On February 14, 2020 Noxopharm (ASX: NOX) is reported positive interim results from its LuPIN Phase 1/2 clinical trial (Press release, Noxopharm, FEB 14, 2020, View Source [SID1234554365]). The data was presented during a poster presentation at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers (GU) Symposium 2020 in San Francisco by St. Vincent’s Hospital Sydney.

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The LuPIN study is being conducted by St. Vincent’s Hospital Sydney and is evaluating Noxopharm’s lead drug candidate, Veyonda, in combination with 177Lu-PSMA-617, in 56 patients with late-stage metastatic castration-resistant prostate cancer (mCRPC).

"Today’s results are highly encouraging for patients, for Noxopharm shareholders, and for the St. Vincent’s Hospital Sydney team," said Dr. Gisela Mautner, Noxopharm chief medical officer. "The study reported an unprecedented median overall survival of 17.1 months. In a patient group that normally would have a survival expectation of much less than this, such a result is astoundingly good. The combination treatment of Veyonda and 177Lu-PSMA-617 has delivered a clinically meaningful and strong anti-cancer effect in a high proportion of men and, importantly, continues to have an excellent safety profile."

All patients had received and failed two prior lines of therapy (chemotherapy and androgen-signaling inhibitors), and most patients (29 of 32) had failed a third line of therapy (another chemotherapy) prior to entering the trial.

"The study investigators at St. Vincent’s Hospital Sydney continue to do excellent work through the LuPIN trial and we are pleased to support them," Dr. Mautner added.

"Being able to deliver a meaningful anti-cancer response for at least 50% of patients with Stage 4 for any form of cancer would be a remarkable outcome," said Noxopharm CEO Dr. Graham Kelly. "But it is even more remarkable to do so in late-stage prostate cancer, where the disease typically involves a substantial number of secondaries in the skeleton, which are a significant and poorly accessible tumor load. A median overall survival of 17.1 months is remarkable for this novel radiosensitizing and immuno-oncology drug."

On February 14, 2020 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated commercial-stage biopharmaceutical company developing novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for the accelerated approval of TAZVERIK (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy (Press release, Epizyme, FEB 14, 2020, View Source [SID1234554364]). The FDA granted Priority Review and has designated the company’s application as a supplemental NDA (sNDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 18, 2020. Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.

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"Follicular lymphoma is an incurable disease for which patients are in need of a safe, durable treatment option," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "If approved, we believe TAZVERIK could become an important new option for these patients and their physicians. We are thrilled with FDA’s acceptance of our application as an sNDA with Priority Review, for TAZVERIK for patients with relapsed or refractory FL. We look forward to working with the Agency during their review and would like to thank the many patients, caregivers and physicians whose contributions have been invaluable in bringing us to this point."

"On the heels of our first approval for TAZVERIK for epithelioid sarcoma last month and a successful launch into the market, this sNDA filing acceptance brings us one step closer to providing TAZVERIK to a larger patient population," said Robert Bazemore, chief executive officer of Epizyme. "The June 2020 PDUFA date positions TAZVERIK for two FDA approvals within six months of each other, which would be a remarkable achievement for Epizyme. We are actively building off our experience with our ES commercial launch, in order to seamlessly expand to an FL launch where we anticipate rapid market adoption, if approved."

Epizyme’s sNDA submission is based primarily on updated Phase 2 efficacy and safety data for TAZVERIK in this patient population, which were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data demonstrated that treatment with TAZVERIK resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC), and was shown to be generally well tolerated in FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54).

To support a full approval of TAZVERIK for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of TAZVERIK with "R2" (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. The safety run-in portion of the trial is underway, and the company expects to advance into the efficacy portion of the Phase 1b/3 trial in 2020.

About TAZVERIK
TAZVERIK (tazemetostat) is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). For the full prescribing information, please visit www.TAZVERIK.com.

On February 14, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported feedback from a Type C review with the U.S. Food and Drug Administration (FDA) regarding its clinical development program for nelipepimut-S (NPS) in patients with triple negative breast cancer (TNBC) (Press release, Sellas Life Sciences, FEB 14, 2020, View Source [SID1234554363]). Based on written feedback from the FDA and on the totality of clinical, safety and translational NPS data presented to date, the Company has finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment. If successful, this study may be considered as the basis for a Biologics License Application (BLA) submission to the FDA.

