On September 22, 2021 EXUMA Biotech, Corp., a clinical-stage biotechnology company discovering and developing cell and gene therapies and delivery solutions for liquid and solid tumors, reported that Chairman and Chief Executive Officer, Gregory Frost, Ph.D., will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Wednesday, September 29th, 2021, from 2:40-3:10 p.m. ET (Press release, EXUMA Biotechnology, SEP 22, 2021, View Source [SID1234590156]).

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Investors and the general public are invited to listen to a live webcast of the session at View Source

An archived edition of the session will be available at exumabio.com for at least 30 days following the event.

On September 22, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that it has entered into a distribution agreement for COPIKTRA (duvelisib) with Clinigen Group Plc (Clinigen) covering 39 countries in Europe including Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, The Netherlands, Poland, Portugal, Spain, Sweden and Switzerland (Press release, Secura Bio, SEP 22, 2021, View Source [SID1234590155]). Secura Bio will promote and distribute COPIKTRA directly in Germany and the United Kingdom.

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Clinigen is a global, specialist pharmaceutical services and products company who partner with pharmaceutical and biotech companies to provide ethical access to medicines for patients with unmet medical needs.

COPIKTRA was granted marketing authorization by the European Medicines Agency in May 2021 as monotherapy for the treatment of relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in patients, who have received at least two prior therapies and for the treatment of Follicular Lymphoma (FL) that is refractory to at least two prior systemic therapies. CLL and FL are slow-growing incurable blood cancers that can lead to life-threatening complications such as anemia, serious infections, and bone marrow failure requiring treatment. The goal of therapy for patients with these cancers is to improve overall survival and quality of life. COPIKTRA is a dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation of malignant cells and are thought to play a role in the formation and maintenance of the supportive tumor microenvironment.

Secura Bio is currently working with the haematology community and relevant authorities to ensure COPIKTRA is widely reimbursed and commercially launched across Europe in the coming months.

"Partnering with Clinigen will enable COPIKTRA, an oncology therapeutic with a novel mode of action, to be widely and rapidly available to patients across Europe." said Joseph M. Limber, President and CEO of Secura Bio. "Leveraging Clinigen’s commercial resources, supply and distribution infrastructure and regulatory expertise will allow physicians and patients throughout Europe to have access to another valuable and beneficial option to combat the debilitating illnesses of CLL and FL. We are excited to be working with Clinigen to ensure successful market access, commercialization and supply of Copiktra across the European geographies".

Sam Herbert, Chief Operating Officer and Head of Products Division at Clinigen said that "Clinigen is very pleased to be partnering with Secura Bio. This new and exclusive agreement will help address a significant unmet need for patients with B-cell blood cancers across Europe. This agreement underlines Clinigen’s strength in partnering with pharmaceutical companies and leveraging our significant commercial knowledge and infrastructure to ensure the right medicine gets to the right patients at the right time."

Below is the full list of countries covered by the agreement:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Albania, Andorra, Bosnia Herzegovina, Iceland, Kosovo, Liechtenstein, Monaco, Montenegro, Northern Macedonia, Norway, San Marino, Serbia, Switzerland

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.