On August 27, 2019 Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal tissue ablation, reported publication of first in human data of the company’s AuroLase Therapy for the focal ablation of prostate tissue (Press release, Nanospectra Biosciences, AUG 27, 2019, View Source [SID1234539039]). Initial study outcomes were published in the prestigious Proceedings of the National Academy of Sciences (PNAS) in a paper titled, ‘Gold Nanoshell-Localized Photothermal Ablation of Prostate Tumors in a Clinical Pilot Device Study.’

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The overall multi-site study, sponsored by Nanospectra Biosciences, utilized laser-excited gold-silica nanoparticles (GSN or AuroShells) in combination with multiparametic MRI (mpMRI)/ultrasound (US) fusion imaging, to focally ablate low to intermediate grade tumors within the prostate. GSN are designed to absorb near-infrared light at wavelengths of high tissue transparency, converting the light energy to heat, and provide a new and highly localized light-based strategy for the treatment of prostate cancer with substantially reduced risks of harmful treatment-related side effects.

"Jennifer West, bioengineer at Duke University, and I initiated development of the gold-silica nanoshells nearly 20 years ago," said Naomi J. Halas, PhD, Professor of Biophysics at Rice University, GSN inventor and original co-founder of Nanospectra Biosciences. "By varying the thickness of the gold outer shell, we demonstrated that we could tune the nanoshells to interact with specific wavelengths of light. By tuning the resonance beyond the visible and into the near-infrared region, we opened the door to a wide range of applications in nanomedicine."

Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in men. The trend towards overtreatment of prostate cancer with whole gland treatments has highlighted a need for better focal therapies with fewer complications.

The pilot device study reports effectiveness and safety data from Mt. Sinai’s first 16 enrolled subjects diagnosed with localized, low to intermediate risk prostate cancer. After GSN infusion and targeted laser ablation, patients underwent MRI of the prostate at 48 – 72 hours, followed by post-procedure mpMRI/US targeted fusion biopsies at three and 12 months, as well as a standard 12-core systematic biopsy at 12 months. GSN-mediated focal laser ablation was successfully achieved in 94% (15 of 16) patients. At the one-year study endpoint, 87.5% (14/16 lesions) were negative for tumor as confirmed by pathology and considered successful treatment outcomes.

"This first in human pilot device study demonstrates that GSN-directed laser excitation and ablation is a safe and technically feasible procedure for the targeted thermal destruction of prostate tumors and I am very excited to be part of this new frontier in nanomedicine," said lead study author and principal investigator, Ardeshir R. Rastinehad, DO, Department of Urology, Icahn School of Medicine at Mount Sinai. "The early results are very encouraging and with feasibility study enrollment now complete we anticipate publishing results at the initial three month endpoint for mpMRI targeted fusion biopsies for the entire 45 subject population early next year."

"As the first ultra-focal therapy for prostate cancer, AuroLase has the potential to maximize treatment efficacy while minimizing side effects associated with surgery, radiation, and traditional focal therapies," said David Jorden, CEO of Nanospectra. "We are encouraged by the clinical success of our feasibility study to date and look forward to the initiation, potentially next month, of the pivotal study with an expected cumulative treatment population of 100 subjects."

On August 27, 2019 Machavert Pharmaceuticals, a preclinical stage pharmaceutical company focused on precision medicine cancer therapies, reported that it has obtained a full exclusive license on RAL GTPase (RAL) inhibitors from the University of Colorado (Press release, Machavert, AUG 27, 2019, View Source [SID1234539038]). The licensed patent portfolio covers small molecule RAL inhibitors against KRAS mutant cancers.

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Machavert will advance the new class of cancer therapeutics, RAL GTPase inhibitors, targeting KRAS mutant cancers. The RAL inhibitors were discovered at the University of Colorado School of Medicine (CU) and relevant research was published in Nature in 2014. Machavert has been developing the RAL inhibitors since it entered into an exclusive option and evaluation license agreement in 2018 with CU for its RAL related intellectual property. The exercise of the option rights represents a significant advancement of this project toward the IND-enabling stage.

KRAS mutant cancers are linked to nearly one-third of all cancers and are difficult to treat. The novel RAL inhibition approach addresses treatment complexities and provides promise for anti-cancer therapy. RAL GTPases are effectors of RAS signaling and play a role in tumor proliferation, survival, and metastasis. A significant advantage to targeting RAL is the applicability against all subtypes of KRAS mutations and the potential to inhibit tumor metastasis and recurrence.

"Drugging the RAL GTPase pathway offers promise to achieving efficacy against multiple human cancers, including lung cancer. This unique therapeutic approach will be advantageous for patients who currently have few precision medicine treatment options for KRAS mutant cancers," said Dr. Neal Goodwin, Chief Scientific Officer of Machavert. "The applicability of these molecules will go beyond lung cancer toward other KRAS mutant solid tumors such as colon cancer."

The RAL inhibitors are being investigated pre-clinically to complete necessary lead optimization and efficacy testing in preparation of initiating IND enabling studies, a prerequisite for seeking FDA IND approval for human clinical trial entry.

On August 27, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Morgan Stanley 17th Annual Global Healthcare Conference on Tuesday, September 10, 2019 (Press release, AbbVie, AUG 27, 2019, View Source [SID1234539037]). Richard A. Gonzalez, chairman and chief executive officer, will present at 10:10 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On August 27, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported that the Company will host a physician-led informational discussion for investors and analysts during the 2019 American Society of Radiation Oncology (ASTRO) Annual Meeting in Chicago (Press release, ViewRay, AUG 27, 2019, View Source [SID1234539036]).

