On September 22, 221 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Panna Sharma, President & CEO of Lantern Pharma will present at the Benzinga Healthcare Small Cap Conference, which is being held virtually from September 29 – 30, 2021 (Press release, Lantern Pharma, SEP 22, 2021, View Source [SID1234590154]).

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Mr. Sharma will deliver his corporate presentation on Wednesday, September 29th at 11:55 AM ET and will also be available for one-on-one meetings throughout the conference.

Investors can register for the conference here: View Source

On September 22, 2021 Synlogic (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that it has commenced an underwritten public offering of its common stock (Press release, Synlogic, SEP 22, 2021, View Source [SID1234590153]). All shares of common stock to be sold in the offering will be offered by Synlogic. Synlogic intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies and SVB Leerink are acting as joint book-running managers 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 will be filed with the SEC and will be available on the SEC’s website at View Source When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Jefferies LLC, 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, One Federal Street, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, 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 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 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a Fast Track Designation (FTD) by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic melanoma, relapsed/refractory to prior immuno-oncologic agent (IO) treatments (Press release, Ascentage Pharma, SEP 22, 2021, View Source [SID1234590152]). Previously, alrizomadlin was already granted five Orphan Drug Designations (ODDs) by the US FDA, one of which was for the treatment of stage IIB-IV melanoma.

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Melanoma is a potentially deadly dermatologic malignancy that has been increasingly prevalent globally. The current lifetime risk of developing melanoma is 1 in 63 in the US1. In 2019, an estimated 96,480 patients have been diagnosed with melanoma and about 7,230 patients with melanoma have died in the United States2. Advanced melanoma presents an enormous clinical challenge as it is prone to metastasis and lacks survival benefit from chemotherapies. Immune checkpoint inhibitors (ICIs) are currently recommended for the first-line treatment of most patients with metastasized melanoma3. Although approximately 35% to 60% of the patients have a response evaluation criterion in solid tumors (RECIST) response to ICIs, the remaining 40% to 65% have shown minimal or no RECIST response at the outset, and 43% of the responders develop acquired resistance in the three years after receiving ICIs4. Therefore, patients who failed on or developed acquired resistance to ICIs are in urgent need of new treatment options.

This FTD for alrizomadlin is based on combined preclinical results and preliminary clinical data from an ongoing Phase II study (APG-115-US-002, Clinicaltrials.gov Identifier: NCT03611868). The preliminary clinical data released in an oral report at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed that alrizomadlin has favorable antitumor activity and a manageable safety profile. The cohort of patients with PD-1/PD-L1 inhibitor-resistant melanoma treated with alrizomadlin in combination with pembrolizumab achieved one case of complete response (CR), an objective response rate (ORR) of 24.1%, and a disease control rate (DCR) of 55.2%.

The FTD expedites the development and review of drug candidates to treat serious diseases/conditions that present urgent unmet clinical needs. This FTD for alrizomadlin will lead to a series of benefits that could accelerate the clinical development and review for this drug candidate, including more frequent communications and meetings with the FDA during its clinical development; and if the FDA determines appropriate, to be allowed to enter Rolling Review, a process that allows a company to submit New Drug Applications (NDAs) by sections, rather than waiting until all required materials become available. This FTD also paves the way for alrizomadlin to potentially obtain Accelerated Approval and Priority Review designations in the future.

"Alrizomadlin is a key drug candidate in Ascentage Pharma’s apoptosis-targeting pipeline. An ODD and a FTD have already been granted to alrizomadlin by the US FDA for the treatment of melanoma, signifying the enormous therapeutic potential of the asset," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "This FTD will help strengthen our communications with the US FDA in the clinical development of alrizomadlin, speed up the clinical development of alrizomadlin in the US and globally, thus potentially accelerating the drug candidate towards NDA submissions. We will move forward in full speed with the clinical development of alrizomadlin in the hope of offering a new treatment option to patients with melanoma."

References

1. Stephanie C, Christy S, Jessica W. Epidemiology and Risk Factors of Melanoma. Surg Clin North Am. 2020 Feb;100(1):1-12.

2. Cancer Facts & Figures 2019. American Cancer Society. Link: View Source

3. National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of Cancers, Version 2.2021

4. Tuba G, James W, Richard S, et al. Primary and Acquired Resistance to Immune Checkpoint Inhibitors in Metastatic Melanoma. Clin Cancer Res. 2018 Mar 15;24(6):1260-1270.

About APG-115 (alrizomadlin)

Being developed by Ascentage Pharma, alrizomadlin is an orally administered, selective, small-molecule inhibitor of the MDM2 protein. Alrizomadlin has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. Alrizomadlin is the first MDM2-p53 inhibitor entering clinical development in China and is currently being investigated in multiple Phase Ib/II studies in solid tumors and hematologic malignancies in China, Australia, and the US. To date, alrizomadlin has been granted a total of five Orphan Drug Designations (ODDs) by the US FDA for the treatment of gastric cancer, acute myeloid leukemia, soft tissue sarcoma, retinoblastoma, and stage IIB-IV melanoma.

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.