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Adaptimmune and Noile-Immune Announce Agreement to Develop SPEAR T-Cell Products expressing IL-7 and CCL19 as a next-generation treatment for cancer patients

On August 27, 2019 Adaptimmune Therapeutics plc, Philadelphia, PA, and Oxfordshire, UK (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and Noile-Immune Biotech, Inc., Tokyo, Japan, a biotechnology company focusing on the development of innovative cancer immunotherapies, reported that they will co-develop next-generation SPEAR T-cell products, incorporating Noile-Immune’s PRIME (proliferation inducing and migration enhancing) technology, based upon co-expression of IL-7 and CCL19 (Press release, Adaptimmune, AUG 27, 2019, View Source [SID1234539042]). The PRIME technology, which is already being investigated for augmentation of CAR-T cell activity, will be investigated with Adaptimmune’s SPEAR T-cells, as part of Adaptimmune’s next-generation programs.

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"We recently started our Phase 2 trial in sarcoma called SPEARHEAD-1 as well as the SURPASS trial, our first next-generation product clinical trial. We will continue to develop enhanced products with the aim of increasing the efficacy and durability of anti-tumor responses," said Karen Miller, Adaptimmune’s Senior Vice President of Pipeline Research. "This agreement with Noile-Immune will enable us to generate next-generation SPEAR T-cells secreting both IL-7 and CCL19, which may improve proliferation and trafficking of not only our engineered SPEAR T-cells, but also the patient’s own T-cells into solid tumors. This increased T-cell proliferation and trafficking may enhance anti-tumor activity for cancer patients."

"We are very pleased to step into co-development of next-generation T-cell products with Adaptimmune," said Hidenobu Ishizaki, M.D., Ph.D., President & CEO of Noile-Immune. "This agreement is another example of our collaborations to apply PRIME technology, which was invented by Dr. Koji Tamada, our scientific founder, to highly innovative cell therapies, and to work with top external scientific and clinical teams. This technology may establish more effective cancer treatments that address the needs of patients."

Under the terms of the agreement, Noile-Immune and Adaptimmune will collaborate on preclinical development of next-generation SPEAR T-cells directed to a limited number of T-cell targets incorporating Noile-Immune’s PRIME technology. Adaptimmune will have exclusive rights to develop and commercialize resulting products on a worldwide basis. Adaptimmune will make an upfront cash payment and milestone payments to Noile-Immune of up to $312M across all programs. Noile-Immune is also entitled to receive mid-single digit royalties on net sales of resulting products. The companies plan to gain regulatory approval for human testing of the first target program by 2021.

Nanospectra Biosciences Announces PNAS Publication of Initial Results of First Clinical Trial of Gold Nanoshell-Localized Photothermal Ablation of Prostate Tissue

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.’

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."

Machavert Pharmaceuticals Signs Exclusive License Agreement to Control RAL GTPase Inhibitors against KRAS Cancers

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.

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.

AbbVie to Present at the Morgan Stanley Healthcare Conference

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.

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.

ViewRay to Host Investor Meeting at 2019 ASTRO Annual Meeting in Chicago

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]).

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