On May 10, 2018 Polaris Group reported that it has signed a multiyear strategic Collaboration Agreement with MD Anderson Cancer Center to utilize its Immunotherapy Platform, led by world-renowned immunotherapy pioneer Dr. James Allison, Dr. Padmanee Sharma, and Dr. Patrick Hwu, to design clinical studies and monitor biomarkers in immune functions associated with the therapies (Press release, Polaris Pharmaceuticals, MAY 10, 2018, View Source [SID1234526491]).

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As one of the ten research platforms that support the Cancer Moon Shots ProgramTM, MD Anderson’s Immunotherapy Platform conducts preclinical research to assess feasibility and efficacy of new treatments; it also monitors immune function changes as a result of clinical therapies through cellular and molecular analysis of patient samples in hope of discovering biomarkers for personalized medicine.

"We are very excited to join MD Anderson’s Immunotherapy Platform and be part of its cutting-edge pre-clinical and clinical research programs in the immunotherapy area," said Dr. Bor-Wen Wu, CEO of Polaris Group. "We believe the unique mechanism of action of ADI‑PEG 20 may complement that of the existing immunotherapy drugs, hence potentially achieve higher overall efficacy as combination therapy. We look forward to having a fruitful collaboration on our journey to develop more effective treatments, and the exploration of other immunotherapy targets."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20

On May 10, 2018 Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology to improve protein therapies for unmet patient needs, reported financial results for the first quarter ended March 31, 2018 and provided a business update (Press release, Pfenex, MAY 10, 2018, View Source [SID1234526490]).

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"We are on track to report topline results from our PF708-301 Phase 3 trial in the second quarter. This study compares PF708, a therapeutic equivalent to Forteo, to Forteo after 24 weeks of daily treatment in osteoporosis patients. If the data from the trial are in line with our expectations, this will be a significant milestone for our lead program. Assuming sufficiently positive results from our PF708-301 Phase 3 trial, we plan to submit the NDA for PF708-301 to the FDA in the third quarter," stated Eef Schimmelpennink, chief executive officer of Pfenex. "I am a strong believer in the value of leveraging key competencies different parties may have, and to that extent we continue to evaluate commercial partnership opportunities for PF708, in parallel to planning and preparing to potentially bring the product to the market ourselves. Importantly, we will always focus on the pathway that creates the most value for our stockholders. To that end, we recently entered into a development and license agreement with NT Pharma for our PF708 product, through which they will oversee the regulatory and commercialization activities for the product in Mainland China, Hong Kong, Singapore, Malaysia and Thailand. NT Pharma’s demonstrated experience in the orthopedic space makes them a valuable partner in this territory."

"Beyond advancing our current pipeline, our development partnerships with Jazz, NT Pharma, BARDA and CRM197, our long-term strategy is to fill out our pre-clinical and clinical pipelines with new programs created through our Pfēnex Expression Technology Platform. We look forward to leveraging the platform’s high rate of success in developing complex therapeutic proteins, our experienced clinical research team and our network of development and commercialization partners. This strategy strengthens the business through a more diversified pipeline to build stockholder value," concluded Schimmelpennink.

Business Review and Update

PF708 therapeutic equivalent to Forteo (teriparatide)

In April, Pfenex entered an agreement under which Pfenex granted NT Pharma non-exclusive development and exclusive commercialization rights to PF708 in Mainland China, Hong Kong, Singapore, Malaysia and Thailand. In accordance with the agreement, Pfenex may be eligible to receive up to $25 million in payments based on the achievement of certain development, regulatory and sales-related milestones. In addition, Pfenex is eligible to receive double-digit royalties on any future net product sales. NT Pharma will be responsible for any further development required to achieve regulatory approval as well as commercialization activities in the applicable territories.

In February 2018, Pfenex completed the last patient visit for its on-going PF708-301 trial. The trial compares PF708 and Forteo after 24 weeks of daily treatment in osteoporosis patients. Pfenex expects top-line immunogenicity data results in the second quarter of 2018. Pfenex believes that results from its PF708-301 trial, if sufficiently positive, along with the previously-announced bioequivalence findings from its Study PF708-101 in healthy subjects will support submitting a New Drug Application (NDA) for PF708 in the United States. Assuming sufficiently positive results from its PF708-301 trial, Pfenex expects to submit an NDA to the U.S. Food and Drug Administration (FDA) in the third quarter of 2018, with a potential commercial launch possible in the United States as early as the third quarter of 2019, subject to receipt of FDA marketing authorization.

