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NantKwest and ImmunityBio Present Results of Landmark Trial of First-in-Human Natural Killer Cell Combination Immunotherapy With Durable, Complete Response Data and 78% Disease Control in Refractory Triple Negative Breast Cancer at SABCS

On December 16, 2019 NantKwest Inc. (Nasdaq: NK), a clinical-stage natural killer cell-based therapeutics company, and ImmunityBio, a privately held immunotherapy company, reported results from their Phase 1b trial investigating a novel, first-in-human immunotherapy protocol consisting of NantKwest’s off-the-shelf, antibody-targeted NK cells (haNK) combined with ImmunityBio’s IL-15 superagonist (N-803), low-dose metronomic chemoradiation therapy, adenoviral and yeast tumor-associated antigen vaccines (MUC1, brachyury, CEA) and a PD-L1 checkpoint inhibitor in patients with metastatic triple negative breast cancer (TNBC) who had relapsed after prior therapy (Press release, NantKwest, DEC 16, 2019, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-and-immunitybio-present-results-landmark-trial-first?field_nir_news_date_value[min]=2019 [SID1234552402]).

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The results were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) on December 13, 2019, in San Antonio, Texas, in a poster titled "Safety and efficacy from first-in-human immunotherapy combining NK and T-cell activation with off-the-shelf, antibody-targeted CD16 NK cell line (haNK) in patients with 2nd-line or greater metastatic triple-negative breast cancer (TNBC)."

This landmark study is the world’s first trial to combine cellular therapy with checkpoint inhibitors and IL-15 cytokine stimulation, as well as with adenoviral vectors, all acting in concert to induce immune simulation of both NK cells and T cells.

"We are extremely pleased that the FDA granted us IND authorization to initiate this novel immunotherapy trial enabling the safety and efficacy study of multiple novel biological agents administered as a single protocol in the outpatient setting," said Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. "This important trial forms the basis of our approach to induce immunogenic cell death and long-term memory, and avoid the ravages of high dose chemotherapy."

"Achieving durable, complete responses in metastatic TNBC patients that have failed all current standards of care is a promising finding and further validates our approach to orchestrate both the innate and adaptive immune system," continued Soon-Shiong. "TNBC is a highly aggressive cancer, with limited treatment options and poor prognosis. These results are important proof-of-concept supporting our hypothesis that comprehensively activating the immune responses of the NK, T and Dendritic cells would induce immunogenic cell death leading to durable responses, even among this challenging patient population. We are thrilled with the safety and efficacy data from this first-in-human clinical trial of combination NK cell therapy, cytokine fusion protein, chemoradiation and checkpoint inhibitor, and look forward to advancing this exciting off-the-shelf cell therapy approach to randomized clinical trials in this setting."

Data Highlights Include:

Of 9 patients treated, efficacy results include a disease control rate of 78% (7/9 patients) and an overall response rate of 67% (6/9 patients).
2 out of 9 patients to date have ongoing complete responses with durations ranging from 8 to 11 months, with a 3rd patient demonstrating a partial response (near complete response) in the target lesion after initiation of targeted and endocrine therapy off-study.
To date, 7 patients are alive with durations of response ranging from 2 to 12 months with 4 patients remaining on study. Median progression-free survival rate is 13.7 months.
All patients were treated in an outpatient setting with treatment generally safe and well tolerated and no observed cytokine release syndrome.
No immune related SAEs were attributed to the immunotherapy investigational agents
All patients had at least 1 grade ≥ 3 TRAE, primarily chemotherapy-related neutropenia or anemia. Grade ≥ 3 haNK-related AEs, namely fever and fatigue, were observed in 2 patients.
Early data from peripheral blood analysis demonstrate clonal selection occurs with the immunotherapy regimen enabling targeted therapy tailored to patient specific mutations identified via next generation sequencing.
"The approximately 10-20% of breast cancer patients who are triple negative are faced with a grim prognosis with limited treatment options. These results are clinically significant, with overall response rates and complete response rates in this highly refractory, advanced metastatic patient population," said Dr. Chaitali Nangia, a Hematologist/Oncologist with the Chan Soon-Shiong Immuno-Oncology Network and study co-author. "Importantly, these responses to treatment are also durable, with median progression free survival exceeding 13 months compared to historical controls of approximately 3 months in this heavily pretreated population. We also observed a positive safety and tolerability profile, with no cytokine release syndrome. Taken together, these efficacy and safety results point to the emergence of a new treatment paradigm for TNBC."

