Johnson & Johnson to Participate in the Goldman Sachs 39th Annual Global Healthcare Conference

On May 29, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the Goldman Sachs 39th Annual Global Healthcare Conference on Tuesday, June 12, at the Terranea Resort in Rancho Palos Verdes, California (Press release, Johnson & Johnson, MAY 29, 2018, View Source [SID1234527088]). Tom Cavanaugh, President, Oncology, Janssen Pharmaceuticals and Scott White, President, Immunology will represent the Company in a session scheduled at 9:20 a.m. (Pacific Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.

Oncoceutics Abstracts at ASCO Highlight Efficacy of ONC201 in High-Grade Gliomas

On May 29, 2018 Oncoceutics, Inc. reported that two abstracts will be presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that will highlight clinical success of the company’s lead compound in treating high-grade gliomas (HGG), including those that harbor the H3 K27M mutation (Press release, Oncoceutics, MAY 29, 2018, View Source [SID1234558368]).

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The first abstract, entitled "Integrated clinical experience with ONC201 in H3 K27M glioma," describes preliminary clinical data indicating ONC201 induces durable radiographic regressions and clinical benefit in patients with HGG that harbor the H3 K27M mutation. This mutation is prevalent among certain types of brain tumors that develop in children and young adults and is known to confer one of the most dismal and uniformly lethal prognoses amongst HGG. There is no proven medical therapy for these patients. The integrated cohort of H3 K27M-mutant glioma patients who have received ONC201 that will be reported at the meeting include children and adults with different tumor locations. The durability of regressions and clinical benefit will be reported, which is an important measure of efficacy in this disease that is consistent with the immunostimulatory activity of ONC201 that was recently reported in the Journal of Clinical Investigation. ONC201 is currently being evaluated in pediatric and adult H3 K27M-mutant gliomas in three ongoing clinical trials at several institutions around the United States: NCT03416530, NCT03295396, NCT02525692.

The second abstract, entitled "Intratumoral activity of ONC201 in adult recurrent glioblastoma patients" describes the concentrations, targeted signaling pathways, and apoptosis associated with ONC201 directly within tumors that have been surgically removed from adult recurrent glioblastoma patients who have received two doses ONC201. These results serve as an important complement to macroscopic clinical imaging by enabling microscopic studies that demonstrate the drug is inducing the intended therapeutic impact that causes tumor cells to undergo cell death.

In addition to the two abstracts focused on HGG, there is another abstract that reports the safety and pharmacodynamics of ONC201 in advanced solid tumor patients. Additional results support the conclusion that weekly, oral ONC201 is well-tolerated and results in prolonged stable disease, intratumoral apoptotic signaling and immunomodulatory activity.

The abstracts are listed below.

2059. Integrated clinical experience with ONC201 in H3 K27M glioma. Presented Saturday, June 2, 2018.

E14034. Intratumoral activity of ONC201 in adult recurrent glioblastoma patients.

2595. Safety and pharmacodynamics of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration. Presented Monday, June 4, 2018,

Laminar Pharma announces IND approval by the FDA to proceed with a PhI paediatric trial assessing 2OHOA in children with advanced brain and other solid tumours

On May 29, 2018 Laminar Pharma, a pioneering clinical stage biopharmaceutical company developing a new generation of products modulating metabolism of membrane lipids based on the groundbreaking MLT platform, reported that the FDA has approved an IND for a paediatric trial entitled "a phase I study of 2-hydroxyoleic acid (2OHOA) in pediatric patients with malignant glioma and other advanced solid tumors (Press release, Laminar Pharma, MAY 29, 2018, View Source [SID1234562094])"

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This will be the first clinical study with 2OHOA in children with advanced malignant cancer and will be conducted in collaboration with two leading US paediatric clinical research institutions: Hackensack University Medical Center, in New Jersey and Dana-Farber Cancer Institute in Boston. The main objectives of this study are to determine the safety and tolerability of 2OHOA in paediatric population (under 18 years), to characterize the pharmacokinetic profiles in this population and to assess the preliminary anti-tumour efficacy of the product. The trial follows a standard 3+3 design in the dose escalation phase, where 9 to 18 patients will be recruited in three cohorts, and that will be followed by an expansion cohort with 10 additional patients.

High-grade gliomas (HGG) are relatively rare forms of paediatric brain tumours, constituting only 8–12% of primary central nervous system (CNS) tumours in children. The management of these tumours involves surgical resection to the extent feasible, as well as adjuvant radiation and chemotherapy. Even with these interventions, the prognosis for patients with these tumours is poor, with most patients succumbing to their disease within 12–18 months. The incidence rate of primary malignant and non-malignant brain and CNS tumours in the US in paediatric and adolescent population (0-19 years) is 5.42 cases per 100,000 for a total count of around 23,000 incident tumours per year, of which over 2.500 cases correspond to HGG.

Laminar Pharma is committed to advance the clinical development of this promising product and is excited about the prospect of providing a potential therapeutic alternative for children and adult patients with brain and other aggressive cancers.

The approval by the FDA of the Investigational New Drug (IND) application for this paediatric trial in the US is a significant regulatory milestone for 2OHOA, (re)validating the extensive preclinical and clinical development that Laminar Pharma is carrying out with this innovative product.

A PIIb trial in adult patients with newly-diagnosed glioblastoma (CLINGLIO) with 2OHOA added to the current chemoradiation standard of care for this type of tumours is also planned to open within this year in leading Hospitals in Europe and Israel, following the award of an important H2020 grant by the European Commission to an international consortium lead by Laminar Pharma.

Tarveda Therapeutics to Present at 2018 BIO International Convention

On May 29, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective medicines to treat a wide range of cancers, reported that Drew Fromkin, President and Chief Executive Officer, will present at the 2018 BIO International Convention occurring June 4-7, 2018 in Boston, MA (Press release, Tarveda Therapeutics, MAY 29, 2018, View Source [SID1234526929]). The presentation will take place on Tuesday, June 5, 2018 at 11:00 AM ET in Theatre 1 within the Boston Convention & Exhibition Center.

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Mr. Fromkin will provide an overview of the company’s Pentarin platform with a focus on its clinical stage drug candidates, PEN-221 and PEN-866. PEN-221 is currently being studied in the Phase 2a portion of a Phase 1/2a trial in patients with small cell lung cancer as well as GI-midgut and pancreatic neuroendocrine tumors that express somatostatin receptor 2 (SSTR2). PEN-866 recently entered into the Phase 1 portion of a Phase 1/2a trial to assess safety and efficacy across a range of tumor types.

To schedule a meeting with Tarveda’s management team at the Convention, please submit a meeting request through the BIO One-on-One Partnering system or contact [email protected].

About Pentarins

Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

Aileron Therapeutics to Present at the Jefferies 2018 Global Healthcare Conference

On May 29, 2018 Aileron Therapeutics (Nasdaq:ALRN), the leader in the field of stapled peptide therapeutics for cancers and other diseases, reported that Manuel Aivado, CMO and CSO, will present at the Jefferies 2018 Global Healthcare Conference being held in New York, NY (Press release, Aileron Therapeutics, MAY 29, 2018, View Source;p=RssLanding&cat=news&id=2350973 [SID1234527055]).

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Presentation Details:

Event: Jefferies 2018 Global Healthcare Conference
Date: Tuesday, June 5, 2018
Time: 2:00 p.m. EDT
Location: New York, NY

A live webcast of the presentation may be accessed from the Events & Presentations section of Aileron’s website. An archived version of the webcast will be available for replay following the event.

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild type p53 tumor suppression by disrupting the interactions between p53 and the two primary p53 suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.