Jazz Collaboration Agreement

Pfenex and Jazz Pharmaceuticals are collaboratively developing certain hematology/oncology products, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology. Jazz will have the exclusive right to manufacture and commercialize such products throughout the world. Under the agreement with Jazz, Pfenex will be eligible to receive up to $224.5 million in total value of payments and potential payments associated with the collaboration. To date, Pfenex has received $35.2 million through this agreement. Pfenex may also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration.

Px563L and RPA563

The development of Pfenex’s novel anthrax vaccine candidates is funded through an advanced development contract with the Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA) valued at up to approximately $143.5 million. Potential next milestones in 2018 are triggering of analytical and non-clinical animal study options leading to a potential Phase 2 study in 2019, subject in each case to continued funding by BARDA.

CRM197

Pfenex provided an update on a legacy program, CRM197, for which Pfenex has several development and commercial partnerships in place. CRM197 is a non-toxic mutant of diphtheria toxin. It is a well characterized protein and functions as a carrier for polysaccharides and haptens making them immunogenic. In the early days of its existence, Pfenex developed a unique CRM197 based on its Pfēnex Expression Technology platform and sells non-GMP and cGMP CRM197 to mostly vaccine development focused pharmaceutical partners. As a result of those efforts, Pfenex previously entered into commercial licenses for production strains capable of producing CRM197 with both Merck and Serum Institute of India. Pfenex’s CRM197 is currently being used or planned to be used in multiple late-stage clinical trials for such diseases as pneumococcal and meningitis bacterial infections.

Financial Highlights for the First Quarter 2018

Total Revenue increased to $3.7 million in the three-month period ended March 31, 2018, compared to $2.8 million in the same period in 2017. The increase in revenue was due to additional activity related to development of Pfenex’s Px563L product candidate under its government contract, as two options were exercised by the government in 2017. Minimal activity related to planning and start-up activities for the new options occurred in early 2017, progressing to increased development activities later in the year and into 2018. Reagent protein product sales also increased. In addition, as a result of an amended license agreement with Jazz signed in December 2017, license revenue increased in the first quarter of 2018.

Cost of revenue increased to $1.5 million in the three-month period ended March 31, 2018, compared to $0.8 million in the same period in 2017. The increase was primarily due to greater costs for Pfenex’s Px563L product candidate under its government contract, resulting from increased activity under this contract during the first quarter of 2018, as well as additional sales of reagent protein product.

Research and development expenses increased to $8.8 million in the three-month period ended March 31, 2018, compared to $6.4 million in same period in 2017. This was primarily due to increased activity for PF708 to satisfy the clinical filing requirements for an NDA, which Pfenex expects to submit to the FDA in the third quarter of 2018, assuming sufficiently positive results from its Study PF708-301. These costs were offset by a decrease in expenses due to Pfenex’s decision to pause its development activities on certain product candidates in 2017.

Selling, general and administrative expenses decreased to $4.5 million in the three-month period ended March 31, 2018, compared to $5.7 million in the same period in 2017. The decrease was primarily due to costs incurred in the first quarter of 2017 for the change in senior management.

Cash and cash equivalents as of March 31, 2018 was $47.1 million. Pfenex believes it has sufficient cash to meet its anticipated cash needs for at least the next 12 months. Assuming sufficiently positive results from its PF708-301 study, Pfenex also believes it has sufficient cash resources to fund all necessary activities leading up to and including the expected submission of an NDA for PF708 to the FDA

On May 10, 2018 Omeros Corporation (NASDAQ: OMER) reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2018, which include (Press release, Omeros, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348558 [SID1234526489]):

