1stOncology™: Cancer Intelligence Service – Page 4932 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

TG ImmunoPharma Announces FDA Clearance for Clinical Trial of TGI-6 Bispecific Antibody

On June 16, 2023 TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, reported that the FDA has granted clearance for the clinical trial of TGI-6, its groundbreaking bispecific antibody (Press release, TG Immunopharma, JUN 16, 2023, View Source [SID1234632757]). TGI-6 targets unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, enabling potent anti-tumor responses. The antibody demonstrates exceptional anti-tumor activity, favorable safety profiles, and remarkable druggability.

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!

TGI-6’s TAA is highly expressed in various solid tumors, including colorectal cancer, breast cancer, hepatocellular carcinoma, gastric cancer, ovarian cancer, pancreatic cancer, and more. This makes TGI-6 a promising candidate for the treatment of a wide range of solid tumors. Preclinical studies have shown outstanding potential, with TGI-6 inducing complete tumor regression in animal models of colorectal cancer following a single administration. Importantly, TGI-6 is designed to maintain high cytotoxic activity while minimizing the risk of cytokine release syndrome (CRS).

"We are thrilled to receive FDA clearance for the clinical trial of TGI-6," said Professor Zhigang Tian, founder of TGI and member of the Chinese Academy of Engineering and the Academia Europaea. "TGI-6 has demonstrated superior anti-tumor activity and safety in preclinical studies. We have great confidence in its potential as a novel therapy for solid tumors."

With this significant milestone, TGI is actively seeking global partners to collaborate on the development, clinical trials, and eventual commercialization of TGI-6. By partnering with pharmaceutical and biotechnology companies, TGI aims to leverage their expertise in clinical development and market access, expediting the availability of TGI-6 for patients worldwide.

TGI remains steadfast in its mission to revolutionize cancer treatment through innovative immunotherapies. With FDA clearance for the clinical trial of TGI-6, the company is poised to advance the development of precise therapies for solid tumors. Interested parties are invited to explore partnership opportunities and join TGI in their pursuit of delivering novel treatment options that improve patient outcomes.

vTv Therapeutics Partner Cantex Pharmaceuticals Licenses Exclusive Rights to Intellectual Property from Georgetown University for Azeliragon as a Potential Treatment for Cancer-Related Cognitive Decline

On June 16, 2023 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), reported that Cantex Pharmaceuticals, Inc. recently obtained an exclusive worldwide license from Georgetown University for intellectual property related to the potential use of azeliragon to treat, prevent or alleviate cancer treatment-related cognitive decline (Press release, vTv Therapeutics, JUN 16, 2023, View Source [SID1234632755]). Azeliragon, a small molecule receptor for advanced glycation end products (RAGE) inhibitor, was originally discovered by vTv and studied as a potential treatment for Alzheimer’s disease. Prior to licensing azeliragon to Cantex, vTv produced a substantial body of clinical data supporting the safety and tolerability of azeliragon, as well as preclinical data demonstrating the potential therapeutic benefit of vTv’s RAGE antagonists on several diseases, including cancer and diabetic complications.

"We once again extend our congratulations to our partners at Cantex on the continued strengthening of their IP estate for azeliragon. Already protected by a robust composition of matter patent and a variety of regulatory exclusivities, azeliragon has broad therapeutic potential which, if realized, could result in sizeable commercial opportunities in oncology and multiple other indications in which RAGE is implicated," said Paul Sekhri, President and Chief Executive Officer of vTv Therapeutics. "We look forward to the results of Cantex’s collaboration with Georgetown, which will provide greater visibility into the potential of azeliragon to alleviate cognitive decline caused by chemotherapy."

About Azeliragon
Azeliragon is an orally administered small molecule drug, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was originally under development for Alzheimer’s disease by vTv Therapeutics from whom Cantex licensed it. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex is also developing azeliragon for the treatment of brain metastasis, metastatic pancreatic cancer, glioblastoma, and neoadjuvant therapy of breast cancer. In addition, a phase 2/3 trial is currently enrolling hospitalized COVID-19 patients, evaluating the efficacy of azeliragon in the prevention of acute kidney injury.

Autolus Therapeutics Presents Positive Results from AUTO4 in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma

On June 16, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported clinical data of AUTO4 (Phase 1/2 LibrA T1 study), a TRBC1-targeting CAR T cell therapy in relapsed/refractory TRBC1-Positive Peripheral T-Cell Lymphoma (PTCL) at the International Conference on Malignant Lymphoma (ICML) being held June 13 to 17, 2023 in Lugano, Switzerland (Press release, Autolus, JUN 16, 2023, View Source [SID1234632754]). PTCL is a rare and heterogeneous form of non-Hodgkin lymphoma.

The LibrA T1 trial is a single arm, open label, multi-center, Phase 1/2 study evaluating the safety and efficacy of AUTO4, a single dose intravenous CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1-positive selected PTCL. At the cutoff date of April 28, 2023, 19 patients were enrolled into the study and 13 were dosed. Using manufacturing process A, 10 patients were dosed. Using manufacturing process B, 3 additional patients were dosed very recently. Overall, the treatment was well tolerated with no dose limiting toxicities. In Process A, at the highest dose tested (450 x 106 cell dose), 4 out of 4 patients achieved a response with 2 out of 4 remaining in ongoing complete metabolic response (CMR) at 15 and 18-months post-dose, respectively. Presence of CAR T cells in the lymph nodes of patients suggest fast homing of CAR T cells to the tumor site, despite absence in the blood. Efficacy data from Process B was not provided given median follow up is <3 months.

