bridgebio pharma launches coa therapeutics to target coenzyme-a for rare genetic disorders

On June 13, 2018 BridgeBio Pharma reported the launch of CoA Therapeutics, a biopharmaceutical company developing novel small-molecules designed to increase Coenzyme-A (CoA) levels in genetic disorders where CoA deficiency is implicated (Press release, BridgeBio, JUN 13, 2018, https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-pharma-launches-coa-therapeutics-target-coenzyme-rare [SID1234576279]). BridgeBio has committed funding to drive the program toward clinical studies. CoA Therapeutics’ lead compound will be entering the clinic in 2019 with a planned initial focus on pantothenate kinase-associated neurodegeneration, or PKAN.

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PKAN is an autosomal recessive genetic disorder caused by mutations in the pantothenate kinase 2 (PANK2) gene. The PANK2 enzyme plays a critical role in the synthesis of CoA, which is crucial in energy metabolism and implicated in a large number of developmental disorders. Patients with PKAN either have a complete absence or a significant deficiency of the PANK2 enzyme, which may lead to reduced CoA levels in the brain. There are currently no treatments approved for PKAN.

The CoA Therapeutics’ lead compounds, which were obtained under a license from St. Jude Children’s Research Hospital, were discovered and developed by St. Jude investigators Suzanne Jackowski, Ph.D., Charles Rock, Ph.D., Richard Lee, Ph.D., and Stephen White, Ph.D.

The prevalence of PKAN is estimated to be three in every 1,000,000 people. In the typical form of PKAN, symptoms present before the age of 10, and patients may rapidly experience neuronal degeneration, causing problems with movement, speech and vision.

"PKAN is a progressive, debilitating disease with no current approved therapy, and patients and their families currently rely on supportive treatments, which partially address the symptoms but not the root cause," said Shafique Virani, M.D., CEO of CoA. "We believe that our novel approach, using a highly brain-penetrant compound to directly target enzyme activity in neurons, can safely increase CoA levels, ease patients’ symptoms and make a meaningful difference in their quality of life. Our novel approach also holds promise for other diseases with defects in CoA metabolism, including the organic acidemias."

Joining Dr. Virani is Adam Shaywitz, M.D., Ph.D., who will serve as chief medical officer at CoA as well as CMO-in-residence at BridgeBio. Shaywitz was most recently executive director in clinical sciences at BioMarin Pharmaceuticals where he was involved in the design and planning of a number of clinical studies in rare disease including serving as program lead for the natural history and clinical treatment studies in Sanfilippo Syndrome B (MPS IIIB).

"We are privileged to be working with Drs. Jackowski, Rock, Lee and White, who have been at the forefront of CoA metabolism research in health and disease," said Neil Kumar, Ph.D., CEO of BridgeBio. "Their novel approach, which relies on increasing activity of the PANK enzyme family, is a great example of an allosteric agonist approach to potentially treat patients who have very few options."

Nordic Nanovector Announces Archer-1 Trial of Betalutin® plus Rituximab in 2L Follicular Lymphoma Approved to Start in Norway

On June 13, 2018 Nordic Nanovector ASA (OSE: NANO) reported that it has received approval from the Regional Committees for Medical and Health Research Ethics (REK) in Norway with regard to the Clinical Trial Application (CTA) for the Archer-1 Phase 1b trial with Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab in second-line follicular lymphoma patients (2L FL) (Press release, Nordic Nanovector, JUN 13, 2018, View Source [SID1234553498]).

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Nordic Nanovector has now received all necessary approvals to begin Archer-1 in Norway and will commence start-up activities immediately. Archer-1 is a Phase 1b clinical trial designed to investigate the safety, tolerability, pharmacokinetic and preliminary efficacy of the Betalutin/rituximab combination in approx. 20 2L FL patients, and the study will initially be conducted in Norway. Further countries are expected to be added later. The first patient is expected to be dosed in the second half of 2018.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

TYME has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, TYME, 2018, JUN 13, 2018, View Source [SID1234527293]).