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1Q 2018 total and OMIDRIA revenues were $1.6 million, compared to $12.3 million in 1Q 2017; the decrease is the result of the scheduled expiration of OMIDRIA pass-through reimbursement status on January 1, 2018.
The Consolidated Appropriations Act, signed into law in March 2018, includes a provision granting a two-year pass-through extension, beginning on October 1, 2018, for a small number of drugs including OMIDRIA.
Net loss in 1Q 2018 was $30.1 million, or $0.62 per share. Non-cash expenses for 1Q 2018 were $4.3 million, or $0.09 per share. Overall decrease in cash, cash equivalents and short-term investments for the quarter was $10.9 million.
At March 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $72.8 million. An additional $45.0 million available under the company’s existing credit facility is expected to fund on May 18, 2018.
Patient enrollment began in the OMS721 Phase 3 clinical trial (known as ARTEMIS-IGAN) in patients with Immunoglobulin A (IgA) nephropathy.
OMS721 was granted breakthrough therapy designation for treatment of patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who have persistent TMA despite modification of immunosuppressive therapy.
Following recent interactions with FDA, Omeros believes that it has a clear path to approval for OMS721 in high-risk HSCT-TMA, intends to continue working closely with FDA to achieve this objective and has begun preparations to submit a Biologics License Application (BLA).
OMIDRIA was added to the Veterans Health Administration National Formulary in April 2018.
"During the first quarter of 2018, we made tremendous progress in our MASP-2 program," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We believe that we now have clear paths to accelerated approval for OMS721 in both stem-cell TMA and IgA nephropathy. With breakthrough therapy designations in both of these indications, we look forward to continuing to work closely with FDA and, for stem-cell TMA, we have initiated preparations for a BLA submission. Our PDE7 inhibitor OMS527 is poised to enter the clinic in mid-year and, in late 2019 through 2020, we expect to begin clinical trials for our MASP-3 antibody OMS906 and for our small-molecule MASP-2 inhibitors. A number of our GPCR programs are also moving toward the clinic, providing the potential for wholly new mechanisms for the treatment of a broad range of diseases and disorders, including cancers. With the Omeros team and the reinstatement of CMS separate payment for OMIDRIA, we believe that we will have the resources to deliver on the immense promise of these programs to benefit patients, many of whom have conditions for which there are no treatments."

First Quarter and Recent Developments

Developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) programs for the treatment of HSCT-TMA, IgA nephropathy, and atypical hemolytic uremic syndrome (aHUS), include:
Omeros announced in April 2018 that the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk HSCT-TMA, specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy designation for OMS721, which last year received the designation from FDA for the treatment of IgA nephropathy.
Omeros recently met with FDA to discuss requirements for approval of OMS721 in high-risk HSCT-TMA. Based on that meeting, Omeros believes that it has clear paths to both accelerated and full approval of OMS721 in this indication. In addition to the data provided to FDA, the Agency requested that the company further characterize the patients treated with OMS721 – all of whom had high-risk TMA – and compile and submit additional information on the historical control population for the purpose of further comparing outcomes across corresponding patients. FDA also requested an analysis plan to assess the company’s biomarker data. Should FDA grant OMS721 accelerated approval for the treatment of high-risk stem cell-TMA patients, the drug would be made commercially available for stem-cell patients with this highly lethal disorder. Concurrently, Omeros would conduct a confirmatory trial for subsequent full approval. Omeros intends to continue working closely with FDA as the company further compiles all required information with the objective of initiating a rolling BLA submission later this year. In Europe, the company is scheduling meetings with regulatory authorities to discuss plans for submission of an application for conditional marketing authorization for OMS721 in HSCT-TMA.
In February and April 2018, Omeros reported new results in patients with HSCT-TMA from the ongoing Phase 2 study. The estimated median survival for OMS721-treated patients was an order of magnitude greater than that for a matched historical control (p<0.0001). After study patients had reached an adequate duration of follow-up, further data analysis examined 100-day mortality, an important measure previously used as an approval endpoint in HSCT. That analysis also showed that OMS721-treated patients had improved survival relative to the historical control (53 percent vs 10 percent; p = 0.0002). Biomarkers of disease (i.e., mean platelet count and mean levels of lactate dehydrogenase and haptoglobin), demonstrated statistically significant improvement. Study patients also showed substantial improvement in red blood cell and platelet transfusion requirements.
In February 2018, the EMA granted OMS721 orphan drug designation in the treatment of IgA nephropathy. Enrollment in the Phase 3 clinical trial ARTEMIS-IGAN is ongoing.
Recent developments regarding OMIDRIA include:
In March 2018, the Consolidated Appropriations Act, 2018 (Consolidated Appropriations Act) was signed into law and included a two-year extension of pass-through reimbursement status for OMIDRIA and a small number of other drugs used during procedures performed on Medicare Part B fee-for-service patients. As a result, OMIDRIA will receive a reinstatement of separate payment beginning October 1, 2018 through September 30, 2020.
OMIDRIA was added to the Veterans Health Administration (VA) National Formulary in April 2018. With its addition to the formulary, the drug is now available in all VA facilities that perform ophthalmic procedures. The initial recommendation is that OMIDRIA be limited to use in high-risk patients as determined by each VA ophthalmic surgeon at his or her discretion.
In April 2018, Omeros announced that the results of four "real-world" clinical studies were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting held in Washington, D.C. The studies demonstrate significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.
In April 2018, the company’s credit facility with CRG was amended to eliminate the revenue and market capitalization covenants with respect to the twelve-month period ending on December 31, 2018 and to reduce the market capitalization threshold for future periods to three times the aggregate principal amount of loans outstanding (excluding any payment-in-kind loans) on the applicable determination date. Omeros issued five-year warrants to the lenders for up to 200,000 shares of the company’s common stock at an exercise price per share of $23.00, which represents approximately a 70-percent premium to the closing price of Omeros’ common stock at that time. In addition, the company has requested the $45.0 million currently available under the CRG credit facility and expects funding to occur on May 18, 2018.
Financial Results