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"We are indeed pleased with the feedback and final outcome from our discussions with the Agency, after extended interaction with them, on the optimal and mutually acceptable design of a potential registration-enabling Phase 3 clinical trial for NPS in combination with trastuzumab. Importantly, we believe we have established an appropriate and expedient pathway to potentially bring NPS in combination with trastuzumab to patients in need as quickly as possible," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We believe this regulatory clarity will enhance our business development efforts to seek out-licensing opportunities to fund and conduct the future clinical development of NPS in order to maximize the potential of the program as we continue to focus all of our resources on the development of our lead asset, galinpepimut-S, which recently entered a registrational Phase 3 study in acute myeloid leukemia."

The planned Phase 3 study will be a 1:1 randomized, blinded two-arm study to evaluate the efficacy and safety of the NPS vaccine (NPS plus granulocyte macrophage-colony stimulating factor (GM-CSF)) in combination with trastuzumab vs. GM-CSF alone as maintenance treatment in the adjuvant setting following standard-of-care therapy in patients with TNBC, defined as hormone receptor-negative, HER2 1+/2+ tumors (as assessed by immunohistochemistry tumors), at high risk of recurrence. The FDA indicated in its feedback that there is adequate safety information to support the use of NPS in combination with trastuzumab.

SELLAS previously reported the final efficacy and safety results from a Phase 2b study of NPS in combination with trastuzumab in TNBC patients (n=97). The disease-free survival (DFS) rate at 24 months was 92.6% for the combination arm vs. 70.2% for the trastuzumab alone arm, a clinically meaningful and statistically significant improvement in favor of the combination therapy (p=0.01). This was associated with a statistically significant reduction of 71.9% (p=0.01) in the frequency of clinically detected recurrences also in favor of the combination arm. Immune response analysis showed that non-recurrent TNBC patients mounted both vigorous NPS-specific clonal CD8+ cytotoxic T-lymphocyte expansion and enhanced in vivo post-antigen challenge cutaneous delayed type hypersensitivity. Most treatment-emergent adverse events were mild or moderate and consisted of manageable local injection site reactions, skin induration, pruritus, and fatigue.

"TNBC is an aggressive type of breast cancer with limited treatment options and poor prognosis, as it is associated with high levels of refractoriness and relapse not only in the metastatic setting, which is true for all types of breast cancer, but also at an early stage. Indeed, following standard frontline chemotherapy, TNBC can relapse as early as within 1−3 years, often with a pattern including visceral metastases. Therefore, optimizing relapse-mitigating approaches in women with TNBC following initial standard therapy (surgery + radiotherapy + chemotherapy) with further safe and effective adjuvant therapy is paramount," said Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of this planned Phase 3 study. "A Phase 3 study investigating the potential clinical benefit accorded by NPS with trastuzumab, an easily-administered maintenance therapy with a generally manageable toxicity profile, has the potential, assuming positive results, to be practice-changing in the treatment of TNBC, by introducing the first peptide vaccine-based immunotherapy in the therapeutic choices for women with this aggressive malignancy."

On February 14, 2020 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that Dr. Heman Chao, Helix’s Chief Executive Officer, will be presenting at NobleCon – Noble Capital Markets’ Sixteenth Annual Investor Conference at the Hard Rock Hotel & Casino, Hollywood, Florida – on Monday, February 17th at 3:00PM Eastern Standard Time (View Source) (Press release, Helix BioPharma, FEB 14, 2020, View Source [SID1234554361]).

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In addition to the company’s presentation on Monday, February 17th Dr. Chao has been invited to be a panelist on "Cancer Treatment: Tackling the Disease Through Innovative Strategies". The panel discussion is being held on February 17th between 5:30pm and 6:30pm in Terrace Ballroom D. The panel will discuss current revolutionary new strategies to defeat cancer, including innate immunity, modulation of tumor micro-environment, treatment of solid tumors with CAR-T, cancer vaccines and cell cycle inhibitors.

Furthermore, Helix has been selected to present to Noble Capital Markets Life Sciences Scientific and Advisory Board ("LSAB"), in an invitation only event. Noble Capital Markets’ LSAB is composed of world-class healthcare professionals with extensive experience in the medical and pharmaceutical industries.

"We are very pleased to be presenting at this conference in addition to having been invited to partake in a panel discussion and to present Helix’s technology to Noble Capital Markets Life Sciences Scientific and Advisory Board", said Dr. Chao. "We look forward to introducing Helix to a wider investment community".

A high-definition video of Helix’s presentation will be available the following day on the Company’s website at www.helixbiopharma.com and will also be available on Noble Capital Markets’ conference website at www.nobleconference.com as part of the conference’s complete catalogue of presentations and on Noble Capital Markets’ investor portal website, Channelchek, at www.channelchek.com.

