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Kairos Pharma Receives FDA Approval of Investigational New Drug (IND) Application for Its Phase 1 Clinical Trial of KROS 201 for the Treatment of Glioblastoma; Announces New Patent for KROS 401

On March 14, 2022 Kairos Pharma, Ltd. ("Kairos"), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, reported that its activated T cell therapy, KROS 201, has received FDA approval to proceed with a Phase 1 clinical trial in patients with recurrent glioblastoma, a type of brain cancer (Press release, Kairos Pharma, MAR 14, 2022, View Source [SID1234610057]). The phase I trial is sponsored by Kairos Pharma and will be conducted at Cedars Sinai Medical Center in Los Angeles.

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Kairos CEO John Yu, M.D. commented, "This IND acceptance is the second substantial clinical milestone within the past month as Kairos accelerates toward its clinical goals for 2022. This first-in-man Phase 1 clinical trial will activate T cells against the cancer stem cells at the root of glioblastoma."

Kairos Chief Scientific Officer Neil Bhowmick, Ph.D. added, "This achievement pushes the envelope of immune therapies designed to target T cells against devastating cancers."

KROS 201 activated T cells (ATCs) are killer T cells that are developed in a cell culture by activating a a patient’s white blood cells with cytokines or T cell activating signals and by priming dendritic cells loaded with glioblastoma cancer stem cell specific antigens. The potent activated T cells are infused intravenously into patients with recurrent glioblastoma. These cells have been shown to kill cancer stem cells, the root cause of cancer.

In addition to the upcoming Phase 1 trial of activated T cell therapy for KROS 201, a Phase 2 trial of ENV105 with apalutamide was recently granted an IND by the FDA in February. A Phase 1 trial of ENV105 with Tagrisso (AstraZeneca) for lung cancer is planned to start in 2022.

Along with this advancement of its clinical milestones, Kairos Pharma announced a notice of allowance of the United States Patent and Trademark Office of their patent Compositions and Methods for Treating Fibrosis. This patent covers the method of treating fibrosis and certain forms of cancer, the composition of matter, and administering a therapy using KROS-401, a cyclic peptide inhibitor of the IL-4 and IL-13 cytokine receptor complex. This therapeutic has been shown to treat both fibrosis and cancer by reversing the M1 to M2 immunosuppressive macrophage transition in both cancers and fibrosis.

Dr. John Yu, CEO of Kairos Pharma stated, "This milestone further supports the already substantial and diversified intellectual property portfolio of Kairos and enables the unfettered clinical development of this novel and transformative therapeutic."

Kairos VP of Research and Development Dr. Ramachandran Murali, inventor of the KROS 401 molecule, commented, "KROS-401, in addition to fibrosis and cancer, opens a new avenue in therapeutic development for neurological disorders such as Alzheimer’s disease."

Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation from the FDA for the Treatment of T-Cell Lymphoma

On March 14, 2022 Dialectic Therapeutics, Inc. (Dialectic), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DT2216 for the treatment of T-cell lymphoma (Press release, Dialectic Therapeutics, MAR 14, 2022, View Source [SID1234610056]). DT2216 is Dialectic’s first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology platform.

"This is an important milestone in the development of DT2216, our lead APTaD compound. The FDA’s decision to grant orphan drug designation underscores our belief that DT2216 could be a promising therapeutic for T-cell lymphoma patients" said Dr. David Genecov, Dialectic’s President and Chief Executive Officer. "There is a critical unmet need for people diagnosed with this rare cancer, in which current approved therapies have relatively low response rates".

Normal T-cells require BCL-XL expression to survive thymic selection during their development. After thymic selection BCL-XL normal T-cells no longer express BCL-XL. However, many T-cell lymphomas re-express BCL-XL as a mechanism of their neoplastic transformation and permits their continued survival as a malignancy. Studies have demonstrated the importance of BCL-XL in T-cell lymphoma survival. Dialectic has shown that DT2216 is an effective treatment for T-cell lymphoma in preclinical studies.

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

About DT2216 and the APTaD Technology Platform
DT2216 is currently being investigated in a Phase 1 clinical trial designed as an open-label, first-in-human, dose escalation study in patients with histologically or cytologically confirmed advanced or metastatic solid tumors and hematologic malignancies who are no longer responsive to approved or accepted standard-of-care interventions. Patients in the Phase 1 trial will receive a single intravenous (IV) infusion of DT2216 twice weekly for at least 4 weeks, with each cycle consisting of 28 days. Additional information about the clinical trial is available at ClinicalTrials.gov (NCT04886622).