Pfizer Declares First-Quarter 2020 Dividend and Announces Upcoming Investor Day to Highlight Strength of Innovative R&D Pipeline

On December 16, 2019 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared a 38-cent per share first-quarter 2020 dividend on the company’s common stock, payable March 6, 2020 to holders of the Common Stock of record at the close of business on January 31, 2020 (Press release, Pfizer, DEC 16, 2019, View Source [SID1234552401]). Pfizer increased the dividend over the fourth-quarter 2019 dividend by approximately 6 percent to 38 cents from 36 cents per share. The first-quarter 2020 cash dividend will be the 325th consecutive quarterly dividend paid by Pfizer.

"The dividend increase is a testament to our commitment to returning capital to shareholders and reflects our continued confidence in the business and in our pipeline," stated Dr. Albert Bourla, Pfizer chief executive officer. "It also reinforces that our focus on creating meaningful value for patients benefits all our stakeholders."

Pfizer also announced plans to host an Investor Day on Tuesday, March 31, 2020, starting at 9:00 a.m. EDT, at its global headquarters in New York, NY. Pfizer business executives and scientific leadership will provide updates on the company’s progress in advancing its R&D pipeline, specifically on product candidates with blockbuster potential that are expected to launch by 2025.

Dr. Bourla continued, "We look forward to highlighting the range of therapeutic areas and modalities in our R&D pipeline, demonstrating the growth momentum in our Biopharma businesses and providing an opportunity to meet scientific and commercial leadership in each of our core therapeutic areas. We are excited to share key aspects of our strategy to deliver sustainable, long-term growth by developing transformational medicines and vaccines that address some of the world’s greatest unmet needs in healthcare."

Invitations for in-person attendance will be distributed in coming weeks. A live webcast, including audio, video and presentation slides, will be accessible on the Pfizer’s Investor Relations website (www.pfizer.com/investors) at the time of the meeting. Interested parties unable to attend in-person or watch the live webcast will be able to view and listen to an archived copy of the webcast, which will be available on Pfizer’s Investor Relations website following the conclusion of the event.

MEI Pharma Announces Proposed Public Offering of Common Stock

On December 16, 2019 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it plans to offer shares of its common stock in an underwritten public offering (Press release, MEI Pharma, DEC 16, 2019, View Source [SID1234552400]). In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, as well as for working capital and other general corporate purposes.

Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. When available, copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York NY 10152, by telephone at 800-326-5897 or by email at [email protected]. An electronic copy of the preliminary prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Kura Oncology Receives Fast Track Designation for Tipifarnib in HRAS Mutant HNSCC and Provides Enrollment Guidance for AIM-HN Trial

On December 16, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead drug candidate, tipifarnib, for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) after progression on platinum therapy (Press release, Kura Oncology, DEC 16, 2019, View Source [SID1234552399]).

"We are very encouraged by our growing body of clinical data for tipifarnib in HRAS mutant HNSCC and believe that the FDA’s Fast Track designation puts us one step closer to delivering a precision medicine treatment for patients with this devastating disease," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "We continue to work with regulatory authorities in the U.S. and abroad in our effort to bring tipifarnib to patients as quickly as possible."

Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.

