On October 12, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it has appointed Ingmar Bruns, M.D., Ph.D., as Vice President of Clinical Development (Press release, Pieris Pharmaceuticals, OCT 12, 2017, View Source [SID1234520882]). Dr. Bruns is an accomplished physician and brings to Pieris a wealth of oncology and hematology experience, a deep science background, and a strong clinical development acumen.

“We are pleased to welcome Ingmar to the Pieris team at this time of rapid growth and advancement of key therapeutic programs into the clinic,” commented Louis Matis, M.D., Senior Vice President and Chief Development Officer. “His strong biomedical background, academic and industry networks, and track record in both research and clinical development bring exceptional value to the Company. We look forward to his leadership in advancing our lead immuno-oncology therapeutic, PRS-343, a HER2-CD137 first-in-class bispecific, as well as our other programs in immuno-oncology, respiratory and other diseases.”

Prior to joining Pieris, from 2013 through October 2017, Dr. Bruns led clinical development of several high priority oncology assets at Bayer Pharmaceuticals. Before his tenure at Bayer, Dr. Bruns served as an attending hematologist and oncologist as well as a basic, translational and clinical researcher at the University Hospital of Dusseldorf in Germany and Albert Einstein College of Medicine in New York. Dr. Bruns has authored over 50 papers in the field of hematology and oncology. He received his M.D. and Ph.D. from the University of Lubeck in Germany.

“I’m excited to join the dynamic Pieris team and look forward to contributing to the advancement of Pieris’ preclinical and clinical-stage Anticalin-based therapeutics into and through the clinic,” added Dr. Bruns. “In particular, the Company’s lead immuno-oncology program, PRS-343, a HER2-CD137 first-in-class bispecific, represents a potentially transformative therapy for a number of metastatic cancer patients without viable treatment options today.”

In connection with the hiring of Dr. Bruns, the Company’s Board of Directors authorized the grant to Dr. Bruns of a non-qualified stock option to purchase up to 175,000 shares of the Company’s common stock, effective as of the first day of his employment. The option grant is an inducement material to Dr. Bruns’ entering into employment with the Company in accordance with NASDAQ listing Rule 5635(c)(4). The option will have an exercise price corresponding to today’s closing price of Pieris stock, the fair market value of the Company’s common stock on the date of grant, and will vest as to 25% of the shares on the first anniversary of Dr. Bruns’ employment and as to an additional 6.25% of the shares per quarter thereafter for the following 12 quarters, provided that he continues to provide service to the Company on the applicable vesting dates. The option has a ten-year term and is subject to the terms and conditions of a stock option agreement.

On October 12, 2017 OncoSec Medical Incorporated (“OncoSec”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that it will present new clinical data on ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or “tavo”] with electroporation), its lead program focused on oncology, at the upcoming 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR). In addition, Chris Twitty, Ph.D., Executive Director of Clinical Science, gave an oral presentation at the 2nd Annual Biomarkers & Precision Medicine USA Congress earlier this week (Press release, OncoSec Medical, OCT 12, 2017, View Source;a-joint-meeting-with-the-society-for-melanoma-research [SID1234520880]).

“We are excited to share updated data from our phase 2 clinical monotherapy trial with ImmunoPulse IL-12 in patients with stage III/IV melanoma,” said Punit Dhillon, CEO and President at OncoSec. “These data, along with the emerging clinical data from the phase 2 combination study, further support the rationale for our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018.”

9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research

Dr. Alain Algazi, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, will give an oral presentation contrasting monotherapy ImmunoPulse IL-12 to its combination with pembrolizumab. The presentation includes an assessment of clinical and immune biomarker data from the company’s recently completed monotherapy phase 2 trial. The 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR) is to be held on October 18-22, 2017, in Brisbane, Australia.

Details of the presentation are as follows:

Abstract Title: Clinical Immune Monitoring and Biomarker Data of pIL-12 Monotherapy Compared to pIL-12 with Pembrolizumab in Metastatic Melanoma Supports the Rationale for Combination Therapy (Abstract # FC05-3)

Session Title: Biology and Biomarkers

Date and Time: October 19, 2017 at 3:30 PM – 3:40 PM

Location: Brisbane Convention & Exhibition Centre

Dr. Algazi will present new clinical and immune monitoring data from patients treated with ImmunoPulse IL-12, as a monotherapy (n=51 patients) versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab (n=22 patients) to better understand the mechanisms associated with each immunotherapy protocol. In the 51 patients treated with ImmunoPulse IL-12 as monotherapy, an average of 33.5% best overall response rate (BORR) at 180 days by a modified “skin” RECIST was demonstrated, in addition to a favorable safety profile (no life threatening or grade 4 AE). In the combination trial of 22 patients treated to date, a 48% BORR was observed at 24 weeks. Biomarker analyses suggest ImmunoPulse IL-12 drives a cellular response leading to an inflamed tumor with an increased TIL frequency whether as a monotherapy or combined with pembrolizumab, converting “cold” tumors to “hot”.

Further details on this presentation will be provided in upcoming Company communications. For more information about this conference, please visit: View Source

2nd Annual Biomarkers & Precision Medicine USA Congress

Chris Twitty, Ph.D., Executive Director of Clinical Science at OncoSec, gave an oral presentation entitled: “Interrogation of the tumor microenvironment and associated immunity in patients with melanoma” in addition to leading a panel discussion at the 2nd Annual Biomarkers & Precision Medicine USA Congress on October 10, 2017 at the Hilton San Diego Mission Valley Hotel in San Diego, CA. For more information, please visit: View Source

On October 12, 2017 The National Institutes of Health and 11 leading biopharmaceutical companies reported that it launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot (Press release, US NIH, OCT 12, 2017, View Source [SID1234520878]). PACT will initially focus on efforts to identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role.

“This new public-private partnership is a significant step forward in the battle against cancer and a real boost to the potential of immunotherapy,” said Acting Health and Human Services Secretary Eric Hargan. “We are excited for this partnership, which will strengthen efforts already underway across HHS.”

New immunotherapies have resulted in dramatic responses in certain cancer cases. They have also been the focus of intense investment by biopharmaceutical companies seeking to provide new options for patients who do not respond to other cancer therapies, but they don’t work for all patients. Development and standardization of biomarkers to understand how immunotherapies work in some patients, and predict their response to treatment, are urgently needed for these therapies to provide benefit to the maximum number of people.

“We have seen dramatic responses from immunotherapy, often eradicating cancer completely for some cancer patients,” said NIH Director Francis S. Collins, M.D., Ph.D. “We need to bring that kind of success — and hope — for more people and more types of cancers, and we need to do it quickly. A systematic approach like PACT will help us to achieve success faster.”

PACT will facilitate systematic and uniform clinical testing of biomarkers to advance our understanding of the mechanisms of response and resistance to cancer therapy. The research conducted under the partnership will also integrate immune and other related oncology biomarkers into clinical trials by defining a set of standardized biomarkers to be tested across a variety of studies. This approach will allow for consistent generation of data, uniform and harmonized assays to support data reproducibility, comparability of data across trials, and discovery and validation of new biomarkers for immunotherapy and related combinations. PACT will also facilitate information sharing by all stakeholders to better coordinate clinical efforts, align investigative approaches, reduce duplication and enable more high-quality trials to be conducted.

“A scientific and organizational challenge this complex cannot be addressed effectively by any one organization acting alone,” said Maria C. Freire, Ph.D., President and Executive Director of the FNIH. “Instead, it requires the energies and resources of public and private partners working in close collaboration.”

PACT partners include AbbVie, North Chicago, Illinois; Amgen, Thousand Oaks, California; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; Bristol-Myers Squibb, New York; Celgene Corporation, Summit, New Jersey; Genentech, a member of the Roche Group, San Francisco; Gilead Sciences, Foster City, California; GlaxoSmithKline plc, Brentford, United Kingdom; Janssen Pharmaceutical Companies of Johnson & Johnson, New Jersey; Novartis Institutes for Biomedical Research, Basel, Switzerland; and Pfizer, Inc., New York. (See what the partner organizations are saying about PACT). Additional support has been provided by the Pharmaceutical Research and Manufacturers Association (PhRMA). The 11 partner organizations will contribute up to $1 million per year for five years through the FNIH for a total private sector contribution of $55 million. NIH will contribute $160 million over the five years of the partnership, pending availability of funds.

NIH’s National Cancer Institute (NCI) recently awarded cooperative agreements to support four Cancer Immune Monitoring and Analysis Centers (CIMACs) and a Cancer Immunologic Data Commons (CIDC) with a total of $53.6 million in funding over five years. The four CIMACs and one CIDC will form a network of laboratory centers that will support both adult and pediatric immunotherapy trials. Researchers at the CIMACs will perform deep tumor and immune profiling. The resulting data will be collected in the CIDC database for exploration of biomarkers of immune response. This network will also provide a foundation for the core laboratory, assay development and database functions required by PACT.

“NCI’s long-term support for basic and translational research in immunotherapy paved the way for the recent dramatic clinical successes in this area,” said Douglas R. Lowy, M.D., Acting Director of NCI. “This partnership, and the data the partners have committed to making publicly accessible to the broader research community, will facilitate our continued progress in helping to find the cancer treatments that benefit the greatest number of patients.”

