1stOncology™: Cancer Intelligence Service – Page 9841 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

NANOBIOTIX Announces Fast Track Designation Granted By U.S. FDA For Investigation of First-in-class NBTXR3 In Head and Neck Cancer

On February 10, 2020 NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205 – the "Company"), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy (Press release, Nanobiotix, FEB 10, 2020, View Source [SID1234554105]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.

A product that receives Fast Track designation is eligible for1:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from the FDA about such things as the design of proposed clinical trials and the use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of the New Drug Application (NDA) for review by the FDA, rather than waiting until the entire NDA is completed before the application can be reviewed
About NBTXR3

NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide radiotherapy radiation therapy standards of care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

NBTXR3 is actively being evaluated locally advanced head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I trial regarding local control. In the United States, the company has started the regulatory process for the clinical authorization of a phase II/III trial in locally advanced head and neck cancers.

Nanobiotix is also running an Immuno-Oncology development program. The Company received FDA approval to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in locoregional recurrent (LRR) or recurrent and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and lung or liver metastases (mets)from any primary cancer eligible for anti-PD-1.

The other ongoing NBTXR3 trials are treating patients with hepatocellular carcinoma (HCC) or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Furthermore, the company has a large-scale, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

Elorac to Present Naloxone Lotion Phase III Study Update at the 4th World Congress of Cutaneous Lymphomas in Barcelona

On February 10, 2020 Elorac, Inc., a biopharmaceutical company focused on developing best-in-class, innovative, proprietary drugs, reported that Scott Phillips, M.D., Sr. V.P. Scientific Affairs will present an update of its ongoing Phase III SPIRIT-2 trial evaluating the safety and efficacy of naloxone lotion for relief of pruritus (itching) associated with Cutaneous T-Cell Lymphoma ("CTCL") on February 12 at the 4th World Congress of Cutaneous Lymphomas in Barcelona (Press release, Elorac, FEB 10, 2020, View Source [SID1234554104]).

SPIRIT-2 is a multi-center, randomized, double-blind, crossover study comparing naloxone lotion 0.5% to its vehicle. CTCL patients with moderate-to-severe pruritus for at least 1-month duration receive either naloxone 0.5% or vehicle daily for a 14-day treatment period (Treatment Period 1), and then following a wash-out period, the alternative study medication for a second 14-day treatment period (Treatment Period 2). The study is currently being conducted at 20 sites in the United States and is being expanded to include sites in Europe, Canada, Australia and Asia.

Elorac received Orphan Drug Designation for naloxone lotion from both FDA and the European Medicines Agency (EMA). Elorac also has Fast Track designation from FDA for this novel investigational new drug. Fast Track designation provides for earlier and more frequent interaction with FDA during a drug’s development, eligibility for receiving priority review and accelerated approval from FDA. Elorac holds worldwide marketing rights to naloxone lotion.

About Naloxone

Naloxone is an opiate antagonist with no agonist activity. Intravenous and subcutaneous formulations of naloxone are used to treat opiate overdoses, and naloxone is used orally in combination with buprenorphine to treat opiate dependence.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL affects approximately 30,000 patients in the United States, with an estimated 3,000 new cases diagnosed each year. During the course of this disease most patients will experience chronic intractable pruritus unresponsive to standard antipruritic agents (e.g., antihistamines and topical corticosteroids). In addition to a very detrimental impact on quality of life, chronic intractable pruritus has been associated with a doubling of the mortality rate for individuals with CTCL. There are currently no approved therapeutic treatment options for pruritus associated with CTCL.

McKesson Launches Exchange Offer to Split-Off Its Interest in Change Healthcare

On February 10, 2020 McKesson Corporation (NYSE:MCK) reported the commencement of an exchange offer for the split-off of its wholly-owned subsidiary, PF2 SpinCo, Inc. ("SpinCo"), which will hold all of McKesson’s interest in Change Healthcare LLC ("Change Healthcare"), as part of McKesson’s previously announced agreement with Change Healthcare Inc. (Nasdaq:CHNG) ("Change") to merge SpinCo with and into Change (Press release, McKesson, FEB 10, 2020, View Source [SID1234554103]).

