On January 20, 2021 Celularity Inc., a clinical stage cell therapeutics company focused on the development of innovative allogeneic placenta-derived cellular therapies, reported that Robert J. Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity and members of the management team will be participating in a fireside chat at the B. Riley Virtual Oncology Investor Conference on Thursday, January 21, 2021, at 3:30 p.m. ET (Press release, Celularity, JAN 20, 2021, View Source [SID1234574156])

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The live audience is limited to institutional investors, investor relations, and employees of Celularity. Private investors will not be given access to the live conference, but a video recording will be available on the "Newsroom" section of the Celularity website following the conference.

On January 20, 2021 ONCOtherapeutics and Dr. James Berenson reported that promising new data demonstrating that ruxolitinib (RUX), an oral JAK1/2 inhibitor, with only steroids is well tolerated and shows promising efficacy for treating heavily previously treated MM patients (Press release, Oncotherapeutics, JAN 20, 2021, View Source [SID1234574155]).

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Recently published results from a Phase 1 trial for 28 heavily previously treated MM patients administered RUX, LEN and methylprednisolone (MP) demonstrated that the therapy was well tolerated and RUX overcame refractoriness to LEN and steroids (Berenson et al., Clin Cancer Res. 2020). The clinical and overall response rates were 46% and 28%, respectively, and all 12 responding patients were refractory to LEN.

To further evaluate whether RUX and steroids without LEN demonstrate clinical activity and its tolerability in the same patient population, an ongoing Phase I trial was expanded to also include a cohort of patients treated with only this two-drug combination (NCT03110822). RUX (15mg BID) was given orally twice a day continuously and oral methylprednisolone (MP; 40 mg) every other day.

Of the 17 evaluable patients treated with RUX and steroids so far, the CBR and ORR were 53% (n=8) and 33% (n=5), respectively. The median duration of response was 4 months (range, 1-12) and median progression free survival was 5 months (range, 1-14). The combination was well tolerated with no unanticipated adverse effects.

As noted by lead investigator Dr. James R. Berenson, "Multiple myeloma patients continue to need new treatment options, especially for those who have become refractory to previously effective treatment options. Besides having a direct MM killing effect, ruxolitinib’s ability to resensitize lenalidomide is a major advantage that allows clinicians to recycle drugs and recapture disease control, while maintaining the convenience of an all-oral regimen. This is an entirely new treatment approach for MM patients."

With these promising results, ONCOtherapeutics has expanded the current study to further investigate the potential of this novel two-drug combination for treating MM including those with poor kidney function.

On January 20, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a late-stage biotechnology company focused on designing, developing and commercializing innovative therapies and proprietary medical approaches to stimulate and to guide an anti-tumor immune response for the treatment of cancer reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, OncoSec Medical, JAN 20, 2021, View Source [SID1234574152]). 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. All of the shares to be sold in the offering will be offered by OncoSec.

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BTIG, LLC is acting as sole book-running manager for the offering.

OncoSec intends to use the net proceeds from this offering for (i) clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of its product candidates; (ii) clinical development of our product candidates; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.

OncoSec will file a preliminary prospectus supplement and accompanying base prospectus to its effective shelf registration statement on Form S-3 (File No. 333-233447) with the U.S. Securities and Exchange Commission ("SEC") for the proposed public offering of its common stock. The offering will be made only by means of a prospectus and a prospectus supplement, which will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to these securities may also be obtained, when available, by contacting BTIG, LLC 65 East 55th Street, New York, NY, 10022, or by telephone at (212) 593-7555 or by e-mail at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. 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 under the securities laws of any such state or jurisdiction.

About TAVO

OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 ("IL-12"), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer ("TNBC"). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.

On January 20, 2021 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, reported the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering price of $8.50 per share (Press release, Inovio, JAN 20, 2021, View Source [SID1234574151]). In addition, INOVIO has granted the underwriters a 30-day option to purchase up to an additional 2,655,000 shares of common stock at the public offering price, less underwriting discounts and commissions. Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 million, before deducting underwriting discounts and commissions and estimated offering expenses, but excluding any exercise of the underwriters’ option. All of the shares are being sold by INOVIO.

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INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

BofA Securities, Jefferies and Cantor are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering. The Benchmark Company, Maxim Group LLC and National Securities Corporation are acting as co-managers for the offering. The offering is expected to close on or about January 25, 2021, subject to customary closing conditions.

The shares were offered by INOVIO pursuant to a shelf registration statement filed by INOVIO with the Securities and Exchange Commission (SEC) that became automatically effective on January 20, 2021. This offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 20, 2021 Turnstone Biologics Corp., a clinical-stage biotechnology company pioneering the development of cancer immunotherapies, reported that it has acquired California-based Myst Therapeutics, a privately held biotechnology company focused on advancing novel T-cell therapies for solid tumors (Press release, Turnstone Biologics, JAN 20, 2021, View Source [SID1234574150]). The acquisition adds a pipeline of innovative TIL programs to Turnstone’s portfolio of oncolytic virus candidates. Financial terms were not disclosed.

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TIL therapy treatment protocols utilize populations of T-cells that are isolated from a patient’s own tumor, expanded and stimulated before being re-administered to the patient. There has been strong clinical evidence demonstrating the benefit of TIL therapy in solid tumors such as melanoma and cervical cancer, however, driving clinical benefit in harder-to-treat cancers has been elusive. The Myst TIL therapy platform has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients.

"Myst has created an industry-best selection strategy for identifying, expanding and stimulating antigen-reactive T-cells in a patient’s tumor," said Mike Burgess, M.D., Ph.D., President of R&D at Turnstone. "It represents the most straight-line solution for broadening the benefit of TILs to other solid tumor indications while maintaining commercial feasibility. We are excited to advance this technology both independently and in combination with our viral immunotherapies."

Myst has focused on applying their innovative T-cell selection strategies to clinically proven TIL treatment protocols. With this acquisition, Turnstone gains full access to this technology, the complete R&D capabilities of Myst along with existing development collaborations, and a pipeline of TIL programs with the lead candidate expected to enter the clinic this year.

"The Myst platform builds on validated and durable responses in the field and represents a next-generation approach to TILs that aligns directly with our commitment to exploiting the full potential of innate and adaptive tumor immunity," said Sammy Farah, Ph.D., CEO at Turnstone. "It further strengthens our internal development expertise and expands our opportunity to deliver transformative medicines to the millions of cancer patients underserved by current treatment options."

The acquisition of Myst will see an integration of talent across Turnstone’s senior management and R&D teams. Myst CEO, TJ Langer, will join Turnstone’s senior leadership team as Senior Vice President, Cell Therapy Development and External Innovation.

"The Turnstone team has extensive experience in the field of cancer immunotherapy, and I am delighted to join them to further develop this cutting-edge therapeutic modality," said Mr. Langer. "We are confident that our TIL platform has the potential to offer a substantial improvement over current TIL therapies by driving meaningful and robust responses in a wide spectrum of tumors. It is extraordinary to have these leading oncolytic virus and cell therapy programs together under one roof."