On February 1, 2019, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will participate and present at the following upcoming conferences (Press release, Iovance Biotherapeutics, FEB 1, 2019, View Source;p=RssLanding&cat=news&id=2385716 [SID1234533021]):

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5th Annual Immuno-Oncology 360° conference in New York, February 6-8, 2019
Presenter: Maria Fardis, Ph.D., President and Chief Executive Officer
Session: Next Generation Cell Therapy Plenary
Title: Advancing the Development of Tumor Infiltrating Lymphocytes for Solid Tumors
Location: Crowne Plaza Times Square
Date/Time: February 8 at 11:10 a.m. EST

Guggenheim Healthcare Talks Idea Forum Oncology Day in New York on February 14, 2019
Date/Time: Thursday, February 14, 2019 at 3:00 p.m. EST
Location: The St. Regis New York Hotel
Webcast: A live and archived audio webcast of the presentation will be available in the Investors section at www.iovance.com.

ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco, February 28-March 2, 2019
Presenter: Amod Sarnaik, M.D. – H. Lee Moffitt Cancer Center
Poster Presentation Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients previously treated with at least one prior systemic therapy
Abstract Number: 136
Date/Time: The poster will be presented on Friday, March 1, 2019 from 11:30 a.m.-1:00 p.m. and 5:30 p.m.-6:30 p.m. PST (Poster Session B, Board F1)
Location: San Francisco Marriott Marquis

On February 1, 2019 CTI BioPharma Corp. (NASDAQ: CTIC) reported that the Company will withdraw its European Marketing Authorization Application (MAA) for pacritinib as a treatment for myelofibrosis (Press release, CTI BioPharma, FEB 1, 2019, View Source [SID1234533006]). The decision follows recent interactions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), during which the Company learned that the committee was likely to formally adopt a negative opinion in its evaluation of the application. The CHMP indicated that the risk-benefit profile for pacritinib for the intended indication has not been sufficiently established with the clinical data available to date.

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The Company is continuing to develop pacritinib for both U.S. and European registration as a treatment for myelofibrosis patients with severe thrombocytopenia. CTI plans to seek scientific guidance from the EMA before beginning the planned Phase 3 study, having already discussed the protocol design with the FDA last month. The Phase 3 trial is expected to begin enrollment in the third quarter of 2019.

In addition, the Company announced that on January 23, 2019, a planned third interim review of the PAC203 study was held by the Independent Data Monitoring Committee (IDMC) and the study will continue as scheduled. The IDMC did not identify significant drug- or dose-related safety concerns and specifically did not identify any concerns around hemorrhagic or cardiac toxicity.

About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

On January 31, 2019 Invenra and WARF (Wisconsin Alumni Research Foundation) reported they have entered into a collaboration to discover and develop a bispecific antibody therapeutic for the treatment of neuroblastoma, a cancer that is the third most common childhood cancer, after leukemia and brain tumors (Press release, Invenra, JAN 31, 2019, View Source [SID1234532990]). The collaboration will use Invenra’s proprietary SNIPERTM technology to allow for precise targeting of the cancer cells while sparing normal nerve cells, and potentially alleviating unwanted toxicities and pain related side effects. The idea for the therapeutic candidate came out of a collaboration between Invenra and University of Wisconsin, Madison Professor, Dr. Paul Sondel, a pediatric oncologist who treats these children in his practice.

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"Invenra’s SNIPERTM technology should enable creation of antibody-based therapies that are specifically able to target tumor cells while not binding to normal tissues. We are excited to be working with Invenra to initiate this approach by directing it towards improving treatment for pediatric neuroblastoma," notes Sondel.

Roland Green, Ph.D., Chief Executive Officer and Co-Founder of Invenra states, "We are very excited about this program and the potential it has for helping these children with neuroblastoma. This program also has the potential to treat patients with a variety of other cancers such as glioblastoma (a form of brain cancer), melanoma and small cell lung cancer (SCLC). This collaboration is a good example of the benefits that can come from partnerships between the UW-Madison and industry."

On January 31, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will host a conference call and live webcast on Thursday, February 14, 2019 at 8:00 a.m. ET to report its fourth quarter and full year 2018 financial results and other business highlights (Press release, Agios Pharmaceuticals, JAN 31, 2019, http://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-fourth-quarter-and-full-year-2018 [SID1234533007]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 9886713. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

On January 31, 2019 Phyton Biotech and PellePharm reported an exclusive partnership to develop a plant cell culture-based process to enable the future renewable production of the raw material for PellePharm’s patidegib, an investigational topical therapy for Gorlin Syndrome and High Frequency Basal Cell Carcinoma (BCC) (Press release, Phyton Biotech, JAN 31, 2019, View Source [SID1234532991]). PellePharm is currently investigating the safety and efficacy of patidegib topical gel for the reduction of surgically-eligible BCCs in Gorlin Syndrome patients in a Phase 3 trial.

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The foundation for this joint initiative is Phyton Biotech’s proprietary Plant Cell Fermentation (PCF) technology, a unique platform that enables renewable, reliable and scalable supply of plant-derived compounds like cyclopamine, the key building block in the synthesis of patidegib. Under its agreement with PellePharm, Phyton Biotech will begin development of the new process immediately.

"We are incredibly excited to partner with PellePharm as pioneers in precision medicine to advance this topical skin cancer treatment to the next level of excellence with our patented PCF technology," said Colin Marr, president of Phyton Biotech. "This application of our ‘green chemistry’ process is just the latest example of how Phyton Biotech is advancing traditional manufacturing approaches for high-value phytochemicals and markedly improving patient care."

Currently, cyclopamine is sourced from the perennial herb Veratrum californicum (corn lily), a member of the Liliaceae plant family found in remote mountainous parts of western North America.

"PellePharm’s partnership with Phyton Biotech underscores our commitment to bring a new therapeutic option to patients with Gorlin Syndrome and other skin cancers," said Sanuj Ravindran, president and chief executive officer of PellePharm. "As we begin our pivotal Phase 3 clinical trial of patidegib topical gel and prepare for commercial-scale production of patidegib if approved, we anticipate the demand for cyclopamine will grow, spurring the need for a supplemental and more scalable source."

Gorlin Syndrome, also known as Basal Cell Carcinoma Nevus Syndrome, is a rare, genetic disease that leads to the chronic formation of multiple basal cell carcinomas, often on the face. With no FDA-approved drugs currently available for Gorlin Syndrome, the standard of care is surgery. People with severe Gorlin Syndrome may have as many as 30 or more surgeries per year, which can be repetitive, scarring and disfiguring.

The partnership with PellePharm follows Phyton Biotech’s successful demonstration of its ability to express cyclopamine directly from Veratrum californicum plant cell cultures via PCF. Further development and full scale-up into commercial-size bioreactors of up to 75 m³ in volume, operated in Phyton Biotech’s facility in Germany, is anticipated to follow the current program.

In addition to this project with PellePharm, Phyton Biotech is working on expanding its patent for the renewable production of alkaloids by Liliaceae cell culture to Europe as it is already granted in the United States and other jurisdictions.

Phyton Biotech’s award-winning green chemistry model focuses on plant cell culture development and offers superior quality, reliability, environmental and cost advantages over other methods of production of complex small molecules, plant-based actives and recombinant proteins.