"We are very pleased to launch the split-off of our investment in Change Healthcare. We have concluded that now is the appropriate time to distribute our remaining stake in Change Healthcare," said Brian Tyler, chief executive officer, McKesson. "We expect this exchange offer will continue to deliver value to McKesson shareholders by reducing our number of outstanding shares in a tax-efficient manner. This transaction better positions McKesson to focus on our core business and signifies another important step in McKesson’s transformation to become a simpler, more focused organization."

The exchange offer represents the next step in McKesson’s planned exit from its investment in Change Healthcare, which will be effected through a "Reverse Morris Trust" transaction. In the exchange offer, McKesson stockholders will have the opportunity to exchange their shares of McKesson common stock for shares of SpinCo common stock, which will be immediately converted into an equal number of shares of Change common stock upon completion of the proposed merger, in each case subject to certain customary terms and conditions. The exchange offer and merger are generally expected to be tax-free to participating McKesson stockholders for U.S. federal income tax purposes except to the extent of any cash received in lieu of fractional shares of Change common stock.

Details of the Exchange Offer:

Holders of McKesson common stock will have the opportunity to exchange some or all of their shares for SpinCo common stock at a 7.0% discount per-share value, subject to an upper limit (as described below).
The discount means that tendering stockholders are expected to receive approximately $107.53 of SpinCo common stock for every $100 of McKesson common stock tendered and accepted in the exchange offer.
The number of shares a McKesson stockholder can receive in the exchange offer is subject to an upper limit of 11.4086 shares of SpinCo common stock for each share of McKesson common stock tendered and accepted in the exchange offer.
If the upper limit is in effect, then the exchange ratio will be fixed at that limit and tendering stockholders will receive less than $107.53 of SpinCo stock for each $100 of McKesson common stock.
McKesson will offer 175,995,192 shares of SpinCo common stock in the exchange offer. The number of shares of McKesson common stock that will be accepted in the exchange offer will depend on the final exchange ratio, the number of shares of McKesson common stock tendered and whether the upper limit is in effect.
SpinCo common stock will not be transferred to participating stockholders following the exchange offer. Such participants will instead receive shares of Change common stock in the merger immediately following the completion of the exchange offer. No trading market currently exists or will exist for shares of SpinCo common stock.
The exchange offer is scheduled to expire at 11:59 p.m., New York City time, on March 9, 2020, unless the exchange offer is extended or terminated.
Holders of McKesson common stock may withdraw their tendered shares at any time before the expiration date of the exchange offer.
Participants in the McKesson Corporation 401(k) Retirement Savings Plan (the "McKesson 401(k) Plan") will receive special directions from the plan administrator of the McKesson 401(k) Plan and to allow sufficient time for the tender of shares by the trustee of the McKesson 401(k) Plan, plan participants must provide the requisite instructions as directed by 4:00 p.m., New York City time, on March 3, 2020, unless the exchange offer is extended or terminated.
Subject to the upper limit, the final exchange ratio used to determine the number of shares of SpinCo common stock that participating stockholders will receive for each share of McKesson common stock accepted in the exchange offer will be calculated by McKesson by reference to the simple arithmetic average of the daily volume–weighted average prices, on each of the three Valuation Dates (as defined below), of McKesson common stock and Change common stock on the New York Stock Exchange and The Nasdaq Global Select Market, respectively, during a period of three consecutive trading days (the "Valuation Dates") ending on and including the second trading day preceding the expiration date of the exchange offer. Based on an expiration date of March 9, 2020, the Valuation Dates are expected to be March 3, March 4 and March 5, 2020. Unless the exchange offer is extended or terminated, the final exchange ratio will be announced in a press release no later than 11:59 p.m., New York City time, on March 5, 2020, and the exchange offer will expire at 11:59 p.m., New York City time, on March 9, 2020, leaving two trading days between the date that the final exchange ratio is announced and the expiration of the exchange offer.

The final exchange ratio, as well as a daily indicative exchange ratio beginning at the end of the third day of the exchange offer period, will also be available at www.dfking.com/McKesson.

Immediately following the completion of the exchange offer, SpinCo will merge with and into Change, whereby the separate corporate existence of SpinCo will cease and Change will continue as the surviving company. In the merger, each share of SpinCo common stock will be converted into one share of Change common stock. Change will issue 175,995,192 shares of Change common stock in the merger.

The exchange offer will be subject to proration if the exchange offer is oversubscribed, and the number of shares accepted in the exchange offer may be fewer than the number of shares tendered.

