On January 17, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported the advancement of its Telomere-Targeting Molecule Program ("Project T3") (Press release, MAIA Biotechnology, JAN 17, 2023, View Source [SID1234626319]). MAIA is designing and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell – intrinsic telomerase activity – and thus cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules. The compounds belong to a new chemical class of molecules called telomere targeting divalent dinucleotides.

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!

MAIA has nominated one lead new molecular entity candidate (designated as MAIA-2021-20) and one back-up new molecular entity candidate (MAIA-2022-12) for further advancement into preclinical GLP-toxicity and other studies, and may advance one of these candidates into human clinical trials upon completion of the required preclinical evaluations. MAIA also has filed a broad provisional patent application covering the composition of matter for the new telomere-targeting molecules in the fourth quarter of 2022.

"The discovery and preclinical advancement of these new telomere-targeting compounds represent the beginning of a significant new chapter for MAIA," said Sergei Gryaznov, Ph.D., MAIA Chief Scientific Officer. "We have generated highly encouraging data in vitro and in vivo in several different tumor models showing impressive single-agent activity for the new compounds, as well as in combination with immune checkpoint inhibitors. The observed anti-cancer activity is quite remarkable, often leading to complete tumor eliminations in in vivo models. We are working diligently to advance these candidates toward clinical development."

"Project T3 is a major step forward as we are generating novel direct telomere-altering compounds," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "We are advancing multiple compounds through comprehensive preclinical development as potential follow-on candidates to our lead therapeutic candidate, THIO, which is currently being evaluated in a Phase 2 trial (THIO-101 trial) in patients with Non-Small Cell Lung Cancer. We look forward to announcing further developments of MAIA’s proprietary new molecular entity candidates in 2023 and beyond."

At the XXIV International Round Table on Nucleosides, Nucleotides, and Nucleic Acids in Stockholm in August 2022, MAIA presented an overview of its promising THIO drug discovery platform for generating potential anti-cancer agents. The presentation demonstrated the importance of cancer cell telomeric DNA structural and functional integrity, as well as therapeutically attractive opportunity to induce stress, increase innate sensing and adaptive anti-tumor immunity via "cancer cell self-produced" chemical modification of telomeres.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with LIBTAYO (cemiplimab) an anti-PD1 therapy, developed and commercialized by Regeneron. Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or higher line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On January 17, 2023 Shanghai Henlius Biotech, Inc. (2696. HK) reported that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic name: serplulimab injection), in combination with carboplatin and etoposide for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC), has been approved by the National Medical Products Administration (NMPA), making it the world’s first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC) (Press release, Henlius Biopharmaceuticals, JAN 17, 2023, View Source [SID1234626315]). HANSIZHUANG had already been approved for the treatment of Microsatellite Instability-High (MSI-H) solid tumors and squamous non-small cell lung cancer (sqNSCLC).

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!

Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, "This is the second approval HANSIZHUANG has received in the first-line treatment of lung cancer, after approval of sqNSCLC, demonstrating its great potential in lung cancer treatment. It is another milestone for HANSIZHUANG as well as a remarkable achievement for anti-PD-1 mAbs to improve survival notably in patients with SCLC. Looking forward, as the representative of China’s innovative drugs, HANSIZHUANG is expected to be approved in overseas markets to benefit more lung cancer patients with its consistent efficacy."

Professor Ying Cheng, the leading principal investigator of the phase 3 clinical study of HANSIZHUANG on ES-SCLC, from Jilin Province Cancer Hospital, said, "SCLC is the most aggressive subtype of lung cancer, patients with SCLC deteriorate rapidly in clinical behavior and the overall prognosis is poor. The success of ASTRUM-005, a multi-center clinical trial of HANSIZHUANG, is a breakthrough in the treatment of ES-SCLC. Apart from providing a better immunotherapy option, this approval will also reshape the first-line treatment of ES-SCLC and promote the treatment of lung cancer around the world."

Innovate to solve the dilemma of SCLC treatment

Lung cancer (LC) is one of the most common malignancies around the world. According to GLOBOCAN 2020, there were 2.2 million new LC cases and 1.8 million new deaths in 2020 worldwide, and LC is still the leading cause of cancer death[1]. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases[2]. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Most patients are in extensive stage when diagnosed[3]. Their clinical condition deteriorates rapidly and the overall prognosis is poor. In the past 20 years, etoposide combined carboplatin/cisplatin was still the standards of care for ES-SCLC, but almost all patients in extensive stage relapse within one year[4], with a median overall survival (OS) of only 10 to 11 months. The advent of immune checkpoint inhibitors has brought new hope to patients with ES-SCLC. At present, anti-PD-L1 mAbs combined with chemotherapy has prolonged the OS of patients with SCLC to 12-13 months compared to chemotherapy, but the improvements were still modest. Meanwhile, a number of anti-PD-1 mAbs have failed in SCLC, and more effective solutions are urgent needed.

