On February 11, 2020 Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of therapies for the treatment of autoimmune diseases, inflammatory diseases reported an update on the pending 1000 to 1 reverse stock split and name change of Immune Therapeutics (Press release, Immune Therapeutics, FEB 11, 2020, View Source [SID1234554149]).

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Immune Therapeutics originally submitted the reverse and name request for a corporate action to FINRA and paid the applicable fees on November 27, 2019. Since then, the company has responded to FINRA’s requests for further information multiple times, and we continue in our efforts to work diligently and cooperatively with FINRA to process the reverse and name change. Please note that the Company has no control of the FINRA approval process and as such the timing of any decisions our not in the Company’s control.

Michael K. Handley, CEO of Immune, said, "We are disappointed in the delay in processing the reverse and name change and remain fully committed to the restructuring and success of IMUN. I would personally like to thank all of our shareholders for their patience in this process. We realize this delay has eroded share value, and confidence however, based on the extensive review by FINRA, we are optimistic that their approval could be given soon, at which time we will certainly inform shareholders immediately. Immune would like to thank our shareholders for standing behind us, as we continue to work in your interests with a commitment to the reverse and merger with Aletheia as soon as possible."

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 Penumbra, Inc. (NYSE: PEN) reported that it will host a conference call to discuss financial results for the fourth quarter and full year 2019 after market close on Tuesday, February 25, 2020 at 5:00 PM Eastern Time (Press release, Penumbra, FEB 11, 2020, View Source [SID1234554183]). A press release with fourth quarter and full year 2019 financial results will be issued after market close that day.

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Webcast & Conference Call Information
The conference call can be accessed live over the phone by dialing (833) 227-5837 for domestic callers or (647) 689-4064 for international callers (conference id: 3899277), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

On February 11, 2020 Novartis reported that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA) (Press release, Novartis, FEB 11, 2020, View Source [SID1234554129]). Capmatinib is a MET inhibitor being evaluated 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). 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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Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to ten months under Standard Review. Novartis was previously granted Breakthrough Therapy designation for capmatinib.

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. As part of the continued collaboration between Novartis and Foundation Medicine, Inc., companion diagnostics for capmatinib are in development for both tumor tissue and liquid biopsies to be included on FoundationOneCDx* and the forthcoming version of Foundation Medicine’s liquid biopsy platform, which is currently under review with the FDA. Foundation Medicine is a leading provider of comprehensive genomic profiling solutions for patients with advanced cancer, including NSCLC.

"We are extremely encouraged by the FDA’s Priority Review designation for capmatinib, a MET inhibitor that may be a major treatment advance for patients with this particularly aggressive form of lung cancer," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis. "Results of the GEOMETRY mono-1 trial clearly identify METex14 as an oncogenic driver and we are inspired to bring capmatinib, potentially the first METex14 targeted therapy, to patients and to reimagine medicine and outcomes for people with lung cancer."

The NDA submission for capmatinib is supported by results from the GEOMETRY mono-1 Phase II study, which demonstrated an overall response rate 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 Lung Cancer
Lung cancer is the most common cancer worldwide, accounting for 2.1 million new cases and 1.8 million deaths in 20188. There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)9. NSCLC accounts for approximately 85% of lung cancer diagnoses, inclusive of known oncogenic mutations4. The MET exon 14 skipping mutation occurs in 3-4% of newly diagnosed advanced NSCLC cases5. There are currently no approved therapies specifically targeted to treat METex14 mutated advanced lung cancer.

About Capmatinib
Capmatinib (INC280) is an investigational, oral, potent and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

On February 11, 2020 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Marker’s planned trial investigating safety and efficacy of its novel MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia (AML) (Press release, Marker Therapeutics, FEB 11, 2020, View Source [SID1234554150]).

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Marker previously announced on November 12, 2019, that the FDA placed the trial on clinical hold. The FDA requested additional information and technical specifications for two legacy reagents supplied by third parties used in the MultiTAA-specific T cell manufacturing process. The technical specifications and data requested by the FDA could not be produced by the original suppliers. The Company identified alternative suppliers, satisfying the Agency’s request.

Based on data Marker provided, the FDA permitted the Company to initiate its AML trial, beginning with a safety lead-in portion. The FDA placed a partial clinical hold on the trial for the use of the MultiTAA-specific T cell product manufactured using one of the reagents supplied by the alternative supplier, until the final data and certificate of analysis for the reagent are reviewed and accepted by the Agency. The safety lead-in portion of the trial is expected to enroll approximately six patients as part of the amended trial design. Three patients will be dosed with MultiTAA-specific T cells manufactured using the legacy reagent, and three patients will be dosed with T cells manufactured using the reagent from the alternative supplier.

Marker currently estimates that the alternative supplier will deliver the final reagent, along with the final data and certificate of analysis required by the FDA, by the end of the second quarter of 2020. Marker anticipates to complete enrollment of the first three patients and submission of the final technical specifications and comparability data of the new reagents to the FDA during the second half of 2020, thereby satisfying the requirements for lifting the partial hold on the clinical trial. Given this expected timing, Marker does not currently expect the partial clinical hold to significantly impact site and patient enrollment of the AML trial.

The safety lead-in will be followed by the 160-patient randomized portion of the study at approximately 20 transplant centers. Group 1 will comprise 120 adjuvant (disease-free) patients, with the primary endpoint of relapse-free survival of patients receiving MultiTAA-specific T cell therapy versus a control group. Group 2 will comprise 40 active disease patients in a single arm, with primary endpoints of complete remission and duration of complete remission.

"With a clear path identified for getting our study of MultiTAA-specific T cell therapy underway in patients with AML, we’re focused on addressing the remaining requirements from the FDA and enrolling up to 20 clinical centers to conduct our Phase 2 trial," stated Peter L. Hoang, President and CEO of Marker Therapeutics. "We appreciate the productive dialogue with the FDA throughout the process and look forward to advancing MultiTAA-specific T cell therapy for patients with post-transplant AML in a randomized and multicenter clinical trial."