On February 11, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that it will participate in the 9th Annual SVB Leerink Global Healthcare Conference on February 25, 2020 (Press release, FibroGen, FEB 11, 2020, View Source [SID1234554170]). Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at 3:30 PM Eastern Time. A live audio webcast will be available on the "Events & Presentations" section of the FibroGen website at www.fibrogen.com. A replay of the webcast will be available for 30 days.

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On February 11, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, and Personalis Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported a collaboration to leverage Personalis’ ImmunoID NeXT Platform in Advaxis’ ongoing Phase 1/2 ADXS-503 (HOT Lung) program evaluating ADXS-503 alone and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) (Press release, Advaxis, FEB 11, 2020, View Source [SID1234554169]). The ADXS-503 construct targets 11 public or shared, hotspot neoantigens in KRAS, EGFR and TP53 as well as 11 proprietary tumor-associated antigen targets. Under the terms of the expanded agreement, Personalis will conduct comprehensive tumor immunogenomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.

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Via the deep analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one; providing a multidimensional view of the tumor and the immune microenvironment from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery and CDx development.

"We are thrilled to expand our relationship with Personalis and believe the resulting analyses may lead to the establishment of predictive biomarkers and the characterization of immunological impact of treatment which will be relevant to the successful development of ADXS-503 and our other off-the-shelf neoantigen constructs," said Dr. Andres A. Gutierrez, Chief Medical Officer of Advaxis. "With the emerging clinical signals we are seeing in our ongoing ADXS-503 clinical study and the extensive capabilities of ImmunoID NeXT to interrogate a patient’s tumor and immune response at both the DNA- and RNA-level from a single FFPE tissue sample, the analysis will help guide our development plans in order to target the right patient population and to potentially increase the clinical benefit of our off-the-shelf, ADXS-HOT drug constructs."

This new agreement builds upon the prior two-year collaboration between Advaxis and Personalis for the genomic analysis of clinical tumor samples to manufacture the Company’s ADXS-NEO drug construct, its personalized, neoantigen-directed immunotherapy to treat a variety of late stage cancers. As previously published, the ADXS-NEO drug constructs were able to efficiently generate de novo CD8+ T cells versus KRAS and EGFR hotspot mutations in late stage-cancer patients, thus providing proof-of-mechanism for our ADXS-HOT program.

On February 11, 2020 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, reported financial results for the fiscal year ended December 31, 2019, and provided a business update (Press release, Taiwan Liposome Company, FEB 11, 2020, View Source [SID1234554167]).

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"We saw a monumental year for TLC in 2019, marked not only by tremendous clinical and manufacturing advancements in both our programs in pain management – TLC599 and TLC590, but also by new business development agreements, addition of internationally experienced personnel to the management team, and presentation and publication of impressive data at numerous investor conferences as well as prestigious scientific conventions," said George Yeh, President of TLC. "With this continual momentum, we look forward to achieving more milestones in 2020, including the completion of patient enrollment in the EXCELLENCE trial and data readout from the TLC590 Phase II trial, both of which will bring us closer to the goal of mitigating the proliferation of highly addictive opioids with the availability of our non-opioid alternatives."

Clinical Pipeline Update and Upcoming Milestones

Commencement of patient enrollment in EXCELLENCE trial evaluating single and repeated administrations of TLC599 for knee osteoarthritis pain. The Phase III pivotal study, which enrolled its first patient in November 2019, will dose about 500 patients at a 2:1:1 ratio with TLC599, dexamethasone or placebo across 45 sites in the United States and Australia. At Week 24, patients can receive a second blinded injection of TLC599 or placebo. Primary endpoint is the magnitude of pain relief by WOMAC Pain score versus placebo at Week 16 and Week 40. Patient enrollment is expected to take about one year, and all patients will be followed for 52 weeks.

