AIM ImmunoTech Announces the Expansion of its Pancreatic Cancer Program to Include New Patients in the Netherlands

On February 10, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that the Dutch Health and Youth Care Inspectorate (IGJ) has approved treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program (EAP) at Erasmus Medical Center in the Netherlands (Press release, AIM ImmunoTech, FEB 10, 2021, View Source [SID1234574862]). Subject to further authorization we plan to treat up to 16 pancreatic cancer patients with rintatolimod (Ampligen) under the EAP, which follows the success of a previous multi-year Ampligen EAP for pancreatic cancer patients at Erasmus MC. The new approval was designed to include several patients treated under the previous EAP, who are still alive despite their diagnoses several years ago of locally advanced or metastatic pancreatic cancer.

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AIM announced on September 22, 2020 that the initial EAP had demonstrated statistically significant positive pancreatic cancer survival benefits in its Ampligen arm, as compared to a historical control cohort. The use of Ampligen, following the current standard of care for pancreatic cancer (FOLFIRINOX), yielded an overall survival of 19 months, or 7.9 months greater than FOLFIRINOX treatment alone. This new group will help focus on immunological markers which will aid in identifying high-level Ampligen responders.

"We are extremely pleased to continue our study in pancreatic cancer patients with Ampligen, given the hopeful previous results," said Prof. Casper van Eijck, MD, PhD, the lead investigator for the EAP at Erasmus MC. "By more selectively including patients for this treatment, we hope to better define the ultimate application area. We are grateful to AIM ImmunoTech Inc. for their constructive contribution to enabling this treatment in this aggressive cancer."

This announcement is an important step in AIM’s ongoing efforts to expand its pancreatic cancer treatment program, as data gathered in the new study may assist in the company’s plans to transition into a clinical trial with clinical sites in the European Union (EU) and the United States. Both Erasmus MC and the Buffett Cancer Center at the University of Nebraska Medical Center (K. Klute, MD, M.A. Hollingsworth, PhD) have tentatively agreed to serve as clinical trial sites. Additionally, AIM announced in December 2020 that the U.S. Food and Drug Administration had granted Orphan Drug Designation to Ampligen as a treatment for pancreatic cancer; the European Medicines Agency (EMA) recently recommended to the European Commission (EC) that AIM’s wholly owned subsidiary – Hemispherx Biopharma Europe – receive a similar designation in the EU for Ampligen in pancreatic cancer, and the company awaits a final EC decision.

AIM’s planned next steps in its pancreatic cancer program include filing an Investigational New Drug (IND) application in the United States and a Clinical Trial Application (CTA) in the EU to move forward in the study of Ampligen for treating this disease. The company is also exploring the possibility of applying for Fast Track status to assist in the swift advance of Ampligen as a potential treatment for this unmet medical need. Fast Track designation would give AIM the opportunity to meet more often with the FDA to quickly advance Ampligen through the different phases of the IND, potentially accelerating approval.

The benefits of having an orphan-designated medication with commercial approval in the EU include up to ten years of protection from market competition from similar medicines with similar active components, and indication for use that are not shown to be clinically superior.

Blueprint Medicines to Report Fourth Quarter and Full Year 2020 Financial Results on Wednesday, February 17, 2021

On February 10, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, systemic mastocytosis, and cancer immunotherapy, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, February 17, 2021 to report its fourth quarter and full year 2020 financial results and provide a corporate update (Press release, Blueprint Medicines, FEB 10, 2021, View Source [SID1234574861]).

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To access the live conference call, please dial (855) 728-4793 (domestic) or (503) 343-6666 (international), and refer to conference ID 4844138. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Cyclacel Pharmaceuticals Announces Presentation at 2021 BIO CEO & Investor Digital Conference

0n February 10, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that the Company will present at the 2021 BIO CEO & Investor Digital Conference (Press release, Cyclacel, FEB 10, 2021, View Source [SID1234574860]). The conference is taking place online between February 16-18, 2021 and a prerecorded presentation by Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs. The presentation will be available to registered conference attendees for on-demand viewing beginning February 15, 2021 at 9:00AM ET via the virtual conference link.