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Actinium Pharmaceuticals Announces Treatment of First Patient in Novel Combination Trial of Actimab-A Plus CLAG-M

On June 13, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported that the Medical College of Wisconsin has treated its first patient in a Phase 1 trial studying Actinium’s Actimab-A in combination with CLAG-M for patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) (Press release, Actinium Pharmaceuticals, JUN 13, 2018, View Source [SID1234527311]). This Phase 1 dose-escalation trial will study a single administration of Actimab-A following treatment of CLAG-M and will evaluate safety and tolerability, response rates, rates of bone marrow transplant (BMT), progression-free survival (PFS), and overall survival (OS).

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Dr. Mark Berger, Actinium’s Chief Medical Officer said, "We are grateful for all of the hard work that the team at MCW has put in to get to this important milestone. Actimab-A has demonstrated promising activity as a single agent in difficult to treat patient populations that we attribute to its targeting ability, potency and tolerability. We are excited to be leveraging these strengths of Actimab in a combination regimen to bring this potentially important therapy to a greater number of patients in indications that need improved outcomes. We are confident that the addition of Actimab to a salvage chemotherapy regimen has the potential to improve outcomes through improved response rates and by increasing the number of patients that can receive a bone marrow transplant."

Actimab-A is an ARC or Antibody Radio-Conjugate comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the radioisotope actinium-225. CD33 is a marker expressed on AML cells of virtually all AML patients. Actinium’s CD33 ARC has been studied in over 100 patients to date and is the only CD33 targeting agent being studied in a broad range of diseases in which the CD33 antigen is expressed including AML, myelodysplastic syndrome (MDS) and multiple myeloma. CLAG-M is a salvage chemotherapy regimen commonly used to treat patients with AML that consists of cladribine, cytarabine, filgrastim, and mitoxantrone.

Sandesh Seth, Actinium’s Chairman and CEO said, "Through the utilization of targeted radioisotopes we are able to add a new modality of treatment to a salvage cytotoxic chemotherapy regimen with the aim of improving efficacy. Further, we can apply our ARC technology to targeted conditioning to enable a bone marrow transplant that we will explore in this trial as well as our anticipated Actimab-MDS trial. In short time, our team has leveraged our capabilities to create the broadest CD33 program in terms of indications and addressable patient population. We believe our approach for this program which is supported by the strong hypothesis that combinations of targeted internalized radiation using ARC’s with chemotherapeutics is underpinned by a strong biologic rationale that can yield the best in class CD33 program".

About Our CD33 Program

We are developing a potentially best in class CD33 program using our ARC comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the alpha-particle emitter Actinium-225 (Ac225-lintuzumab). Our CD33 program was originally developed in conjunction with Memorial Sloan Kettering Cancer Center and has been studied in over 100 patients to date. CD33 is a marker shown to be expressed on cancerous blast cells of virtually all patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) and approximately 25%- 35% of patients with multiple myeloma. Actinium-225 is highly differentiated radioisotope that emits high amounts of energy through the release of four alpha-particles that can cause double-stranded breaks in DNA with known resistance mechanisms to Actinium-225. Given the limited distance of its energy in the body, it is potentially sparing of non-targeted cells leading to better tolerability and less toxicities.

Our CD33 program includes a Phase 2 clinical trial of for patients advanced over the age of 60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy an indication we have been granted Orphan Drug designation for in the US and EU. We are conducting a Phase 1 trial for patients with refractory multiple myeloma and planning to start a clinical trial for targeted conditioning prior to a bone marrow transplant for patients with high-risk MDS. We are studying Ac225-lintuzumab in combination with the chemotherapy regimen CLAG-M. We intend to continue to develop our CD33 program as a targeted therapy and for targeted conditioning of the bone marrow with Ac225-lintuzumab as a single agent and with novel combinations.

CYTOKINETICS TO PRESENT AT THE JMP SECURITIES LIFE SCIENCES CONFERENCE

On June 13, 2018 Cytokinetics, Inc. (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the JMP Securities Life Sciences Conference on Wednesday, June 20, 2018 at 11:00 AM EDT at the St. Regis Hotel in New York (Press release, Cytokinetics, JUN 13, 2018, View Source [SID1234527303]).

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Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.