On October 25, 2017 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in hard-to-treat cancers, reported that the Company will participate in the Life Sciences Summit 2017 on November 1-2 in New York City and the Jefferies 2017 London Healthcare Conference on November 15-16 (Press release, 2X Oncology, OCT 25, 2017, View Source [SID1234526101]).

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!

Chief Executive Officer George O. Elston will participate in and hold 1x1s with investors at both conferences, joined by Chief Financial Officer Jarne Elleholm.

Additionally, Mr. Elston will present in the Emerging Company Showcase at the Life Sciences Summit on Thursday, November 2, 2017 at 3:30pm EDT, with a discussion period to follow.

Investors wishing to meet with 2X Oncology at or around either conference should notify the respective conference one-on-one desk, or contact Amy Raskopf to schedule a meeting.

On October 25, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of anti-HER2 humanized monoclonal antibody, "Perjeta I.V. Infusion 420mg/14mL [generic name: pertuzumab (genetical recombination)] (hereafter, Perjeta)" for the additional indication of adjuvant therapy for HER2-positive early breast cancer (Press release, Chugai, OCT 25, 2017, View Source [SID1234521138]).

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!

"Currently, adjuvant chemotherapy with Herceptin for HER2-positive early breast cancer has been recommended in the clinical practice guidelines for breast cancer and has contributed to patients," said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. "We are going to continue discussions with the health authorities so that adjuvant chemotherapy using Perjeta in combination with Herceptin, which has outperformed the current standard of care, will be used as a new treatment option for patients."

Chugai filed the application with the MHLW based on the results from the APHINITY study (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer) and several clinical studies. The APHINITY study is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy (anthracycline medicine followed by docetaxel monotherapy / docetaxel plus carboplatin) compared to Herceptin and chemotherapy as adjuvant therapy in 4,805 patients with HER2-positive early breast cancer who undergone curative surgery. The primary endpoint of the APHINITY study is invasive disease-free survival (iDFS), which is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. The secondary endpoints were cardiac and overall safety, and other endpoints.

The results of the APHINITY study are as follows:

– At three years, iDFS, the primary endpoint, was 94.1% in the Perjeta arm and 93.2% in the control arm, and a statistically significant improvement was observed in the Perjeta arm. Perjeta arm significantly reduced the risk of recurrence or death by 19% compared to control arm (HR=0.81, 95%CI 0.66-1.00, stratified log-rank test, p=0.045).

– The iDFS at four years estimated by the Kaplan-Meier method showed that 92.3% (95%CI: 91.1-93.4) of people treated with the Perjeta arm did not have their breast cancer return compared to 90.6% (95%CI: 89.3-91.8) treated with control arm.

– The safety profile of Perjeta was consistent with that seen in previous studies. The incidence of cardiac events was 0.7% in the Perjeta arm and 0.3% in the control arm.

In the US and Europe, Perjeta is under review for postoperative adjuvant chemotherapy for HER2-positive breast cancer, and the US Food and Drug Administration has granted Priority Review to Perjeta for this indication. Perjeta was approved for adjuvant therapy (before surgery) for HER2-positive early breast cancer in September 2013 in the US and in July 2015 in Europe.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will work for early approval to provide Perjeta as a new treatment option for patients with HER2-positive early breast cancer.

On October 25, 2017 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare diseases, reported that the American Association for Cancer Research (AACR) (Free AACR Whitepaper) has published Phase 1 data from an ongoing Phase 1/2 study of X4P-001-IO in combination with Inlyta (axitinib), Pfizer’s VEGFR kinase inhibitor (Press release, X4 Pharmaceuticals, OCT 25, 2017, View Source [SID1234521155]). Updated preliminary efficacy data along with safety and tolerability of the combination will be highlighted in a poster presentation at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 26-30 in Philadelphia, Pennsylvania.

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!

Details of the Poster Presentations on X4P-001-IO:
Poster Title: A Phase 1 dose finding study of X4P-001 (an oral CXCR4 inhibitor) and axitinib in patients with advanced renal cell carcinoma (RCC)
Author: Atkins, Michael
Session Category: Tumor Microenvironment
Session Date and Time: Sunday Oct 29, 2017 12:30 PM – 4:00 PM
Location: Hall E, Pennsylvania Convention Center
Permanent Abstract Number: B201

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule inhibitor of CXCR4 (C-X-C receptor type 4) that regulates the tumor microenvironment thereby enhancing endogenous anti-tumor responses. CXCR4 is a chemokine receptor that modulates immune function and angiogenesis through the trafficking of key immune cells such as T- cells, dendritic cells, and myeloid derived suppressor cells. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment.

About Renal Cell Carcinoma

Kidney cancer is among the ten most common cancers in both men and women with more than 60,000 new diagnoses each year in the United States.1 Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer, and advanced ccRCC accounts for approximately 20% of the patient population. Therapies for advanced ccRCC include immunotherapies, mammalian target of rapamycin (mTOR) kinase inhibitors, and angiogenesis inhibitors, such as vascular endothelial growth factor (VEGF) inhibitors.2 There continue to be unmet medical needs with advanced ccRCC because durable responses remain a serious clinical challenge for patients with advanced disease.

