On October 5, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported dosing of the first patient in China in the global Phase 3 POD1UM-304 study evaluating retifanlimab, an investigational anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with first-line metastatic non-small-cell lung cancer (NSCLC) (Press release, Zai Laboratory, OCT 5, 2020, View Source [SID1234568280]).

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"Non-small cell lung cancer is the most common tumor type and represents a significant unmet medical need in China," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "Anti-PD-1 therapies are the backbone to many current and future immuno-oncology therapy combinations and we are excited to contribute patients to the POD1UM-304 Phase 3 registrational study and join Incyte in its endeavor to bring this potential new therapy to patients globally."

POD1UM-304 is a Phase 3, randomized, multicenter, double-blind study evaluating retifanlimab in combination with platinum-based chemotherapy in patients with first-line metastatic squamous and non-squamous non-small cell lung cancer. The study is expected to enroll approximately 530 adult patients randomized to receive retifanlimab or placebo in combination with standard therapy of platinum-based chemotherapy. Zai Lab and its partner, Incyte, will cooperate in conducting the study in Greater China with Zai Lab taking the operational lead by conducting the screening, enrollment and treatment of patients in Greater China. The primary endpoints of the study are overall survival (OS) and progression-free survival (PFS) as determined by blinded independent central review using RECIST v1.1. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), safety and pharmacokinetics.

About NSCLC

Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 774,000 new cases and 690,500 deaths of lung cancer in China in 2018, respectively. NSCLC accounts for approximately 85 percent of lung cancer, and approximately 70 percent of NSCLC is locally advanced or metastatic at initial diagnosis.

About Retifanlimab (INCMGA0012)

Retifanlimab (formerly INCMGA0012), an investigational anti-PD-1 antibody, is currently under evaluation in registration-directed studies as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

On October 5, 2020 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs reported the inclusion of the first-in patient in a clinical study aimed at demonstrating the bioequivalence between Kimozo, the first pediatric formulation of temozolomide under clinical development, and Temodal capsule (Press release, ORPHELIA Pharma, OCT 5, 2020, View Source [SID1234568070]).

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Although not approved in this indication, temozolomide is an essential anticancer medicine recommended for use in treatment protocols of relapsed or refractory neuroblastoma, a condition that affects young children. However, the only oral formulations that are commercially available are in the form of capsules that are poorly adapted to children. Caretakers are thus compelled to open capsules and disperse the content into a soft food prior to administration to the child, which harbors several risks such as the uncertainty with regards to the delivered dose, the exposure of the caregiver to the cytotoxic drug and the instability of the drug in aqueous milieu. To overcome the risks this situation implies, Kimozo, a ready to use oral formulation has been specifically designed to address the needs of the pediatric population.

Kimozo has been developed in collaboration with Gustave Roussy, one of the leading cancer centers in Europe. The current clinical trial conducted by ORPHELIA Pharma aims at demonstrating, first for regulatory purposes, the bioequivalence between Kimozo and the Temodal capsules in adult patients having brain cancers, with additional clinical investigation to come in the pediatric population of interest.

"We have reached an important milestone for Kimozo with the clinical trial approval from competent authorities and the recruitment of a first patient", said Caroline Lemarchand, Chief Pharmaceutical Development Officer of ORPHELIA Pharma "We plan to enroll 30 patients by mid-2021 thanks to the support of the three neuro-oncology teams involved in the study: Professor Ducray of the Hospices Civils de Lyon (coordinating investigator), Professor Chinot of the Timone Hospital in Marseille and Dr Bronnimann of Saint-André Hospital in Bordeaux. "

"We are pleased to contribute to the development of this new pediatric formulation of temozolomide. A liquid form is unambiguously of interest for treating children.", underlines Pr. François Ducray. Hugues Bienaymé, General Manager of ORPHELIA Pharma further comments: "This first administration is a major milestone in the development of Kimozo. We are now preparing the opening of our second clinical trial, which will evaluate Kimozo in pediatric patients, by the end of the year ", he concludes.

About the Bioequivalence Study (NCT04467346)

The clinical trial entitled "Bioequivalence Study between temozolomide oral suspension (Ped-TMZ) and Temodal capsules" (NCT04467346) is an open label phase I study, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ, the code name of Kimozo) or Temodal, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations. The primary objective is to evaluate the bioequivalence between Kimozo and Temodal capsules for oral administration. The secondary objectives are to define the pharmacokinetic parameters of Kimozo administration and to assess its buccal safety.

The clinical centers are Hospices Civils de Lyon, Bron, France ; CHU de Bordeaux, Bordeaux, France and Hôpital de la Timone (AP-HM), Marseille, France. The Study sponsor is ORPHELIA Pharma.

