On July 22, 2024 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported that on July 16, 2024, the USPTO granted another patent for its lead clinical asset, NEO-201, which is currently being tested in Phase 2 human Clinical Trials in the US (Press release, Precision Biologics, JUL 22, 2024, View Source [SID1234645007]).

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!

NEO-201 is a humanized IgG1 monoclonal antibody with multiple mechanisms of action. It has been shown previously to kill cancer cells expressing its target (truncated Core 1 O-glycans) which is expressed in numerous cancers; however, it does not bind to most normal tissues. In addition, NEO-201 binds to immune suppressor cells, including regulatory T cells (Treg cells) and granulocytic myeloid-derived suppressor cells (gMDSCs), which are thought to diminish the efficacy of cancer immunotherapy.

The patent granted by USPTO on July 16, 2024 (Patent No. US 12,037,410B2) describes the ability of NEO-201 to bind to Treg cells, and its use in targeting Treg cells. NEO-201 may be used for isolation and detection of Treg cells. In addition, the patent claims that NEO-201 can mediate the killing of Treg cells through complement mediated cytotoxicity (CDC) in vitro. Therapeutic methods and combination therapies using NEO-201 in combination with another anti-cancer agent are also described in the patent.

According to claims of the patent, in the Phase I clinical trial, using NEO-201 as single agent for the treatment of subjects with advanced solid tumors which have progressed on or not responded to standard treatments, NEO-201 was proven to bind and reduce the amount of circulating Tregs in subjects with stable disease after treatment.

This finding supported the rationale of the ongoing phase II clinical trial evaluating the activity of NEO-201 with pembrolizumab (Keytruda) in adults with solid tumors resistant to prior checkpoint inhibitors. This trial is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancer, Endometrial Cancer and Cervical Cancer, whose disease has previously progressed through prior checkpoint inhibitor therapy (including prior Keytruda). (View Source)

This ongoing Phase 2 trial is testing to see if combining NEO-201 with Keytruda can reactivate the effectiveness of checkpoint inhibitors when they no longer work.

Data from the ongoing Phase 2 trial was recently presented on June 1st, 2024, at ASCO (Free ASCO Whitepaper) Annual Meeting 2024, at the Mc Cormick Convention Center, Chicago, Illinois, USA. This data demonstrated that NEO-201 reduces the quantity of regulatory T cells and gMDSCs in peripheral blood mononuclear cells (PBMCs) of cancer patients and this reduction is associated with durable stabilization of disease. (click here).

In addition, a recent study, performed by Drs. Atsushi Tanaka and Shimon Sakaguchi from Osaka University, Japan, independently analyzed by flow cytometry the ability of NEO-201 to recognize Treg cells in from PBMCs from healthy donors, confirming findings from Precision Biologics in PBMCs from cancer patients. This study was presented as poster at the Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 on April 8th, 2024. Here there is the link to the poster: View Source

On July 22, 2024 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 and other indications, reported that on July 16, the sixth patient in ACHIEVE (UK) was treated (Press release, TC Biopharm, JUL 22, 2024, View Source [SID1234645008]). This is the first patient treated with a higher dose of TCB-008 post the amendment approved by the MHRA on Feb 22, 2024.

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 ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB-008 in patients with AML or MDS/AML, with either refractory or relapsed disease. ACHIEVE is comprised of two cohorts representing separate disease states. The protocol allows for either cohort to be advanced as an independent Phase III Pivotal Trial upon completion of the cohort, presuming the primary efficacy endpoints is met.

Cohort A represents relapsed/refractory patients who have been unable to attain remission and are in palliative care as they are unable to tolerate further chemotherapy. Initially, 5 patients were treated at the lower dose. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort A for a total of 24 patients.

Cohort B represents patients who have attained remission following prior treatment, however, continue to have a detectable residual disease. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort B for a total of 24 patients.

Interim data review is not reliant on the completion of either Cohort, and consequently the Company is not required to complete investigation of both Cohorts prior to advancing to a Pivotal Phase 3 study in one or both Cohorts simultaneously.

Enrolled patients will be treated with an increased dose of TCB-008, containing up to 230,000,000 cells per dose compared to the previous dose of 35,000,000. The increased dose is commensurate with the proposed medium dose cohort in the Company’s FDA trial in AML. Eligible patients will receive up to three additional infusions of TCB008, starting 14 days after the previous infusion and administered every subsequent 14 days, representing a total of 4 doses of TCB-008 or approximately 1,000,000,000 cells. Details of the ACHIEVE Study can be found at View Source

"The dosing and restart of ACHIEVE represents an important milestone in our progress towards Phase 2b efficacy data in AML with an interim data announcement in the next six to nine months, as well as proof in our ability to successfully navigate potentially arduous regulatory and clinical trial environments in both ACHIEVE and ACHIEVE2," said Bryan Kobel, CEO of TC BioPharm. "In addition to dosing our 6th patient and restarting ACHIEVE, we’ve screened and enrolled additional patients into the trial and expect to dose up to 10 more in 2024 and expect to open at least one additional clinical trial site in Q3. These efforts, combined with additional refinement of TCB-008 over the last 6 months, escalating the dose size in the ACHIEVE trial and existing data, have us poised for inflection points in 2024 and confidence in our ability to continue to execute on our clinical trial plans. Based on the substantial clinical safety and efficacy data to date and encouraging tolerability information generated in the five-patient safety cohort of ACHIEVE, we are excited to realize the potential of TCB-008 as a mono-therapy and continue to pursue partners for combination therapies."

