translational study were highly representative of the original SOFT trial.

The data found that the Breast Cancer Index genomic assay identified which premenopausal women with early-stage, HR+ breast cancer benefited from more intensive endocrine therapy (exemestane plus OFS) compared to tamoxifen alone. The Breast Cancer Index test identified 58% of women who benefited from the addition of OFS, experiencing an absolute benefit of 11.6%, compared with 42% who did not benefit (p<0.01 in adjusted analysis). The data also found that the Breast Cancer Index test’s predictive performance was generally consistent across subgroups, including nodal status, prior chemotherapy, age and HER2-negative patients. Compared to the benefit shown with exemestane plus OFS versus tamoxifen alone, the benefit for tamoxifen plus OFS versus tamoxifen alone was smaller, which is consistent with data reported from the SOFT trial itself. The study also confirmed the prognostic value of the Breast Cancer Index test, as women with higher Breast Cancer Index test risk scores were more likely to experience disease recurrence.

"Multiple clinical studies and national oncology guidelines affirm the predictive ability of the Breast Cancer Index test for extended endocrine therapy," said Kevin Thornal, Group President, Global Diagnostic Solutions at Hologic. "These new data further establish the Breast Cancer Index test as a significant endocrine response biomarker and reveal additional predictive capabilities of the test. As we explore its predictive power earlier in a patient’s journey, we aim to uncover broader potential clinical utility in more women with early-stage, HR+ breast cancer."

About the Breast Cancer Index Test

The Breast Cancer Index test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncologists and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the European Group on Tumor Markers (EGTM) and St. Gallen acknowledge the Breast Cancer Index test as a biomarker to inform the chemotherapy decision; and ASCO (Free ASCO Whitepaper), EGTM and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index test as a biomarker to inform the extended endocrine treatment decision.4 It is the only validated, commercially available test that predicts benefit from extended endocrine therapy. The Breast Cancer Index test is intended for routine clinical use, and treatment decisions based on results are the responsibility of the physician. It is a laboratory developed test (LDT) performed in a single CLIA-certified and CAP-accredited diagnostic laboratory and is not required to be cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com.

On December 6, 2022 Researchers at Exai Bio and UCSF reported data demonstrating that Exai’s novel, RNA-based liquid biopsy platform accurately detected breast cancer at the earliest stages and for the smallest tumors (Press release, Exai Bio, DEC 6, 2022, View Source [SID1234624863]). Earlier detection of breast cancer is crucial for optimal patient outcomes but cannot always be achieved based on symptoms or mammography.

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Exai’s technology uses RNA sequencing to identify a novel category of cancer-associated, small non-coding RNAs, termed orphan non-coding RNAs (oncRNAs). In a poster entitled, "Early-stage breast cancer detection using orphan noncoding RNAs", presented at the 2022 San Antonio Breast Cancer Symposium, Exai demonstrated that oncRNA biomarkers in blood, combined with machine learning, detected breast cancer with high accuracy overall, including across all cancer stages and tumor sizes. The poster also showed that even at the earliest stages and smallest tumors, sensitivity was greater than 80% at 95% specificity. These findings suggest that Exai’s liquid biopsy test for earlier detection of cancer will improve care and outcomes for cancer patients.

OncRNAs are secreted from cancer cells and are abundant in the blood of cancer patients. Exai has created a catalog of hundreds of thousands of oncRNAs from all major cancer types. This vast catalog gives the Exai platform several scientific and practical advantages over tests that focus on circulating tumor DNA.

These SABCS 2022 results complement and build on breast cancer data presented at SABCS 2021, where changes in oncRNAs reflected breast cancer treatment response, predicted overall survival and added significant information to standard clinical endpoints such as tumor tissue pathology.

With this study, Exai demonstrated again that oncRNAs can be used as a biomarker for earlier cancer detection from a blood sample. Exai recently presented results from a colorectal cancer patient cohort at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting, where Exai’s RNA-based platform accurately detected colorectal cancer at the earliest stages and for the smallest tumors.

"Our results presented at SABCS 2022 represent another important step in establishing the role of oncRNAs in addressing the unmet need of detecting cancer at its earliest stages from a simple blood sample," said Patrick Arensdorf, Chief Executive Officer of Exai. "The oncRNA-based liquid biopsy technology will be compatible with standard blood sample requirements enabling easy integration into conventional clinical workflows. Exai’s goal is to improve patient care with a variety of liquid biopsy tests for early cancer detection and monitoring of residual disease and recurrence in multiple types of cancer."

This poster will be available on-demand on the website for SABCS attendees (www.sabcs.org) beginning December 6, 2022. The poster will also be accessible on Exai’s website.