The approval was primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-center phase 3 clinical study. The study has set up a total of 128 sites in various countries including China, Turkey, Poland, and Georgia, and enrolled 585 subjects who were screened from 114 sites, among whom 31.5% were White. The results of ASTRUM-005 were presented in oral for the first time at the 2022 ASCO (Free ASCO Whitepaper) annual meeting，and the results were updated at the 2022 European Society for Medical Oncology Asia (ESMO Asia) Congress in December 2022. In September 2022, the results of ASTRUM-005 had been published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world, which made ASTRUM-005 the first study published on JAMA in SCLC immunotherapy, demonstrating the high level of academic acclaim on a global scale.

According to the study analysis, the median OS was significantly longer in the serplulimab group (15.8 months) than in the placebo group (11.1 months), and a 38% reduction in risk of death was observed in the serplulimab group compared with the placebo group(HR=0.62, 95%CI:0.50-0.76).The Asians subgroup also showed a 4.8 months longer median OS in the serplulimab group (HR=0.63，95%CI: 0.49-0.81). Median PFS assessed by the independent radiology review committee per RECIST v1.1 was prolonged with the addition of serplulimab (5.8 vs. 4.3 months; HR=0.47, 95%CI:0.38-0.58).The results indicated that HANSIZHUANG (serplulimab injection) in combination with chemotherapy (Carboplatin-Etoposide) could bring significant benefits against chemotherapy (Carboplatin-Etoposide) in the treatment of previously untreated patients with ES-SCLC, met the pre-defined primary endpoint criteria, and had good safety and tolerability. HANSIZHUANG could potentially bring more significant benefits to Asian patients.

Global footprint for more patients

HANSIZHUANG is the first innovative mAb developed by Henlius. Since launched in March 2022, HANSIZHUANG has become one of the pioneering anti-PD-1 mAb for the "pan-cancer" treatment of MSI-H solid tumors in China. Up to date, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, sqNSCLC and ES-SCLC, its new drug application(NDA) in combination with chemotherapy for the first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma(ESCC) has also been accepted by the NMPA. As a backbone, HANSIZHUANG’s synergy with in-house products of the company and innovative therapies are forging ahead. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc.

Guided by unmet clinical needs, Henlius has devoted itself to lung cancer and built a comprehensive layout of the first-line treatment for lung cancer in sqNSCLC, ES-SCLC, nsNSCLC and LS-SCLC, which covers more than 90% of lung cancer patients. In the field of SCLC, multi-regional clinical trials regarding ES-SCLC and LS-SCLC have been conducted and the results will support NDAs in overseas markets. In 2022, HANSIZHUANG was also granted orphan drug designations by the Food and Drug Administration (FDA) and European Commission (EC) for the treatment of SCLC. Based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion results of the FDA’s Class C consultation meeting, Henlius has initiated a bridging head-to-head trial in US patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG, which propels the product towards US market approval further. According to the research progress in SCLC, the company plans to submit new drug applications of the product in the EU and US in the coming years.

In addition, Henlius actively promotes the commercialization of HANSIZHUANG to enhance its accessibility by marketing, channel management, pricing and market access. By the end of 2022, HANSIZHUANG has completed the tendering process on the procurement platform in 28 provinces in Chinese mainland and was included into the commercial medical insurance directory in 5 cities such as Ningbo, Jinhua, etc., benefiting more than 10,000 Chinese patients. As early as 2019, Henlius forged a partnership with PT Kalbe Genexine Biologics (KG Bio) to grant it an exclusive license to develop and commercialize HANSIZHUANG in relation to a monotherapy and two combination therapies in 10 Southeast Asian countries. To accelerate the launch of HANSIZHUANG in the United States, Henlius entered into an exclusive license agreement with Fosun Pharma for the commercialization of HANSIZHUANG in December 2022. By virtual of Fosun Pharma’s advantages and commercial capabilities, HANSIZHUANG will expand its overseas distribution fast to benefit more patients. Going forward, Henlius will continue to expand global commercialization layout of HANSIZHUANG to reach out to more countries and regions, which urges this product to step on to the world PD-1 stage and benefits a broader patient population worldwide with its world-class quality.

With HANSIZHUANG as a model, Henlius will further promote its innovative and differentiated product portfolio and expand the global footprint to establish a prestigious national brand and bring hope to more patients across the world.

On January 17, 2023 Accuray Incorporated (NASDAQ: ARAY) reported that Auckland Radiation Oncology (ARO) is the first center in New Zealand to treat patients with the CyberKnife System, a robotic radiation therapy device known for delivering treatments with sub-millimeter precision and accuracy in typically 1 to 5 outpatient sessions (Press release, Accuray, JAN 17, 2023, View Source [SID1234626314]). The ARO medical care team selected the latest generation CyberKnife S7 System to provide stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) to patients more efficiently, minimizing the time they spend in daily treatments and maximizing the number of New Zealand cancer patients they can treat each day.

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!

