On September 22, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for Sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) for the first-line treatment of esophageal squamous cell carcinoma (ESCC) (Press release, Innovent Biologics, SEP 22, 2021, View Source [SID1234590151]).

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The sNDA application is based on the interim analysis of the global randomized, double-blind, multi-center Phase 3 ORIENT-15 clinical trial – which evaluated sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy, regardless of PD-L1 expression status. The results of ORIENT-15 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on September 17.

The principal investigator of the ORIENT-15 study, Prof. Shen Lin from Peking University Cancer Hospital and Institute, stated," Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, and squamous cell carcinoma is the predominant histologic type. In China, cisplatin plus paclitaxel is widely used to treat patients with ESCC. The results of ORIENT-15 demonstrated that sintilimab plus chemotherapy significantly improved overall survival and progression-free survival compared to chemotherapy. These results suggest that this sintilimab regimen could be a suitable treatment option for ESCC patients in China."

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "There is a huge unmet clinical need for advanced or metastatic ESCC. The acceptance of this sNDA by the NMPA represents an important milestone in demonstrating the potential value of sintilimab in the first-line treatment of ESCC. We look forward to working with the China regulatory authorities on the sNDA review and we hope to bring the new regimen of sintilimab plus cisplatin and paclitaxel to Chinese patients with ESCC as quickly as possible."

About the ORIENT-15 Study

ORIENT-15 is a global randomized, double-blind, multicenter Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ClinicalTrials.gov, NCT03748134). At the time of interim analysis, a total of 659 eligible patients (of the planned 676 estimated participants) were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. The primary endpoints were overall survival (OS) in all randomized patients and OS in PD-L1 positive (defined as CPS ≥10) patients.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer (EC) is one of the most common malignant tumors worldwide that begins in the inner layer (mucosa) of the esophagus, which connects the throat to the stomach. Based on GLOBOCAN 2020 estimates, approximately 600,000 new cases of esophageal cancer are diagnosed and approximately 540,000 deaths result from the disease worldwide each year. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. More than half of new and fatal cases of esophageal cancer in the world occur in China. In China, it is estimated there were approximately 320,000 new cases of esophageal cancer diagnosed and approximately 300,000 deaths resulting from the disease in 2020. Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, where it has a five-year survival rate of only 30%. In the US, it is estimated there were approximately 18,000 new cases of esophageal cancer diagnosed and approximately 16,000 deaths resulting from the disease in 2020. The five-year survival rate of esophageal cancer is only 20% in the US.

The two main types of esophageal cancer are squamous cell carcinoma (SCC) and adenocarcinoma. In China, SCC is the predominant histologic type, accounting for more than 90% of all esophageal cancer. In western countries, SCC is approximately 25% of all esophageal cancer. In the past, first-line standard systemic therapy was chemotherapy based on platinum drugs for unresectable locally advanced, recurrent or metastatic ESCC. Pembrolizumab has been approved as first-line treatment in combination with chemotherapy.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma
Additionally, Innovent currently has two regulatory submissions under review in China for sintilimab, for the first line treatment of esophageal squamous cell carcinoma and the second-line treatment of squamous non-small cell lung cancer.

Innovent also has additional two clinical studies of sintilimab that have met their primary endpoints:

In combination with oxaliplatin and capecitabine for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
The second-line treatment of esophageal squamous cell carcinoma
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

On September 22, 2021 Synlogic (Nasdaq: SYBX) a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported the pricing of its underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $3.00 per share (Press release, Synlogic, SEP 22, 2021, View Source [SID1234590150]). The gross proceeds to Synlogic from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Synlogic, are expected to be $45.0 million. All shares of common stock to be sold in the offering are being sold by Synlogic. In addition, Synlogic has granted to the underwriter a 30-day option to purchase up to 2,250,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about September 27, 2021, subject to the satisfaction of customary closing conditions.

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Jefferies and SVB Leerink are acting as joint book-running managers for the offering. Chardan is acting as lead manager for the offering and H.C. Wainwright & Co. is acting as co-manager for the offering.

The securities described above are being offered by Synlogic pursuant to its shelf registration statement on Form S-3 (File No. 333-258151) filed with the Securities Exchange Commission (the "SEC") on July 23, 2021 and declared effective by the SEC on July 30, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and a final prospectus supplement and the accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by phone at 877-821-7388; or SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. The preliminary prospectus supplement and accompanying prospectus is also available, and the final prospectus supplement and accompanying prospectus will be available, on the SEC’s website at View Source

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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On September 22, 2021 AbCellera (Nasdaq: ABCL) and Everest Medicines Limited (HKEX 1952.HK, "Everest") reported that they have entered into a multi-year collaboration and license agreement to discover therapeutic antibodies for up to 10 targets selected by Everest (Press release, AbCellera, SEP 22, 2021, View Source [SID1234590149]). The partnership will help to expand Everest’s portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology.

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"We are proud to partner with Everest as they build a robust pipeline of innovative medicines for patients in Asia and beyond," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We believe our full-stack discovery engine, combined with Everest’s clinical development capabilities, creates synergy and the opportunity to speed the delivery of therapies to patients around the world."

By partnering with AbCellera, Everest will benefit from an operating system that supports many antibody modalities to unlock new target classes and open new disease areas to therapeutic access. The collaboration will leverage the full breadth of AbCellera’s technology stack, including sourcing fully humanized antibodies from the Trianni Mouse, sourcing single domain antibodies from camelids, and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.

"This collaboration will allow us to gain access to AbCellera’s cutting edge, AI-powered antibody discovery platform, which will greatly accelerate and increase the efficiency of our internal discovery efforts," said Jennifer Yang, Ph.D., Chief Scientific Officer of Everest Medicines.

Under the terms of the agreement, Everest will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Everest downstream clinical and commercial milestone payments and royalties on net sales of products.

On September 22, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported that Purnanand Sarma, Ph.D., Immunome’s President and CEO, will present at the Cantor Global Healthcare Conference on Wednesday, September 29, 2021, at 8:40 a.m. ET (Press release, Immunome, SEP 22, 2021, View Source [SID1234590148]).

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

On September 22, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will present at the 2021 Cantor Virtual Global Healthcare Conference on Wednesday, September 29th, 2021 at 11:20 a.m. ET (Press release, Scholar Rock, SEP 22, 2021, View Source [SID1234590147]).

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A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.