Details of the SABCS 2022 poster presentation:
Title: Early-stage breast cancer detection using orphan noncoding RNAs
Poster ID: P1-05-18
Abstract category: Detection/Diagnosis
Authors: Taylor Cavazos, Jeffrey Wang, Oluwadamilare I. Afolabi, Alice Huang, Dung Ngoc Lam, Seda Kilinc, Jieyang Wang, Lisa Fish, Xuan Zhao, Andy Pohl, Helen Li, Kimberly Chau, Patrick Arensdorf, Fereydoun Hormozdiari, Hani Goodarzi, Babak Alipanahi

On December 6, 2022 Akeso Inc. (HKEX Code: 9926.HK, "Akeso", or the "Company"), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, reported a collaboration and license agreement (the "Agreement") with Summit Therapeutics Inc. (NASDAQ: SMMT) (the "Summit"), to out-license its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112) for development and commercialization in the United States, Canada, Europe, and Japan (the "License Territories") (Press release, , DEC 6, 2022, View Source [SID1234624861]). In addition, the Company will co-brand the product in the License Territories.

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Ivonescimab, known as AK112 in China and Australia and also as SMT112 in the License Territories, is a novel, potential first-in-class bispecific antibody independently developed by the Company. Ivonescimab combines the power of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. It is our belief that the novel design has the potential to reduce side effects and safety concerns. Ivonescimab is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic: there are no known PD-1-based bispecific antibodies approved by the US Food and Drug Administration ("FDA") or the European Medicines Agency ("EMA").

Currently, Akeso is conducting a phase III clinical trial of ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of Ivonescimab plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. Ivonescimab has received breakthrough therapy designation status in China from the NMPA for three indications: the two aforementioned indications, as well as combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.

As presented at ASCO (Free ASCO Whitepaper) 2022, ivonescimab treatment was associated with an overall response rate (ORR) in a Phase II study in patients with NSCLC who have failed EGFR-TKI’s of 68.4% and a median Progression-Free Survival (mPFS) time period of 8.2 months when combined with combination chemotherapy (pemetrexed and carboplatin) as compared to historical mPFS of 4.3 months in patients treated with combination chemotherapy (pemetrexed and platinum-based chemotherapy) alone, the current standard of care. In a separate cohort, ivonescimab combined with docetaxel in patients who have failed PD-(L)1 and chemo therapies demonstrated a mPFS of 6.6 months as compared to a historical mPFS of 4.5 months with docetaxel alone, a current standard of care regimen for these patients. The study which similarly had patients receiving ivonescimab plus chemotherapy as their first line therapy for metastatic disease, was considered to have demonstrated a tolerable safety profile and a low discontinuation rate for adverse events.

"Ivonescimab has demonstrated the potential to deliver superior clinical benefit for patients." said Dr. Michelle Xia, co-founder, Chairwoman, CEO, and President of Akeso, "The Akeso team has been dedicated to the development of ivonescimab in the past 8 years and advanced the molecule to the clinical Phase III stage. The global value of ivonescimab awaits great work from a great team to realize. We are so pleased to partner with the world-class Summit team, who has the track record of successfully bringing over a dozen indications to market for the first-in-class blockbuster drug IMBRUVICA (ibrutinib). Following intense and in-depth strategic, scientific, and operational discussion on ivonescimab between the Akeso and Summit teams in recent months, we are more confident than ever on a winning path for ivonescimab’s global development. With this tremendous momentum, we look forward to the swift execution of clinical development and commercial plan in a global setting for ivonescimab."

"The partnership between Summit and Akeso is a strategically compelling opportunity," stated Robert W. Duggan, Chairman and Chief Executive Officer of Summit. "It represents bringing together Akeso’s extraordinary team, which has built an innovation engine capable of creating novel bispecific technologies, and the talented members of team Summit with their proven track record of success of global clinical development, regulatory approvals, and commercialization, particularly in oncology. We believe the potential exists for enormous creation through this partnership. We are extremely encouraged by ivonescimab and the potential for improving the quality and duration of patients’ lives based on clinical data to support this point. Summit team is honored and enthusiastic to partner with Akeso. Our shared mission and vision are to create a significant difference for the betterment of patient healthcare outcomes around the world."

"After reviewing a substantial number of opportunities, much of which was focused on potential treatments for solid tumors, we have found the ideal partnership with the potential to change the paradigm for treating patients facing difficult odds with devastating diagnoses," added Dr. Maky Zanganeh, Co-Chief Executive Officer, President, and a member of Summit’s Board of Directors. "Ten years ago, metastatic lung cancer patients rarely survived for more than ten to twelve months from diagnosis. Today, survival can be measured in years. Our goal is to improve the quality of life of a patient facing immeasurable odds while extending the duration of that patient’s life. Our focus is always on how we can improve the lives of patients. We sought patient-friendly medicinal therapies through our search to expand our pipeline portfolio, and we are proud to take this meaningful step towards accomplishing this goal. We have significant work to do, but we are steadfastly committed to bringing ivonescimab into the hands of patients who need it most. We are thrilled to reach this agreement with Michelle and the team at Akeso, and we are excited to make this vision a reality. I am proud of Summit team who have diligently worked these past few months to establish a strong bond with the team at Akeso, and I would like to thank the talented people of Team Akeso for spending so much quality time creating this meaningful partnership."

Under the terms of the Agreement, Akeso will receive US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive low double-digit percentage of royalties on net product sales of ivonescimab. The Summit will receive the exclusive rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. In addition, Dr. Michelle Xia will be appointed as one member of the board of directors of Summit. The deal is subject to customary closing practices, including applicable waiting periods under the Hart-Scott-Rodino (HSR) Act.