For the quarter ended March 31, 2018, revenues were $1.6 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $12.3 million for the same period in 2017. On a sequential quarter-over-quarter basis, OMIDRIA revenues decreased $12.2 million, which is attributable to reduced ASC and hospital purchasing following the scheduled loss of pass-through reimbursement status as of January 1, 2018. As part of the Consolidated Appropriations Act, pass-through status for OMIDRIA was reinstated for a two-year period, effective October 1, 2018 through September 30, 2020.

Total costs and expenses for the three months ended March 31, 2018 were $29.3 million compared to $25.0 million for the same period in 2017. The increase in the current year quarter was primarily due to higher manufacturing scale-up costs for the OMS721 programs as Omeros continues to increase production capacity to meet anticipated clinical and commercial requirements as well as to incremental costs associated with initiating the OMS721 IgA nephropathy Phase 3 clinical trial.

For the three months ended March 31, 2018, Omeros reported a net loss of $30.1 million, or $0.62 per share, which included non-cash expenses of $4.3 million ($0.09 per share). In comparison, for the prior year’s first quarter Omeros reported a net loss of $15.1 million, or $0.34 per share including non-cash expenses of $4.4 million ($0.10 per share).

As of March 31, 2018, the company had $72.8 million of cash, cash equivalents and short-term investments available for operations and another $5.8 million in restricted investments. In addition, the company has requested $45.0 million currently available under the company’s existing credit facility and expects funding to occur on May 18, 2018.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 8579459. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 8579459.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On May 10, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the first quarter ended March 31, 2018 (Press release, Nektar Therapeutics, MAY 10, 2018, View Source [SID1234526487]).

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Cash and investments in marketable securities at March 31, 2018 were $333.8 million as compared to $353.2 million at December 31, 2017. This does not include the $1.0 billion upfront payment and $850.0 million share purchase proceeds received on April 3, 2018, as a result of our new Bristol-Myers Squibb collaboration.

"Nektar begins 2018 in a very strong position with a major collaboration with Bristol-Myers Squibb for NKTR-214 and key advancements in our immuno-oncology and immunology pipeline," said Howard W. Robin, President and CEO of Nektar. "The PIVOT study of NKTR-214 in combination with nivolumab continues to enroll patients and we are exceptionally pleased that the preliminary data from PIVOT was accepted for an oral presentation at this year’s ASCO (Free ASCO Whitepaper) Meeting. We initiated two new clinical studies this quarter, the first with our novel I-O combination of NKTR-262 and NKTR-214 and the second with our autoimmune disease candidate, NKTR-358. Based on positive preclinical results, we entered into a clinical collaboration with Takeda to evaluate NKTR-214 with their TAK-659, a SYK/FLT inhibitor. Finally, in the area of pain, we plan to submit our NDA filing for NKTR-181 this month."

