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 Astellas Venture Management LLC (President: Kazunori Maruyama, Ph.D., "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc., and LabCentral, a launchpad for early-stage life-sciences startups, reported their collaboration on the "Future Innovator Prize" formerly known as the Astellas Golden Ticket Competition (Press release, Astellas, AUG 18, 2021, View Source [SID1234586737]). The Future Innovator Prize offers entrepreneurial scientists or emerging biotechnology start-ups one-year usage of LabCentral’s state-of-the-art lab facility in Cambridge, Massachusetts, as well as access to Astellas’ research and development (R&D) capabilities and business leaders.

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Astellas’ sponsorship of the Future Innovator Prize follows AVM obtaining Gold Sponsorship of LabCentral in October of 2019. With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, Astellas and LabCentral are proud to support scientists and early stage companies to accelerate their novel therapeutic programs, modalities or platforms.

"External innovation is critically important in helping us achieve our VISION of turning innovative science into VALUE for patients," said Maruyama, President, AVM. "Combining our R&D capabilities and expertise with LabCentral’s established network and launchpad in the Boston area, we look to bring hope to patients worldwide by partnering with emerging biotechnology companies and transforming their ideas into reality."

"We are extremely pleased to be working with Astellas to foster life-science innovation in the Boston area," said Johannes Fruehauf, LabCentral Co-founder and President. "Our labs offer a fertile environment in which biotechnology visionaries can thrive by providing them with the space and resources they need to test out, challenge, and nurture early ideas. We are excited that Astellas has chosen to create the Future Innovator Prize program to supplement their external innovation initiatives."

About the Future Innovator Prize at LabCentral
Astellas is offering up to two Future Innovator Prizes for pioneering scientists with innovative research that complements Astellas’ areas of interest that fit with the Astellas Focus Area Approach and pipeline, including oncology, immunology, neuroscience including neuromuscular and sensory disorders.

Companies awarded an Astellas Future Innovator Prize will gain one year’s priority admission or renewal to LabCentral’s state-of-the-art laboratory as well as access to Astellas’ R&D scientists and leaders. Time for submitting applications for the competition is from Wednesday August 18, 2021 to Monday September 20, 2021. Entrepreneurial scientists, emerging life-science or biotech start-ups are encouraged to apply and can learn more about the opportunity at View Source The decision to award any Future Innovator Prize, and the assessments underlying such decision, are solely the judgment of Astellas and LabCentral, and are not subject to objection or appeal.

On August 18, 2021 Optellum, a lung-health AI company, reported that it has entered a strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson* (Press release, Johnson & Johnson, AUG 18, 2021, View Source;johnson-applying-ai-to-transform-early-lung-cancer-treatment-301357553.html [SID1234586734]). Through the collaboration, Optellum will apply its AI-powered clinical decision support platform with the goal of increasing lung cancer survival rates through early intervention and prevention.

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Lung cancer is the most common type of cancer and the leading cause of cancer deaths in the world. Approximately 1.8 million people worldwide die from lung cancer each year. The current five-year survival rate is only 20%, primarily due to most patients being diagnosed after the disease has progressed to an advanced stage (Stage III or IV). However, the survival rate for small tumors treated at Stage IA is as high as 90%.

At the core of the collaboration is Optellum’s commercial software, Virtual Nodule Clinic, including an AI-powered digital biomarker based on neural networks and imaging analytics. It identifies and tracks at-risk patients and assigns a Lung Cancer Prediction score to lung nodules; small lesions, frequently detected in chest Computed Tomography (CT) scans, that may or may not be cancerous. The Optellum AI will be used to drive accurate early diagnosis and optimal treatment decisions with the aim of treating patients earlier, potentially at a pre-cancerous stage, increasing survival rates.

The Optellum software achieved US Food and Drug Administration (FDA) clearance in March 2021 and is being implemented in clinical care by leading hospitals initially across the United States, with rollouts in select Asia-Pacific and European markets to follow. The software was extensively validated in multi-center studies led by co-authors of clinical guidelines. In the clinical study underpinning the FDA clearance, all pulmonologists and radiologists in the study showed a statistically significant improvement in their diagnostic accuracy and consistency, and made more optimal clinical management decisions.

Optellum’s vision is to redefine the early intervention of lung cancer by enabling every patient to be diagnosed and treated at the earliest possible stage when the chances of cure are highest. In addition to its lung cancer product portfolio, the company is exploring solutions applying the same technology platform to other deadly diseases of the lungs such as interstitial lung disease and COPD.

"This collaboration is a significant milestone for Optellum," commented Václav Potěšil, PhD, founder and CEO of Optellum. "It brings us one step closer to Optellum’s vision of redefining early lung cancer treatment by helping every clinician, in every hospital to make the right decisions and provide their patients the best chance to fight back."