On July 22, 2024 Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, reported that the independent Data Safety Monitoring Board (or DSMB) has undertaken a review of the safety data for the patients participating in the NOTOXIS Phase 2a Proof-of-Concept (POC) clinical study of SENS-401 for the prevention of Cisplatin-Induced Ototoxicity (CIO) (Press release, Sensorion, JUL 22, 2024, View Source [SID1234645009]).

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 DSMB has recommended the continuation of the study and confirmed the absence of any concern as to the safety of SENS-401 when administered in adult patients receiving a daily dose of 43.5 mg, administered twice daily, over a period of up to 23 weeks. Data previously published in December 2023, indicated a favorable safety profile when administered continuously for up to 11 weeks in patients receiving SENS-401.

The patient enrolment continues to progress at a steady pace, in 13 clinical centers open to date. Sensorion’s management team will report preliminary safety and efficacy data of the Phase 2a POC clinical trial of SENS-401 CIO at the World Congress of Audiology, to be held on September 19-22, 2024, in Paris, France.

The NOTOXIS Phase 2a trial is a multicenter, randomized, controlled, open-label study designed to assess the efficacy of SENS-401 in preventing cisplatin-induced ototoxicity in adult patients with neoplastic disease, four weeks after completion of cisplatin-based chemotherapy. The trial assesses several endpoints, including the rate and severity of ototoxicity, changes in pure tone audiometry (PTA) (dB) throughout the study compared to before cisplatin treatment, and tolerability.

About SENS-401
SENS-401 (Arazasetron), Sensorion’s clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion currently develops SENS-401 in a Phase 2a for the prevention of residual hearing loss in patients scheduled for cochlear implantation and in a Phase 2 clinical trial for the prevention of Cisplatin-Induced Ototoxicity. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population.

On July 21, 2024 GC Cell Corporation (hereinafter referred to as "GC Cell"; 144510:KOSDAQ) and Lukas Biomedical Co., Ltd. (hereinafter referred to as "Lukas," TWSE 6814) reported that it has formally signed an international strategic cooperation agreement (Press release, GC Cell, JUL 21, 2024, View Source [SID1234644995]).

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!

GC Cell is a fully integrated pioneer in cell and gene therapy and a subsidiary of the renowned Korean-listed pharmaceutical group GC Biopharma Corp.

This collaboration aims to increase awareness of autologous T cell therapy as well as to expand the patient access market through leveraging each other’s strengths in innovative cell treatment areas. By sharing cutting-edge research projects, clinical trial data, regulatory knowledge across multiple countries, and exploring clinical research, market development, and various activities for cancers and other challenging diseases, both parties strive to accelerate drug development and establish a platform for precision medicine solutions. This partnership seeks to bring the benefits of innovative cell therapy to a wider range of patients.

Having successfully completed clinical trials in Japan and Korea, GC Cell’s Immuncell-LC autologous T cell therapy obtained approval from the Ministry of Food and Drug Safety (MFDS) in 2007 following favorable Phase IV trials. With a track record of over 10,000 treatment cases, GC Cell has been obtaining successful clinical and commercial records in Korea. Lukas’s LuLym-T memory T cell cultivation technology originated from Japanese National Cancer Center and GC LTEC, formerly Lymphotec, a subsidiary of Green Cross Group. Based on the licensing agreement with originator of the technology and the tech transfer from the company, Lukas has brought this technology to Taiwan for market expansion and further enhancement.

Taiwan’s government has demonstrated significant commitment to the advancement of the regenerative medicine sector. Following the implementation of the Special Regulations on Regenerative Medicine, the Regenerative Medicine Act was enacted on June 4 this year. Lukas’s LuLym-T cell therapy technology, supported by international clinical trials and evidence-based data generated by GC Cell, aligns closely with Taiwan governmental policies and regulations. It appears poised to secure a five-year conditional approval under the new regulations, thus establishing Lukas as a prominent player in Taiwan’s cell therapy landscape, with a focus on domestic growth and global market expansion. Presently, Lukas has entered agreements with 13 medical institutions, including National Taiwan University Hospital, Chang Gung Memorial Hospital, and Taipei Veterans General Hospital, to conduct Phase II clinical trials focused on preventing liver cancer recurrence and exploring combined immunotherapy with chemotherapy/radiotherapy for head and neck cancer at Taipei Veterans General Hospital.