Revenue in the first quarter of 2018 was $38.0 million as compared to $24.7 million in the first quarter of 2017. Revenue in the first quarter of 2018 was higher primarily because of the recognition of $10.0 million received from Shire for the approval of Adynovi in Europe.

Total operating costs and expenses in the first quarter of 2018 were $124.8 million as compared to $79.2 million in the first quarter of 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the first quarter of 2018 was $99.4 million as compared to $61.1 million for the first quarter of 2017. R&D expense was higher in the first quarter 2018 as compared to the same period in 2017 primarily because of expenses for our pipeline programs, including the completion of Phase 3 clinical studies for NKTR-181, Phase 1/2 clinical studies of NKTR-214 and NKTR-358, initiation of the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative expense was $18.7 million in the first quarter of 2018 as compared to $12.0 million in the first quarter of 2017 and increased primarily due to increased stock based compensation.

In the first quarter of 2018, net loss was $95.8 million, or $0.60 loss per share as compared to net loss of $63.9 million, or $0.42 loss per share in the first quarter of 2017.

2018 Business Highlights

In May, Nektar began dosing patients with systemic lupus erythematosus in a Phase 1b multiple ascending dose study of NKTR-358, a first-in-class regulatory T cell stimulator, designed to correct the underlying immune system dysfunction found in patients with immune disorders.

In April, Nektar announced a new clinical collaboration agreement with Takeda to evaluate NKTR-214 in combination with TAK-659, a dual SYK and FLT-3 inhibitor in liquid and solid tumors with the first of these studies expected to begin in the second half of 2018 in patients with Non-Hodgkin Lymphoma.

In April, Nektar presented positive preclinical data for its immuno-oncology programs at the 2018 AACR (Free AACR Whitepaper) Annual Meeting. Preclinical data presented by Nektar researchers and collaborators demonstrate how NKTR-214 synergizes with multiple modalities including TLRs, HDAC and ACT, highlighting the potential of NKTR-214 as a backbone therapy in immuno-oncology.

In April, Nektar began dosing patients in the REVEAL Phase 1/2 study, which will evaluate the safety and efficacy of NKTR-262, a novel toll-like receptor agonist, in combination with NKTR-214. This novel-novel combination is designed to engage both the innate and adaptive immune response to fight cancer and may ultimately provide another option for patients with many types of advanced or metastatic solid tumor cancers.

In February, Nektar and Bristol-Myers Squibb entered into a global development and commercialization agreement to evaluate the full potential of NKTR-214 plus Opdivo (nivolumab) in more than 20 indications in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder and triple negative breast cancer.

The company also announced upcoming presentations at the following scientific congresses during the second quarter of 2018:

Treg Directed Therapy for Autoimmune Disorders Meeting, Boston, MA:

Preclinical Data Presentation: "NKTR-358: An IL-2 Pathway Agonist that Selectively Expands and Activates Regulatory T cells for the Treatment of Allergy and Autoimmune Disease"
Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
Session: Enhanced Treg-based therapy with the use of IL-2
Date: Wednesday, May 23, 2018, 3:40 p.m. Eastern Daylight Time
3rd Annual Advances in Immuno-Oncology Congress, London, U.K.:

Presentation: "Accessing The Potential Of An Immunotherapeutic Agent"
Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
Session: Translational Immuno-Oncology
Date: Thursday, May 24, 2018, 5:40 p.m. British Summer Time
American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting, Chicago, IL:

Oral Presentation: "NKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT".
Abstract #3006
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: Developmental Therapeutics – Immunotherapy
Date: Saturday, June 2, 2018, 3:00 p.m. – 6:00 p.m. Central Daylight Time