About Kimozo

Kimozo (also known as ORP-005 or Ped-TMZ) is a ready-to-use and taste-masked oral suspension of temozolomide that is currently under development to address children needs. Kimozo is an investigational medicinal product not yet approved for marketing anywhere in the world.

On October 5, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that it has entered into a strategic collaboration with Angel Pharmaceuticals that will enable the development and commercialization of its pipeline of precisely targeted investigational medicines in China (Press release, Corvus Pharmaceuticals, OCT 5, 2020, View Source [SID1234568105]).

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Angel Pharmaceuticals is a new China-based biopharmaceutical company with a mission to bring innovative quality medicines to Chinese patients for treatment of serious diseases including cancer, autoimmune diseases and infectious diseases. It was formed as a Corvus wholly-owned subsidiary and was launched with a post-money valuation of $106 million, based on a $41 million cash investment from a Chinese investor group that includes funds associated with Tigermed and Betta Pharmaceuticals, Hisun Pharmaceuticals and Zhejiang Puissance Capital, which investments are subject to the satisfaction of certain customary conditions. Contemporaneously with the financing, Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – ciforadenant, CPI-006 and CPI-818 – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus will initially retain a 49.7% equity stake in Angel Pharmaceuticals and will be entitled to designate three individuals on Angel’s five-person Board of Directors.

"The formation and launch of Angel Pharmaceuticals to develop our product pipeline in greater China opens a significant new opportunity for Corvus," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "We expect Corvus shareholders will benefit from this collaboration in two main ways: our ownership position in Angel in the rapidly growing Chinese biotech market, and the acceleration of our product development capabilities through the participation of patients in China. We believe Angel is positioned for success as a science-based Chinese biopharmaceutical company backed by an impressive group of investors with financial resources, and significant regulatory, drug development and commercialization experience. Their investment is strong validation of Corvus’ pipeline and its importance in addressing unmet needs in the Chinese and global markets. We have already begun working with the Angel leadership to initiate clinical trials in China with ciforadenant, CPI-006 and CPI-818 in cancer, autoimmune diseases and infectious diseases within the next 12 to 18 months. We believe that the expertise and development capabilities at Angel will accelerate and enhance Corvus’ global development capabilities."

"Dr. Miller is a world-renowned drug developer and he has built a first class management team at Corvus. The Angel team is fortunate to partner with Dr. Miller and his team on their novel product portfolio, which has demonstrated impressive results to date in the clinic," said Dr. Ted Wang, managing partner of Puissance Capital, co-founder and board member of Angel Pharmaceuticals. "Angel is launching at an opportune time, benefiting from China’s explosive growth in demand for innovative medicines, reform in drug regulation and approvals, and change in IPO listing requirements specifically designed to encourage drug innovation."

"Our goal in launching Angel is to build a company that will have a long-term, positive impact on society. We have brought together a local team that is aligned with this mission and that is very experienced in the Chinese market, including expertise in research and development, clinical operations and regulatory affairs, business development, and intellectual property protection. By standing on the shoulders of Corvus, Angel can accelerate drug development and bring innovative medicines, including internally developed programs, to patients in China and globally faster."

Strategic Rationale for Corvus

Establishes 49.7% ownership in a uniquely positioned biopharmaceutical company in the rapidly growing Chinese market.
Clinical study synergies and accelerated timelines, whereby data from patients enrolled in China studies could potentially be used as part of U.S. regulatory submissions as part of a global pivotal study protocol.
Research and development synergies, whereby Corvus will benefit from Angel’s research and development efforts and China’s deep pool of talented researchers.
Establishes collaboration with leading Chinese investors, biopharmaceutical companies and scientists with experience in regulatory affairs, clinical development, manufacturing and commercialization.
Launching with a Uniquely Positioned and Validated Oncology Pipeline
Angel Pharmaceuticals will be responsible for the clinical development and commercialization, including all related expenses, of the licensed pipeline programs in China, and for the pre-clinical BTK program globally. It plans to initiate clinical trials in China for ciforadenant, CPI-006 and CPI-818 in the next 12 to 18 months. In the United States, Corvus is planning to meet with the U.S. Food & Drug Administration (FDA) in December 2020 to discuss the study design and plans for a pivotal ciforadenant study in advanced refractory renal cell cancer (RCC) using the Adenosine Gene Signature as a biomarker. Angel Pharmaceuticals’ clinical trial activity in China is expected to be part of this global pivotal study. Angel Pharmaceuticals’ cash position at launch is expected to provide runway beyond its first two years. Such cash will not be available for uses by Corvus.

Strong Leadership Team, and Board of Directors
Angel Pharmaceuticals will have well-known, experienced local pharmaceutical executives with management experience in multinational companies in clinical, regulatory and research. At launch, the senior team includes seven leaders that hold a medical degree or Ph.D., and the company plans to expand its team with leading scientific talent in China. In addition, Dr. Miller, a co-founder of Angel, will serve as Chairman of the Board and interim chief executive officer, working closely with the founding leadership team.

