On April 25, 2017 Immune Therapeutics, Inc. (OTCQB: IMUN), a clinical-stage biopharmaceutical company developing therapies for a range of conditions using LodonalTM its proprietary formulation of lower-dose naltrexone, reported it has submitted its New Drug Application (NDA) to the Pharmacy and Poison Board (PPB) in Kenya for Lodonal for the treatment of patients with HIV and cancer, both as a standalone treatment as well as an adjunct treatment, and as an immunomodulator (Press release, TNI BioTech, APR 25, 2017, View Source [SID1234518733]).

"This NDA submission initiates the process we believe will result in broad access to our therapy for those suffering from immune deficiency disease and cancer." said Noreen Griffin, Chief Executive Officer of Immune Therapeutics. "We recognize the difficulty the immune-comprised community has had in obtaining affordable non-toxic therapies and look forward to working closely with the PPB as they review our application."

A full preclinical and clinical study program supports the filing including: four clinical efficacy trials involving more than 500 HIV/AIDS patients, and one clinical trial with 89 patients for cancer and over 1,200 patients with autoimmune disease. The clinical data showed that Lodonal could improve CD4 count, decrease viral load and reduce the number of opportunistic infections in patients suffering from comprised immune systems.

Omaera Pharmaceuticals, Ltd. and GB Pharma Holding supported this filing. "Without their support, the fast track of this process would not have been possible." noted Griffin. The PPB had a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. "The application was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distribution agreement." concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017.

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"We look forward to a smooth regulatory process for Lodonal in Kenya. We have significant experience with Kenya’s PPB and have meetings planned with the Ministry of Health before the end of the month." notes Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings of Washington, DC.

On April 25, 2017 SignalRx Pharmaceuticals Inc., a clinical-stage company developing novel small-molecules therapeutics to inhibit key orthogonal and synergistic oncotargets for the treatment of cancer, reported the presentation of its novel triple PI3K/CDK4-6/BRD4 inhibitor program and first-in-class triple inhibitor SRX3177 (Press release, SignalRx, APR 25, 2017, http://www.ireachcontent.com/news-releases/signalrx-to-present-at-the-12th-annual-drug-discovery-chemistry-2017-meeting-on-its-first-in-class-triple-pi3kcdk4-6brd4-inhibitor-srx3177-for-treating-cancer-620334743.html [SID1234527323]). The presentation by Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, will be at 5pm on Tuesday April 25th, 2017, in the Fragment-Based Drug Discovery session at the Drug Discovery Chemistry 2017 meeting in San Diego, CA.

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Using SignalRx’s proprietary CRIMP technology platform, the company developed SRX3177 to simultaneously inhibit three key cancer-driving oncotargets: PI3K, CDK4-6 and BRD4. Cancer biology has demonstrated that PI3K inhibition abrogates resistance to CDK4/6 inhibition, and the combined CDK4/6 and PI3K inhibition leads to synthetic lethality in a number of cancer types (e.g., breast cancer, mantle cell lymphoma). BRD4 is a key epigenetic target that drives many cancers and the transcription of cyclin D1 and MYC, the latter in turn drives the immuno-oncology targets CD47 and PD-L1. The simultaneous inhibition of PI3K/CDK4-6/BRD4 with a single molecule presents the opportunity to deliver synthetic lethality to cancers dependent on these onco-pathways where kinase resistance is also developed.

The presentation will cover the discovery and in silico design of the small-molecule triple inhibitor SRX3177. Key highlights to be presented include:

Potent target profile (IC50: CDK4/6 = 2-3 nM; PI3Kα/δ @ 80 nM, BRD4-BD1 = 33 nM, BRD4-BD2 = 89 nM).
In silico design.
Cell cycle arrest and apoptosis induction.
Biomarkers (p-AKT, p-Rb, BRD4-chromatin release).
82-Fold more potent than FDA-approved palbociclib against mantle cell lymphoma, neuroblastoma, and hepatocellular carcinoma cells.
5-Fold more potent in cancer cells than combination of palbociclib (CDK4/6 inhibitor) + BKM120 (PI3K inhibitor) + JQ1 (BRD4 inhibitor).
Much safer with 40-fold less toxicity to normal epithelial cells vs palbociclib + BKM120 + JQ1.
SignalRx is also seeking partnering opportunities to accelerate the development of its programs and advance novel anticancer therapeutics into first-in-man clinical trials based on the promising profile and mode of action of its inhibitors. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to streamline their development alone and in combination therapies.

On April 25, 2017 Tessa Therapeutics, an immunotherapy company dedicated to revolutionizing the treatment of cancer, and Vyriad, an oncolytic virotherapy company using engineered viruses to destroy tumors and boost the antitumor immune response, reported a collaboration that will enable Tessa and Vyriad to investigate T cell and oncolytic virus combination therapies (Press release, Vyriad, APR 25, 2017, View Source [SID1234527874]). The combination of these two therapies is highly synergistic and has the potential to target a wide range of solid tumors with increased efficacy.

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Tessa and Vyriad have signed a collaboration agreement to combinae Tessa’s HPV-specific T cells with Vyriad’s vesicular stomatitis virus (VSV) for the treatment of HPV-associated cancers such as cervical as well as head and neck cancers. Tessa is currently employing its HPV-specific T Cell technology in an FDA Phase I trial targeting these cancers, and aims to commence Phase II trials in 2017/2018. Vyriad is currently testing its oncolytic VSV technology in FDA Phase I trials. Additionally, Vyriad plans to clinically test a virus that has been engineered to drive proliferation of HPV-specific T cells in early 2018.