Abstract #2567: "TAK-659 in Combination with NKTR-214 and anti-PD-1 Therapy Leads to Complete and Sustained Tumor Regression and Immune Memory In Pre-Clinical Syngeneic Models", Huck, J., et al.
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Date: Monday, June 4, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

Abstract #3085: "Efficacy and immune modulation by BXCL701 a dipeptidyl peptidase inhibitor, NKTR-214 a CD122-biased immune agonist with PD1 blockade in murine pancreatic tumors", Rastelli, L., et al.
Session: Developmental Therapeutics – Immunotherapy
Date: Monday, June 4, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

Abstract #5582: "Efficacy and immune modulation of the tumor microenvironment in murine ovarian tumor with the PARP inhibitor rucaparib and CD122-biased immune agonist NKTR-214", Simmons, A., et al.
Session: Gynecologic Cancer
Date: Monday, June 4, 2018, 1:15 p.m. – 4:45 p.m. Central Daylight Time

Abstract #TPS3115: "PROPEL: A phase 1/2 trial of NKTR-214 (CD122-biased agonist) combined with anti-PD-1 (pembrolizumab) or anti-PD-L1 (atezolizumab) in patients (pts) with advanced solid tumors", Vaena, D., et al.
Session: Developmental Therapeutics – Immunotherapy
Date: Monday, June 4, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

Abstract #TPS1111: "ATTAIN: Phase 3 study of etirinotecan pegol (EP) vs. treatment of physician’s choice (TPC) in patients (pts) with metastatic breast cancer (MBC) who have stable brain metastases (BM) previously treated with an anthracycline, a taxane, and capecitabine (ATC)", Tripathy, D., et al.
Session: Breast Cancer – Metastatic
Date: Saturday, June 2, 2018, 8:00 a.m. – 11:30 a.m. Central Daylight Time

College on Problems of Drug Dependence 80th Annual Scientific Meeting (2018), San Diego, CA:

Oral Presentation: "Assessment of Drug Abuse-Related Events with MADDERS in SUMMIT-07: A Phase-3 Study of NKTR-181 in Patients with Moderate to Severe Chronic Low-Back Pain"
Abstract #76
Presenter: Ryan Lanier, Ph.D., Analgesic Solutions
Session: The Pain and the Strain Comes Mainly from the Brain
Date: Wednesday, June 13, 2018, 1:30 p.m. – 1:45 p.m. Pacific Daylight Time

Oral Presentation: "Neuropharmacodynamic Profile of NKTR-181: Correlation to Low Abuse Potential"
Abstract #335
Presenter: Laurie Vanderveen, Ph.D., Nektar Therapeutics
Session: Basically Opioids
Date: Tuesday, June 12, 2018, 10:15 a.m. – 10:30 a.m. Pacific Daylight Time

Abstract #168: "NKTR-181 demonstrates low abuse potential in recreational opioid users in two double-blind, randomized crossover human abuse potential studies", Henningfield, J., et al.
Session: Abuse Liability
Date: Thursday, June 14, 2018, 12:00 p.m. – 2:00 p.m. Pacific Daylight Time
Conference Call to Discuss First Quarter 2018 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, May 10, 2018.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, June 11, 2018.

To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 2379326 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On May 10, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its first quarter 2018 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348539 [SID1234526486]).

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"Our January 2018 financing puts us in a strong position to advance and expand our robust TIL product pipeline. We continue enrollment in our ongoing trials and have expanded our melanoma study to enroll an additional 25 patients. We are initiating investigation of TIL therapy in new indications as part of our collaboration with MD Anderson, and one of those studies investigating our LN-145 TIL product in patients with sarcomas and ovarian cancers, is now active," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We also recently received orphan-drug designation from the FDA for autologous tumor infiltrating lymphocytes for the treatment of patients with cervical cancer with a tumor size of greater than 2 cm in diameter."

