On August 29, 2023 InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies targeting drug resistance for hard-to-treat solid tumors，reported the first-in-class ADC OMTX705 has obtained the IND (Investigational New Drug) approval from China National Medical Products Administration (NMPA) recently (Press release, InxMed, AUG 29, 2023, View Source [SID1234634764]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OMTX705 is a novel antibody–drug conjugate (ADC) molecule targeting fibroblast-activating protein α (FAPα). FAPα is a dimeric type II serine protease highly focal expressed in cancer-associated fibroblasts (CAF) surrounding the tumor cells and microvasculature. InxMed’ studies and other publications consistently show that FAP-expressing CAFs play important roles in tumor drug resistance.

InxMed has explored and demonstrated the potential antitumoral efficacy of FAPα targeting treatment for various caner types, especially those with high incidence in Chinese population e.g., gastric cancer, esophagus cancer, etc. The company reached a collaboration with Oncomatryx, a company developing novel drugs targeting the tumor microenvironment, to co-research and develop OMTX705 preclinically and clinically, and own the commercialization rights of OMTX705 in Asia.

InxMed has been developing novel ADC drugs for hard-to-treat solid tumors since 2019. The company has demonstrated promising synergistic anticancer effects of combination therapy comprising various ADC drugs and its pivotal-trial stage drug IN10018 (Ifebemtinib), a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in animal models. InxMed is actively exploring and maximizing the potential of this treatment regimen through its own synergistic pipelines and partnering.

On August 29, 2023 Akeso Inc. ("Akeso", 9926. HK) reported completion of patient enrollment in a head-to-head study of ivonescimab (AK112, PD-1/VEGF bispecific antibody) compared with pembrolizumab as first-line treatment for patients with PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Akeso Biopharma, AUG 29, 2023, View Source [SID1234634763]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The patient enrollment completion represents another milestone in ivonescimab’s major indications development after the recent New Drug Application (NDA) acceptance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

Ivonescimab was already granted Breakthrough Therapy Designation (BTD) by CDE as first-line treatment for NSCLC patients with positive PD-L1 expression, which will expedite the new drug launch and commercialization of ivonescimab.

In 2020, the worldwide number of newly diagnosed lung cancer patients surpassed 2.2 million, with over 810,000 new cases in China. NSCLC patients account for approximately 85% of all lung cancer cases, and approximately 70% are diagnosed at advanced stages of the disease. Pembrolizumab monotherapy, as a first-line standard therapy for the treatment of PD-L1-positive advanced NSCLC, has been approved by the U.S. Food and Drug Administration (FDA) and recommended by the National Comprehensive Cancer Network (NCCN) Guidelines and the Chinese Society of Clinical Oncology (CSCO) Guidelines. Pembrolizumab is also an immunotherapy to treat various cancers which is widely recognized by the global medical community, with its global sales revenue exceeding $20.9 billion in 2022.

The ongoing Phase III head-to-head clinical trial of ivonescimab for NSCLC in comparison with standard-of-care PD- (L)1 inhibitors conducted in China, the United States, Europe, and other developed countries has demonstrated Akeso’s determination and confidence in pursuing the evidence-based medical evidence for the use of ivonescimab in NSCLC on the basis of clinical value, which will help to accelerate the success of ivonescimab in product launch and commercialization in the global market.

Following an acceptance of the marketing application of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug:

A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression (AK112-303), which has been granted BTD in China.
An international multicenter Phase III study of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi/AK112-301), which has been granted BTD in China.
A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy（AK112-306).
An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC (HARMONi-3).
About Ivonescimab

Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.

In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics("Summit"). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. Ivonescimab is known as AK112 for Akeso’ R&D code at China and Australia, and as SMT112 for Summit’s license territories.

On August 29, 2023 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported that it will be presenting virtually at the upcoming H.C. Wainwright event from Monday, September 11th through Wednesday, September 13th starting at 7:00 a.m. ET (Press release, TC Biopharm, AUG 29, 2023, https://www.prnewswire.com/news-releases/tc-biopharm-to-present-at-hc-wainwright-25th-annual-global-investment-conference-301912479.html [SID1234634762]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bryan Kobel, Chief Executive Officer of TC BioPharm, will be giving the presentation. Management will also be hosting in-person and virtual one-on-one meetings during the conference.

Event: TC BioPharm at the H.C. Wainwright 25th Annual Global Investment Conference
Date: Monday, September 11th through Wednesday, September 13th
Time: On Demand from 7:00 a.m. ET to 7:00 p.m. ET daily

A webcast of the event will be available on the ‘Events & Presentations’ section of TC BioPharm’s Investor Relations website at View Source

For more information on the H.C. Wainwright Conference or to schedule a one-on-one meeting with TC BioPharm management, please contact your conference representative or you may also email your request to [email protected].

On August 29, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported the publication of a manuscript reporting on the ability of Shuttle’s lead Histone deacetylase 6 (HDAC6) inhibitor drug candidate (SP-2-225) to stimulate the innate immune system following radiation therapy (Press release, Shuttle Pharmaceuticals, AUG 29, 2023, View Source [SID1234634761]). The manuscript, titled "Radiation therapy-induced immune response enhanced by selective HDAC6 Inhibition," was reported by first author Dr. Satish Noonepalle, Assistant Professor at Georgetown University and the Lombardi Comprehensive Cancer Center, and published in Molecular Cancer Therapeutics, a scientific journal affiliated with the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the premier international cancer research society.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The report highlights to the scientific and financial community how our novel selective inhibitor (SP-2-225) is able to target the HDAC6 function in tumors to inhibit tumor growth and enhance the M1/M2 ratio of infiltrating macrophages within tumors as a combination therapy with RT," commented Anatoly Dritschilo, M.D., CEO of Shuttle Pharmaceuticals and a co-author of the report. "These observations support a strategy to advance the use of selective HDAC6 inhibitors to improve antitumor immune responses and prevent tumor relapse post-radiation therapy."