Whilst oncolytic viruses are known for their ability to specifically infect and destroy tumors, Vyriad’s oncolytic viruses have been engineered to express antigens to improve the immune response against the tumor. This increased antigen expression is expected to significantly enhance the efficacy of Tessa’s VSTs by improving their ability to recognize, target, and destroy cancer cells, thus making the combination of both treatments highly synergistic. Furthermore, oncolytic viruses can be engineered to express viral tumor antigens in nonvirus associated cancers, hence widening the potential range of cancers that can be targeted by Tessa’s VST-based treatments.

Andrew Khoo, co-founder and CEO of Tessa Therapeutics, commented on the partnership "We are constantly looking for ways to expand the efficacy and potential applications of our cancer treatments to benefit as many patients as possible. The combination of VSTs with oncolytic viruses is a novel approach that is entirely aligned with our philosophy of redirecting the body’s highly effective anti-viral immune response to target and destroy solid tumors."

Dr Stephen Russell, co-Founder, President and CEO of Vyriad, said "Through this partnership, Tessa and Vyriad can build on each company’s expertise to develop treatments that are more potent with broader applications. The use of engineered viruses, together with VSTs, is highly synergistic and has the potential to benefit a greater range of patients in areas of significant unmet medical need."

On April 25, 2017 Circle Pharma , Inc. reported that it has completed an expansion of its Series A financing, with new investors WI Harper Group, Elements Partners, LLC, Whitesun Healthcare Ventures Limited and LifeForce Capital joining the round (Press release, Circle Pharma, APR 25, 2017, View Source [SID1234635668]). Mission Bay Capital led Circle’s Series A, with Pfizer Inc. (NYSE:PFE), ShangPharma Investment Group, Ltd. and a syndicated group of individual investors subscribing at the initial close. With this subsequent closing, a total of approximately $6.5M of shares of Circle’s Series A Preferred Stock has been issued in the Series A financing.

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"We are gratified to have this new group of high-caliber investors joining our first equity financing," said David J. Earp, J.D., Ph.D., Circle’s president and CEO. "The funds will support Circle’s platform development and our therapeutic pipeline, which is focused on intracellular protein-protein interactions that are key drivers in oncogenic pathways. This is an exciting time for Circle. We are adding new targets to our pipeline, including MCL1 and the substrate binding site of cyclinA / cdk2, both of which are important oncology targets that have proven challenging for small molecule drug development. Our chemistry process development work has recently successfully achieved key steps required for a more highly automated synthesis platform. Finally, with support from Pfizer, we are building a physical library of macrocycles which are predicted to have optimized permeability. This library will complement our rational design/virtual library screening approach. We will begin synthesis of the physical library shortly, enabling us to deliver it to Pfizer, and potentially other collaborators, for screening use later this year. We are especially delighted to welcome James Lu to our board in connection with this expanded Series A investment. He brings deep experience building high-growth, global companies both as an investor and in management roles."

Mr. Lu is a Managing Director of WI Harper, a cross border venture capital firm investing in leading healthcare and technology startups in the U.S. and China. Previously, Mr. Lu co-founded and was a General Partner of iD Ventures America (formerly Acer Technology Ventures), which managed several funds that were early investors in companies such as iRobot (NASDAQ:IRBT); Harmonix Music (acquired by MTV/Viacom (NYSE:VIA)); and Monolithic Power Systems (NASDAQ:MPWR). In prior roles, Mr. Lu was General Counsel of the Acer Group and earlier was a corporate and commercial attorney with the McCutchen law firm in San Francisco and a banker at JP Morgan in New York. Mr. Lu graduated with a BA from Yale College, an MBA from Harvard Business School and a JD from UC Berkeley School of Law.

Peter Liu, Founder and Chairman of WI Harper Group commented, "We are seeing excellent opportunities for investing in ground-breaking life science companies that are advancing new technologies and addressing unsolved problems. Circle Pharma is one such company; we are pleased to participate in their Series A financing and look forward to building a strong relationship with the management team and the other investors."

"Completion of Circle’s Series A financing strengthens Circle’s investor base and brings additional depth on the technical side, relations with strategic partners and, with WI Harper and Elements, connections to activities and initiatives outside of the U.S., and especially in key Asia markets," said Douglas Crawford, Ph.D., managing director of Mission Bay Capital.

About Macrocyclic Peptides
Macrocyclic peptides have the potential to allow drug developers to address the large proportion of known therapeutic targets (estimated at up to 80%) that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited by the need for a greater understanding of how to develop macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Circle is applying its ability to design potent macrocycles with intrinsic cell permeability and drug-like characteristics to unlock access to challenging, high value therapeutic targets that have been out of reach to other approaches.

On April 25, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported the United States Patent and Trademark Office has granted a method of use patent for CLR 1501, CLR 1502 and an additional CLR 1401-boron-dipyrromethene analog for the detection of multiple cancer types (Press release, Cellectar Biosciences, APR 25, 2017, View Source [SID1234518684]). All of these compounds utilize Cellectar’s proprietary phospholipid drug conjugate (PDC) delivery platform.

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The recently issued patent, 9,616,140, outlines the method of use of these fluorophore compounds to detect a variety of solid tumors in patients, including melanomas, colorectal adenocarcinoma, uterine carcinoma, pancreatic carcinoma, ovarian adenocarcinoma, glioblastoma, clear cell carcinoma, and prostate adenocarcinoma. The current patent provides intellectual property protection through May 11, 2029.

"We continue to successfully execute our plan to expand the company’s intellectual property portfolio to protect and enhance the value of our PDC pipeline assets, both in diagnostic and therapeutic applications," said Jim Caruso, president and CEO of Cellectar. "While our focus continues to be the development of our therapeutic assets, specifically CLR 131, for the treatment of multiple myeloma and other hematologic malignancies, our platform assets offer significant additional opportunity in a variety of clinical applications."

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.