On June 24, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to evaluate ADI-270, an armored allogeneic "off-the-shelf" gamma delta chimeric antigen receptor (CAR) T cell therapy candidate targeting CD70+ cancers, for the treatment of relapsed/refractory renal cell carcinoma (RCC) (Press release, Adicet Bio, JUN 24, 2024, View Source [SID1234644522]). The Company plans to initiate a Phase 1 clinical trial to assess the safety and anti-tumor activity of ADI-270 in RCC patients in the second half of 2024.

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"ADI-270 is the first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for the treatment of solid tumors," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "The FDA’s clearance of our IND application to evaluate ADI-270 in patients with RCC underscores a significant achievement for Adicet. ADI-270 is a third-generation CAR T designed to target CD70+ tumors with high specificity, increased exposure, persistence and tumor infiltration, while addressing immunosuppressive factors in the tumor microenvironment. RCC is the most common type of kidney cancer and has a high unmet need with limited viable treatment options available. With its highly differentiated profile, we believe that ADI-270 has the potential to become an important therapeutic option for patients with RCC and other CD70+ tumors."

The Phase 1 multicenter, open-label clinical trial is designed to investigate ADI-270 as monotherapy in adults with relapsed or refractory clear cell RCC. Following lymphodepletion, patients will be eligible to receive a single dose of ADI-270 with a starting dose level of 3E8 CAR+ cells. Subject to meeting protocol defined criteria, patients enrolled in the study may be eligible to receive a second dose of ADI-270.

The dose escalation and dose expansion portions of the trial will evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity as assessed by overall response rate, duration of response and disease control rate.

About ADI-270

ADI-270 is an armored allogeneic "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. CD70 is a compelling target due to its high expression in both solid and hematological malignancies. ADI-270 is engineered with a third-generation CAR design to target CD70 using its natural receptor, CD27, as the binding moiety and is further armored with a dominant negative form of the Transforming growth factor-β receptor II (dnTGFβRII) designed to provide functional resilience to the immunosuppressive tumor microenvironment. ADI-270 is also designed to increase exposure and persistence by reducing susceptibility to host vs. graft elimination. These properties of ADI-270 combined with the potent tumor infiltration demonstrated with gamma delta 1 T cells aim to improve clinical responses of RCC patients and other patients with CD70+ tumors.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common tumor of the kidney, constituting 80% to 85% of primary renal neoplasms. Clear cell RCCs (ccRCC) are the most common subtype, accounting for 80% of all RCCs. ccRCC is an aggressive subtype arising from renal stem cells commonly arising in the proximal nephron and tubular epithelium, and often metastasizes to the lungs, liver, and bones. Approximately 20% of newly diagnosed cases of RCC are locally advanced or metastatic and up to 30% of patients will develop metastatic disease following nephrectomy. While the 5-year survival rate for localized RCC is 93%, the 5-year survival rate for advanced disease is 15%.

On June 24, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has treated the sixth patient in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, JUN 24, 2024, View Source [SID1234644521]). This patient is expected to be the last patient in the second dosage cohort. If there continue to be no adverse effects experienced by the second cohort participants, enrollment of the third dosage cohort may commence within the next month. The study is being conducted through a research partnership with Moffitt Cancer Center.

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Anixa’s FSHR-mediated CAR-T technology, also known as chimeric endocrine receptor T-cell (CER-T), differs from traditional CAR-T therapy by targeting the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, including the vasculature of tumors. The first-in-human trial (NCT05316129) is enrolling female adult patients with recurrent/progressing ovarian cancer who have progressed on at least two prior therapies. The study is designed to evaluate safety and identify the maximum tolerated dose, while monitoring efficacy.

Safety was previously confirmed in the first three-patient cohort. The fourth through sixth patients, enrolled in the second cohort of the Phase 1 clinical trial, received triple the dose of CAR-T cells compared with the dose of the first cohort, with no dose-limiting toxicities observed.