RT is a curative cancer treatment modality that imparts damage to cellular DNA, induces immunogenic cell death, and activates antitumor immunity. Despite the RT-induced direct antitumor effect seen within the treated volume, accumulating evidence indicates activation of innate antitumor immunity. Acute proinflammatory responses mediated by anticancer M1 macrophages are observed in the immediate aftermath following RT. However, after a few days, these M1 macrophages are converted to anti-inflammatory and pro-cancer M2 phenotype, leading to cancer resistance and underlying potential tumor relapse.

The study was supported by NIH grant R01CA249248, and Cancer Research Institute Grant #228514 to Dr. Alejandro Villagra, and HDAC6 inhibitor SP-2-225 was provided at no charge by Shuttle Pharmaceuticals, Inc. under a material transfer agreement.

A copy of the publication is available at: View Source

Molecular Cancer Therapeutics publishes translational research studies focused on the discovery and preclinical development of therapeutic agents for oncology. To reflect the evolving field of therapeutics, the journal’s interest extends to all selective drugs including small molecule inhibitors, antibody-drug conjugates, antibody cytokine fusions, bispecific antibodies, cell therapies, gene therapies, radio-immunotherapeutics, vaccines, viral therapies, and other experimental approaches in oncology.

On August 29, 2023 Akeso (9926. HK) reported its 2023 interim performance: the Company achieved financial profitability for the first time in the first half of 2023, reaping success in new drug development, commercialization and globalization (Press release, Akeso Biopharma, AUG 29, 2023, View Source [SID1234634760]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Currently, Akeso has a total of 13 registrational Phase III clinical trials underway for 4 products, 3 drugs are approved.

Cadonilimab (PD-1/CTLA-4)

Patient enrollment was completed on the registrational Phase III clinical trials of PD-1/CTLA-4 bispecific antibody cadonilimab for the first-line treatment of advanced cervical cancer and gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.
The Phase III clinical trial of cadonilimab for the adjuvant treatment of hepatocellular carcinoma is undergoing efficiently.
The clinical development for lung cancer, pancreatic cancer, esophageal squamous cancer and other major tumor diseases is also in orderly progress.
In addition, 40+ Investigator initiated trials (IITs) for cadonilimab are underway.
Ivonescimab(PD-1/VEGF)

Ivonescimab(PD-1/VEGF) is Akeso’s another bispecific antibody. 1 NDA of ivonescimab has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

There are 4 Phase III clinical trials been initiated/are underway globally, of which 3 are Phase III clinical trials with PD-1 monoclonal antibody as the positive control drug, 2 are international multicenter Phase III clinical trials; 9 Phase II clinical trials for Ivonescimab have been conducted.

4 Phase III trials of ivonescimab:

Patient enrollment was complete in the registrational Phase III clinical trial of ivonescimab versus pembrolizumab for the first-line treatment of PD-L1 positive NSCLC;
Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi / AK112-301) is enrolling patients;
An international Phase III clinical trial of ivonescimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as first-line treatment for metastatic squamous NSCLC has also been initiated；
In China, a registrational Phase III clinical trial of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy as first-line treatment for advanced squamous NSCLC is underway.
In December 2022, Akeso out-licensed Summit Therapeutics exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan in. Akeso is to receive a 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 a low double-digit percentage of royalties on net product sales of ivonescimab .

Ivonescimab is engaged in many clinical trials for multiple types of lung cancer, gastric cancer, biliary tract cancer, pancreatic cancer, triple-negative breast cancer, head and neck squamous cell carcinomas, ovarian cancer and other gynecologic cancer, colorectal cancer, hepatocellular carcinoma, as well as other solid tumors.

It is noteworthy that Akeso announced clinical progress and new products and therapies. In addition to the two bispecific antibodies mentioned above, AK129 (PD-1/LAG-3 bispecific antibody) and AK130 (TIGIT/TGF-β bispecific antibody) have already entered into the clinical trial, and AK131 (PD-1/CD73 bispecific antibody) and AK132 (Claudin18.2/CD47 bispecific antibody) are about to be approved for the clinical trial. Akeso also announced that a number of ADC drugs will soon enter clinical trials, including bispecific antibody ADC drugs.

The clinical development of CD47, IL-4R, IL-17, CD73, TIGIT and other phase II and III target products is also in orderly progress.

"We are very encouraged to see that our team has continued to achieve excellent results.In the first half of 2023 we had our best results since the company’s inception in terms of financial performance, commercialization of new drugs, clinical development, and operation." Said Dr. Michelle Xia, founder, Chairwoman, CEO, and President of Akeso.

"Such achievements do not come easily in a complex and difficult external situation. We would like to thank Akeso’s team for their ten years of continual pursuit of excellence and improvement. We have put into practice the concept of new drug development driven by clinical value, maintain a forward-looking strategic layout and exceptional managerial efficiency, calmly respond to market changes, seize development opportunities, and grow on an ongoing basis. In the future, with successive approval of our innovative core products and their broad indications, and the further increase in our operational and managerial capabilities, Akeso will enter another period of rapid growth. We will continue to work diligently, professionally, and effectively to promote the more rapid, thorough, and wide-ranging translation of new drug innovations into global value, and we look forward to seeing the company enter a new stage of commercialization and sustained profitability in the coming years, to better deliver innovative clinical value to patients, and reward society and investors."Dr. Michelle Xia said.