On December 6, 2022 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported positive results for HER2X in a range of clinical scenarios, demonstrating the test’s reliability (Press release, REVEAL GENOMICS, DEC 6, 2022, View Source [SID1234624860]). This new validation data confirms its suitability for general use in clinical practice.

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The results of 4 studies (APT, ATEMPT, DAPHNe and GOM) have been made public during the San Antonio Breast Cancer Symposium (SABCS), held from December 6 to 10 in San Antonio, Texas (USA).

"We are delighted to share important new results for HER2DX during SABCS, which confirm the robust ability of the test to predict long-term survival and response to anti-HER2 therapy. The HER2DX risk score and pCR score have now been validated across more than 1800 and 800 patients, respectively," says Dr. Aleix Prat, Co-founder and CSO of REVEAL GENOMICS.

"These extraordinary results will undoubtedly be key to achieving our goal of making HER2DX available globally and reaching all patients with HER2+ breast cancer. We are very excited about what the future holds for us as a company," adds Dr. Patricia Villagrasa-Gonzalez, Co-founder and CEO of REVEAL GENOMICS.

APT and ATEMPT studies: confirming the HER2DX️ risk score

The analysis of the HER2DX in the APT and ATEMPT studies is the result of the agreement between REVEAL GENOMICS and Dana-Farber Cancer Institute (US), consisting of using the test to analyze tumor samples from 471 patients with early-stage HER2+ breast cancer from both Phase II trials.

The APT clinical trial, published in the New England Journal of Medicine in 2015, demonstrated that a de-escalation treatment strategy based on weekly paclitaxel during three months and one year of trastuzumab is highly efficacious for a large proportion of stage 1 patients.

The ATEMPT clinical trial, published in the Journal of Clinical Oncology in 2021, demonstrated that 17 cycles of the anti-HER2 antibody drug-conjugate trastuzumab emtansine (T-DM1, Kadcyla, Roche) is highly useful for a large proportion of stage 1 patients, and can help them avoid alopecia when compared to paclitaxel.

The results presented at SABCS 2022 during a Spotlight Session show that HER2DX risk score was significantly associated with relapse-free interval despite the low number of events in both studies. Overall, these results show that HER2DX can reliably identify patients who might be ideal candidates for de-escalation of systemic therapy.

DAPHNe and GOM studies: confirming the HER2DX pCR score

The analysis of the HER2DX in DAPHNe and GOM studies is the result of the agreement between REVEAL GENOMICS and Dana-Farber Cancer Institute (US) and Hospital Universitario Gregorio Marañón (Spain), respectively, consisting of using the test to analyze tumor samples from 235 patients with early-stage HER2+ breast cancer from both trials.

The DAPHNe clinical trial was a single-arm prospective academic phase II trial in which patients with treatment-naïve stage II-III HER2+ breast cancer received a de-escalated neoadjuvant regimen of weekly paclitaxel for 12 cycles along with trastuzumab and pertuzumab (THP) every 3 weeks for 4 cycles. The results of this study have prompted the COMPASS-HER2-pCR study, led by ECOG-ACRIN, which aims to recruit more than 2000 patients.

The GOM study is a prospective observational study, ongoing since 2018, of consecutive patients with newly diagnosed stage I III HER 2 breast cancer candidates for 6 cycles of neoadjuvant docetaxel, carboplatin and trastuzumab (TCH) or TCH plus pertuzumab (TCHP) across 7 public hospitals in Spain.

The results presented at SABCS 2022 show that HER2DX pCR scores were found to strongly predict pCR in both trials, independently of known clinical-pathological variables and intrinsic subtype. It was also observed that the group with high pCR likelihood according to HER2DX benefited from the inclusion of pertuzumab to trastuzumab-based neoadjuvant chemotherapy, in contrast to the group with low pCR. Notably, the pCR rate of the DAPHNe group of patients with a HER2DX high pCR likelihood HER2DX result was 93%.

Overall, these results show that HER2DX pCR score can reliably identify patients who might be ideal candidates for neoadjuvant paclitaxel, trastuzumab and pertuzumab.

About HER2DX️

HER2DX️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS️ since January 2022, HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX️ is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️ predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low, and HER2+ breast cancer.

On December 6, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that the closing of an underwritten public offering with gross proceeds to the Company of approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company (Press release, RedHill Biopharma, DEC 6, 2022, View Source [SID1234624859]). The offering consisted of 32,000,000 units/pre-funded units consisting of (a) one American Depositary Share ("ADS") (or one pre-funded warrant to purchase one ADS in lieu thereof) and (b) one warrant to purchase one ADS (the "Warrants") at a price to the public of $0.25 per unit (or $0.249 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. RedHill intends to use the net proceeds of the offering for working capital, acquisitions, and general corporate purposes.

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Aegis Capital Corp. acted as the sole book-running manager for the proposed public offering.

The securities described above were offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-258259) declared effective by the Securities and Exchange Commission (the "SEC") on August 9, 2021.

The securities were offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering were filed with the SEC and, is available on the SEC’s website at www.sec.gov and may also be obtained from Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.