"There are limited options for patients with PTCL, so new treatments for this aggressive malignancy are desperately needed," said Dr. Kate Cwynarski, Chief Investigator, UCLH, London. "The LibrA T1 study of AUTO4 is a novel approach using a CAR T cell designed to selectively target and eliminate T cells that include the malignant clone which harbors the TRBC1 receptor, while preserving the T cell compartment with the TRBC2 receptor which helps to maintain immune-competence. AUTO4 is well tolerated and the data to date in this early phase study are very promising."

"AUTO4, with its unique targeting mechanism, represents an opportunity for advanced programmed T cell therapies that will make a difference in patients who traditionally suffer from severe immunosuppression as a result of current therapeutic options," said Dr. Edgar Braendle, Chief Development Officer of Autolus. "This is a trial with a small number of patients, but with all 4 patients at the highest dose in the study achieving a response and 2 out of the 4 remaining in a complete metabolic response beyond 12 months, AUTO4 shows potential to provide a novel therapy option for PTCL patients."

Oral Presentation

Title: First in Human Study of AUTO4, a TRBC1-Targetting CAR T Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma

Abstract No: 044 – Link to Abstract
Session: Peripheral T-cell Lymphomas
Session Date and Time: Thursday, June 15, 2023, 4.30 – 4.45pm CET

Presenting Author: Dr Kate Cwynarski, Consultant Haematologist University College London Hospitals (UCLH)

TRACON Pharmaceuticals to Present at the Maxim Group Healthcare Virtual Conference

On June 16, 2023 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with other life science companies to develop and commercialize innovative products in the United States, reported that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview at the Maxim Group Healthcare Virtual Conference on Tuesday, June 20, 2023 at 3:30 pm Eastern Time (Press release, Tracon Pharmaceuticals, JUN 16, 2023, View Source [SID1234632753]).

This conference will be live on M-Vest. To attend, sign up to become an M-Vest member.

Tessa Therapeutics Announces Positive Results from CD30 CAR-T Combination Study with Nivolumab in 2nd line Hodgkin Lymphoma

On June 16, 2023 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported encouraging safety and efficacy data from a combination study of its autologous CD30 CAR-T therapy (TT11) with Bristol Myers Squibb’s nivolumab at the 17th International Conference on Malignant Lymphoma taking place from June 13-17, 2023, at Lugano, Switzerland (Press release, Tessa Therapeutics, JUN 16, 2023, https://www.tessacell.com/2023/06/16/tessa-therapeutics-announces-positive-results-from-cd30-car-t-combination-study-with-nivolumab-in-2nd-line-hodgkin-lymphoma/ [SID1234632752]).

TT11 is an autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy that harvests the patient’s own T-cells and modifies them to target cancer cells expressing the CD30 protein, a well-validated lymphoma target. TT11 is currently being investigated in combination with Nivolumab in Phase 1B (ACTION) study targeting R/R classical Hodgkin Lymphoma (cHL) patients after frontline therapy failure (NCT05352828).

ACTION is a single arm multi-centre Phase 1b study. Study protocol involves patients being treated with 2 cycles of Nivolumab, followed by a single infusion of CD30.CAR-T preceded by lymphodepletion (LD) chemotherapy. An additional 2 cycles of Nivolumab are then given, followed by response assessment by PET/CT per Lugano 2014 criteria. Patients without progressive disease may undergo either autologous stem cell transplant (ASCT) or continue Nivolumab up to 6 additional cycles per physician and patient preference.

A total of 15 patients were enrolled of which 13 were treated with Nivolumab + CD30 CAR-T therapy. 10 patients reached End of Treatment (Post-Nivo Cycle 4) and were evaluable for response. Of the 10 patients 9 responded to the treatment with complete disappearance of tumor observed by PET/CT in 7 patients and partial reduction in tumor size observed in 2 patients. One patient had stable disease. Of note, no patients proceeded to receive autologous stem cell transplant (ASCT) as of the data cut off. All 10 patients reaching EOT (Post-Nivo Cycle 4) proceeded to additional Nivo cycles.

The therapy was well tolerated with no grade 3 or higher Cytokine Release Syndrome (CRS) and no neurotoxicity. Two patients experienced grade 1 CRS, which resolved without use of steroid or tocilizumab.

CD30.CAR-T expansion and persistence was observed post infusion. CAR-T cells continued to persist until data cut-off for the results (day 77 post infusion) with peak expansion observed in peripheral blood at 8 days post infusion.

"CD30 CAR-T therapy in combination with Nivolumab has demonstrated promising anti-tumor efficacy with a very good safety profile in r/r cHL patients after primary treatment." Said Sairah Ahmed, M.D., lead presentation author, and Associate Professor, The University of Texas MD Anderson Cancer Center. "The results are quite encouraging and warrant further development of this combination therapy among r/r cHL patients."

Circulating tumor ctDNA-MRD (minimum residual disease) was assessed with PhasED-Seq (Foresight Diagnostics) in 3 patients with complete responses at End of Treatment (EOT). All 3 patients (100%) had undetectable ctDNA-MRD demonstrating deep molecular response. Additional patient samples are currently under assessment.

"We are very encouraged by the exciting results demonstrated by the ACTION study. These results offer the potential to re-define Hodgkin lymphoma treatment paradigm, offering a second line treatment alternative free of transplant and high dose chemotherapy to patients who fail frontline therapy." Said Thomas Willemsen, President and CEO, Tessa Therapeutics. He added "The well tolerated safety profile is especially meaningful for older patients with poor tolerability and young adolescents with risk of long-term sequelae from current standard of care."