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Stabilizing Actions and End of Stabilization Period in connection with the Global Offering

On July 23, 2021 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM: HCM; HKEX: 13) reported that the stabilization period in connection with the Global Offering ended on July 23, 2021, being the 30th day after the last day for the lodging of applications under the Hong Kong Public Offering on June 23, 2021 (Press release, Hutchison China MediTech, JUL 23, 2021, View Source [SID1234586917]). The stabilizing actions undertaken by Morgan Stanley Asia Limited, as the Stabilizing Manager (or any person acting for it) during the stabilization period were:

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(1) over-allocations of an aggregate of 15,600,000 Offer Shares in the International Offering, representing approximately 15% of the total number of the Offer Shares initially available under the Global Offering before any exercise of the Over-allotment Option;

(2) borrowing of an aggregate of 15,600,000 Shares by Morgan Stanley & Co. International plc (an affiliate of Morgan Stanley Asia Limited) from Hutchison Healthcare Holdings Limited (an indirect wholly-owned subsidiary of CK Hutchison Holdings Limited) pursuant to the Stock Borrowing Agreement dated June 23, 2021, to cover over-allocations in the International Offering; and

(3) the full exercise of the Over-allotment Option by the Joint Global Coordinators, on behalf of the International Underwriters, on July 12, 2021, in respect of an aggregate of 15,600,000 Offer Shares, representing approximately 15% of the total number of the Offer Shares initially available under the Global Offering before any exercise of the Over-allotment Option, at the Offer Price, to facilitate the return to Hutchison Healthcare Holdings Limited of all the borrowed Shares under the Stock Borrowing Agreement which were used to cover over-allocations in the International Offering.

There has been no purchase or sale of any Shares on the market for the purpose of price stabilization by the Stabilizing Manager during the stabilization period.

For further details of the full exercise of the Over-allotment Option, please refer to the HUTCHMED announcement dated July 12, 2021.

Theratechnologies Establishes New At-The-Market Facility

On July 23, 2021 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has established an at-the-market ("ATM") equity program allowing Theratechnologies to issue and sell up to US $50 million common shares from treasury (the "Common Shares") to the public at the Company’s sole discretion and at the prevailing market price. Sales of the Common Shares under the ATM program will be made pursuant to the terms of a sales agreement dated July 23, 2021 with Cantor Fitzgerald & Co (the "Agent") (Press release, Theratechnologies, JUL 23, 2021, View Source [SID1234585223]). The volume and timing of distributions under the ATM program, if any, will be determined at the Company’s sole discretion, subject to applicable regulatory limitations.

All Common Shares sold pursuant to the ATM will be sold through the Nasdaq Capital Market or another marketplace upon which the Common Shares are listed, quoted or otherwise traded in the United States, at the prevailing market price at the time of sale.

In connection with the ATM, Theratechnologies has filed a prospectus supplement dated July 23, 2021 (the "Prospectus Supplement") with the securities regulatory authorities in each of the provinces of Canada and with the United States Securities and Exchange Commission ("SEC"), which supplements the Company’s Canadian short form base shelf prospectus dated November 15, 2019 (the "Base Shelf Prospectus"), and the Company’s shelf registration statement on Form F-10 declared effective on November 15, 2019 by the SEC. A copy of the Prospectus Supplement is available on our SEDAR profile at www.sedar.com or on EDGAR at www.sec.gov. Alternatively, a copy of the Prospectus Supplement and accompanying base shelf prospectus are available upon request by contacting the Agent, Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any offer, solicitation or sale of, the securities under the ATM program in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful.

GNTbm’s Trial on New Epigenetic Drug Generates Hope for Patients with Breast Cancer

On July 23, 2021 GNT Biotech & Medicals Corporation (GNTbm), a Taiwan-based biotechnology company, reported to focus on other treatment options against breast cancer (Press release, GNT Biotech & Medicals, JUL 23, 2021, View Source [SID1234585144]). Dr. Chia-Nan Chen, President of GNTbm, explains, "Fortunately, endocrine therapy combined with other target drugs can overcome endocrine resistance and significantly prolong the progression-free survival of patients."

In treatment-resistant cancer, "epigenetic" abnormalities (changes unrelated to our genetic sequences) are common. These abnormalities can often be found in enzymes that act on "histones"—proteins that support the DNA structure. Thus, these enzymes can be targeted to suppress tumor growth in breast cancer. An example is "chidamide/tucidinostat," a benzamide-based selective inhibitor of "histone deacetylase" (HDAC; a histone-modifying enzyme that is seen to be overexpressed in certain cancers). This motivated GNTbm to collaborate with Shenzhen Chipscreen Biosciences (a drug development company in China) and conduct a phase III clinical trial in Taiwan and China. Dr. Chen says, "In a clinical study in China, Chipscreen Biosciences showed that chidamide, in combination with exemestane, effectively reduced tumor growth in hormone-receptor (HR)-positive patients, inspiring the final outcome of this cross-strait clinical trial. And thereafter, chidamide was approved and launched in China."

In this new randomized, double-blind, placebo-controlled trial, GNTbm used chidamide (brand name Kepida in Taiwan) in combination with exemestane (a standard endocrine drug against breast cancer) in 55 patients from Taiwan and 365 patients from China. These patients had HR-positive and HER-2-negative advanced breast cancer, resistant to endocrine therapy. And, the results were promising!

