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Alligator Bioscience: First Patient Dosed in Phase I study of ATOR-1015

On March 7, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the first patient has successfully been dosed in its phase I study of ATOR-1015, its drug candidate in development for tumor-directed immunotherapy (Press release, Alligator Bioscience, MAR 7, 2019, View Source [SID1234538669]). ATOR-1015 is designed with properties that shall enable it to accumulate in the tumor area after an intravenous injection, and selectively exert its effect there.

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The study, being initiated in five different clinics across Sweden and Denmark, is a first-in-human dose-escalation study in up to 53 patients with advanced solid tumor disease. The primary aim of the study is to investigate the safety and tolerability of the drug and to identify the recommended dose for subsequent phase II studies. The results of the study are expected to read out in the second half of 2020.

"I state with satisfaction that ATOR-1015 is the first investigational tumor-localizing bispecific CTLA-4 antibody ever being tested in the clinic. With this, Alligator takes the lead in a very hot area of research. While immune activation through CTLA-4 has shown impressive efficacy in multiple cancers, it is coupled with severe toxicity. We believe that ATOR-1015 will be at least as effective as the approved monospecific CTLA-4 antibody Yervoy, and with less side effects," said Per Norlén, CEO of Alligator. "As the study progresses we look forward to learning more about the potential of this investigational medicine to improve the treatment of multiple cancers".

As previously communicated, Alligator has appointed Theradex Oncology, a global contract research organization with extensive expertise in oncology clinical development, to conduct the phase I study.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11:45 a.m. CET on March 7, 2019.

About ATOR-1015
ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T-cell depletion. It is wholly-owned by Alligator. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

About Yervoy
The active ingredient in Yervoy is ipilimumab, a protein that helps the body’s immune system to attack and destroy cancer cells. Yervoy is approved for the treatment of advanced melanoma (a type of skin cancer), and for combination treatment of advanced renal cell cancer (RCC) and colorectal cancer (MSIhigh CRC). The global total sales of Yervoy amounted to USD 1.2 billion in 2017. (Source: Fass.se, Cowen Therapeutics Outlook March 2018.)

First Patient Dosed in a Phase II Randomized Study of L-DOS47 With Vinorelbine and Cisplatin

On March 7, 2019 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, is reported the first patient has been successfully dosed with L-DOS47, vinorelbine and cisplatin in its Phase IIB, open-label, randomized study in metastatic lung adenocarcinoma patients (LDOS003 study) (Press release, Helix BioPharma, MAR 7, 2019, View Source [SID1234536458]). The goals of the study are to compare the safety, tolerability and preliminary efficacy of L-DOS47 in combination with vinorelbine/cisplatin as compared to vinorelbine/cisplatin alone, in patients with lung cancer.

The LDOS003 study involves two parts: In Part 1 of the study (dose escalation), patients in cohorts will receive escalating amount of L-DOS47 in combination with vinorelbine/cisplatin. Once the maximum tolerated dose of L-DOS47 as an adjunct to vinorelbine/cisplatin is determined, patients in Part 2 of the study (randomized treatment) will be randomly assigned to receive L-DOS47 in combination with vinorelbine/cisplatin or vinorelbine/cisplatin alone. Additional information about the trial can be found in the EU Clinical Trials Register (View Source).

"This is our second chemo-combination study for L-DOS47 in advanced non-small lung cancer study," said Dr. Heman Chao Ph.D., Chief Executive Officer of Helix. "We are very excited to see that L-DOS47 continues to advance in this disease indication.

CASI PHARMACEUTICALS ANNOUNCES CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) APPROVAL OF CTA TO CONDUCT REGISTRATION TRIAL FOR MARQIBO®

On March 7, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. based pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world, reported that the National Medical Products Administration (NMPA) has approved the Company’s Clinical Trial Application (CTA) allowing for a registration clinical trial to evaluate the efficacy and safety of vincristine sulfate LIPOSOME injection (MARQIBO) (Press release, CASI Pharmaceuticals, MAR 7, 2019, View Source [SID1234534307]).