Lukas’ Chairman, Dr. Eric Tang, highlighted that GC Cell and Lukas will collaborate through a Joint Committee (JC) to exchange expertise and experience in researching memory T cell technology for various cancers in their respective countries. This collaboration involves sharing clinical and commercial knowledge, insights, and strategies, as well as exploring opportunities for cross-licensing and conducting joint clinical trials (IITs and SITs) in each other’s regions. Moreover, they aim to discuss the opportunities to jointly explore new international markets, joint investment and beyond.

James Park, CEO of GC Cell, stated, "This strategic cooperation agreement represents a pivotal milestone in accelerating the advancement of innovative cell therapies in Korea and Taiwan and also in establishing global network and ecosystem of Cell and Gene Therapy. Looking ahead, we are committed to accelerating the global expansion of Immuncell-LC through the continuous exchange of clinical research data and the establishment of a strong, long-term partnership between our two companies."

Dr. Eric Tang, Chairman of Lukas stated that: "In addition to our clinical trial for preventing liver cancer recurrence, the Taiwanese government’s implementation of the Special Regulations on Regenerative Medicine has allowed us to apply our LuLym-T cell technology on advanced stage cancer patients with various types of solid tumors. We have accumulated vast clinical experience in concomitant use of LuLym-T cell together with conventional treatment, such as: chemotherapy, radiotherapy, and checkpoint inhibitors. We are able to achieve significant prognostic improvements using a multi-modality treatment paradigm for advanced stage cancers and we hope we will be able to help more cancer patients in need by sharing our experience with other countries".

This strategic cooperation represents a significant step toward a shared vision of improving patient outcomes through innovative cell therapies and precision medicine.

About Immuncell-LC

Immuncell-LC is the only commercially available treatment option of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events. 

On July 21, 2024 The University of Oxford ("Oxford"), one of the world’s leading research institutions and Apollo Therapeutics ("Apollo"), a portfolio biopharmaceutical company, reported the signing of a drug discovery and development collaboration aimed at translating breakthroughs made by biomedical researchers at Oxford (Press release, Apollo Therapeutics, JUL 21, 2024, View Source [SID1234644996]).

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!

Under the agreement, Apollo will identify and assess novel, validated therapeutic targets from Oxford’s researchers for their potential to become important new medicines. Whilst Oxford’s research teams will gain access to therapeutic development expertise and programme funding from Apollo. This will provide more access to clinical trials for patients and deliver faster routes to market for new medicines arising from Oxford’s researchers.

The collaboration is driven by the quality of science and the burgeoning innovation environment at Oxford that has elicited a critical mass of early drug development translational research programmes. Apollo’s drug discovery experts will look for the potential to transform the standard of care globally by supporting the development of new medicines across areas such as oncology and immunological and inflammatory disorders.

Science and Technology Secretary, Peter Kyle, Department for Science, Innovation & Technology, said: "We want to harness life sciences to transform the UK’s healthcare and drive economic growth. Together, Apollo and Oxford University could deliver new medicines to help us tackle cancer, autoimmune disease, and more, improving and saving thousands of lives."

"The life sciences sector is open for business under this Government. We know that the best and boldest breakthroughs happen when industry and academia join forces, backed by government, and this partnership between Apollo and Oxford is proof of exactly what can be unlocked, when we open the doors to collaboration."

Professor Chas Bountra, Pro-Vice Chancellor for Innovation at the University of Oxford, said:

"My amazing colleagues at Oxford have numerous cutting-edge research programmes for producing novel therapeutics for patients. Apollo Therapeutics has assembled a world leading team of drug discovery and development experts. Together we are going to transform the lives of millions of patients. I am immensely excited about this collaboration."

This latest collaboration, Apollo’s sixth agreement with a university or academic research centre, will bring the in-house expertise and resources of Apollo to Oxford’s world class researchers from across the university. It will further bolster Apollo’s scalable R&D platform for the evergreen discovery and development of new medicines.

Dr. Richard Mason, Chief Executive Officer of Apollo Therapeutics, said:

"At Apollo Therapeutics we are ambitious in our mission to translate important new research discoveries into valuable new drugs. We are therefore delighted to be collaborating with the University of Oxford, a university that is consistently at the top of global rankings for scientific research and innovation. We are now working together with six of the world’s top universities and research centres to transform the standard of care in major commercial markets based on breakthroughs in biology and basic medical research made by scientists at these institutions."

The University of Oxford joins Apollo’s other five world-class research institutions: the University of Cambridge, Imperial College London, University College London, King’s College London and the Institute of Cancer Research.

Dr. Mairi Gibbs, Chief Executive Officer of Oxford University Innovation, said:

"We’re keen to provide our academic researchers with multiple avenues to realise the full potential of their cutting-edge research as quickly as possible. If we boost the funding and expertise provided to very early phase drug development programmes this will hasten their progress towards becoming medicines with the potential to licence to industry or become spinout companies. With the support of the research commercialisation team at Oxford University Innovation and our investment partners, we want to speed up the development of more life-saving medicines to help patients most in need."