On November 27, 2019 NantKwest, Inc. (Nasdaq: NK), a next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and other diseases, reported that on Monday, December 2, 2019, it will host a key opinion leader (KOL) meeting in New York City on the current treatment landscapes and unmet medical needs of patients with Merkel cell carcinoma, triple-negative breast cancer, solid tumors and the state-of-the-art treatment in the induction of Immunogenic Cell Death (Press release, NantKwest, NOV 27, 2019, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-hosting-key-opinion-leader-meeting-novel?field_nir_news_date_value[min]=2019 [SID1234551760]).

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This event will feature presentations from KOLs George Ansstas, MD, Washington University of Medicine in St. Louis, Chaitali Nangia, MD, Chan Soon-Shiong Institute for Medicine, and Clint Allen, MD, Johns Hopkins Kimmel Cancer Center, as well as Dr. Patrick Soon-Shiong, Chief Executive Officer and Chairman of NantKwest.

NantKwest’s management team will also provide pipeline updates on their haNK and PD-L1.t-haNK programs utilizing the Company’s Activated Natural Killer (aNK) cell platform to target these diseases. This platform harnesses the power of the innate immune system and is uniquely positioned to provide broadly available, off-the-shelf cell therapies capable of being administered in the outpatient setting.

Clint Allen, MD is an Associate Professor of Otolaryngology-Head and Neck Surgery at the Johns Hopkins School of Medicine, Principal Investigator of the Translational Tumor Immunology Program, National Institute on Deafness and Other Communication Disorders, NIH. His research focuses on understanding how the immune system responds to squamous cell carcinoma of the head and neck, and how this can be enhanced therapeutically. He leads a large pre-clinical and clinical laboratory program focused on translational pre-clinical studies in syngeneic models of squamous cell carcinoma and the assessment of clinical trial specimens. He is the director of the inpatient Otolaryngology consultation service at the NIH Clinical Center and maintains a surgical practice for the Johns Hopkins School of Medicine based out of Suburban Hospital in Bethesda, MD.

George Ansstas, MD is an Assistant Professor of Medicine, Section of Medical Oncology, Division of Oncology at Washington University School of Medicine. Dr. Ansstas’s clinical expertise includes brain tumors, neuro-oncology, skin cancer, and melanoma. He received his medical degree from University of Tishreen, Latakia, Syria in 2001. Dr. Ansstas completed a fellowship in hematology and oncology at Washington University, St. Louis.

Chaitali Nangia, MD is an Hematologist/Oncologist based in Costa Mesa, California and is affiliated with Hoag Hospital System. She received her medical degree from Lady Hardinge Medical College in New Delhi, India and completed her residency in Internal Medicine at Resurrection Westlake Medical Center in Illinois. She then completed her Fellowship in Hematology/Oncology at the Henry Ford Hospital in Michigan. She worked as an Associate Professor at University of California-Irvine and as an Associate Program Director at University of California-Irvine Hematology/Oncology Fellowship Program prior to her current role. She acted as the principal investigator for several clinical trials and has been an author of several publications.

This event is intended for institutional investors, sell-side analysts, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. Members of the media and the public are invited to participate via the live webcast, which can be accessed through our company website at https://nantkwest.com/nantkwest-key-opinion-leader-event/. The event is expected to start at noon EST on Monday, December 2, 2019.

On November 27, 2019 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to make the following presentations in December (Press release, CRISPR Therapeutics, NOV 27, 2019, View Source [SID1234551759]):

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Evercore ISI 2nd Annual HealthCONx
Date: Wednesday, December 4, 2019
Presentation: 11:00 a.m. ET
Location: Boston, MA

Piper Jaffray 31st Annual Healthcare Conference
Date: Thursday, December 5, 2019
Presentation: 2:00 p.m. ET
Location: New York, NY

A live webcast of the events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days following the presentation.

On November 27, 2019, Protagonist Therapeutics, Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Agreement") with Jefferies LLC ("Jefferies") under which the Company may offer and sell, from time to time, shares of its common stock, par value $0.00001 per share (the "Common Stock"), having an aggregate offering price of up to $75,000,000 through Jefferies as its sales agent (Filing, 8-K, Protagonist, NOV 27, 2019, View Source [SID1234551752]). The shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-234414).

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The Company is not obligated to make any sales of Common Stock under the Agreement. Jefferies may sell the Common Stock by any method that is deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Global Market or any other trading market for our Common Stock. Jefferies will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Stock sold through Jefferies under the Agreement, and also has provided Jefferies with customary indemnification rights.

The offering of shares of Common Stock pursuant to the Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Agreement or (ii) termination of the Agreement in accordance with its terms.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference. The legal opinion of Cooley LLP relating to the shares of Common Stock being offered pursuant to the Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On November 27, 2019 Pfizer Inc. reported investors and the general public to listen to a webcast of a discussion with Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical, and Michael Vincent, Senior Vice President and Chief Scientific Officer, Inflammation and Immunology, at the Evercore ISI 2nd Annual HealthCONx Conference on Wednesday, December 4, 2019 at 10:15 a.m. Eastern Standard Time (Press release, Pfizer, NOV 27, 2019, View Source [SID1234551751]).

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To listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today.

Visitors will be able to listen to an archived copy of the webcast at www.pfizer.com/investors.

On November 27, 2019 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements (Press release, Incyte, NOV 27, 2019, View Source [SID1234551749]).

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The NDA submission is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. Study results, recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36 percent (primary endpoint), and median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. Adverse events were manageable and consistent with the mechanism of action of pemigatinib.

"There is a significant need for new therapies for patients with cholangiocarcinoma, who have limited treatment options beyond first-line chemotherapy and often face a poor prognosis," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "We are very pleased that the FDA has accepted our NDA for Priority Review which we believe represents an important step toward providing the first treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. We intend to work closely with the FDA to bring this innovative targeted therapy to patients suffering from this devastating disease as soon as possible."

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period to eight months compared to 12 months for Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date is May 30, 2020.

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.1,2 The incidence of cholangiocarcinoma varies regionally and ranges between 0.3 – 3.4 per 100,000 in North America and Europe.1 FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients.3-5

About FIGHT-202

The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

For more information about FIGHT-202, visit View Source

About FIGHT

The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type. FIGHT-205 is a Phase 2 study investigating pemigatinib plus pembrolizumab combination therapy and pemigatinib monotherapy in patients with previously untreated, metastatic or unresectable bladder cancer harboring FGFR3 mutations or fusions/rearrangements who are not eligible to receive cisplatin. FIGHT-302 is a recently initiated Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

About FGFR and Pemigatinib

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. The U.S. Food and Drug Administration (FDA) has granted pemigatinib Breakthrough Therapy designation for the treatment of previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma. The FDA’s Breakthrough Therapy designation is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines. Additionally, the FDA granted pemigatinib Orphan Drug designation for the treatment of cholangiocarcinoma, a designation granted to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.