MARQIBO is a U.S. Food and Drug Administration (FDA)-approved product currently marketed in the U.S. by Spectrum Pharmaceuticals, Inc. (Spectrum), for the treatment of adult patients with Philadelphia chromosome–negative (Ph‒) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. CASI acquired greater China rights to this drug from Spectrum.

The Company is currently reviewing certain requirements provided by the Center for Drug Evaluation (CDE), a division of the NMPA, and upon satisfying those requirements, the Company will commence the registration trial for MARQIBO.

Wei-Wu He, Ph.D., CASI’s Executive Chairman commented, "Ph negative ALL is a rare but aggressive disease and while patient outcomes have vastly improved over the last three decades, patients continue to relapse and current salvage therapies are inadequate, particularly among the aging Chinese patient population. MARQIBO is the first and only liposome-encapsulated vincristine approved and marketed in the U.S. for second line treatment of adult Philadelphia chromosome-negative acute lymphoblastic leukemia and has been safely administered in patients since its U.S. approval in 2012. Receiving NMPA approval to conduct the registration trial in China with MARQIBO is an important milestone for CASI. This approval, along with the recent CTA approval for ZEVALIN and the fast track market approval of EVOMELA, further demonstrates CASI’s regulatory strength in working with the NMPA to advance products through the approval process."

Athenex Regains Rights to KX2-391 in China

On March 7, 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 upon Athenex’s request, Athenex and Chongqing Jingdong Junzhuo Pharmaceutical Co., Ltd. ("Chonqing Jingdong Pharmaceutical") have mutually agreed to terminate the licensing and partnership agreement entered into on December 30, 2018 (Press release, Athenex, MAR 7, 2019, View Source [SID1234534172]).

Pursuant to the original agreement, Athenex, via Chongqing Taihao Pharmaceutical Co., Ltd. (an Athenex subsidiary in China), granted to Chongqing Jingdong Pharmaceutical the rights to exclusively commercialize KX2-391 for the treatment of actinic keratosis and oncology indications in humans in mainland China (excluding Hong Kong, Macau and Taiwan). Under the terms of the termination agreement, Athenex has regained the rights to commercialize KX2-391 in mainland China. The decision of both parties to terminate the licensing and partnership agreement has no connection with the progress or the results of any of the clinical studies of the KX2-391 program.

Johnson Lau, Chief Executive Officer of Athenex, commented, "We believe KX2-391 is an important drug candidate with the potential to drive significant economic value for Athenex. We remain committed to the global development and commercialization efforts. The compelling clinical profile of KX2-391 ointment was highlighted in the Late-Breaking Program at the recent 2019 American Academy of Dermatology Annual Meeting, where the topline results of our two pivotal Phase III studies were presented. We believe we are well positioned to align our development strategies in mainland China as we continue to evaluate options for KX2-391 globally."

For further information on the topline results from the two pivotal Phase III studies of KX2-391 ointment in the treatment of actinic keratosis released on March 4, 2019, please visit the Press Releases page of the Investor Relations section of Athenex’s website at www.athenex.com and review SEC filings on www.sec.gov.

KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor. KX2-391 ointment is a topical medicinal product for the treatment of actinic keratosis that is in late stage Phase III development. Actinic keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly, or crusty skin. Other drug candidates with KX2-391 as the active ingredient are also being developed for oncology indications.

Alnylam to Webcast Presentation at Cowen & Company 39th Annual Health Care Conference

On March 7, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present a company overview at the Cowen & Company 39th Annual Health Care Conference on Wednesday, March 13, 2019 at 11:20 am ET at the Marriott Copley Place in Boston (Press release, Alnylam, MAR 7, 2019, View Source [SID1234534171]).

A live audio webcast of the presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after the event.