Commencement of patient dosing in Part 2 of Phase II trial evaluating the analgesic efficacy of TLC590 following bunionectomy. With the first batch of patients dosed in January 2020, a total of about 150 patients will receive TLC590, bupivacaine or normal saline placebo at a ratio of 1:1:1 at the end of their bunion removal surgery. Primary endpoint is area under the curve (AUC) from 0 to 72 hours on the numerical pain rating scale.
Corporate Highlights

Completed US$27.3 million financing. The Company completed a cash capital offering of ordinary (common) shares in Taiwan in October 2019. The offering consisted of 10,200,000 new common shares issued at a price of NT$82 per common share for gross proceeds of NT$836.4 million (~US$27.3 million).

Presented at Berenberg Pain Seminar and JP Morgan Healthcare Conference. At the Berenberg Pain Seminar in November 2019, TLC presented recent data on TLC599 and TLC590 and discussed how they can potentially deter the spread of the opioid crisis with prominent figures in the pain management space. TLC also presented and participated in one-on-one meetings at the 38th annual JP Morgan Healthcare Conference in January 2020, marking the Company’s sixth consecutive attendance at the world’s largest healthcare investment symposium.

Expanded global intellectual property protection to 197 patents, with 126 patents granted and 71 applications worldwide as of December 31, 2019.
Fiscal Year End Financial Results

Operating revenue for the fiscal year 2019 was NT$209.1 million (US$7.0 million), a 235.6% increase compared to NT$62.3 million (US$2.0 million) in the fiscal year 2018. Operating expenses for the fiscal year 2019 was NT$1,026.8 million (US$34.3 million), a 4.7% increase compared to NT$980.3 million (US$32.0 million) in the fiscal year 2018. Net loss for the fiscal year 2019 was NT$807.5 million (US$27.0 million), compared to net loss of NT$901.6 million (US$29.5 million) in the fiscal year 2018, or a net loss of NT$12.32(US$0.41) per share for the fiscal year 2019, compared to a net loss of NT$14.37(US$0.47) per share for the fiscal year 2018.

The Company’s cash and cash equivalents and time deposits with maturity over three months (which are classified as "current financial assets at amortized cost" in the Company’s consolidated financial statements) were NT$1,023.9 million (US$34.2 million) as of December 31, 2019, compared to NT$1,114.6 million (US$36.4 million) as of December 31, 2018.

On February 11, 2020 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for capmatinib, an investigational, selective MET inhibitor, as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC) (Press release, Incyte, FEB 11, 2020, View Source [SID1234554166]). If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis2,3.

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There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses4. METex14 mutations occur in 3-4% of newly-diagnosed advanced NSCLC cases5 and is a recognized oncogenic driver6,7.

"Patients with METex14 mutated advanced NSCLC, an aggressive form of the disease, often face a poor prognosis due to lack of available treatment options," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We are pleased the FDA has accepted the NDA for capmatinib for Priority Review – a critical step toward providing the first METex14 mutation targeted therapy to this subset of lung cancer patients."

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to 10 months for Standard Review. Capmatinib was previously granted Breakthrough Therapy designation by the FDA.

The NDA submission for capmatinib was supported by results from the Novartis-sponsored GEOMETRY mono-1 Phase 2 study, which demonstrated overall response rates of 67.9% (95% CI, 47.6 – 84.1)1 and 40.6% (95% CI, 28.9–53.1)1 among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The study also demonstrated that capmatinib provided durable responses among all patients: median duration of response was 11.14 months (95% CI, 5.55 – NE) in treatment-naïve patients and 9.72 months (95% CI, 5.55 – 12.98) in previously treated patients1.

All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response1. The most common treatment-related adverse events (AE) (≥ 10% all grades) across all cohorts (N=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%). The majority of the AEs were grades 1/21.

About GEOMETRY mono-1

The Novartis-sponsored GEOMETRY mono-1 trial is an international, prospective, multi-cohort, non-randomized, open-label Phase 2 study to evaluate the efficacy and safety of single-agent capmatinib in adult patients with EGFR wildtype, ALK-negative rearrangement, advanced NSCLC harboring a MET amplification and/or mutation. Patients with locally advanced or metastatic NSCLC harboring a MET exon-14 skipping mutation (centrally confirmed) were assigned to Cohorts 4 (previously treated patients) or 5B (treatment-naïve), regardless of MET amplification/gene copy number and received 400 mg capmatinib tablets orally twice daily. The primary endpoint was ORR based on BIRC assessment per RECIST v1.1. The key secondary endpoint was DOR by BIRC.