Professor Sam Janes, MD, Head of the Respiratory Research Department at UCL Hospitals, Vice-Chair of the UK National Clinical Reference Group for Lung Cancer and member of the Optellum Medical Advisory Board, commented:

"I believe the next step in lung cancer diagnosis and treatment is seeing the emerging new technologies coming together. AI is key to enabling integration of imaging, clinical, and molecular data—such as liquid biopsies—to diagnose disease even earlier. This convergence of technologies has tremendous potential to help physicians prevent, intercept, and ultimately cure patients with early-stage lung cancer."

On August 18, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for STRO-002, a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of systemic therapy (Press release, Sutro Biopharma, AUG 18, 2021, View Source [SID1234586733]).

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"We are pleased with the FDA’s decision to grant Fast Track designation for STRO-002 and welcome the opportunity to have more frequent interactions with the agency," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "We continue to be enthused by the potential of the STRO-002 program, which has shown encouraging preliminary activity and tolerability in our Phase 1 dose-escalation study in ovarian cancer, and plan to continue to work with the FDA to potentially accelerate our clinical and regulatory efforts."

Bill Newell, Chief Executive Officer of Sutro Biopharma added, "Receiving Fast Track designation is an important recognition for STRO-002 as a potentially best-in-class FolRα ADC for women with ovarian cancer. We look forward to further collaboration with the FDA to bring this potentially important therapeutic option to women in advanced stages of their disease with limited treatment options."

About Fast Track Designation

The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions or life-threatening conditions and demonstrate the potential to address an unmet medical need. A drug candidate that receives Fast Track designation can expect more frequent interaction with the FDA to discuss the drug candidate’s development plan, the potential for accelerated approval, and the possibility of priority review, if relevant criteria are met at the time of submission of a Biologic Licensing Application (BLA).

About STRO-002 Clinical Development

STRO-001-GM1 is a Phase 1 trial for STRO-002 for patients with advanced ovarian cancer that have progressed or relapsed after standard of care treatments, to assess efficacy, safety, and tolerability. The dose-escalation cohort has been completed and the dose-expansion cohort has enrolled patients from sites in the U.S. and in Spain, with enrollment ongoing. Patients are not pre-selected for FolRα expression but are required to provide a tissue sample for FolRα analysis prior to study treatment. Patients are randomized 1:1 and treated with STRO-002 at either 4.3 or 5.2 mg/kg every three weeks.

On August 18, 2021 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with recurrent sonic hedgehog (SHH) driven Medulloblastoma (Press release, Senhwa Biosciences, AUG 18, 2021, View Source [SID1234586732]).

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Fast Track Designation expedites the review of new drugs for serious conditions currently without effective treatments. Through Fast Track, Senhwa is eligible to apply for Accelerated Approval and Priority Review upon reaching relevant criteria with the US FDA. "We are delighted to receive Fast Track Designation and look forward to working closely with the FDA to accelerate the development of Silmitasertib, aiming to promptly bring a meaningful treatment to patients with recurrent SHH driven Medulloblastoma," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.

Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium (PBTC, www.pbtc.org), is currently conducting a Phase I/II and Surgical Study of Silmitasertib in both children and adults with recurrent SHH Medulloblastoma. This study is taking place at the PBTC’s participating member academic medical centers and children’s hospitals across the United States. The PBTC is sponsoring this clinical trial and is funded through the Consortium grant awarded by the US National Institute of Health – Cancer Therapy Evaluation Program (CTEP).

Medulloblastoma is the most common cancerous brain tumor in children, but no targeted therapy is currently available. On July 6, 2020, Silmitasertib was also granted Rare Pediatric Disease (RPD) Designation from the US FDA. If certain criteria are met with the RPD Designation, Senhwa is eligible for a transferrable Priority Review Voucher (PRV). The PRV allows its recipient an expedited review process of any one of its new drug products from a ten-month to a six-month timeframe.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 (casein kinase 2) pathway and acts as a CK2-inhibitor. It is safe and well-tolerated in humans and is easily administered due to its oral formulation. A Phase II Investigator-Initiated Trial (IIT) for the treatment of moderate COVID-19 recently completed enrollment, and another Phase II IIT to treat severe COVID-19 patients is currently enrolling patients in the United States. Silmitasertib is also being provided under compassionate use for patients with severe COVID-19 in Taiwan (initiated in June 2021).

In addition to COVID-19, Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase II studies of Silmitasertib in cancer patients. US FDA granted Silmitasertib an Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016 and a Rare Pediatric Disease Drug Designation for the treatment of Medulloblastoma in July 2020.