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Annual Results for the year ended December 31, 2017

On April 13, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) and relapse after hematopoietic stem cell transplantations (HSCT), reported its audited 2017 Annual Results for the year ended December 31, 2017, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union (Press release, Kiadis, APR 13, 2018, View Source [SID1234525293]).

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Operating highlights (including post reporting period)

In April 2017, based on the positive results from the Phase 2 ‘007’ trial, filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of lead program ATIR101 as an adjunctive treatment in haploidentical (genetically half-matched) hematological stem-cell transplantations for adult patients with malignant disease.
In September 2017, received the Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for ATIR101. The RMAT pathway is equivalent to the Breakthrough Therapy designation that allows companies, such as Kiadis Pharma, that are developing regenerative medicine therapies to interact with the US FDA more frequently. During 2017 only 12 companies obtained an RMAT designation.
In December 2017, enrolled first patient in a Phase 3 trial of ATIR101 with participating sites in the US, Canada and Europe.
In December 2017, secured access to build in-house manufacturing capabilities with an agreement to lease an existing state of the art commercial manufacturing facility. This includes process development and quality control laboratories, as well as office space.
Strengthened Kiadis organization and Supervisory Board with key people who have a successful track record in developing and commercializing innovative products, including Mr. Arthur Lahr as CEO, Mr. Jan Feijen as COO, Dr. Andrew Sandler as CMO and Dr. Karl Hård as Head of Investor Relations. Dr. Otto Schwarz, former COO of Actelion and Mr. Subhanu Saxena, former Head of Global Product Strategy at Novartis and CEO of Cipla, are proposed as new Supervisory Board members.
In March 2018, submitted responses to the EMA’s list of questions, potentially allowing to obtain an opinion from the EMA as early as the fourth quarter of 2018. If positive, this would enable a conditional marketing approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.
Financial highlights (including post reporting period)

Significantly strengthened cash position, raised more than EUR 60 million in equity and debt since June 2017.
The cash position increased to EUR 29.6 million at year-end 2017 compared to EUR 14.6 million at the end of 2016. This is mainly due to cash received from share offerings less the cash used in operating activities in 2017. Cash position was EUR 47.7 million at end of March 2018.
Operating loss increased to EUR 16.1 million in 2017 from a loss of EUR 11.4 million in 2016.
Operating expenses increased by EUR 4.7 million compared to last year as the number of employees increased from

Commenting on the financial results, Arthur Lahr, CEO of Kiadis Pharma, said: "We can look back at 2017 as a truly transformational year and are well on our way turning Kiadis Pharma into a Phase 3 clinical and commercial stage company. I am very proud of what the entire Kiadis Pharma team achieved. We are on track to obtain a CHMP opinion in the fourth quarter of 2018 for our lead program ATIR101. If positive, this would enable an approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.

"I wish to thank our employees, partners and shareholders for their support and confidence. ATIR101 has the potential to address a very significant unmet need in transplantation, reducing relapse and Graft versus Host Disease. We look forward to continue this journey together to achieve our vision to become a fully integrated biopharmaceutical company and improve the lives of patients suﬀering from
serious diseases."

Conference call and presentation
The Kiadis management will host a conference call for analysts and investors today, Friday April 13, 2018 at 2:00pm CEST / 1:00pm BST / 8:00am EDT. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement of the call:

A question and answer session will follow the presentation of the results. The presentation may be accessed by visiting View Source

For more information, please contact:

Kiadis Pharma:
Karl Hård, Head of IR & Communications
Tel. +31 (0) 611 096 298
[email protected]

Optimum Strategic Communications:
London: Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1789
Amsterdam: David Brilleslijper
Tel: +31 (0) 610 942 514
[email protected]

Bloom Burton & Co. Healthcare Investor Conference

On April 12, 2018 Triumvira reported that it will be presenting at the Bloom Burton & Co. Healthcare Investor Conference on May 2 and 3, 2018 at the Sheraton Centre Toronto Hotel in Toronto, ON., Canada (Press release, Triumvira Immunologics, APR 12, 2018, View Source [SID1234525820]).

This year, BBHIC will host approximately 60 of Canada’s premier publicly-traded and venture-backed private companies together with the most promising pre-venture companies in the healthcare industry. Our agenda includes company presentations, keynote sessions and panel discussions by industry leaders.

Active Biotech’s partner NeoTX presents new data at AACR demonstrating that ANYARA enhances the efficacy of checkpoint blockade in preclinical models of cancer

On April 12, 2018 Active Biotech (NASDAQ STOCKHOLM: ACTI) reported that its partner NeoTX Therapeutics Ltd. will present new data for ANYARA (Naptumumab Estafenatox) at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago on April 14-18, 2018 (Press release, Active Biotech, APR 12, 2018, View Source [SID1234525482]). The poster Naptumumab Estafenatox Induces T cells Tumor Recognition, Turning anti-PD1 Unresponsive "Cold" Tumors into "Hot" Responsive Tumors will be presented between 1:00 p.m. and 5:00 p.m. local time on April 16, 2018, at the session "Immune Checkpoints 2". The data to be presented demonstrates a synergistic anti-tumor effect when ANYARA is combined with a PD-1 checkpoint inhibitor in several different tumor models that are marginally responsive to PD-1 inhibition.

Checkpoint inhibitors are drugs that unleash an immune system attack against tumor cells. It is well established that a key factor that limits the effectiveness of checkpoint inhibition is tumor recognition. ANYARA is a Tumor Targeted Superantigen (TTS) that enhances the ability of the immune system to recognize and kill the tumors and is therefore attractive for combination therapy to enhance the efficacy of checkpoint inhibition.

"We are enthusiastic that our partner NeoTX has been selected to present these important data showing that ANYARA, through its tumor-targeted mode of action, enhances the effect of PD-1 inhibition and thereby potentially increases the clinical benefit of such treatment in the long term," says Helén Tuvesson, CEO of Active Biotech.

A summary of the poster presentation will be published at: View Source!/4562/presentation/9330

About ANYARA

ANYARA is a Tumor Targeting Superantigen (TTS) that enhances the ability of the immune system to recognize and kill tumors. Active Biotech has an agreement with NeoTX Therapeutics Ltd since October 2016 for the global development and commercialization of ANYARA for the treatment of cancer. Clinically, the development of ANYARA has focused on cancer forms with a high medical need. Positive data was reported from clinical Phase 1 and 2/3 studies in lung cancer, renal cell cancer and pancreatic cancer, where ANYARA was studied both as a single agent and in combination with an established tumor therapy in patients with advanced cancer. Preparations for a clinical trial in combination with a checkpoint inhibitor are ongoing.

Lund, April 12, 2018
Active Biotech AB (publ)

For further information, please contact:
Helén Tuvesson, CEO
Tel. +46 46 19 20 95
Email: [email protected]

Hans Kolam, CFO
Tel. +46 46 19 20 44
Email: [email protected]

ImmunoCellular Therapeutics Announces Achievement of Next Key Milestone in Stem-to-T-Cell Research Immuno-Oncology Program

On April 12, 2018 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the Company) (NYSE American: IMUC) reported that it has been able to verify successful transfer of the selected T cell receptor genetic material into human hematopoietic stem cells (Press release, ImmunoCellular Therapeutics, APR 12, 2018, View Source [SID1234525479]). This milestone represents the next important step in validating the Stem-to-T-Cell approach, and is a key component of the proof-of-concept work for this technology. This achievement is a key next step to begin preclinical testing. ImmunoCellular’s Stem-to-T-Cell technology is designed to stimulate the patient’s immune system to produce an unlimited supply of killer T cells that specifically target and destroy tumor cells with minimal side effects.

ImmunoCellular Therapeutics Logo. (PRNewsFoto/ImmunoCellular Therapeutics) (PRNewsFoto/IMMUNOCELLULAR THERAPEUTICS)

At the end of 2017, the research team at ImmunoCellular successfully transfected genetic material into human hematopoietic stem cells. That work was the basis for this most recent achievement. Successful completion of this phase of work enables the Company to begin preclinical testing in animals, which, if successful, could allow ImmunoCellular’s Stem-to-T-Cell technology to advance into human clinical testing.

