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Impact Therapeutics Announces Completion of Series D1 Financing

On March 14, 2022 IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, reported the successful completion of its Series D1 financing (Press release, Impact Therapeutics, MAR 14, 2022, View Source [SID1234610060]). Institutional investors that participated in this round include new investors Dingxin Capital, CCBT, C&D EMERGING CAPITAL, Bestride, Exome Asset Management led by Sam Isaly, along with existing shareholders LAV (Lilly Asia Ventures), China Summit, and Yuexiu. Proceeds will be used to accelerate the development of its synthetic lethality programs, many of which are showing best-in-class potential.

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IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. In 2021, IMPACT achieved breakthroughs on multiple targets including PARP, Wee1, and ATR, becoming one of the biotech companies with the widest DDR pipelines in the world and is expanding to other novel synthetic lethality targets to broaden its pipelines. Today, the company already has three synthetic lethality compounds in the clinical stage.

Dr. Jun Bao, President and CEO of IMPACT Therapeutics said: "We thank these excellent investment institutions for their support and trust in IMPACT. The successful closing gave us more confidence to implement our global development strategy and advance various clinical trials at full speed. We look forward to working with clinical investigators and other partners to bring more efficacious therapies to patients around the world."

IDEAYA and Pfizer Expand Clinical Trial Collaboration and Supply Agreements for Evaluation of Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma and Additional cMET-Driven Tumors

On March 14, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has entered into additional clinical trial collaboration and supply agreements with Pfizer Inc. (NYSE: PFE) to support further evaluation of darovasertib and crizotinib combination therapy in a Phase 2 potential registration-enabling clinical trial in patients with metastatic uveal melanoma (MUM) and in a Phase 1 clinical trial in patients with cMET-driven tumors, such as hepatocellular carcinoma (HCC) and/or non-small cell lung cancer (NSCLC) (Press release, Ideaya Biosciences, MAR 14, 2022, View Source [SID1234610059]).

IDEAYA is currently evaluating the combination of darovasertib, a PKC inhibitor, and crizotinib, a cMET inhibitor, in patients with metastatic uveal melanoma (MUM) and in patients with GNAQ or GNA11 mutant skin melanoma in an ongoing Phase 1/2 clinical trial, pursuant to a clinical trial collaboration and supply agreement with Pfizer.

"We are pleased to have Pfizer’s support in connection with a potential registrational clinical trial as our clinical data on the darovasertib / crizotinib combination in MUM continues to mature. Our preliminary clinical data on the darovasertib and crizotinib combination in MUM, reported in December 2021, showed robust clinical activity with a manageable side effect profile. We have an opportunity to positively impact the treatment of patients in this high unmet medical need population," said Dr. Matthew Maurer, M.D., Vice President and Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.

"The clinical efficacy of the combination therapy in MUM patients provides proof of concept for potential expansion opportunities in other cMET-driven tumors. We believe that the darovasertib and crizotinib combination therapy can potentially improve on current standard of care treatment paradigms, for example in HCC, where response rates are modest," added Michael White, Ph.D., Senior Vice President and Chief Scientific Officer at IDEAYA Biosciences.

IDEAYA is targeting a clinical data update for its Phase 1/2 clinical trial evaluating the darovasertib and crizotinib combination in MUM in mid-year 2022, including tolerability and clinical efficacy. IDEAYA is also planning to seek FDA regulatory guidance for potential registration-enabling trial design to evaluate darovasertib and crizotinib combination in MUM in mid-year 2022. The timing of the clinical data and FDA regulatory guidance may be influenced by data maturity, including for example, appropriate interim assessments of supportive median duration of response (DoR) and/or median progression free survival (mPFS).

NuclixBio Announces a Collaborative Research Agreement with PharmAbcine

On March 14, 2022 NuclixBio Inc., a South Korean biotech company that focuses on research and development of mRNA therapeutics, reported that it has signed a Collaborative Research Agreement with PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics (Press release, PharmAbcine, MAR 14, 2022, View Source [SID1234610058]).

Under the agreement, both companies will conduct collaborative research utilizing NuclixBio’s proprietary circular mRNA platform named ‘ringRNA’ to develop novel mRNA therapeutics that can generate PharmAbcine’s antibodies. These novel therapeutics will express antibodies intracellularly to target human TIE2 receptors present on epithelial cells.

The newly developed drugs based on circular mRNA can have a better therapeutic effect compared to conventional linear mRNA-based therapies due to the proven prolonged half-life of circular mRNA. The circular form of mRNA also allows ribosomes, the particles that function to synthesize proteins, to continuously circulate around the loop of mRNA to produce a greater quantity of polypeptides, including therapeutic antibodies. Thus, the elongated half-life and therapeutic efficiency can improve patient convenience in terms of drug administration routes and intervals.

"This partnership will give both parties an extraordinary opportunity to utilize advanced proprietary technologies and provide tremendous growth opportunities," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are thankful for this strategic partnership and are looking forward to developing breakthrough therapeutic approaches that can both expand our pipeline and help patients with unmet medical needs."

"The distinctive feature of our mRNA platform is that we circularize the linear precursor RNAs and make them into circular mRNAs. This method allows more desirable protein expressions in in vivo settings, with higher stability and efficiency. Our ringRNA can be used in a wide range of indications," said Dr. Hoyoung Kang, CEO of NuclixBio. "We are thrilled to have entered this collaborative agreement with PharmAbcine, one of the leading antibody-based therapeutic companies. We hope our collaborative work will show many possibilities and result in the rapid development and expansion of the pipeline assets."

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.

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.