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Aadi Bioscience Announces FDA Acceptance and Priority Review for the New Drug Application of FYARRO™ for the Treatment of Advanced Malignant PEComa

On July 26, 2021 Aadi Bioscience, Inc. ("Aadi"), a privately-held, clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for its nanoparticle albumin-bound mTOR inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009;) and has granted the company Priority Review status with a Prescription Drug User Fee Act (PDUFA) target action date of November 26, 2021 (Press release, Aadi Bioscience, JUL 26, 2021, View Source [SID1234585170]).

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Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention, or diagnosis of a serious condition when compared to standard applications. FYARRO has previously been granted Orphan Drug, Fast Track and Breakthrough Therapy designations.

Neil Desai, Ph.D., Founder, CEO and President of Aadi, stated, "We are very pleased with FDA’s acceptance of our NDA with Priority Review for FYARRO in patients with advanced malignant PEComa, an ultra-rare sarcoma. If approved, FYARRO will be the first FDA-approved therapy for the treatment of patients with this disease. We look forward to working with the FDA during its review and would like to thank the many patients, caregivers and physicians whose contributions have been invaluable and allowed us to develop this important therapy. In parallel, we continue to work on our commercial preparations to ensure a timely launch for the PEComa patient population."

Aadi’s NDA submission is based on data from the AMPECT registration trial evaluating FYARRO as a monotherapy in patients with advanced malignant PEComa. FYARRO achieved a 39% (95% CI: 22%-58%) independently reviewed confirmed overall response rate (ORR) in this patient population. These data were presented at the 2020 ASCO (Free ASCO Whitepaper) meeting.1

PAT-DX1 Significantly Improves Survival in Animal Model of Pancreatic Cancer

On July 26, 2021 Patrys reported that New preclinical data from the Garvan Institute of Medical Research has shown that it’s deoxymab antibody PAT-DX1 is able to slow tumour growth and increase survival in an animal model of pancreatic cancer (Press release, Patrys, JUL 26, 2021, View Source [SID1234585169]).

The study, conducted by Associate Professor Marina Pajic, showed that twice weekly treatment with PAT-DX1 for 4 weeks was able to significantly reduce the growth of pancreatic tumours by 26% and increase median survival by 47%.

Pancreatic cancer remains one of the most challenging cancers to treat, with fewer than 25% of patients surviving their first year after diagnosis. Patrys’ deoxymabs have natural tumour targeting qualities, allowing them to bind to DNA and disrupt the tumour’s intracellular DNA Damage Repair systems. This makes them a promising candidate for a range of hard to treat cancers.

Patrys CEO and MD, Dr James Campbell said:

The demonstration that PAT-DX1 is able to inhibit growth and improve survival in an animal model of pancreatic cancer validates the approach we are taking with our deoxymab antibody platform. We recently reported on the ability of PAT-DX1 to cross the blood brain barrier and treat both primary and secondary brain cancers. This new data from Garvan reinforces that Patrys’s deoxymabs may also have clinical utility for the treatment of non-brain cancers as well.

F. Hoffmann-La Roche Announces Half Year Results 2021

On July 26, 2021 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan] reported its half year results 2021 (January 1 – June 30, 2021) on July 22, 2021 (local time) (Press release, Chugai, JUL 26, 2021, View Source [SID1234585168]).

Roche owns 59.89% of Chugai’s outstanding shares (61.16% of the total number of shares issued excluding treasury stock) as of the end of June 2021.

Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI321 (Anti-PD-1/TIGIT Bispecific Antibody) in Patients with Advanced Malignant Tumors

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]).

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).

Hanmi Pharm, LegoChem partner to develop bispecific antibody-based ADC

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]).

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.