On August 18, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported positive interim results from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC) (Press release, Coherus Biosciences, AUG 18, 2021, View Source [SID1234586739]). The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy alone.

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The results will be summarized September 13 in an oral presentation by Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, during the Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The abstract is now available on the WCLC website.

"The CHOICE-01 study in patients with advanced non-small cell lung cancer has demonstrated the clinical benefit of toripalimab in yet another first-line setting, building on the evidence of efficacy in first-line studies in nasopharyngeal carcinoma and esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer at Junshi Biosciences. "With an excellent clinical profile being established across multiple tumor types, we expect to pursue registration for toripalimab for a broad array of indications in China, the United States and other markets."

"The CHOICE-01 efficacy and safety data are compelling and demonstrate the potential for toripalimab to deliver the significant benefits of the PD-1 class of checkpoint inhibitor drugs to patients with non-small cell lung cancer," said Ildiko Csiki, MD, PhD, Chair of the Coherus Scientific Advisory Board and Chief Commercial Research and Development Officer at City of Hope, a comprehensive cancer center. "As data accumulate in the pivotal studies in the broad clinical development program, toripalimab is showing itself to be an excellent checkpoint inhibitor. We eagerly anticipate results from additional Phase 3 studies in esophageal, lung, liver, breast, kidney, bladder, stomach, and skin cancers."

About CHOICE-01
A total of 465 treatment-naive advanced NSCLC patients (220 squamous and 245 non-squamous) were randomized (2:1): 309 to the toripalimab plus chemotherapy arm and 156 to the placebo plus chemotherapy arm. The primary endpoint of PFS was assessed by the investigator. Secondary endpoints included PFS assessed by a blinded independent review committee (BIRC), overall survival (OS), objective response rate (ORR) and duration of response (DoR). Crossover to toripalimab was allowed for patients from the placebo plus chemotherapy arm upon disease progression.

As of November 17, 2020 (the data cut-off date of the interim analysis), 218 PFS events were observed, with a median follow-up of 7.1 and 7.0 months in the toripalimab arm and the placebo arm, respectively.
At the interim analysis, a significant improvement in PFS was detected for toripalimab over placebo [hazard ratio (HR)=0.58,95% confidence interval (CI): 0.44-0.77, P=0.0001] with median PFS of 8.3 vs. 5.6 months. The 1-year PFS rates for toripalimab and placebo arms were 32.6% and 13.1%, respectively.
This improvement in PFS was observed in both squamous [HR = 0.55 (95% CI: 0.38-0.83)] and non-squamous [HR=0.59 (95% CI: 0.40-0.87)] NSCLC and regardless of PD-L1 expression.
PFS assessed by BIRC showed similar results as PFS assessed by the investigator.
Toripalimab in combination with chemotherapy, as compared with chemotherapy alone, resulted in better ORR (squamous NSCLC: 68.7% vs. 58.9%; non-squamous NSCLC: 58.6% versus 26.5%) and median DoR (squamous NSCLC: 6.9 months vs. 4.2 months; non-squamous NSCLC: 8.6 months vs. 5.1 months).
Patients in the placebo plus chemotherapy arm were actively crossed over to toripalimab treatment at the time of disease progression.
Overall survival data were not yet mature as of March 7, 2021. There was a trend favoring the toripalimab arm [median OS of 21.0 vs. 16.0 months, HR = 0.81 (95% CI: 0.57-1.17)].
The addition of toripalimab to standard first-line chemotherapy in patients with advanced NSCLC showed a manageable safety profile with no new safety signal observed. The incidence of Grade ≥3 adverse events (AEs) was 76.3% in the toripalimab arm vs. 80.1% in the control arm. AEs leading to discontinuation of toripalimab or placebo were 12.3% vs. 1.9%, respectively.
Junshi Biosciences and Coherus plan to meet with the United States Food and Drug Administration to discuss a potential submission of a biologics license application for toripalimab for first line treatment of advanced NSCLC.

About toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

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On August 18, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported it has upsized its public offering (the "Offering") of units ("Units") to US$17.5M from US$15M at a price of US$0.16 per Unit. If the Agent’s Option (as defined below) is exercised in full, the aggregate gross proceeds of the Offering will be approximately US$20.1M (Press release, ProMIS Neurosciences, AUG 18, 2021, View Source [SID1234586724]).

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Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at a price of US$0.21 per Warrant Share at any time up to 60 months following the issuance date thereof, subject to acceleration.