Recent Achievements and Upcoming Milestones

Manufacturing

TIL therapy manufacturing in Europe is now fully operational at PharmaCell B.V., a subsidiary of Lonza Group Ltd., in the Netherlands.
Clinical

As part of a collaboration program, Iovance and MD Anderson Cancer Center (MDACC) initiated a new Phase 2 clinical study, 2017-0672 (NCT03449108). The clinical trial site is currently active and screening patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer. The study will treat patients with LN-145 manufactured by Iovance using the company’s Gen 2 manufacturing process.
Enrollment in the melanoma study, C-144-01, was expanded from 60 patients to up to 85 patients, 60 of which will be in Cohort 2 utilizing the company’s Gen 2 manufacturing process. The sample size in the study was expanded as Iovance may use the study in support of a potential registration of LN-144.
As of May 2018, Iovance has expanded to over 50 clinical sites for its four company-sponsored studies. Of the 50 total sites, four sites are now active for the Iovance IOV-LUN-201 study to treat checkpoint naïve patients with NSCLC.
Regulatory

As of May 2018, Iovance had received approvals to commence clinical trials in six countries in Europe including Switzerland, the Netherlands, France, Hungary, Spain and the United Kingdom.
In early May 2018, the company was granted orphan-drug designation from the U.S. Food and Drug Administration (FDA) for autologous tumor infiltrating lymphocytes for the treatment of cervical cancer with a tumor size of greater than 2 cm in diameter.
Research

A late-breaking abstract, titled Anti-OX40 agonistic antibody enhances ex vivo CD8+ TIL expansion with increased T-cell effector function, was presented on Monday, April 16, 2018 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL.
In conjunction with one of the Phase 2 clinical trials being conducted as part of Iovance’s alliance with MDACC, Iovance has access to the supply of the 4-1BB agonist antibody, urelumab, for use in the manufacturing of TIL.
Iovance has obtained non-exclusive rights to uses of 4-1BB agonists, including uses of urelumab, in the manufacturing of TIL for adoptive cell therapy through an intellectual property license agreement with Moffitt Cancer Center.
The company entered into a material transfer agreement with RXi Pharmaceuticals Corporation to evaluate potential uses of sd-rxRNA compounds in the development of TIL therapies which could be applied to various cancer types.
Corporate

In January 2018, the company closed an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $11.50 per share, before underwriting discounts. The shares sold at closing included 1,956,521 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the company, were $172.5 million with net proceeds to the company of $162.0 million.
In March 2018, the company announced the appointment of Michael Weiser, M.D., Ph.D., to Iovance’s Board of Directors. Dr. Weiser is the chair of Iovance’s Compensation Committee and serves on Iovance’s Nominating & Corporate Governance and Audit Committees.
First Quarter 2018 Financial Results

Net loss for the quarter ended March 31, 2018 was $26.5 million, or ($0.31) per share, compared to net loss of $20.7 million, or ($0.33) per share for the same period ended March 31, 2017.

Research and development expenses were $19.9 million for the quarter ended March 31, 2018, an increase of $4.3 million compared to $15.6 million for the same period ended March 31, 2017. The increase in research and development expenses was primarily attributable to a $2.2 million increase in payroll related expenses and consulting fees due to higher head count and dedicated consultants as the Company expanded its research efforts and clinical development programs, and a $2.0 million increase attributable to higher clinical trial costs due to an increase in patient enrollment and an increase in the number of clinical sites for the clinical trial of the Company’s lead product candidate, LN-144, for the treatment of metastatic melanoma, and the initiation of clinical trials of LN-145 for the treatment of cervical, head and neck cancers in 2017. These increases were partially offset by a $1.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $7.0 million for the quarter ended March 31, 2018, an increase of $1.7 million compared to $5.3 million for the same period ended March 31, 2017. The increase was primarily attributable to a $0.9 million increase in payroll related expenses due to an increase in head count, and a $0.6 million increase in professional service and legal expenses primarily to support the expansion of the Company’s intellectual property portfolio.

At March 31, 2018, the company held $297.1 million in cash and cash equivalents, compared to $145.4 million at December 31, 2017. The company anticipates that the year-end balance of cash, cash equivalents and short-term investments may be between $190 to $210 million.

Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss these first quarter 2018 results and provide a corporate update. The conference call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 2995797. The live webcast can be accessed under "News & Events" in the "Investors" section of the company’s website at View Source or you may use the link: View Source

A replay of the call will be available from May 10, 2018 at 7:30 p.m. ET to May 17, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID number for the replay is 2995797. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source