On September 22, 2021 CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) for the treatment of patients with solid tumors (Press release, Carisma Therapeutics, SEP 22, 2021, View Source [SID1234590161]).

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"The FDA’s decision to grant Fast Track designation to CT-0508 is another important milestone in gene-based cell therapy development," said Steven Kelly, Chief Executive Officer of CARISMA. "This designation further demonstrates the critical need to expedite the development and review of new therapies that can potentially address the unmet needs of patients, whose cancer may have not responded to existing methods of treatment."

CT-0508 was originally developed by Saar Gill, MD, PhD, Scientific Co-founder of CARISMA Therapeutics, and an Associate Professor of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania, and Michael Klichinsky, PharmD, PhD, Scientific Co-founder, and Senior Vice President of Discovery at CARISMA Therapeutics. It is currently being evaluated in a first-in-human Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have any approved HER2-targeted therapies or who do not respond to treatment. Preclinical findings for CT-0508 indicated that CAR-M therapy may have the potential to overcome challenges that T-cell therapies have encountered in the solid tumor setting.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational treatments that demonstrate a potential to address unmet medical needs in serious conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA in addition to a rolling submission of the marketing application.

CARISMA will continue to treat and evaluate patients at three clinical trial sites, including the Abramson Cancer Center of the University of Pennsylvania, the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, and City of Hope in Duarte, California.

On September 22, 2021 BioChain Institute, ("BioChain"), a leader in high quality processed bio-sample products, reported an expanded line of Next Generation Sequencing (NGS) characterized bio-samples encompassing a variety of cancer-related mutations available for preclinical drug development and as reference samples for CLIA labs (Press release, Biochain, SEP 22, 2021, View Source [SID1234590160]).

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"Scientists are looking for specific gene mutations; however, this process is time-consuming and expensive," said BioChain’s Director of Business Development Dr. Vidyodhaya Sundaram. "At BioChain, we do the upfront work of screening for mutations to ultimately provide this information to further research."

BioChain now offers ready-to-use, NGS characterized tissue samples for BRCA1, BRCA2, MSI, HPV, EGFR, and KRAS, developing the new mutation-specific bio-samples in response to the growing need and demand from researchers.

"BioChain also accepts requests for custom projects regarding specific gene mutations," Sundaram said.

About BioChain’s NGS characterized samples

For oncology researchers studying pathways related to BRCA1 and BRCA2, BioChain offers samples from breast cancer donors characterized using the Paragon genomics BRCA1&2 panel. Associated with many cancer types, BRCA gene mutations are strongly linked to breast cancers.

Microsatellite instability (MSI) is the condition of enhanced predisposition to genetic mutation. Associated with many cancer types, MSI is strongly linked with colon cancer, and BioChain offers MSI-High and MSI-Stable control samples characterized using direct PCR or indirect immunochemistry for the cancer research community.

Infection with Human Papillomavirus (HPV) is associated with several cancers, including head and neck squamous cell carcinomas and cervical cancers. BioChain offers HPV positive and negative tissue sections of these cancers as control slides for oncology researchers. Samples are characterized using Diacarta’s QuantiVirus HPV E6/E7 RNA test, detecting mRNA from 16 high-risk HPV genotypes.

BioChain also offers bio-samples involving KRAS mutations. These major drivers of pancreatic cancers and epidermal growth factor receptor (EGFR) mutations are linked to subtypes of non-small cell lung cancer.

BioChain offers all bio-samples in frozen and Formalin-Fixed Paraffin-Embedded (FFPE) formats. Some samples are available as matched sets including normal tissue and adjacent primary tumor tissue along with plasma from the same donor.

On September 22, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the pricing of an underwritten public offering of its common stock at a public offering price of $2.85 per share and of pre-funded warrants to purchase shares of its common stock at a public offering price of $2.849 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant (Press release, Leap Therapeutics, SEP 22, 2021, View Source [SID1234590158]). The gross proceeds to Leap from this offering are expected to be approximately $90 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Leap. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Leap. In addition, Leap has granted the underwriters a 30-day option to purchase up to an aggregate of an additional 4,740,000 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The offering is expected to close on or about September 24, 2021, subject to satisfaction of customary closing conditions.

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Piper Sandler & Co., Raymond James & Associates, Inc. and Mizuho Securities USA LLC are acting as book-running managers for the offering. Robert W. Baird & Co. Incorporated is acting as lead manager for the offering.

Leap intends to use the net proceeds from the offering to fund: (i) the continued development of DKN-01; (ii) manufacturing of clinical trial material; and (iii) general corporate purposes, including working capital and other general and administrative expenses.

The securities will be offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-248797) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on September 14, 2020 and was declared effective by the SEC on October 16, 2020. A preliminary prospectus supplement and the related prospectus has been filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]. These documents may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected]; or from Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY, 10020; by phone at (212) 205-7600; or by email at [email protected].

This press release shall not constitute an offer to sell or a 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 under the securities laws of any such state or jurisdiction.

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