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Registered conference attendees may schedule a 1×1 meeting with Cyclacel via the conference scheduling link.

Cyclacel will host one-on-one meetings with investors and industry stakeholders during the event. Registered conference attendees may request one-on-one meetings with Cyclacel through the scheduling link.

A live webcast of the presentation will be available through the Company’s website: www.cyclacel.com. The webcast will be archived for 90 days.

MD ANDERSON AND MIRATI THERAPEUTICS ANNOUNCE KRAS STRATEGIC RESEARCH AND DEVELOPMENT COLLABORATION IN SOLID TUMORS

On February 10, 2021 The University of Texas MD Anderson Cancer Center and Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported a strategic research and development collaboration to expand the evaluation of Mirati’s two investigational small molecule, potent and selective KRAS inhibitors – adagrasib (MRTX849), a G12C inhibitor in clinical development, and MRTX1133, a G12D inhibitor in preclinical development, as monotherapy and in combination with other agents – which target two of the most frequent KRAS mutations in cancer (Press release, MD Anderson, FEB 10, 2021, View Source [SID1234574859]).

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The collaboration will combine MD Anderson’s clinical trial infrastructure and expertise with Mirati’s differentiated targeted oncology pipeline. Under the terms of the agreement, collaborative preclinical and clinical studies will be conducted in several solid tumors, including non-small cell lung, pancreatic, colorectal, and gynecological cancers over the five-year period of the collaboration.

"This agreement embodies our commitment to further advancing our innovative KRAS programs and complementing our development efforts through strategic collaborations with those who share our vision for breakthrough science," said Joseph Leveque, M.D., Executive Vice President and Chief Medical Officer, Mirati Therapeutics. "We look forward to working with MD Anderson to strengthen our scientific and clinical understanding of KRAS compounds in multiple tumor types with the goal of speeding delivery of new cancer treatments to patients."

The collaborative studies will be overseen by a joint steering committee. Mirati will provide funding, study materials and other ongoing support throughout the term of the collaboration.

"Effective targeted therapies against mutant KRAS could address a major unmet need for many patients," said Christopher Flowers, M.D., ad interimdivision head of Cancer Medicine at MD Anderson. "Our collaboration with Mirati represents an important opportunity to work toward advancing new treatment options for patients using novel KRAS inhibitors that target two of the most frequent KRAS mutations in common cancers."

Scopus BioPharma Announces Closing of Underwriters’ Over-Allotment Option in Full

On February 10, 2021 Scopus BioPharma Inc. (Nasdaq: SCPS) reported the closing of the underwriters’ over-allotment option in full, bringing total follow-on public offering proceeds to $10.35 million (Press release, Scopus BioPharma, FEB 10, 2021, View Source,offering%20proceeds%20to%20%2410.35%20million.&text=Mintz%2C%20Levin%2C%20Cohn%2C%20Ferris,as%20counsel%20to%20the%20underwriters. [SID1234574858]).

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Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

Scopus intends to use the total proceeds of the follow-on public offering, including the proceeds from the exercise of the over-allotment option, principally for further development of the company’s lead drug candidate, including in combination with checkpoint inhibitors.

The Benchmark Company, LLC acted as Sole Bookrunning Manager and Joseph Gunnar & Co., LLC acted as Co-Manager for the offering.

Greenberg Traurig, LLP is acting as counsel to the company. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as counsel to the underwriters.

An offering statement relating to the shares of common stock was filed with the U.S. Securities and Exchange Commission and became qualified on January 26, 2021. The offering is being made only by means of an offering circular, copies of which may be obtained, when available, by contacting: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th Floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected]; or Joseph Gunnar & Co., LLC, Attention: Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, by calling (212) 440-9600 or by email at [email protected]. The offering circular is also available on the U.S. Securities and Exchange Commission website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction