On October 5, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that efficacy results of neratinib in HER2-positive, hormone receptor-positive (HR+), early stage breast cancer (eBC) from the Phase III ExteNET trial were published in Clinical Breast Cancer (Press release, Puma Biotechnology, OCT 5, 2020, View Source [SID1234568118]). The manuscript appears in the October 5, 2020 online issue accessible at View Source(20)30258-5/fulltext.

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ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive eBC patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab. Patients were stratified by hormone receptor status and randomly assigned to one year of treatment with either oral neratinib 240 mg/day or placebo. The primary endpoint of the trial was invasive disease-free survival (iDFS) with overall survival as a key secondary endpoint. Within the European Union, neratinib is approved in patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen.

The manuscript presents data focusing on HR+ patients who initiated treatment within a year of completing an adjuvant trastuzumab containing treatment (HR+ /< 1 yr) and subgroups of clinical interest including patients who did not achieve a pathological complete response (no pCR) after neoadjuvant treatment and therefore were at a high risk of disease recurrence. (HR+/ <1 yr, no pCR)

In the HR+ /< 1 yr patient population, the absolute 5-year invasive disease-free survival benefit versus placebo was 5.1% (HR=0.58, 95% CI 0.41‒0.82) and absolute 8-year overall survival benefit was 2.1%. (HR=0.79, 95% CI 0.55‒1.13). The 5-year cumulative incidence of CNS metastases was 0.7% in the neratinib arm and 2.1% in the placebo arm.

In the HR+/ <1 yr, no pCR subgroup of patients that were at a high risk of disease recurrence the absolute 5-year iDFS benefit in the neratinib arm versus placebo was 7.4% (HR=0.60; 95% CI 0.33‒1.07) and the 8-year overall survival benefit was 9.1% (HR=0.47; 95% CI 0.23–0.92).

Most common grade 3 adverse events were diarrhea (39% vs placebo, 1%; without mandatory anti-diarrheal prophylaxis), vomiting (4% vs <1%), and fatigue (2% vs <1%).

Professor Arlene Chan, Vice Chair Breast Cancer Research Centre – WA, said, "Deciding on which patients benefit most from a given therapy is an important goal for clinicians. This newly published study provides consistent and durable benefits of neratinib in a subset of HER2-positive early stage breast cancer patients who are considered to be at greater risk of relapse: namely patients with HR+ tumors that did not achieve a pCR after neoadjuvant treatment (no pCR). The benefits demonstrated are meaningful in all endpoints evaluated, including iDFS, OS and CNS recurrence, and thus should help guide future clinical decisions."

Hope S. Rugo, MD, Professor of Medicine, University of California San Francisco Comprehensive Cancer Center, said, "HER2-positive HR+ patients who do not achieve a pCR are at increased risk of recurrence, even after receiving current standard of care treatment. In a descriptive subset analysis, extended adjuvant therapy with neratinib demonstrated a positive benefit in these patients not only in iDFS, but also in OS. In addition, the trend toward lower CNS involvement is a very important consideration, given the profound impact of CNS metastasis on future prognosis. These data coupled with the recently published data from the CONTROL study, which shows improved tolerability with dose escalation, should allow more patients to benefit from this important therapy."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "Although there have been many new treatment options for patients with early stage HER2-positive breast cancer, the risk of disease recurrence remains significant and more must be done. These newly published data demonstrate that neratinib provides a clinically meaningful reduction in the risk of recurrence and provides a very important option for these high risk patients."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On October 5, 2020, Corvus Pharmaceuticals, Inc. ("Corvus" or the "Company"), reported that it entered into, and consummated certain transactions contemplated by, a Framework Agreement (the "Framework Agreement") by and among Corvus Hong Kong Limited, a wholly-owned subsidiary of Corvus Cayman (as defined below) ("Corvus HK"), Angel Pharmaceuticals Co., Ltd., a wholly-owned subsidiary of Corvus HK ("Angel Pharmaceuticals"), Jiaxng Puissance Angel Equity Investment Partnership (Limited Partnership) (the "Investment Entity") and AP BIOTECH DEVELOPMENT CORP. ("AP BIOTECH"), pursuant to which, and on the terms and subject to the conditions thereof, Corvus will grant a license to Angel Pharmaceuticals for certain of its intellectual property and dispose of certain assets comprised of the share capital of certain of its wholly-owned subsidiaries (Filing, 8-K, Corvus Pharmaceuticals, OCT 5, 2020, View Source [SID1234568103]). In particular, pursuant to the Framework Agreement and the agreements contemplated therein:

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i.Corvus, Corvus Biopharma International Ltd., a wholly-owned subsidiary of Corvus ("Corvus Cayman") and Corvus HK will grant Angel Pharmaceuticals the right to develop and commercialize Corvus’ three clinical-stage candidates, ciforadenant, CPI-006 and CPI-818, in greater China and global rights with respect to Corvus’ BTK inhibitor preclinical programs;

ii.the Investment Entity will invest RMB 235 million in Angel Pharmaceuticals in exchange for registered capital in the amount of $56,400 (representing an equity interest of approximately 35.0% in Angel Pharmaceuticals) and AP BIOTECH will receive registered capital in the amount of $13,900 (representing an equity interest of approximately 8.6% in Angel Pharmaceuticals) (collectively, the "Initial Capital Increase");

iii.upon completion of the Initial Capital Increase, Corvus HK will issue warrants to purchase its ordinary shares to the Investment Entity and AP BIOTECH and will enter into a related equity transfer agreement with such parties to provide them with an ownership interest in Corvus HK that shall be equal to but replace their ownership interest in Angel Pharmaceuticals following any determination by the board of directors of Angel Pharmaceuticals to list the shares of Angel Pharmaceuticals publicly; and

iv.following the Initial Capital Increase, Angel Pharmaceuticals will enable Hangzhou Betta Investment Management Co., Ltd. ("Betta") to subscribe for increased registered capital of Angel Pharmaceuticals in an amount of $6,000 (representing an equity interest of approximately 3.5% in Angel Pharmaceuticals) in exchange for investments of RMB 25 million and Hangzhou Tiger Equity Investment Partnership LP ("Tigermed") to subscribe for increased registered capital of Angel Pharmaceuticals in an amount of $4,800 (representing an equity interest of approximately 2.8% in Angel Pharmaceuticals) in exchange for investments of RMB 20 million (the "Second Capital Increase" and, together with the Initial Capital Increase, the "Capital Increases").

Following the consummation of the foregoing transactions, it is expected that Corvus HK will hold a 49.7% equity interest in Angel Pharmaceuticals and that Angel Pharmaceuticals will have received aggregate proceeds from the Capital Increases of approximately $41.0 million, indicative of a post-money valuation of approximately $106.0 million. Corvus expects Angel Pharmaceuticals to use the proceeds from the Capital Increases for development of Corvus’ product candidate pipeline and no amount of the proceeds will be available for use by Corvus.

In connection with and subject to the consummation of the foregoing transactions, each of Corvus HK, the Investment Entity, AP BIOTECH, Betta and Tigermed will enter into a shareholders agreement relating to shareholder rights, governance and management of Angel Pharmaceuticals, and pursuant to which Corvus will be entitled to designate three individuals on Angel Pharmaceuticals’ five-person board of directors. It is currently contemplated that the board of directors of Angel Pharmaceuticals will initially be comprised of Richard Miller, chairman and chief executive officer of Corvus, Leiv Lea, chief financial officer of Corvus, Peter Thompson, co-founder and board member of Corvus, and Ted Wang, chief investment officer of Puissance Capital. In addition, Dr. Miller will serve as Angel Pharmaceutical’s interim chief executive officer.

On October 5, 2020 CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, reported that the United States (US) Food and Drug Administration (FDA) has granted orphan drug designation to one of CARsgen’s first-in-class drug candidates, CT041, for the treatment of gastric and gastroesophageal junction adenocarcinoma (Press release, Carsgen Therapeutics, OCT 5, 2020, View Source [SID1234568104]). CT041 is a humanized anti-claudin18.2 autologous chimeric antigen receptor (CAR) T-cell product and is targeted to treat patients with claudin18.2-positive tumors.

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CT041 is the first claudin18.2-targeted CAR T-cell therapy that has received Investigational New Drug (IND) clearance by the US FDA and the first to receive IND clearance by the National Medical Products Administration (NMPA) in China. The initiation of an open label, multicenter, Phase 1b clinical trial (NCT04404595) to evaluate the safety and efficacy of autologous CT041 cell therapy in patients with advanced gastric, gastroesophageal, or pancreatic adenocarcinoma is currently underway.

"The orphan drug designation of CT041 by the FDA is of great significance to patients with advanced gastric cancer," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to the World Health Organization, about 1,030,000 new cases of gastric adenocarcinoma are expected each year [1]. Despite the development of novel therapies, gastric cancer is still a disease with one of the highest unmet medical needs. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."

Orphan drug designation is granted by the FDA Office of Orphan Products Development to investigational treatments that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the US. Under the Orphan Drug Act, the CT041 anti-claudin18.2 product would be eligible for certain benefits including FDA support for clinical studies, special fee exemptions and reductions, and seven years of market exclusivity in the United States following marketing approval by the FDA.

References:

[1] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.

On October 5, 2020 BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) reported to publish the company’s Interim Report for the period January – September 2020 on Wednesday, October 14, 2020, at 08:00 a.m. CET (Press release, BioArctic Neuroscience, OCT 5, 2020, View Source;september-2020-on-october-14-at-9-30-am-cet-301146256.html [SID1234568120]).

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BioArctic invites to an audiocast with teleconference (in English) for investors, analysts and media on October 14, at 09:30 CET, where Gunilla Osswald, CEO, and Jan Mattsson, CFO, will present BioArctic and comment on the Interim Report for the period January – September 2020 followed by a Q&A-session.

Webcast: View Source

The webcast will afterwards also be available on demand at BioArctic’s corporate website View Source

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.