"We are excited to have achieved this critical next milestone in our Stem-to-T-Cell program, and are excited to begin the preclinical animal testing that can lay the foundation for potentially proceeding toward conducting human clinical trials," said Steven J. Swanson, PhD, Senior Vice President, Research. "We and our collaborators are now working to design and implement the necessary animal studies to complete our proof-of-concept work. Our vision is to develop solutions for intractable cancers, extend the lives of cancer patients, and provide hope for a potential cure. We believe that our Stem-to-T-Cell program is potentially a game-changing treatment for cancer, and could be effective in treating many types of cancers."

Anthony J. Gringeri, PhD, President and Chief Executive Officer commented: "We are pleased with the productivity and achievements to date of our research team and the continued generation of scientific validation of our Stem-to-T-Cell program. Continued testing of our novel immuno-oncology technology may elucidate how it can be applied in a real-world therapeutic setting, and lead the way toward conducting clinical trials, including potential exploration of combination with other approaches. From a corporate perspective, we are pleased with our ability to achieve our research goals while continuing to operate in a cost-efficient manner. We are also continuing to explore potential collaborations for our clinical programs and other strategic alternatives for our Company."

About ImmunoCellular’s Stem-to-T-Cell Program

Based on the technology in-licensed from The California Institute of Technology in 2014 ImmunoCellular’s Stem-to-T-Cell program is designed to harness the power of the immune system in highly directed and specific ways to engineer highly antigen-specific tumor killing. At the core of the Stem-to-T-Cell technology is the harvesting of stem cells from cancer patients and then cloning into them T cell receptors that are specific for cancer cells. These engineered stem cells can then be reintroduced into the patient and are pre-programed to produce daughter cells that are antigen specific killer T cells that are capable of identifying, binding to, and killing cancer cells. Because stem cells are immortal, these reengineered stem cells could provide a natural and perpetual source of T cells that can target and destroy cancer cells in the patient.

The Stem-to-T-Cell platform has the potential to address many types of cancer, including both solid and hematological tumors and has the potential to result in a potentially curative therapy for many different types of cancers. The stem cell platform represents a novel and more direct approach to generating killer T cells by using the patient’s stem cells as starting material. Thus, ImmunoCellular’s Stem-to-T-Cell technology shares some similarities with other immuno-oncology technologies, such as CAR-T, and could potentially be used in combination approaches. Unlike CAR-T therapies which deliver a large bolus of active T cells into the patient’s circulation and have been associated with toxicity in some patients, ImmunoCellular’s approach enables a more gradual and measured release of killer T cells and has the potential for lower toxicity while also yielding a more sustained response.

Pulse Biosciences Announces Positive Results from Its First Study Evaluating a Clinical Target at Major Scientific Meeting

On April 12, 2018 Pulse Biosciences, Inc. (Nasdaq:PLSE) reported clinical efficacy results of its first multi-center study of Nano-Pulse Stimulation (NPS) technology for the treatment of seborrheic keratosis lesions (SKs) in humans (Press release, Pulse Biosciences, APR 12, 2018, View Source [SID1234525290]). The findings will be featured at the 2018 American Society for Laser Medicine and Surgery (ASLMS) Annual Conference to be held in Dallas on April 11-15, 2018. The company also will present data from the first-in-human clinical study of NPS dose-response effects. These definitive studies establish the foundation for future therapeutic applications of NPS across a range of benign and cancerous skin growths.

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In the clinical trial of SK elimination using the novel, non-thermal NPS technology, seborrheic keratosis lesion reduction assessments of a single, localized SK treatment showed that 82% of 174 treated lesions were rated as clear or mostly clear after 106 days in 58 adult patients. An independent, blinded photographic review of lesion images scored 71% of lesions as clear or mostly clear. Patients rated 78% of lesion outcomes as satisfied or mostly satisfied, closely mirroring investigator ratings.