About NobleCon

Noble Capital Markets’ 16th Annual Emerging Growth Investor Conference – a multi-sector blend of emerging growth companies with total representation limited to 125 public companies. Four presentation tracks run simultaneously each half hour over two days. One-on-one meetings between qualified investors and corporate executives are arranged and scheduled on behalf of participants. Topical panel presentations open to all attendees. Comprehensive evening networking events. Registration for investors is open to institutions, registered investment advisors, family offices, self-directed high-net-worth individuals and independent brokers.

About Helix BioPharma Corp.

Helix BioPharma Corp. is an immuno-oncology company specializing in the field of cancer therapy. The company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies. Helix’s product development initiatives include its novel L-DOS47 new drug candidate and Chimeric Antigen Receptor ("CAR") based cell therapies. Helix is currently listed on the TSX under the symbol "HBP".

About DOS47

DOS47 is based upon a naturally occurring enzyme isolated from the jack-bean plant called urease that breaks down a natural substance found in the body, urea, into metabolites that include ammonia and hydroxyl ions. By doing so at the site of cancerous tissues in the body, the Company believes DOS47 can modify the micro environmental conditions of cancerous cells in a manner that leads to apoptosis. DOS47 stimulates an increase in the pH of the microenvironment surrounding the cancerous cells, effectively reversing the acidic extra-cellular conditions that are believed to act to defend tumour cells.

About L-DOS47

L-DOS47 is Helix’s first immunoconjugate based drug candidate in development based on the Company’s novel DOS47 platform technology, which is designed to use an innovative approach to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.

On February 14, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported the appointment of Loretta Itri, M.D. as chief medical officer (CMO)(Press release, Immunomedics, FEB 14, 2020, View Source [SID1234554360]). In her new role, Dr. Itri will lead all research and clinical development, regulatory, and medical affairs activities of the Company. Dr. Itri is a well-established pharmaceutical executive with decades of experience and a strong track record of bringing innovative drugs to market for multiple biopharma organizations.

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"I am thrilled Loretta has agreed to join us as our permanent CMO," remarked Dr. Behzad Aghazadeh, executive chairman. "Loretta has been working with us in overseeing our clinical and regulatory activities since the Spring of 2019. She has been an invaluable member of our leadership team, with important contributions to the refiling of our Biologics License Application for sacituzumab govitecan and accelerating our clinical development programs into new indications. I look forward to working closely with Loretta to invest in and expand our novel and differentiated antibody-drug conjugate (ADC) platform assets for the benefit of cancer patients worldwide."

Dr. Itri commented, "It is my distinct pleasure to formally join Immunomedics as CMO. I have had the great opportunity of managing the Company’s sacituzumab govitecan development activities across multiple indications over the past year. The excitement from key opinion leaders and patients about the drug’s potential clinical benefit has been palpable. Working closely with the FDA, we are hopeful that sacituzumab govitecan will soon be available to patients with triple-negative breast cancer. I am especially looking forward to working closely with the executive management team to expand our clinical development plans across our unique ADC platform to advance therapeutic options across hard-to-treat cancers, including indications such as metastatic urothelial cancer and hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer."

Dr. Loretta Itri was most recently the executive vice president of Global Health Sciences & Regulatory Affairs at The Medicines Company where she oversaw the development and regulatory approval of a variety of products, including the early development of inclisiran, and other cardiovascular drugs and antibiotics. Previously, she was president of Pharmaceutical Development and CMO at Genta, Inc., playing a vital role in the development of diverse therapeutic agents that helped treat conditions such as breast cancer and chronic lymphocytic leukemia.

Prior to that, Dr. Itri served as senior vice president of Medical and Regulatory Affairs at Johnson & Johnson’s Pharmaceutical Research Institute, where she oversaw the development and approval of a number of therapeutic products, including Procrit, Cladribine, and Tramadol. In addition, she served as senior vice president of Clinical Affairs and CMO for Ortho Biotech Inc., responsible for the hematology, oncology and immunology product lines. Dr. Itri began her career at Hoffmann-La Roche, where she advanced to the position of assistant vice president of Clinical Development in immunology, virology, hematology, and oncology.

Dr. Itri received her M.D. from New York Medical College, completed her medical residency at SUNY-Stony Brook and her fellowship in medical oncology at Memorial Sloan-Kettering Cancer Center where she was an adjunct attending physician for more than 15 years. Dr. Itri has served as a member of the National Cancer Institute Board of Scientific Counselors in both the Division of Cancer Treatment and the Division of Cancer Prevention and Control. She is the author or co-author of numerous articles in peer-reviewed journals, book chapters and abstracts related to the clinical development of therapeutic agents.