AIM-HN Enrollment Guidance

The Company also provided enrollment guidance for AIM-HN, its ongoing registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC. The global, multi-center trial was initiated in November 2018 and was originally projected to take approximately two years to fully enroll. Based on a recent evaluation of current enrollment rates, the Company now expects the trial to complete enrollment in the first quarter of 2021. The slower pace of enrollment is primarily due to delays in site activation and a higher than anticipated screen failure rate. The trial is now open in more than 81 clinical sites in the U.S., Europe and Asia.

"Although we experienced some delays in site activation, we’re encouraged to have the vast majority of the participating sites now open, with a corresponding increase in the rate of screening," said Kathleen Ford, Chief Operating Officer of Kura Oncology. "We recently presented impressive data from our Phase 2 trial in the same patient population and we believe that awareness of these data will continue to increase HRAS mutation testing and enrollment. Enrollment in AIM-HN remains our top priority and we remain steadfast in our commitment to bring tipifarnib to patients with HRAS mutant HNSCC for whom no treatment options are specifically indicated."

In addition, Kura plans to expand its targeted field-based medical science liaison team to help educate oncology practices on the importance of HRAS testing. The Company believes that this will provide HNSCC-treating physicians and their patients with more information about their diagnoses and enable them to make more educated decisions about their care, including potential clinical trial enrollment.

About Tipifarnib

Kura Oncology’s lead drug candidate, tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen in December 2014. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

Immune Therapeutics Announces Plan to Acquire Aletheia Therapeutics to Create a New Precision Oncology Company

On December 16, 2019 Immune Therapeutics, Inc. (OTCQB: IMUN) ("Immune", "IMUN" or the "Company") and Aletheia Therapeutics Corp. ("Aletheia"), a privately held development-stage oncology therapeutics company, reported that Immune will acquire Aletheia in an all-stock transaction (Press release, Immune Therapeutics, DEC 16, 2019, View Source [SID1234552398]). Pursuant to completion of a definitive agreement, Immune will acquire all of the outstanding shares of Aletheia in exchange for Immune common stock . In connection with the acquisition, the Aletheia management team will join the leadership of the combined Company as well as selected Board members of Aletheia.

Over the past several years researchers have demonstrated that cancer is inherently heterogenous and a single tumor can have up to one hundred different cell phenotypes. This knowledge has led to a new approach in cancer therapy in that targeting several different biological targets in cancer provides for better efficacy and lower toxicity. Specifically, a combination of drugs that each target an independent critical pathway in cancer growth is becoming widely recognized as the future of cancer treatment. The combined company will be focused on developing and commercializing precision cancer therapies by simultaneously targeting two or more of the following biological targets depending on the make-up of a patients’ cancer: DNA repair, T-cell activation, metabolic dysfunction, angiogenesis, apoptosis or inflammation.

"With this acquisition we will be able to develop a diverse platform of therapies that target multiple critical biological pathways that will be designed for an individual’s cancer," said Michael Handley, chief executive officer and president, Immune Therapeutics. "The combination of Aletheia’s diverse oncology product pipeline with Immune’s Lodonal and MENK product candidates will create an industry leading oncology company."

"Following an extensive evaluation and diligence process, the Immune Board of Directors concluded that the acquisition of Aletheia, with a strong platform technology, seasoned leadership team, and compelling clinical development plan, offered an excellent opportunity to create shareholder value for Immune," stated Dr. Roscoe Moore, the chairman of Immunes Board of Directors. "We believe Aletheia represents an attractive acquisition target for Immune, offering a novel approach to creating precision therapies for cancer patients with unmet medical needs."

Under the initial terms announced today, Immune, through a subsidiary, will initiate an offer to acquire all outstanding shares of Aletheia. The closing of the offer will be subject to certain conditions, including completing due diligence, the employment of the Aletheia management team to Immune management team and the assignment of all intellectual property to Immune. Furthermore, Aletheia has signed definitive stock purchase agreement with an investor group for $25 million that should fund before the end of the year. Once the acquisition is complete Aletheia and Immune will be funded with sufficient capital to execute on the product development strategy in 2020. The acquisition is expected to close early in the first quarter of 2020.