The Offering will be conducted on a commercially reasonable efforts basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Leede Jones Gable Inc. (the "Agent"). The Company will also grant the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two business days prior to the Closing Date (as defined herein).

The Offering is expected to close on or about August 24, 2021, or such other date as may be mutually agreed to by the Company and the Agent (the "Closing Date"), subject to satisfaction of customary closing conditions, including the approval of the Toronto Stock Exchange (the "TSX").

The Offering is being made pursuant to a prospectus supplement to the Company’s short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus"), which the Company will file with the securities commissions or other security regulatory authorities in each of the provinces and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement in other jurisdictions where the Offering can lawfully be made.

The Company intends to use the net proceeds from the Offering (including additional proceeds from the possible exercise of the Agent’s Option) to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug application to enable a first clinical trial, expanding the ProMIS portfolio of antibodies and patents, and general corporate purposes, as more fully described in the preliminary prospectus supplement of the Company dated August 17, 2021 (the "Preliminary Prospectus Supplement").

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This news release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On August 18, 2021 The National Cancer Institute reported that it has awarded Van Andel Institute a five-year, $1.7 million grant to establish a cutting-edge training program for postdoctoral fellows in cancer epigenetics, a growing field with untold potential to impact human health (Press release, Van Andel Institute, AUG 18, 2021, View Source;utm_medium=rss&utm_campaign=t32-award-cancer-epigenetics-training-program [SID1234586725]).

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The new Cancer Epigenetics Training Program combines extensive professional development with comprehensive, interdisciplinary research training by VAI’s internationally recognized cadre of experts. Postdoctoral trainees also will have access to the Institute’s state-of-the-art shared scientific resources and technologies as well as opportunities to participate in established translational research programs and partnerships led by VAI investigators.

Epigenetic abnormalities are universally found across cancers and serve as major drivers for malignancy, making them promising new targets for the development of novel cancer therapies. As such, the field — and its capacity for producing breakthroughs — is rapidly expanding.

"In the past few years, VAI has become a global destination for groundbreaking, collaborative cancer epigenetics research," said VAI Chief Scientific Officer Peter A. Jones, Ph.D., D.Sc. (hon). "Postdoctoral trainees will emerge from our Cancer Epigenetics Training Program with extensive, rigorous training and a solid foundation from which to launch their independent research careers."

Jones and VAI Associate Professor Scott Rothbart, Ph.D., will lead the program in collaboration with Erica Gobrogge, Ph.D., program director of VAI’s Office of Postdoctoral Affairs. The program also benefits from the guidance of its advisory committee, which includes renowned scientists from across the U.S.

VAI’s Cancer Epigenetics Training Program is now accepting applications from candidates who are near completion of a Ph.D., M.D. or other appropriate terminal degree. For a full list of eligibility criteria, please visit vari.vai.org/cancer-epigenetics-training-program.

The Cancer Epigenetics Training program is supported by a National Cancer Institute T32 training grant (no. T32CA251066). The content is solely the responsibility of VAI and does not necessarily represent the official views of the National Institutes of Health.

On August 18, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2021 first half results on Wednesday, August 25, 2021 (Press release, Bavarian Nordic, AUG 18, 2021, View Source [SID1234586727]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CEST (8:00 am EDT) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at https://bit.ly/3xzOiQo.

To join the Q&A session dial one of the following numbers and state the participant code 8569159: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.

On August 18, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM) (Press release, BeiGene, AUG 18, 2021, View Source [SID1234586728]). Swissmedic has started the formal review of the MAA. BRUKINSA has already been granted orphan drug status by Swissmedic.

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"The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."

Swissmedic, the Swiss Agency for Therapeutic Products, reviews new products for market authorization. Within this process, Swissmedic evaluates a product’s quality, safety, and effectiveness through clinical trial data.

Gerwin Winter, Senior Vice President, Head of Commercial, Europe, at BeiGene said: "The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."

The MAA is supported by data from the randomized Phase 3 ASPEN clinical trial (NCT03734016), evaluating zanubrutinib compared to ibrutinib in adult patients with WM.1

The approval by Swissmedic would grant marketing authorization for BRUKINSA in WM within Switzerland.

About Waldenström’s Macroglobulinemia

WM is a rare lymphoma representing approximately 1% of all non-Hodgkin lymphomas and typically progresses slowly after diagnosis.2 The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.3 Throughout Europe, the estimated incidence rate of WM is approximately 7 for every 1 million men and 4 for every 1 million women.4

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is currently approved in several regions for various indications.1 To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union, and more than 20 other countries or regions.