Following the requisite wait time, of one month after dosing, enabling confirmation that it is safe to escalate, the trial will immediately begin enrolling patients in the third dose cohort, which will be at a ten times higher dose than the initial dosage.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We are highly encouraged by the favorable safety profile observed thus far in both the first and second patient cohorts, and are eager to evaluate a higher dose in the next cohort. We are particularly encouraged by a notable response in one of the patients in the first cohort, even though the dosage was considered a subtherapeutic level. Our aim is to maintain a positive safety profile as we escalate dosing, with the goal of demonstrating additional objective evidence of efficacy. Unlike conventional CAR-T cell therapies, which have achieved amazing results in various hematological cancers, they have not been effective in solid tumors. In contrast, we believe Anixa’s novel technology has the potential to make CAR-T effective in ovarian cancer and perhaps across multiple solid tumor types. Our unique and highly targeted CER-T approach targets the FSHR, which is exclusively expressed on ovarian cells. A potential dual mechanism of action is operating with our therapy targeting tumor vasculature by starving or shrinking the tumor from the inside out, as well as direct targeting of ovarian cells."

Dr. Kumar continued, "We believe that intraperitoneal (IP) delivery may also be a significant advantage of our therapy, as it allows direct trafficking of the CAR-T cells to the tumor sites, which helps to minimize side effects such as cytokine release syndrome (CRS). We believe this method of delivery not only enhances the targeting of the tumor but also improves the overall safety profile of the treatment. We expect that IP delivery may enable us to use dosages that are much higher than possible with intravenous delivery."

On June 24, 2024 Sustained therapeutics reported that the first patient has entered the Phase II/III trial of ST-02, innovative cancer medication targeting Upper Tract Urethral Carcinoma (UTUC) (Press release, Sustained Therapeutics, JUN 24, 2024, View Source [SID1234644520]).

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A rare form of cancer, UTUC affects over 7,000 individuals annually across North America. UTUC is a cancer of the inside lining of the kidney (the "collecting system" – where urine starts to drain after it is made by the kidney) and the ureter (the tube that carries urine from the kidney to the bladder). Its location in the upper collecting system makes it challenging to access and completely remove with traditional laser resection.

"This is a new opportunity in the treatment of UTUC," says Dr. Peter Black, lead investigator of the clinical trial and a Senior Research Scientist with the Vancouver Prostate Centre. "Currently we have limited treatment options for this uncommon and challenging cancer, and this approach may allow better disease control without having to remove a kidney."

The first patient in the clinical trial has been enrolled at the Vancouver Prostate Centre, and it is anticipated that 5 other sites will take part in the study. The company plans on enrolling approximately 75 patients in the combined Phase II/III trial and believes that ST-02 may be designated an orphan drug. Orphan drug designation can qualify the company for incentives such as tax credits, exemption from user fees, and seven years of market exclusivity after approval.

Sustained Therapeutics’ ST-02 product for UTUC is a sustained release formulation that enables direct delivery of chemotherapy to the site of the carcinoma via a catheter. Using the company’s proprietary platform technology, the medication releases slowly over about 24 hours exactly where the cancer is located, coating the tissue and delivering chemotherapy at higher concentrations and for longer than the current standard of care. The company believes that this direct sustained delivery may be more effective and result in fewer side effects than other forms of chemotherapy that are a current standard of care.

"ST-02 is Sustained Therapeutic’s second product to reach Phase II trials, and demonstrates our potential to develop multiple products using our novel drug delivery platforms. As such, it is a very important development in our portfolio," says Dr. Martin Gleave, Founder and Chief Medical Office of Sustained Therapeutics and Distinguished Professor in the UBC Department of Urologic Sciences and Director of the Vancouver Prostate Centre (VPC). "This new therapeutic, designed specifically for UTUC, could address an important unmet need for patients. It’s an exciting time to be a part of this work."

On June 24, 2024 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, reported its new Residual Acute Myeloid (RAM) Application (Press release, Sophia Genetics, JUN 24, 2024, View Source [SID1234644519]). The new offering expands the company’s comprehensive oncology portfolio to support measurable residual disease (MRD) capabilities and will be available to customers worldwide this summer.

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Acute Myeloid Leukemia (AML) represents about one percent of all cancers worldwide, yet is one of the most common forms of leukemia in adults1. Over 50 percent of AML patients relapse within 3 years after achieving complete remission2, therefore post-treatment monitoring is imperative for AML patients, particularly within the first two years, to help quickly detect any signs of relapse3. MRD solutions can help inform post-remission therapy and identify early relapse, and serve as a primary endpoint in clinical trials, helping researchers detect even the smallest trace of cancer and support better patient outcomes.