In preclinical studies DT2216 selectively induces the degradation of B-cell lymphoma extra-large, or BCL-XL, in cancer cells and either stimulates the return of cellular apoptosis or sensitizes the cells to be more susceptible to chemotherapy, and thus cellular destruction. DT2216 has been shown to be effective in various in vitro models of hematologic and solid tumors as a single agent and in combination with other chemotherapeutic agents. Further, these preclinical studies show cancer cells are less likely to develop resistance to DT2216 compared to other chemotherapy drugs. DT2216 accomplishes this with less impact on platelets.

As with BCL-XL, there are many other significant proteins associated with cancer that cannot be targeted with current therapies. Our proprietary APTaD technology platform is a novel approach that can be applied to the broader BCL family and other protein targets. Our current research and preclinical efforts are focused on developing next generation APTaD candidates to address this high unmet need.

Aldeyra Therapeutics to Participate in Fireside Chat at the Oppenheimer 32nd Annual Healthcare Conference

On March 14, 2022 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, reported that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Oppenheimer 32nd Annual Healthcare Conference (Press release, Aldeyra Therapeutics, MAR 14, 2022, View Source [SID1234610055]). The conference is being conducted in a virtual format March 15-17, 2022.

Dr. Brady’s conversation with Justin Kim, Senior Analyst, Biotech Equity Research at Oppenheimer, is scheduled to begin at 11:20 a.m. ET Wednesday, March 16, 2022. A webcast of the presentation can be accessed on the Investors & Media section of the Aldeyra website at View Source Following the presentation, the webcast will be archived for 90 days.

KIYATEC to Present New Clinical Correlation Data at American Association for Cancer Research

On March 14, 2022 KIYATEC, the leader in clinically correlated, published functional precision oncology technology reported that six abstracts were accepted for poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, KIYATEC, MAR 14, 2022, View Source [SID1234610054]). The meeting will be held in New Orleans from April 8 – 13, 2022 .

KIYATEC’s clinical and pre-clinical technology platforms, 3D PredictTM and KIYA-PREDICTTM, respectively, are leading the functional precision oncology space with published evidence of predictive response correlated to clinical outcomes. The six abstracts accepted for presentation at the conference include applications in multiple tumor types, immunotherapy drug response, and ex vivo application of PDX for pre-clinical drug development. These works feature collaborations with investigators from XenoSTART and the Adenoid Cystic Carcinoma Research Foundation.

"We are proud to showcase our research at the upcoming AACR (Free AACR Whitepaper) conference," said Tessa DesRochers, Ph.D., Chief Scientific Officer at KIYATEC. "The collection of abstracts demonstrates our dedication to leading with evidence. Our strong data demonstrates that our approach works."

Session titles and information for the abstracts are listed below and are also available on the AACR (Free AACR Whitepaper) online itinerary planner. KIYATEC will exhibit at AACR (Free AACR Whitepaper) at Booth #1449.

KIYATEC presentation schedule:

Ex vivo 3D drug response profiling of XPDX-derived tumor cells for acceleration of preclinical drug development
3D models and Microfluidics, Section 9
April 10th 1:30 – 5 PM

Ex vivo 3D culture of adenoid cystic carcinoma PDX models recapitulate disease biomarkers and predict drug response
3D models and Microfluidics, Section 9
April 10th 1:30 – 5 PM

Engineered 3D tissues facilitate preclinical immunotherapy studies in fully human platforms
Tissue Recombinant, Organ slide, and Decellularized Models, Section 14
April 10th 1:30 – 5 PM

3D PredictTM, an analytically and clinically validated platform for evidence-based functional precision medicine
Biomarkers Predictive of Therapeutic Benefit, Section 31
April 12th 9 AM – 12:30 PM

Organoids standardized to a clinically validated drugs response assay for truly predictive in vitro drug response profiling
Organoid-based models, Section 9
April 12th 1:30 – 5 PM

Dissecting personalized PD-1 inhibitor efficacy using patient-derived 3D spheroids
Vaccines/Immunomodulatory Agents and Interventions, Section 34
April 13th 9 AM – 12:30 PM

AngioDynamics to Report Fiscal 2022 Third Quarter Financial Results on April 7, 2022

On March 14, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the third quarter of fiscal year 2022 before the market open on Thursday, April 7, 2022 (Press release, AngioDynamics, MAR 14, 2022, View Source [SID1234610053]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13727875.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, April 7, 2022, until 11:59 p.m. ET on Thursday, April 14, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13727875.