According to the data for Taiwan and China combined, the median progression-free survival was 7.4 months for the chidamide group and 3.7 months for the placebo group, whereas according to Taiwan’s separate data on 55 patients, the median progression-free survival was 8.6 months for the chidamide group and 3.7 months for the placebo group. These findings firmly establish the efficacy of the medication.

"The current clinical study is the first to explore the effects of an HDAC inhibitor combined with exemestane. The findings show progression-free survival benefit in HR-positive endocrine treatment-resistant patients with breast cancer, hopefully, leading to better survival rates for patients in the future," concludes Dr. Chen.

These findings from GNTbm’s new clinical trial generate some much-needed hope for patients fighting against breast cancer!

ImaginAb Announces Extension Of Long-Standing Partnership With Boehringer Ingelheim

On July 23, 2021 ImaginAb Inc, a market leading global biotechnology company, reported that focused on developing next generation immuno oncology imaging agents and therapeutic radiopharmaceuticals (RPT), reported the signing of a new significant multi-year, non-exclusive license agreement with Boehringer Ingelheim (Press release, ImaginAb, JUL 23, 2021, View Source [SID1234585143]).

The agreement, which builds on the long-term collaboration between the two companies that started in 2017 will see ImaginAb supply clinical doses of its market leading 89Zr CD8 ImmunoPET technology to Boehringer Ingelheim for use in the clinical development of its novel oncology therapeutics throughout North America and Europe.

ImaginAb will receive license fees and payments for providing ongoing technical, clinical, and regulatory support to enable the successful implementation of its CD8 ImmunoPET technology. No other terms were disclosed.

Commenting on the announcement, Ian Wilson, Chief Executive Officer of ImaginAb stated:

"Boehringer Ingelheim were the first to partner with us on our CD8 ImmunoPET agent, and we are delighted we can expand our partnership and enable our technology to be used across multiple clinical programs."

Wilson continued: "ImaginAb has a clear aim to become the lead in diagnostic and treatment choices, transforming patient care and helping patients live better and healthier lives. Our CD8 ImmunoPET technology enables quicker identification of drug efficacy, potentially reduce the length of trials and allowing new therapies to advance to market quicker. It also removes the need for repeat, painful biopsies. All of which will ultimately transform patient care."

"This announcement is just the latest in a number of new non-exclusive license agreements that we have announced this year. It is a clear indication that not only is our technology gaining wider acceptance, but many others also share our vision, and belief in the benefits that our CD8 ImmunoPET technology offers."

Castle Biosciences Presents New Data Demonstrating DecisionDx®-SCC Complements Current Risk Assessment Methods in Patients with Cutaneous Squamous Cell Carcinoma of the Head and Neck

On July 23, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported a podium presentation on its DecisionDx-SCC test at the American Head & Neck Society (AHNS) 10th International Conference on Head and Neck Cancer, being held July 22-25, 2021 (Press release, Castle Biosciences, JUL 23, 2021, View Source [SID1234585142]).

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile (GEP) test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

"Comparison of the 40-Gene Expression Profile Test with Clinicopathologic Risk Factor-Based Assessment to Improve Metastasis Risk Assessment in Cutaneous Squamous Cell Carcinoma of the Head and Neck" will be presented by Jason G. Newman, M.D., University of Pennsylvania Health System, Philadelphia, on July 23 at 3:30 p.m.-4:20 p.m. Central time.

"Study data demonstrate that DecisionDx-SCC is a valuable complement to traditional and trusted risk assessment systems, including the American Joint Committee on Cancer Eighth Edition (AJCC8) and Brigham and Women’s Hospital (BWH) tumor (T) classification," said Newman. "The data further demonstrate that Castle’s DecisionDx-SCC test can provide clinicians with additional information on a patient’s metastatic risk to help them make more informed choices about their treatment and follow-up care."

Study methods and findings:

Archival, primary tumor specimens and associated data from a cohort of 278 patients from 33 different clinical sites were included in the study; the patients had high-risk SCC located on the head or neck, and 54 patients (19.4%) developed regional and/or distant metastasis.
All SCC tumor specimens were tested with DecisionDx-SCC and analyzed using Kaplan-Meier for metastasis-free survival (MFS) and Cox regression for risk of regional/distant metastasis.
Patients who received a Class 1 (low biological risk), Class 2A (moderate biological risk) or Class 2B (high biological risk) DecisionDx-SCC result had significantly different three-year MFS rates (92.1%, 76.1% or 44.4%, respectively; p<0.0001, log-rank test) compared to the overall cohort MFS rate of 81.3%.
Univariate Cox regression analysis demonstrated that the GEP test has significant, independent prognostic value. Multivariate Cox regression analysis demonstrated that the DecisionDx-SCC results compared to AJCC8 T staging was the most significant predictor of outcomes with a Hazard Ratio of 9.07 compared to AJCC8 at 2.88. Similar results were shown when the GEP test was compared with BWH T stages and individual clinicopathologic risk factors, such as tumor diameter, deep invasion, poor differentiation and perineural invasion.
The specificity and positive predictive value (PPV) of a high-risk Class 2B DecisionDx-SCC result were improved relative to these metrics for high-stage AJCC8 (T3/T4) and BWH (T2b/T3), while maintaining a similar negative predictive value (NPV).
Overall, the study demonstrated that DecisionDx-SCC offers significant, independent prognostic value for determining a patient’s individual risk of SCC metastasis, and that the test could be used to complement AJCC8 and BWH T staging and a patient’s clinicopathologic risk factor-based assessment.
About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.