About Capmatinib

Capmatinib (INC280) is an investigational, oral and selective MET inhibitor discovered by Incyte and licensed to Novartis in 2009. Under the terms of the Agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications. If capmatinib is successfully developed by Novartis, Incyte may become eligible for over $500 million in future milestones as well as royalties of between 12 and 14 percent on global sales by Novartis.

On February 11, 2020 NorthStar Medical Technologies, LLC (NorthStar), a global innovator in the production and distribution of radioisotopes used for medical imaging, and Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported the signing of a Letter of Intent for the commercial supply of copper-67 (Cu-67) as an active pharmaceutical ingredient for Clarity’s pipeline of copper-based radiopharmaceuticals (Press release, Clarity Pharmaceuticals, FEB 11, 2020, View Source [SID1234554164]). Under terms of the agreement, NorthStar will provide Clarity Pharmaceuticals with Cu-67, a beta-emitting radioisotope with potential applications as a targeted radiopharmaceutical for treatment of a range of cancers. NorthStar will be a major U.S. supplier of Cu-67 for Clarity.

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"NorthStar is committed to developing and commercializing innovative technologies for Cu-67 radioisotope production to advance medical research and meet patient needs," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Technologies. "Clinical development of Cu-67 based radiopharmaceuticals has been limited to date due to lack of stable chelators for Cu-isotopes and limitations in supply. With Clarity Pharmaceuticals’ leading copper chelating technology and product pipeline advancing into a range of theranostic clinical trials that use Cu-64/Cu-67 pairing, industrialization of Cu-67 production is required. NorthStar is addressing this need and advancing towards commercial-scale production. This commercialization process will apply our proven expertise and innovative approach as demonstrated in the successful launch of the RadioGenix System (technetium Tc 99m generator), which provides our customers with reliable domestic Mo-99 supply and is increasingly helping to alleviate supply shortages. We look forward to working with Clarity and supporting its plans for further clinical development and commercialization to improve the lives of patients with serious disease."

"NorthStar is working towards scale-up of Cu-67 production in collaboration with select institutions and laboratories using its electron accelerator technology to produce Cu-67," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "We will advance Cu-67 production technology, with the aim to produce high specific activity and high purity Cu-67, eliminate supply shortages and establish commercial production capacity sufficient to meet anticipated future market demands."

"We believe that NorthStar’s proven experience in the development and commercialization of innovative radioisotope technologies will be helpful for us to further advance our research and clinical development efforts," said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. "Having access to a reliable and scalable supply of Cu-67 in the United States will enable us to apply our proprietary copper-chelating technology to a range of targeting agents for potential treatment of neuroblastoma, prostate, breast and ovarian cancers. The perfect pairing of Cu-64 and Cu-67 labelled radiopharmaceuticals for diagnosis and therapy has been discussed for many years, but has been hampered by poor chelator technology that leaks copper isotopes in-vivo, and has led to limited demands for Cu-67. We have now overcome this issue, and the use of electron accelerator technology
enables Clarity to be free of reliance on the aging fleet of nuclear reactors which currently produce therapeutic radionuclides. This technology will also increase the speed of Clarity’s clinical trials across our SARTATE, SAR-bisPSMA and SAR-Bombesin programs."

About Copper-67 (Cu-67)
Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope which is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumors (NETs), neuroblastoma, glioma, lymphoma, ovarian and bladder cancers. In order to develop safe and effective targeted therapies, a chelator, which strongly binds Cu-67 to the targeting agent, is required. Clarity Pharmaceuticals has successfully developed a highly specific and highly stable chelator for copper isotopes and is now progressing a range of radiopharmaceuticals based on its proprietary MeCOSar chelator. NorthStar is developing a proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and treatment.