On September 11, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that its partner, Guangzhou Xiangxue Pharmaceutical Co., Ltd., initiated a Phase I study in China of KX2-361 (formerly known as KX-02) oral treating advanced malignant solid tumors (Press release, Athenex, SEP 11, 2019, View Source [SID1234573887]).

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KX2-361, which is being developed for the treatment of glioblastoma multiforme (GBM), is the second compound derived from Athenex’s Src kinase inhibition platform. It is a closely related structural analog of Athenex’s tirbanibulin (formerly known as KX2-391 or KX-01) with a distinct ability to cross the blood brain barrier, making it a potential therapeutic candidate for treating brain cancers, including GBM, as well as brain metastases. Studies of KX2-361 oral in preclinical mouse GBM tumor models resulted in complete tumor eradication as well as extended survival compared to the current standard of care, temozolomide.

"KX2-361 is a potentially valuable treatment option for GBM patients, and we are initiating this Phase I study on the strength of encouraging results in preclinical studies," stated Mr. YongHui Wang, Chairman of Xiangxue Pharmaceutical. "We are excited to advance this promising candidate in the clinic to potentially improve the lives of patients with GBM."

"We are impressed by the R&D capabilities of our partner and delighted by their decision to advance another product candidate from our Src kinase inhibition platform," stated Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "KX2-361 may potentially expand the range of cancers we can address with our broad oncology pipeline, especially for rare diseases with significant unmet medical need like GBM."

The Phase I clinical study in China is a single-center, open-label dose escalation trial that will enroll 36-72 patients with advanced malignant solid tumors who have no standard treatment or standard treatment failed.

In 2012, Athenex out-licensed KX2-361 to Xiangxue Pharmaceutical for development and marketing in Greater China and Singapore. In May 2017, the China National Medical Products Administration (NMPA) (formerly China FDA) allowed Xiangxue’s IND to commence clinical trials of KX2-361 in China. Athenex also received U.S. IND allowance for KX2-361 in 2014 and the product candidate was granted Orphan Drug Designation by the U.S. FDA.

On September 11, 2019, Ziopharm Oncology, Inc. (the "Company") reported that it has entered into a securities issuance agreement (the "Securities Agreement") with an institutional and accredited investor (the "Investor") who is a holder of warrants to purchase the Company’s common stock that were issued in November 2018 (the "Existing Warrants"), pursuant to which (i) the Investor agreed to exercise their remaining Existing Warrants for an aggregate of 2,787,879 shares of common stock, at an exercise price of $3.01 per share and (ii) the Company agreed to issue to the Investor new warrants to purchase 2,787,879 additional shares of the Company’s common stock, at an exercise price of $7.00 per share (the "New Warrants"), for gross proceeds to the Company of approximately $8.4 million (collectively referred to as the "Private Placement") (Filing, 8-K, Ziopharm, SEP 11, 2019, View Source [SID1234539500]). The Private Placement closed on September 13, 2019. The form of Securities Agreement, New Warrants and Registration Rights Agreement (as defined below) are substantially similar to the terms of the private placement transaction closed by the Company in August 2019 and described in the Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on August 1, 2019.

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The New Warrants issued to the Investor on the closing date of the Private Placement will become exercisable on the date that is six months following the date of issuance and will have a term of five years from the date of issuance. The New Warrants may be exercised by cashless exercise or by payment of cash, subject to adjustment therein. Subject to limited exceptions, a New Warrant holder will not have the right to exercise any portion of its New Warrants if the New Warrant holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the New Warrant holder may increase, decrease or terminate the Beneficial Ownership Limitation. The Securities Agreement also contains representations, warranties, indemnification and other provisions customary for transactions of this nature.

The securities issued by the Company pursuant to the Securities Agreement and to be issued upon exercise of the New Warrants have not been registered under the Securities Act of 1933, as amended (the "Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The Company is relying on the private placement exemption from registration provided by Section 4(a)(2) of the Securities Act and by Rule 506 of Regulation D, promulgated thereunder and on similar exemptions under applicable state laws. The Company will file a Form D with the SEC in accordance with the requirements of Regulation D.

Registration Rights Agreement

In connection with the Private Placement, the Company also entered into a registration rights agreement, dated September 11, 2019 (the "Registration Rights Agreement") with the Investor. Pursuant to the terms of the Registration Rights Agreement, the Company has agreed to prepare and file a registration statement (the "Registration Statement") with the SEC within 60 business days after the closing of the Private Placement for the purposes of registering the resale of the common stock underlying the New Warrants. The Company has also agreed, among other things, to pay all fees and expenses (excluding any legal fees of the selling holder(s), and any underwriting discounts and selling commissions) incident to the Company’s obligations under the Registration Rights Agreement.

On September 11, 2019 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the Ladenburg Thalmann 2019 Healthcare Conference on Tuesday, September 24, 2019 at 10:30 am at the Sofitel Hotel in New York City (Press release, MediciNova, SEP 11, 2019, View Source [SID1234539470]). Management will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Ladenburg Thalmann.

