On July 25, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the first patient has been dosed in a Phase 1 study of IBI321, an anti-PD-1/TIGIT bispecific antibody (Press release, Innovent Biologics, JUL 25, 2021, View Source [SID1234585161]).

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The objective of this open-label, multi-center Phase 1a dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI321 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.

As a bispecific antibody, IBI321 has the potential to enhance efficacy by synergistically targeting both PD-1 and TIGIT. Preclinical studies of IBI321 have shown that the molecule retained the activity of a PD-1 inhibitor and simultaneously suppressed TIGIT to enhance the anti-cancer efficacy.

Professor Baohui Han, Chief of Respiration Department and GCP center of Shanghai Chest Hospital, stated: "Although immune checkpoint inhibitors have shown great efficacy in a variety of tumor types, we still face challenges of primary and secondary drug resistance. Meanwhile, the efficacy of immune checkpoint inhibitors needs to be further improved. Therefore, the development of the next generation of bispecific antibodies has important clinical value. TIGIT is an important immune checkpoint receptor which plays an important role in tumor immune surveillance. We look forward to the clinical research results of IBI321."

Professor Xiangdong Cheng, secretary of party committee of Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) and Chief of Zhejiang Province Upper Gastrointestinal Tumor Diagnosis and Treatment Technology Research Center, stated: "The progress of immunotherapy in certain types of colorectal cancer and gastric cancer has not been satisfactory compared with the progress of anti-PD-1 monoclonal antibodies in melanoma, lung cancer and esophageal cancer, and this needs further exploration. TIGIT is highly expressed in gastric cancer. And pre-clinical experiments have proved that synergistically targeting PD-1 and TIGIT could significantly repress gastric tumor growth. We look forward to the clinical results of IBI321, particularly in GI tumors."

Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, stated: "By specifically targeting both PD-1 and TIGIT, this type of bispecific antibody is designed to provide synergistic effects by blocking both the PD-1/PD-L1 and TIGIT/CD155 pathways – with the goal of improving the anti-cancer efficacy. Currently, there is no bispecific antibody that has same target as IBI321 in clinical-stage development worldwide. Preclinical studies of IBI321 have demonstrated that the combination of these two monoclonal antibodies further enhanced the immune activation with improved convenience of administration. Therefore, the development of an anti-PD-1/TIGIT bispecific antibody has the potential to provide patients with more effective and convenient treatment. We look forward to hope that IBI321 will benefit more patients."

About IBI321 (anti-PD-1/TIGIT bispecific antibody)

IBI321 was discovered through a collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. The IND for IBI321 has been approved by the NMPA in China, and clinical trials in China are actively being conducted.

About the Phase 1 Study of IBI321 (CIBI321A101)

Conducted by Innovent in China, the CIBI321A101 trial is a Phase 1a open-label, multi-center study of the safety, tolerability and primary efficacy of IBI321 in patients with advanced solid tumors. Phase 1a of the study will evaluate dosing of IBI321 in a variety of solid tumors (ClinicalTrials.gov, NCT04911894).

On July 23, 2023 Hanmi Pharmaceutical and LegoChem Biosciences reported that they will jointly develop a new antibody-drug conjugate (ADC) to treat cancers based on a bispecific antibody developed by Hanmi Pharm’s affiliate in China, the South Korean drug company announced on Friday (Press release, Hanmi, JUL 23, 2021, View Source;no=709881 [SID1234628155]).

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Under an agreement between the two companies, they will use the penta amino acid mutated bispecific antibody or Pentambody independently developed by Beijing Hanmi Pharmaceutical to develop a novel cancer treatment. This is an advanced antibody technology that allows one antibody to simultaneously bind to two different antigens.

Hanmi Pharm will be responsible for commercial development of an ADC candidate made by combining Beijing Hanmi’s proprietary molecule and LegoChem’s ADC technology, the company explained in a press release.

An ADC is a new class of highly potent biopharmaceutical drug composed of an antibody linked to a biologically active drug or cytotoxic compound via a chemical linker. A bispecific antibody-based ADC can recognize cancer cells more easily and minimize toxicity to normal cells. It can be a new treatment option for cancer patients who fail to respond to single antibody ADCs.

Hanmi Pharm said it expects to initiate preclinical trials of the drug next year.

Hanmi Pharm shares finished up 0.45 percent at 331,500 won ($287.64) on Friday.

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.

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.

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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.

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."

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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!