If the exchange offer is consummated but not fully subscribed, or if the upper limit is in effect and not all of the shares of SpinCo common stock owned by McKesson are distributed pursuant to the exchange offer, the remaining shares of SpinCo common stock owned by McKesson will be distributed in a spin-off on a pro rata basis to McKesson stockholders whose McKesson common stock remains outstanding after the consummation of the exchange offer.

The transaction is subject to customary closing conditions, including required regulatory approvals. Change’s board of directors previously approved the Merger and the Merger Agreement prior to the execution of the Merger Agreement on December 20, 2016. On January 17, 2017, the stockholders of Change approved the Merger, the Merger Agreement and the transactions contemplated thereby.

Upon completion of the merger, approximately 51 percent of the outstanding shares of Change common stock are expected to be held by pre-merger holders of McKesson common stock, and approximately 49 percent of the outstanding shares of Change common stock are expected to be held by pre-merger holders of Change common stock.

The terms and conditions of the exchange offer are more fully described in a registration statement on Form S-4 and Form S-1, including a prospectus forming a part thereof, filed by SpinCo with the U.S. Securities and Exchange Commission (the "SEC") today and a tender offer statement on Schedule TO filed by McKesson with the SEC today.

For more information about the exchange offer, please visit www.dfking.com/McKesson or contact the information agent, D.F. King & Co., at 1-866-304-5477 (toll-free in the United States) and 1-212-269-5550 (outside of the United States).

In connection with the transactions, Goldman Sachs & Co. LLC is acting as financial advisor and Davis Polk & Wardwell LLP is acting as legal advisor to McKesson.

OncoSec Announces Closing of the CGP/Sirtex Transaction

On February 10, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported that, following shareholder approval, the proposed strategic investment by and partnership (the "CGP/Sirtex Transaction") with Grand Decade Developments Limited, a wholly owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings Limited ("CGP"), and its U.S. affiliate, Sirtex Medical US Holdings, Inc. ("Sirtex") has closed (Press release, OncoSec Medical, FEB 10, 2020, View Source [SID1234554102]).

The CGP/Sirtex Transaction brings significant benefits to OncoSec, including:

Immediate Capital
An immediate $30 million cash infusion at $2.50 per share, an approximate 25% premium to the average share price over the 20 days prior to the signing of the deal on October 9, 2019. The capital received today will significantly help fund OncoSec’s ongoing KEYNOTE clinical trials of its lead product candidate, TAVO (plasmid-based interleukin-12), in combination with Merck’s KEYTRUDA to completion.
CGP Partnership Provides Access to Chinese Market
China is the second largest market in the world after the U.S., but historically has been challenging for U.S. biopharma companies to enter due to regulatory barriers.
As a public company listed on the Hong Kong stock exchange (with a market capitalization of approximately $1.8 billion), CGP is an active and established pharmaceutical leader in China. CGP currently develops, manufactures and distributes its products in China to approximately 6,000 hospitals and 30,000 pharmacies and has a sales team of more than 2,000 employees. It also has significant experience dealing with regulatory bodies, research and development and product commercialization in China.
OncoSec plans to leverage its strategic alliance with CGP to develop and introduce TAVO to the important Chinese market. Under the license agreement with CGP, OncoSec has granted an exclusive license to develop, manufacture and commercialize OncoSec’s current and future products in greater China and other Asian markets. CGP will pay for all development costs and will also pay OncoSec up to 20% royalties on the net sales of such products in the region, less development costs.
Sirtex Partnership Provides Access to Top-Notch Commercial Talent and Resources
Sirtex will support and assist OncoSec with pre-marketing activities for TAVO and its visceral lesion applicator (VLA) in exchange for low single-digit royalties on those products.
Sirtex is a global life-sciences company that has an approved medical device product for targeted radiation therapy for liver cancer. They have a highly experienced and dedicated oncology sales force and have supplied product to more than 1,300 medical centers in more than 45 countries.
"At a time when our peer companies are engaging in highly dilutive financings that often include discounts and the issuance of warrants, we are grateful that OncoSec’s progress to date enabled us to secure a premium investment by two first-rate healthcare companies," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "The license granted to CGP in greater China has significant value to OncoSec shareholders because it enables us to access the greater China market decades earlier than we ever would have been able to and with CGP bearing the development and commercialization costs. We will also now have the ability to access China for clinical data. Likewise, the services agreement with Sirtex is also very valuable for OncoSec as Sirtex, a company with significant sales and marketing capabilities, will conduct the requisite sales and marketing preparatory activities, which needs to begin now in order to be prepared to launch TAVO, should it gain regulatory approval. Both of these agreements bring significant economic value to our shareholders and we are excited to begin our partnership with CGP and Sirtex."