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On September 11, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that clinical data on its investigational anti-PD-1 antibody tislelizumab, its investigational BTK inhibitor zanubrutinib, and its investigational PARP inhibitor pamiparib, will be presented in seven oral presentations and four poster presentations at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO), taking place September 18-22, 2019 in Xiamen, China (Press release, BeiGene, SEP 11, 2019, View Source [SID1234539469]).

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Oral Presentations:

Title: Tislelizumab in Chinese Patients with Non-Small Cell Lung
Cancer (NSCLC) and Nasopharyngeal Carcinoma (NPC)
Session: Lung Cancer Session 1
Date: Thursday, September 19
Time: 11:20 – 11:25
Location Auditorium, Level 1
Presenter Qing Zhou, M.D., Ph.D., Guangdong Provincial People’s Hospital

Title: Tislelizumab for Relapsed/Refractory Classical Hodgkin
Lymphoma: Updated Follow-up Efficacy and Safety Results
from a Phase 2 Study
Session: Innovative Drug Clinical Data Session 1
Date: Thursday, September 19
Time: 14:30 – 14:40
Location Strait Hall, Level 2
Presenter: Yuqin Song, M.D., Ph.D., Beijing Cancer Hospital

Title: Tislelizumab in Chinese Patients with Melanoma, Urothelial
Carcinoma (UC), and Renal Cell Carcinoma (RCC)
Session: Kidney Cancer Session 4
Date: Thursday, September 19
Time: 16:35 – 16:40
Location Conference Room 2A, Level 2
Presenter: Lili Mao, M.D., Ph.D. Beijing Cancer Hospital

Title: Tislelizumab in Chinese Patients with Esophageal Cancer
(EC), Gastric Cancer (GC), Hepatocellular Carcinoma (HCC),
and Microsatellite Instability-High/Mismatch Repair Deficient
(MSI-H/dMMR) Tumors
Session: Advanced Gastric Cancer Session 3
Date: Friday, September 20
Time: 11:24 – 11:36
Location Banquet Hall 1, Level 2
Presenter: Lin Shen, M.D., Ph.D., Beijing Cancer Hospital

Title: Safety and Efficacy in Patients with Long-Term Exposure
(LTE) to Tislelizumab, an Investigational Anti-PD-1 Antibody,
in a First-in-Human Phase 1 Study
Session: Immuno-Oncology Session 3
Date: Friday, September 20
Time: 11:54 – 12:00
Location Hall 1G, Level 1
Presenter Chia-Jui Yen, M.D., Ph.D., National Cheng Kung University Hospital

Title: Tislelizumab Plus Chemotherapy as First-Line Treatment for
Chinese Patients with Lung Cancer
Session: Lung Cancer Session 3
Date: Saturday, September 21
Time: 11:38 – 11:44
Location Auditorium, Level 1
Presenter: Zhijie Wang, M.D., Ph.D., Cancer Hospital, Chinese Academy of Medical Sciences

Title: Tislelizumab in Combination with Chemotherapy as
Treatment for Chinese Patients with Esophageal Squamous
Cell Carcinoma (ESCC)
Session: Innovative Drug Clinical Data Session 1
Date: Saturday, September 21
Time: 14:30 – 14:40
Location Banquet Hall 2, Level 2
Presenter: Ru Jia, M.D., The Fifth Medical Center, General Hospital of the People’s Liberation Army

Poster Presentations:

Title: Dose Escalation of Pamiparib in Chinese Patients with High-
Grade Non-Mucinous Ovarian Cancer (HGOC) or Advanced
Triple-Negative Breast Cancer (TNBC)
Board #: P-36
Date: Thursday, September 19
Time: Afternoon
Location: Strait Hall Poster Area, Level 2
Presenter: Xiyan Mu, M.D., BeiGene

Title: Zanubrutinib for Patients with Relapsed or Refractory
Chronic Lymphocytic Leukemia or Small Lymphocytic
Lymphoma
Board #: P-45
Date: Friday, September 20
Time: Morning
Location: Strait Hall Poster Area, Level 2
Presenter: Meng Ji, M.D., BeiGene

Title: Zanubrutinib, a Highly Specific BTK Inhibitor in Chinese
Patients with Relapsed/Refractory B-cell Malignancies:
Follow-up Report of a Phase 1 Trial in China
Board #: P-46
Date: Friday, September 20
Time: Morning
Location: Strait Hall Poster Area, Level 2
Presenter: Chenmu Du, M.D., BeiGene

Title: The molecular binding mechanism of tislelizumab, an
investigational anti-PD-1 antibody, is differentiated from
pembrolizumab and nivolumab
Board #: P-60
Date: Friday, September 20
Time: Morning
Location: Strait Hall Poster Area, Level 2
Presenter: Ye Liu, Ph.D., BeiGene

On September 11, 2019 Biogen Inc. (Nasdaq:BIIB) reported it will report third quarter 2019 financial results Tuesday, October 22, 2019, before the financial markets open (Press release, Biogen, SEP 11, 2019, View Source [SID1234539468]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.