The Angel Pharmaceuticals Board of Directors will initially be comprised of:

Richard Miller, chairman and chief executive officer of Corvus Pharmaceuticals
Leiv Lea, chief financial officer of Corvus Pharmaceuticals
Peter Thompson, Private Equity Partner with OrbiMed Advisors and co-founder and board member of Corvus Pharmaceuticals
Ted Wang, chief investment officer of Puissance Capital
Conference Call Details
Corvus will host a conference call and webcast today, Monday, October 5, 2020, at 8:30 a.m. ET (5:30 a.m. PT), to discuss the launch of Angel Pharmaceuticals. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13711371. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

On October 2, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic (CDx) for the tropomyosin receptor kinase (TRK) inhibitor, larotrectinib for the treatment of tropomyosin receptor kinase fusion cancer on July 30, 2020 (Press release, Chugai, OCT 2, 2020, View Source [SID1234567898]).

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"Neurotrophic tyrosine receptor kinase (NTRK) gene fusions are rare and occur across various tumor types regardless of age. Comprehensive genomic profiling is a useful tool for detecting this rare fusion gene," said Dr. Osamu Okuda, Chugai’s President and COO. "We hope FoundationOne CDx Cancer Genomic Profile will become available as a CDx for larotrectinib with this filing and will promote advanced personalized healthcare by providing information that can support informed treatment decisions for more patients."

FoundationOne CDx evaluates substitutions, insertion and deletion alterations (indels), and copy number alteration in 324 genes and select gene rearrangements, inclusive of gene fusions. The filing aims to expand the use of FoundationOne CDx Cancer Genomic Profile as a CDx to identify patients who could benefit from larotrectinib for the treatment of TRK fusion cancer by detecting NTRK gene fusions which produces the TRK fusion protein across solid tumors. The efficacy and safety of larotrectinib was investigated in clinical trials conducted by Bayer; phase I trial of adult patients, the phase II NAVIGATE trial in adult and adolescent patients, and the phase I/II pediatric SCOUT trial. Bayer Yakuhin, Ltd. submitted an application of larotrectinib for the treatment of TRK fusion cancer to the MHLW on May 22, 2020.

As a leading company in the field of oncology, Chugai is committed to advancing personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About larotrectinib
Larotrectinib, a specific oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. Larotrectinib, was granted Orphan Drug Designation by the Ministry of Health, Labour and Welfare for the expected indication of "Locally advanced or metastatic solid tumor harboring an NTRK gene fusion".

Trademarks used or mentioned in this release are protected by laws.

On October 2, 2020 Aptorum Group Limited (Nasdaq:APM, Euronext Paris:APM) ("Aptorum Group" or "Aptorum"), a biopharmaceutical company focused on novel technologies including the targeting of infectious diseases, reported the closing of a public offering of 2,769,231 Aptorum’s Class A ordinary shares (or ordinary share equivalents) and warrants to purchase up to 2,769,231 Class A Ordinary Shares, at a combined public offering price of $3.25 per share and related warrant (Press release, Aptorum, OCT 2, 2020, View Source [SID1234567984]). The warrants have an exercise price of $3.25 per share, are exercisable immediately upon issuance and expire on the five year anniversary of the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to Aptorum Group from the offering are approximately $9.0 million, before deducting the placement agents’ fees and other estimated offering expenses. Aptorum Group intends to use the net proceeds from the offering primarily to conduct further analyses of SACT-1 (a repurposed drug for neuroblastoma & other solid Tumors) and ALS-4 (a small drug molecule candidate for Staphylococcus aureus including MRSA), which are currently on track for IND submission to commence Phase 1b/2a human clinical trials and undergoing final stages of IND enabling studies to initiate Phase 1 human clinical trials respectively, and to accelerate the developments of our pipeline into their respective clinical phases, as well as for expanding businesses, working capital and general corporate purposes.

A registration statement on Form F-1 relating to this offering (file number 333-248743) was declared effective by the Securities and Exchange Commission ("SEC") on September 29, 2020 and an additional registration statement on Form F-1MEF (file number 333-249140) filed pursuant to Rule 462(b) became effective upon filing on that same date. The offering of the Company’s securities was made by means of a prospectus forming a part of the registration statement. The registration statements on Form F-1 and Form F-1MEF and the final prospectus relating to the Offering are available on the SEC’s website at www.sec.gov. Copies of the final prospectus relating to the offering may be obtained by contacting H.C. Wainwright & Co. at 430 Park Avenue, New York, New York 10022, by telephone: (212) 356-0500, or by email at [email protected].

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