About CGP

CGP is a public company listed on the Hong Kong stock exchange with a market capitalization of approximately $2.1 billion USD. CGP develops, manufactures and distributes pharmaceutical products and medical devices to retailers and medical organizations. CGP currently distributes its products to approximately 6,000 hospitals and approximately 30,000 pharmacies and has a sales team of more than 2,000 employees. CGP also has significant experience in R&D and product commercialization in China. Such experience dealing with the relevant Chinese regulatory bodies makes CGP an ideal strategic partner for OncoSec as it looks to gain regulatory approval to introduce TAVO to the Chinese market. For more information, visit www.chinagrandpharm.com.

About Sirtex

Sirtex is a global healthcare business company with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex’s current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 45 countries. Sirtex’s global focus on drug development makes it a natural partner for the Company as it looks to develop and introduce TAVO into markets around the world. For more information, visit www.sirtex.com. SIR-Spheres is a registered trademark of Sirtex SIR-Spheres Pty Ltd.

CEL-SCI Corporation Reports First Quarter Fiscal 2020 Financial Results

On February 10, 2020 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2019 (Press release, Cel-Sci, FEB 10, 2020, View Source [SID1234554101]).

In October 2019, the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) performed an official review of the study data and recommended that the trial continue until the appropriate number of events has occurred. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. The IDMC reviewed "progression free and overall survival and limited demographic and safety data available for the aforementioned protocol."
The Company is now awaiting final study results for the Phase 3 trial, which is the largest study in the world in head and neck cancer. All that remains to be done is to continue to track patient survival until the required number of events have occurred and all of the data have been reviewed and recorded in the study database to allow a determination to be made if the primary endpoint has been met. The primary endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen plus standard of care (SOC) vs. SOC alone, the two main comparator arms of the study.
"Our study has now been running for 9 years with the last patients being enrolled in September 2016. We believe that the delay in reaching 298 events is a good sign for the study because patients appear to be living longer than was expected when the study was planned. However, we would be surprised if the study did not end soon. Since the study is well controlled and the SEER data base shows no improvement in the survival of patients treated with standard of care since the study began, it seems illogical that the patients living longer than expected would be patients receiving the standard of care therapies only. We are therefore preparing for commercial scale production of Multikine at our manufacturing facility," stated CEL-SCI CEO, Geert Kersten.

In December 2019, the Company raised gross proceeds of approximately $5.5 million through an underwritten public offering of 606,395 shares of its common stock at a price of $9.07 per share. In January 2020, the underwriters fully exercised the over-allotment option of an additional 90,959 shares of common stock at a price of $9.07 per share bringing the total gross proceeds to approximately $6.325 million.

CEL-SCI reported a net loss of approximately $5.5 million for the quarter ended December 31, 2019 versus net income of approximately $1.2 million for the quarter ended December 31, 2018. The net income decrease was mainly due to the non-cash derivative gain of approximately $0.8 million for the three months ended December 31, 2019 versus a gain on derivative instruments of approximately $5.6 million for the three months ended December 31, 2018. Net interest expense also decreased by approximately $0.2 million for the three months ended December 31, 2019 compared to the three months ended December 31, 2018.

CEL-SCI’s total operating expense increased by approximately $1.6 million for the quarter ended December 31, 2019 versus the quarter ended December 31, 2018. General and administrative expenses increased by approximately $0.9 million compared to the three months ended December 31, 2018. Approximately $0.7 million of the change relates to an increase in the non-cash employee stock compensation expense. Research and development expenses increased by approximately $0.7 million compared to the three months ended December 31, 2018. Major components of this increase include approximately $0.7 million of cost incurred preparing the manufacturing facility for the potential commercial manufacture of Multikine, $0.5 million increase in non-cash employee stock option expense and $0.2 million increase in depreciation expense on the manufacturing facility as a result of adopting the new leasing standard. These increases were offset by a decrease of approximately $0.7 million in expenses related to the Company’s on-going Phase 3 clinical trial.