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FDA Transfers Investigational New Drug (IND) Application OST-HER2 (Listeria monocytogenes) to OS Therapies in Record Time – Phase IIb Trial in Osteosarcoma in Early 2021

On October 15, 2020 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in children and adults, reported that they have initiated their sponsorship of the FDA Investigational New Drug (IND) application for OST-HER2 a live, attenuated Listeria monocytogenes vector, expressing a tLLO-chimeric HER2 fusion protein (Press release, OS Therapies, OCT 15, 2020, View Source;phase-iib-trial-in-osteosarcoma-in-early-2021-301152798.html [SID1234568535]). This sets the pathway for initiation of the first clinical trial in Osteosarcoma patients in partnership with the Children’s Oncology Group (COG) – AOST-2121: An Open-Label Phase 2 Study of Maintenance Therapy with OST-HER2 (OST31-164) After Resection of Recurrent Osteosarcoma – in early 2021.

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A veterinary formulation of OST-HER2 had previously received accelerated approval from the USDA for Osteosarcoma in canines, and Phase I and III trials conducted in canines have had positive clinical benefit with manageable safety. The AOST-2121 clinical trial sponsored by OS Therapies and in coordination with COG will be the first trial in Adolescents and Young Adults (AYA) with Osteosarcoma, a deadly and debilitating bone cancer.

"OST-HER2 holds the promise of stimulating the patient’s immune system to seek out and combat hidden micro-metastases that can cause the osteosarcoma to recur," said Dr. Robert Petit, Chief Medical & Scientific Officer for OS Therapies. "In the Canine version of osteosarcoma, this form of treatment significantly delayed or prevented further osteosarcoma metastases and improved overall survival by three-fold. This clinical trial of OST-HER2 is an essential step towards bringing this potential clinical benefit to the children and young adults who are battling osteosarcoma."

Cigna Corporation’s Third Quarter 2020 Earnings Release Details

On October 15, 2020 Global health service company Cigna Corporation (NYSE:CI) reported that it will release its third quarter 2020 financial results on Thursday, November 5, 2020 and will host a conference call on the same day (Press release, Cigna , OCT 15, 2020, View Source [SID1234568534]).

Third quarter 2020 financial results will be released no later than 6:30 a.m. Eastern Time (ET). Management will review these results on a conference call beginning at 8:30 a.m. ET that same morning. The call-in numbers for the conference call are as follows:

It is strongly suggested you dial in to the conference call by 8:15 a.m. ET on November 5. A replay of the call will be available from 12:30 p.m. ET on Thursday, November 5 until 11:59 p.m. ET on Thursday, November 19, 2020. Additionally, the conference call will be available on a live Internet webcast at www.cigna.com under the About Cigna, Investor Relations section. Please note that this feature will be in listen-only mode.

A copy of the company’s news release and financial supplement will be available online at www.cigna.com under the About Cigna, Investor Relations section, no later than 6:30 a.m. ET on November 5.

Savran Technologies Inc. Rare Cell Detection Platform Contributes to Successful Clinical Trial for Detecting Breast Cancer Recurrence

On October 15, 2020 Savran Technologies Inc., a Massachusetts based biotech company with a mission to revolutionize non-invasive diagnostics via isolation of ultra-rare cells from blood, reported the completion of an important Phase 2 multi-center clinical trial conducted at 20 sites across the country utilizing its unique detection platform (Press release, Savran Technologies, OCT 15, 2020, View Source [SID1234568533]).

The trial involved about 200 patients with early stage triple negative breast cancer who received chemotherapy and underwent surgery. An important goal of the study was to assess the utility of circulating markers (namely ctDNA and CTCs) in predicting whether the disease would relapse. The study, which is the largest of its kind to date, involved using circulating biomarkers with triple negative breast cancer who had residual disease. Results demonstrated that circulating markers were more successful in predicting relapse than other, more commonly used clinical markers such as tumor size, lymph node status, grade and stage. The study also showed that if a patient is negative for circulating markers, the chances of relapse are low. Augmenting a ctDNA analysis with Savran Technologies’ CTC analysis platform improved the sensitivity of predicting relapse to 90%.

"We are happy to see our technology help manage this agressive cancer," said Dr. Cagri Savran, the Founder and CEO of Savran Technologies Inc. "We expect our platform to be useful in a wide variety of conditions. Whole cells are precious biomarkers. They can be counted like in this clinical trial. They can be cultured to test drugs. They offer access to an intact genome which allows whole genome sequencing without a background. They can also complement other markers like ctDNA because we have seen instances where a patient was negative for ctDNA but positive for CTCs."

The application of Savran Technologies’s platform offers a unique benefit as seen in this landmark study in the field of cancer but also presents a meaningful opportunity in the prenatal field. "We are looking forward to exploring business development opportunities with innovative companies in these two fields of use who are interested in a technology platform offering a real competitive advantage" said Savran.

Kiromic BioPharma Announces Pricing of Initial Public Offering

On October 15, 2020 Kiromic BioPharma, Inc. (the "Company"), a target discovery and gene-editing company utilizing artificial intelligence and a proprietary neural network platform with a therapeutic focus on immuno-oncology, reported the pricing of its initial public offering of 1,250,000 shares of its common stock at a public offering price of $12.00 per share, for gross proceeds of $15,000,000, before deducting underwriting discounts, commissions and offering expenses (Press release, Kiromic, OCT 15, 2020, View Source [SID1234568532]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 187,500 shares of common stock at the initial public offering price, less the underwriting discount, to cover over-allotments.

The shares are expected to begin trading on the Nasdaq Capital Market on October 16, 2020 under the ticker symbol "KRBP." The offering is expected to close on October 20, 2020, subject to satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc. is acting as sole book-running manager for the offering. Paulson Investment Company, LLC is acting as co-manager for the offering.

A registration statement on Form S-1 (File No. 333-238153) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on October 15, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected].

Moderna to Report Third Quarter 2020 Financial Results on Thursday, October 29, 2020

On October 15, 2020 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, October 29, 2020 to report its third quarter 2020 financial results and provide a corporate update (Press release, Moderna Therapeutics, OCT 15, 2020, View Source [SID1234568531]).

To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 1938847. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.