"AML unfortunately still remains an area of high unmet medical need today, with associated suboptimal patient outcomes. MRD measurement and monitoring has a critical role to play, for example by enabling research into the most optimal sequencing of therapies," said Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer, SOPHiA GENETICS. "We are proud to contribute to the fight against AML through our SOPHiA DDM RAM Solution. In particular we feel that the capability to seamlessly track longitudinally the evolution of individual mutations over time through a dedicated add-on module of our SOPHiA DDM Platform has the potential to be a game-changer for clinical researchers."

Next-generation sequencing (NGS)-based MRD testing is among the most advanced in cancer screening and monitoring, and can be found only with highly sensitive methods. The SOPHiA DDM RAM Solution provides users with the confidence that MRD will detect even one cancer cell among 10,000 cells. This application will allow users to stay ahead of disease response with the analytical capabilities of the SOPHiA DDM Platform, enabling sensitive variant detection down to 0.01% VAF and covering guideline-recommended genes to deliver robust insights for residual acute myeloid.

Customers using the SOPHiA DDM RAM Solution will have access to longitudinal variant monitoring, allowing them to visualize the mutational landscape for each patient and its evolution over time. The solution also provides users with the most up-to-date databases and customizable reporting features to generate graphical representations and comprehensive MRD reports.

Additionally, the SOPHiA DDM RAM Solution will continually hone its machine learning algorithms to provide the most accurate MRD results in just four days.

Representatives from SOPHiA GENETICS are available at AMP (Association for Molecular Pathology) Europe June 24-27 to discuss AML monitoring with this new application.

For more information on SOPHiA GENETICS, visit SOPHiAGENETICS.com and connect on LinkedIn.

On June 24, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported clinical program updates for IDE397, a potential first-in-class Phase 2 MAT2A inhibitor targeting MTAP-deletion solid tumors (Press release, Ideaya Biosciences, JUN 24, 2024, View Source [SID1234644518]).

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"We are excited about activating over 35 clinical trial sites globally and the broad advancement of the IDE397 Phase 2 program, including multiple potential first-in-class clinical combinations and Phase 2 monotherapy expansion in priority MTAP-deletion solid tumor types of lung and bladder cancer. We are delighted to provide updated corporate guidance for the IDE397 clinical program, including a clinical date update for the IDE397 Phase 2 monotherapy expansion dose in the second half of 2024," said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.

The Company is now targeting an IDE397 clinical data update for the IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion bladder and lung cancer in over approximately 15 evaluable patients in the second half of 2024. The clinical data update is anticipated to include a clinical efficacy summary, including a RECIST 1.1 clinical efficacy waterfall, swim-lane plot, and ctDNA molecular response analysis. In addition, at this update the Company also anticipates providing an adverse event, pharmacokinetics and pharmacodynamics summary at the IDE397 Phase 2 monotherapy expansion dose. Next, the Company is initiating an IDE397 Phase 2 monotherapy expansion in MTAP-deletion bladder cancer, in addition to the earlier reported Phase 2 expansion in MTAP-deletion squamous lung cancer. The Company has activated over 35 clinical trial sites globally in the U.S., Canada, Europe, and Asia Pacific to enable potential rapid enrollment for the IDE397 Phase 2 monotherapy expansion in MTAP-deletion lung and bladder cancer, and for the IDEAYA sponsored clinical combination(s).

IDE397 is a potential first-in-class potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion.

There is an ongoing Phase 2 expansion of IDE397 monotherapy in MTAP-deletion solid tumors (NCT04794699), and an Amgen-sponsored Phase 1/2 trial of IDE397 and AMG 193 combination in MTAP-Deletion NSCLC (NCT05975073) for which the companies intend to develop a joint publication strategy in 2024. Next, there is a Phase 1 clinical trial that will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy (NCT04794699). IDEAYA is also advancing multiple preclinical stage MTAP-deletion programs to enable wholly-owned combinations with IDE397, including a program targeting a Development Candidate nomination in the second half of 2024.