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Event:

ViewRay Investor Meeting at 2019 ASTRO Annual Meeting

Date:

Monday, September 16, 2019

Time:

7:00 a.m. CT Registration and breakfast

7:30 to 9:00 a.m. CT Physician-led informational discussion

Location:

Hyde Park Room at the Hyatt Regency McCormick Place, Chicago

Guest Speakers:

Dr. Percy Lee, Professor and Vice Chair of Education for the Department of Radiation Oncology,
David Geffen School of Medicine at UCLA

Dr. Ben Slotman, Professor and Chairman of the departments of Radiation Oncology,
Amsterdam University Medical Centers, Amsterdam, The Netherlands

Space is limited. Please RSVP to Kathleen Marvin at [email protected] to attend the meeting in person.

A live webcast and archived replay of the meeting will be available on ViewRay’s investor relations website at View Source

For more information on related events at the 2019 ASTRO Annual Meeting, please visit ViewRay’s website at View Source

On August 27, 2019 PIONYR Immunotherapeutics, Inc., a company developing antibody therapeutics that increase the body’s antitumor immunity by turbocharging the immune system within the tumor microenvironment, reported the appointment of Alicia Levey, Ph.D., as Senior Vice President and Chief Business Officer (Press release, Pionyr Immunotherapeutics, AUG 27, 2019, View Source [SID1234539035]). PIONYR also announced that its lead development candidates, PY314 and PY159 targeting TREM2 and TREM1, respectively, are on track to complete IND-enabling studies and are expected to enter clinical development in 2020.

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"Dr. Levey joins PIONYR at a key inflection point as we build our immuno-oncology pipeline and prepare to advance two development candidates into the clinic. Our two programs target TREM2 and TREM1, both of which play a critical role in immunosuppression in solid tumors," said Steven P. James, president and CEO of PIONYR. "Backed by deep experience in immuno-oncology research and development, our leadership team is uniquely positioned to bring these novel antibodies with unique mechanisms of action to patients in need, notably those who have failed prior immuno-oncology treatments such as checkpoint inhibitors."

Myeloid Tuning Capable of Depleting and Reprogramming Macrophages

Research conducted at PIONYR demonstrates that its approach, called Myeloid Tuning, is capable of rebalancing the tumor microenvironment (TME) to promote anti-tumor immunity. PIONYR’s Myeloid Tuning therapies are expected to treat patients who currently do not benefit from checkpoint inhibitor therapies. PIONYR’s development candidates, PY314 and PY159 target TREM2 and TREM1, respectively, and provide an orthogonal approach for treating solid tumors.

TREM2 is a transmembrane protein enriched on tumor-associated macrophages (TAMs). These immunosuppressive cells use multiple pro-tumor mechanisms to subvert anti-tumor immune responses. By selectively depleting TREM2-positive TAMs, PY314 generates a pro-inflammatory TME that leads to long-term cures in multiple mouse tumor models, including in PD-1-resistant models, both as monotherapy and in combination with anti-PD-1. Further, PY314 was shown to be well tolerated in nonclinical studies and is currently in GMP production. A significant correlation exists between TREM2 expression levels and poor patient survival probability in a broad array of solid tumors, suggesting that TREM2 levels may be a biomarker for patient selection.

TREM1 is expressed not only on TAMs but also on tumor-associated neutrophils (TANs) and myeloid derived suppressor cells (MDSCs) in numerous solid tumor types. PY159 targets TREM1 to reprogram or repolarize suppressive myeloid cells to produce pro-inflammatory cytokines (including IFN-gamma, CXCL9, and CXCL10), as well as to upregulate immune-stimulatory cell surface proteins. PY159 may therefore be particularly useful in targeting immune "cold" tumors. PY159 has demonstrated excellent single-agent efficacy as well as efficacy in combination with checkpoint inhibitors in multiple mouse tumor models. PY159 was well tolerated in preclinical studies and is currently being scaled up for GLP production.

Growing Management Team

As Senior Vice President and Chief Business Officer, Dr. Levey will lead PIONYR’s business development function including strategic partnering, alliance management, portfolio strategy and commercial assessment. Prior to joining PIONYR, Dr. Levey served as Vice President and Chief Business Officer of Tempest Therapeutics following her roles as Vice President of Business Development at Inception Sciences, Operating Principal at Versant Ventures and Project Leader at Boston Consulting Group. She has led the sourcing, negotiations and execution of numerous venture financings and strategic transactions with companies such as Celgene, Bayer and Shire, among others. Dr. Levey is co-founder of Akrotome Imaging, and she earned a Ph.D. in Cancer Biology at Stanford and a B.A. in Molecular, Cellular and Developmental Biology at University of Colorado.

In addition to Steve James as CEO and Dr. Levey as CBO, PIONYR’s executive team includes Michel Streuli, Ph.D., CSO; Leonard Reyno, M.D., CMO; Monte Montgomery, CFO; Kevin Baker, Ph.D., SVP Preclinical; and Evan Greger, VP of CMC/Process Development. In December 2017, PIONYR announced the closing of a $69 million Series B financing. This brought total funding since the company’s founding in 2015 to $78 million. PIONYR’S investors include OrbiMed, NEA, Sofinnova, SV Health Investors, Vida Ventures, Trinitas Capital, Mission Bay Capital, and Osage University Partners.