"These first-in-country patient treatments reinforce the value the CyberKnife System provides to medical care teams around the globe. The addition of the Auckland Radiation Oncology center to the network of facilities using the CyberKnife System will broaden access to a trusted radiation therapy treatment option," said Suzanne Winter, president and CEO of Accuray. "We believe the system has the ability to significantly and positively impact the way the Auckland Radiation Oncology team treats cancer and certain neurological conditions, and will enable them to bring new hope to people who previously would have been without options."

The CyberKnife S7 System combines speed, precision and motion synchronization technology for the treatment of lesions and tumors throughout the body. Treatment is non-surgical, non-invasive and does not require incisions or general anesthesia. Clinical studies support the use of the CyberKnife System, expanding medical care team options for achieving outstanding outcomes for a wide range of indications.

ARO Clinical Director Dr. Benji Benjamin said, "We believe the CyberKnife System is more accurate than traditional radiation therapy, with potentially thousands of smaller beams delivering radiation to the tumor with sub-millimeter precision, minimizing damage to surrounding healthy structures and organs. Introducing the system to our suite of tools is about giving New Zealanders access to one of the world’s most advanced treatment options and doing what we can to minimize the impact of an already challenging time in people’s lives."

Dr. Ian Hanson, ARO’s Chief Physicist, added, "During treatment, the CyberKnife System will detect any movement of the patient or the tumor and will automatically move the robot to ensure that the cancer is always precisely targeted. This allows for higher doses of radiation to be delivered to the tumor each day, substantially shortening overall treatment times while minimizing the likelihood of unwanted side effects.

"For example, instead of up to 20 rounds of radiation over four weeks for prostate cancer, with the CyberKnife, patients will likely only need one week of highly targeted treatment. This could be game changing for New Zealand men."

Click here to learn more about the CyberKnife S7 System at Auckland Radiation Oncology.

Important Safety Information
For Important Safety Information please refer to View Source

About Auckland Radiation Oncology
Auckland Radiation Oncology is a joint venture, owned and operated by MercyAscot and Southern Cross Healthcare. Established in 2008 as the first private radiation therapy treatment centre in New Zealand, Auckland Radiation Oncology treats 70-100 patients daily requiring radiation therapy, from its purpose-built treatment centre in Epsom, Auckland. With an international reputation for being at the forefront of radiation therapy cancer treatment, Auckland Radiation Oncology offers patients a choice of leading-edge radiation therapy aimed directly at improving cancer treatment outcomes and quality of life.

On January 17, 2023 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer treatment, reported a strategic collaboration with The University of Texas MD Anderson Cancer Center to expand the knowledge base of how gamma-delta T cells work in oncology settings (Press release, TC Biopharm, JAN 17, 2023, View Source [SID1234626313]).

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 collaboration brings together MD Anderson’s clinical trial infrastructure and the translational research expertise of its immunotherapy platform with the clinical data of TC BioPharm’s targeted gamma-delta T cell oncology pipeline. Under the terms of the three-year agreement, the research teams will work together on both preclinical and clinical studies to evaluate the potential for gamma-delta T cell therapies and to better understand the behaviors of these cells in patients. The collaborators will form a six-person steering committee to drive the development of both the data set and subsequent assays for each study.

The comprehensive immunoprofiling capabilities of MD Anderson’s immunotherapy platform will enable correlative studies on clinical samples to uncover detailed insights on the behavior of gamma-delta T cells and corresponding responses in patients. The platform is co-led by Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology, and James Allison, Ph.D., regental chair of Immunology.

Formulating a better picture of what is occurring in patients during gamma delta T cell therapies is expected to allow TC Biopharm to better design future studies as well as form a view towards future targeted cancer studies in other blood cancers and solid tumors potentially.

"We are enthusiastic about working with MD Anderson to further our knowledge of gamma delta T cells in order to help TC Biopharm develop future trials and treatments using our platform therapy OmnImmune," said Bryan Kobel, CEO of TC BioPharm. "This collaboration reinforces our mutual commitment to accelerating the discovery and development of cell therapies, and it highlights TC Biopharm’s expertise in the gamma delta T cell space."

On January 17, 2023 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the U.S. Patent and Trademark Office (USPTO) has granted a patent (Patent No. US 11,555,070) for its anti-claudin 18.2 antibodies (Press release, Phanes Therapeutics, JAN 17, 2023, View Source [SID1234626312]).

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 patent relates to the invention of anti-claudin 18.2 monoclonal antibodies and bispecific antibodies comprising an anti-claudin 18.2 arm, which includes Phanes’ first-in-class bispecific antibody, PT886, an anti-claudin 18.2/anti-CD47 bispecific antibody being developed for gastric and pancreatic cancers. Phanes has received clearance from the US FDA to commence Phase I studies with PT886 in June 2022. PT886 has also been granted orphan drug designation from the FDA in June 2022 for the treatment of pancreatic cancer.

"This is the seventh Phanes patent granted in the US and the tenth patent granted worldwide," said Dr. Ming Wang, PhD, MBA, Founder and CEO of Phanes Therapeutics. "As Phanes expands from a research stage to a clinical stage organization, we expect to have additional patent applications issued, further strengthening the intellectual property portfolio and competitiveness of our pipeline."