On October 25, 2017 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported preliminary results from its Phase 1 study of its proprietary oral Endoxifen (Press release, Atossa Genetics, OCT 25, 2017, View Source [SID1234521149]). All objectives were successfully met:

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!

– Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral Endoxifen.

– Tolerability: Oral Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.

– Pharmacokinetics: Oral Endoxifen demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer.
These data demonstrate the suitability of oral Endoxifen for further clinical development.

The Phase 1 Study

The Phase 1 study was a double-blind, placebo-controlled, repeat dose study of 48 healthy female subjects. Atossa assessed safety, tolerability and the pharmacokinetics of proprietary formulations of both topical and oral Endoxifen dosage forms in varying dose levels over 28 days. The study was conducted in two parts based on route of administration. Preliminary results from the topical arm of the study were announced on September 14, 2017.

Atossa’s Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen is a “pro-drug” meaning that it must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. It is these active metabolites that have the therapeutic effect.

Oral Endoxifen. Although approximately one million breast cancer survivors take tamoxifen annually, up to half of them do not fully benefit from tamoxifen, meaning they are “refractory,” for a number of reasons including that they do not properly metabolize tamoxifen into its active metabolites. Low endoxifen levels in breast cancer patients taking oral tamoxifen are associated with an increased risk of recurrence or the development of new breast tumors. Thus providing oral Endoxifen directly to the patient without having to be metabolized may help to address this problem.

Topical Endoxifen. A condition called breast density (or, MBD), typically diagnosed by a mammogram, has been shown to be an independent breast cancer risk factor. To date, 30 states require that findings of MBD be directly communicated to the patient. We believe a topical form of Endoxifen could potentially reduce MBD. Although oral tamoxifen has been shown to reduce MBD, the benefit-cost ratio is not acceptable to most physicians and their patients. For example, it is estimated that less than 5% of women at an increased risk of developing breast cancer including those with MBD take oral tamoxifen to prevent breast cancer because of the risk of, or actual side-effects of, oral tamoxifen. We are planning a Phase 2 study of topical Endoxifen in Stockholm, Sweden for the treatment of MBD.

Based on the number of women with MBD and the number of patients who have survived breast cancer but are not fully benefiting from tamoxifen, Atossa estimates that the potential markets for its proprietary oral and topical formulations of Endoxifen could potentially exceed $1 billion in annual sales.

Next Steps

“Based on these positive preliminary results, we are advancing our oral Endoxifen into Phase 2 studies,” commented Dr. Steven C. Quay, CEO and President. “We expect our initial Phase 2 study will be in women who are refractory to tamoxifen and we expect to begin that study in the first quarter of 2018,” continued Dr. Quay.

Breast Cancer Statistics

The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017.

Conference Call

Atossa Genetics will host a conference call to discuss preliminary results today at 10 am Eastern time.

To listen to the call by phone, interested parties within the U.S. should call 1-844-824-3830, International callers should call 1-412-317-5140 and Canadian callers should call 1-855-669-9657. All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company’s IR events page at View Source

A replay of the call will be available approximately one hour after the end of the call through November 24, 2017. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay conference ID number is 10113835.

On October 25, 2017 Incyte Corporation (NASDAQ:INCY) and MacroGenics, Inc. (NASDAQ:MGNX) reported that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1) (Press release, MacroGenics, OCT 25, 2017, View Source [SID1234521156]). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while MacroGenics retains the right to develop its pipeline assets in combination with MGA012.

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!

"Anti-PD-1 therapy is becoming a mainstay of cancer treatment across multiple tumor types, and we believe the addition of MGA012 to our clinical pipeline is important to fulfilling our long-term development strategy in immuno-oncology. This collaboration with MacroGenics will allow us to rapidly explore the potential clinical benefit of developing MGA012 as a monotherapy and also combining anti-PD-1 therapy with several of our existing portfolio assets," said Steven Stein, M.D., Chief Medical Officer of Incyte.

"We believe Incyte is the ideal partner for MGA012, given its immuno-oncology portfolio and dedication to researching and developing innovative and transformative cancer therapies and we hope that the combined resources of both companies will be able to significantly expand and accelerate the current development efforts for this promising molecule," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Furthermore, we look forward to exploring the combination of MGA012 with multiple molecules in our own portfolio, including DART molecules for redirected T-cell killing, antibodies with enhanced effector function and ADCs, potentially to provide improved patient benefit."

Enrollment in the dose escalation portion of the Phase 1 study of MGA012 has been completed and the molecule is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the study. Data from the dose escalation portion of the Phase 1 study have been accepted for poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in November 2017.

Terms of the Collaboration

Upon closing, Incyte will pay MacroGenics an upfront payment of $150 million. Incyte will receive worldwide rights to develop and commercialize MGA012 in all indications.

Per the terms of the collaboration, MacroGenics will also be eligible to receive up to $420 million in potential development and regulatory milestones, and up to $330 million in potential commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte.

Under the terms of the collaboration, Incyte will lead global development of MGA012. MacroGenics retains the right to develop its pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and MacroGenics commercializing its asset(s), if any such potential combinations are approved.

In addition, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012. MacroGenics intends to utilize its commercial-scale GMP facility, which is expected to be fully operational in 2018.

The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.