Thomas Rohrer, MD, a leading dermatologic and Mohs skin cancer surgeon in Boston, MA will present study results on Friday, April 13 at 4:37pm CST in a talk titled First Clinical Use of Non-Thermal Nano-Pulse Stimulation to Eliminate Seborrheic Keratosis Lesions. "These impressive results demonstrate the reliable removal of SK lesions with a single treatment using NPS technology," said Dr. Rohrer. "Pulse’s NPS technology has made a significant leap from very promising pre-clinical results to its first successful application in the removal of a common benign skin lesion with consistent results observed at each of the four top medical centers participating in the study. This unique mechanism of action of non-thermal NPS shows great potential for treating a range of benign and non-benign skin lesions."

In addition to Dr. Rohrer, other investigators in the SK trial included dermatologist George Hruza, MD, a Mohs skin cancer surgeon in St. Louis, MO; facial plastic surgeon James Newman, MD, Chief of Plastic Surgery at Premier Plastic Surgery Clinics in the San Francisco Bay Area, CA; and dermatologist Brian Zelickson, MD of Minneapolis, MN, who is widely recognized for his research in skin tissue effects related to energy-based devices.

The second publication of Pulse Biosciences research at the energy-based science and medicine conference was conferred the ASLMS Best of Basic Science and Translational Research Award. The winning paper is titled A Dose-Response Study of a Novel Non-Thermal Method of Selectively Modifying Cellular Structures in Skin with Low Energy Nanosecond Electrical Stimulation. Clinical results showed that NPS demonstrates a non-thermal mechanism for targeting cellular structures with very low-grade inflammation that does not affect the viability of the non-cellular dermal tissue across a wide range of energy levels as evaluated by clinical and histological responses observed in human skin. This research will be presented on Friday, April 13 at 10:05am CST.

According to dermatopathologist Dr. Mehregan, "Our dermatopathology lab analyzed over 200 biopsy samples from NPS-treated human skin and observed a pattern of unique cellular-effects that spared the non-cellular dermis at most energy doses. These basic tissue findings demonstrate real promise for clinical studies of multiple future clinical applications."

Publication co-authors included plastic surgeon David Kaufman, MD, Folsom, CA; Michelle Martinez, RN, BSN, of Kaufman Plastic Surgery in Folsom, CA; Brian Zelickson, MD; David Mehregan, MD, of Detroit and Monroe MI; and Pulse Biosciences contributors Richard Nuccitelli, PhD, Edward Ebbers, and Lauren Jauregui.

"We were pleased that histology results and clinical findings from the dose response study were predictive of the high lesion clearance rates observed in our first controlled study of a seborrheic keratosis treatment," said Ed Ebbers, Vice President and General Manager of Dermatology at Pulse Biosciences. "These impressive safety results and robust SK efficacy rates increase our confidence in future planned study treatments of other benign lesions, such as keloids and warts, and non-benign skin lesions."

"The presentation of our initial NPS clinical data at the prestigious ASLMS annual meeting is an important milestone for our dermatology program and Pulse Biosciences, as we continue to build the evidence in support of NPS as a unique and compelling treatment modality across a number of applications," added Darrin Uecker, President and CEO of Pulse Biosciences.

For more information: NPS study data presented at 2018 ASLMS Annual Meeting
View Source

About the SK Study

Fifty-eight (58) adult subjects in four clinical centers were required to have at least four (4) off-face lesions within study criteria for size, and a clinical diagnosis of SK. A local anesthetic was injected prior to treatment with the NPS device. Three lesions were treated in a single session, and one lesion was left untreated as a control. Subjects returned five times over a 106-day period for physician assessment of SK lesions and the cosmetic appearance of treated areas.

About Seborrheic Keratoses

Seborrheic keratosis (SK) typically appears as a raised skin lesion with a waxy, scaly texture that can vary in color from light tan to dark brown or black. It affects more than 80 million people in the United States and is often associated with aging skin. A recently published study in the Journal of Clinical and Aesthetic Dermatology found that 61% of patients took action to hide, disguise, or distract attention from their SK lesions. The published study also noted that 86% of SK sufferers were somewhat or extremely interested in a removal treatment in a dermatologist’s office and willing to pay a reasonable out-of-pocket fee. Leading clinicians generally agree that the effective treatment of SK lesions with a non-surgical and nonthermal procedure represents a highly desired alternative to patient inaction due to limitations of existing treatments.