On February 11, 2020 Biodesix, Inc. reported initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc., New York, NY (Press release, Biodesix, FEB 11, 2020, View Source [SID1234554175]). The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO) (avelumab). Development efforts will now focus on transferring the test into Biodesix’s CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex artificial intelligence (AI) platform. Data from the initial test discovery and development program will be presented at an upcoming scientific meeting in 2020.

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The Diagnostic Cortex platform is based on modern AI techniques to design clinically useful tests that are reproducible and robust, and typically use hundreds of different markers. Based on data found in the circulating proteome and genome, Biodesix designs tests that support treatment decisions including patient selection for immunotherapies, novel therapy combinations, and alternative treatment pathways.

"We are pleased to announce this next phase in our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer with the potential to extend treatment options to more patients. This relationship combines Biodesix’s strengths in test discovery and development, artificial intelligence, and their applications to immunotherapy, with the pharmaceutical leadership of Merck KGaA, Darmstadt, Germany and Pfizer," said Scott Hutton, Biodesix CEO. "The successful progression of this project is another example of how our proprietary Diagnostic Cortex AI-based biomarker platform is uniquely suited to advancing clinical research and investigating new indications for existing therapies."

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US, EU, Japan and other countries for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with mMCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.

On February 11, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that Dr. Brian Poligone, clinical investigator and lead enroller in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating SGX301 in the treatment of early stage cutaneous T-cell lymphoma (CTCL), will present a patient case study from the trial (Press release, Soligenix, FEB 11, 2020, View Source [SID1234554174]). The presentation will be given at the upcoming 4th World Congress of Cutaneous Lymphomas on February 12-14, in Barcelona, Spain.

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Oral Presentation:

Response in a patient with refractory folliculotropic mycosis fungoides to a topical hypericin ointment activated with fluorescent light presented by Brian Poligone, MD, PhD, an Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA, on February 13th, 2020 at 8:00 AM CET. Abstract will be available on corporate website following the conference.

Folliculotropic mycosis fungoides (FMF) is a type of CTCL that is very difficult to treat. FMF is generally considered more severe and aggressive than other types of CTCL due to its greater risk of disease progression and worse prognosis. Treatment usually includes early consideration of systemic therapies, as topical therapies are often not beneficial. The presented case study focuses on a single patient with FMF who has completed the Phase 3 FLASH trial, including the open-label cycles and 6-month follow-up. The patient had previously failed at least five therapies, including topical treatments, oral medications and phototherapy. While in the study, the patient received at least 12 weeks of SGX301 treatment and experienced significant improvement, eventually leading to complete clearance of disease that has been sustained for at least 4 years.

"I’m happy to be presenting this important case study at the world congress," stated Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Group. "This patient community needs safe, skin directed therapies to treat this difficult lymphoma and I’m very excited that SGX301 may be one such therapy. I know I can speak for the other clinical study sites participating in the FLASH study, when I say, we are eager for the topline results this quarter."

About the 4th World Congress of Cutaneous Lymphomas

The 4th World Congress is designed to promote the exchange of scientific ideas and foster interactions between physicians, researchers and anyone engaged in the field of cutaneous lymphomas. The program will include discussions of basic, translational and clinical research and discuss new developments in the diagnosis, practice and management of cutaneous lymphomas. More information about the Congress is found here and the final programme is available here.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively.

The Phase 3 FLASH trial enrolled 169 patients with Stage IA, IB or IIA CTCL. Enrollment of the trial is completed and topline primary endpoint results are expected to be available in Q1 2020. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of Week 8. In the first treatment cycle, approximately 107 subjects receive SGX301 treatment (0.25% synthetic hypericin) and 53 receive placebo treatment of their index lesions. In the second cycle, all subjects receive SGX301 treatment of their index lesions and in the third (optional) cycle all subjects receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The majority of patients enrolled have elected to continue with the optional, open-label component of the study.

The Phase 3 CTCL clinical study was partially funded with this NCI Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.

On February 11, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the SVB Leerink 9th Annual Global Healthcare Conference on Tuesday, February 25 (Press release, AbbVie, FEB 11, 2020, View Source [SID1234554173]). Michael Severino, M.D., vice chairman and president and Robert A. Michael, executive vice president and chief financial officer, will present at 9:30 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 11, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic, will present at NobleCon16 – Noble Capital Markets’ 16th Annual Investor Conference on Tuesday, February 18, 2020 at 2:30 p.m. ET in Hollywood, Florida (Press release, Xenetic Biosciences, FEB 11, 2020, View Source [SID1234554172]).

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As part of his presentation, Mr. Eisenberg will provide a Company overview and discuss the Company’s novel CAR T platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. Xenetic is currently advancing the development program for XCART to confirm the positive preclinical results shown to date and to demonstrate a more attractive safety profile than existing therapies.

In addition to the presentation, management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. To request a meeting, please contact the NobleCon16 one-on-one desk.

On February 11, 2020 Incyte (Nasdaq:INCY) reported that it will present at the Cowen and Company 40th Annual Health Care Conference on Monday, March 2, 2020 at 11:20 a.m. ET in Boston (Press release, Incyte, FEB 11, 2020, View Source [SID1234554171]).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.