The NCI cooperative agreements have been awarded to Dana-Farber Cancer Institute, Boston (CIMAC and CIDC); Stanford Cancer Institute, Stanford, California (CIMAC); Precision Immunology Institute and the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, New York (CIMAC) and University of Texas MD Anderson Cancer Center, Houston (CIMAC).

On October 12, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI) (Karyopharm) and Ono Pharmaceutical Co., Ltd. (ONO), reported their entry into an exclusive license agreement for the development and commercialization of selinexor, Karyopharm’s lead, novel, oral Selective Inhibitor of Nuclear Export (SINE) compound, and KPT-8602, Karyopharm’s second-generation oral SINE compound (Press release, Karyopharm, OCT 12, 2017, View Source [SID1234520877]). The agreement includes the development of selinexor and KPT-8602 for the diagnosis, treatment and/or prevention of all human oncology indications in Japan, South Korea, Taiwan, Hong Kong, and ASEAN countries (the Territory).

Under the terms of the agreement, Karyopharm will receive a one-time upfront payment of ¥2.5 billion (approximately US$22.3 million) from ONO and retains all rights to selinexor and KPT-8602 outside the Territory. Karyopharm is eligible to receive up to an additional ¥19.15 billion (approximately US$170.7 million at the current exchange rate) if specified future development and commercial milestones are achieved by ONO. Karyopharm is also eligible to receive low double-digit royalties based on future net sales of selinexor and KPT-8602 in the Territory. In exchange, ONO will receive exclusive rights to develop and commercialize both compounds in the Territory, at its own cost and expense. ONO will also have the ability to participate in any global clinical study of selinexor and KPT-8602, and will bear the cost and expense for patients enrolled in clinical studies in the Territory.

“We are very delighted to collaborate on the development of selinexor and KPT-8602, an early development stage XPO-1 inhibitor with Karyopharm, a leading pharmaceutical company focused on the research and development of novel first-in-class drugs in the oncology field,” said Gyo Sagara, President, Representative Director of ONO. “We believe both products will present a new treatment option to patients suffering from devastating cancers in Asian countries.”

“Given ONO’s established leadership in oncology, including Opdivo (nivolumab) and Kyprolis (carfilzomib) in Japan, we believe there is no company better suited to advance both selinexor and KPT-8602 in Japan and the other licensed territories,” said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. “ONO is well-known and widely respected for its clinical development and commercial expertise, and this partnership provides important validation for both compounds, while allowing us to remain focused on executing our late-phase selinexor trials and pursue regulatory approval in the United States and European Union. We look forward to working with the ONO team to advance both compounds with the goal of rapidly bringing them to patients who are in need of new treatment options.”

About Selinexor
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,200 patients have been treated with selinexor, and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

About KPT-8602
KPT-8602 is a second generation oral SINE compound. KPT-8602 functions by binding to and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. KPT-8602 has demonstrated minimal brain penetration in animals, which has been associated with reduced toxicities in preclinical studies while maintaining potent anti-tumor effects.
About Karyopharm Therapeutics

On October 12, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that an abstract describing new data for IPI-549, an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), has been selected as a late-breaking presentation during an oral session at the 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting taking place in National Harbor, MD, November 10 – 12 (Press release, Infinity Pharmaceuticals, OCT 12, 2017, View Source [SID1234520876]). Additionally, a clinical trials in progress poster will also be presented on the Phase 1/1b clinical study which is ongoing to explore the safety and activity of IPI-549 both as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors. IPI-549 is believed to be the only PI3K-gamma inhibitor in clinical development.

Details of the presentations are as follows:

Updated Phase 1/1b Data
Title: Monotherapy dose escalation clinical and translational data from first-in-human study in advanced solid tumors of IPI-549, an oral, selective, PI3K-gamma inhibitor targeting tumor macrophages
Abstract number: O43
Oral session: Clinical Trials – New Agents
Oral session date and time: Friday, November 10, 2017, from 1:45 p.m. –3:30 p.m. ET
Lead author: David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX

Additionally, an identically titled poster will be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET.

Clinical Trials in Progress
Title: Phase 1/1b, first-in-human study of the PI3K-gamma inhibitor IPI-549 as monotherapy and combined with nivolumab in patients with advanced solid tumors
Abstract number: P219
Poster session: Clinical trials in progress
Presentation time: Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET
Lead author: Antoni Ribas, M.D., Ph.D., Parker Institute Center Director at the University of California, Los Angeles (UCLA)

About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin in the second half of 2017.

The combination expansion component includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion will also include a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.