On January 25, 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 closing of its previously announced underwritten public offering of 20,355,000 shares of its common stock, which includes 2,655,000 shares sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares, at a price to the public of $8.50 per share (Press release, Inovio, JAN 25, 2021, View Source [SID1234574273]). The gross proceeds to INOVIO from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $173 million.

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BofA Securities, Jefferies and Cantor acted as joint book-running managers for the offering. Oppenheimer & Co. acted as lead manager for the offering. The Benchmark Company, Maxim Group LLC and National Securities Corporation acted as co-managers for the offering.

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 final 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. 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 25, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that it intends to offer shares of its common stock for sale in an underwritten public offering (Press release, Lipocine, JAN 25, 2021, View Source [SID1234574274]). In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering solely to cover over-allotments, if any. The offering is subject to market 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 in the proposed offering are to be sold by Lipocine.

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We intend to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include additions to working capital and capital expenditures.

Raymond James & Associates, Inc. is acting as sole manager for the public offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-250072) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 23, 2020. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at [email protected]. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

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.

On January 25, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma (Press release, Shanghai Junshi Bioscience, JAN 25, 2021, View Source [SID1234574255]). Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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About Toripalimab
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the "NMPA") for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. Two supplemental New Drug Applications (NDAs) of Toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and the second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In addition, Toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy Designation (BTD) by the FDA in September 2020. In December 2020, Toripalimab was included in the updated National Reimbursement Drug List (NRDL) (2020 Edition).

About Combination Clinical Trial
The Combination Clinical Trial is an international, multi-center, randomized Phase III study designed to evaluate the efficacy and safety of Toripalimab in combination with Axitinib versus Pembrolizumab as a first-line treatment in patients with unresectable, locally advanced or metastatic mucosal melanoma. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms. The primary endpoint of the Combination Clinical Trial is progression-free survival (PFS). The secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.

Mucosal melanoma is a subtype of melanoma with mucosal origin. Compared with cutaneous melanoma, mucosal melanoma is less responsive to traditional chemotherapy and immunotherapy, and thus remains an unmet medical need. Toripalimab and Axitinib combination was the world’s first clinical application of PD-1 checkpoint blockade with a VEGFR inhibitor for the treatment of mucosal melanoma in a Phase Ib study (NCT03086174). The results of the study were published in the Journal of Clinical Oncology in August 2019. The study showed that the combination of Toripalimab with Axitinib in the first-line setting achieved an ORR of 48.3% and a disease control rate (DCR) of 86.2% for advanced mucosal melanoma with a manageable safety profile. The median progression-free survival (mPFS) was 7.5 months. In March 2020, Toripalimab in combination with Axitinib for the treatment of mucosal melanoma was granted the Orphan-Drug Designation (ODD) by the FDA.

About Fast Track Designation (FTD)
The FTD aims to facilitate the development and accelerate the review process of treatments for serious or life-threatening diseases or conditions that remain unmet clinical needs. The FTD is designed to make important new drugs accessible to patients faster. According to FDA regulations, drugs that receive FTDs will be granted an accelerated review process through various forms, including but not limited to (1) more frequent interactions and meetings with the FDA to discuss drug development and clinical trial design; (2) eligibility for priority review and accelerated approval after meeting relevant criteria; (3) rolling review, which means instead of waiting until all sections of the NDA are completed, a company can submit completed sections of its biologic license application (BLA) or new drug application (NDA) for review on a rolling basis.

The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States. This marks another important milestone, after Toripalimab was granted the ODD and the BTD by the FDA.

On January 25, 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 guide an anti-tumor immune response for the treatment of cancer reported the closing of a previously announced underwritten public offering of 7,711,284 shares of its common stock at a price of $5.45 per share (Press release, OncoSec Medical, JAN 25, 2021, View Source [SID1234574276]). The gross proceeds to OncoSec from the offering, before deducting underwriting discounts, commissions and other offering expenses payable by OncoSec, were approximately $42 million.

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BTIG, LLC acted as sole book-running manager for the offering. A.G.P./Alliance Global Partners and ThinkEquity, a division of Fordham Financial Management, Inc. acted as lead managers for the offering, and Maxim Group LLC and Dawson James Securities, Inc. acted as co-managers 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 the company’s product candidates; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.

OncoSec has filed a final prospectus supplement and accompanying base prospectus to its effective shelf registration statement on Form S-3 (File No. 333-233447), and the related registration statement on Form S-3 (File No. 333-252281), filed under Rule 462(b) of the Securities Act of 1933, as amended, with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. Copies of the final prospectus supplement and the accompanying base prospectus relating to these securities may also be obtained 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 25, 2021 MorphoSys (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab (NASDAQ: IMAB) reported that the first patient has been dosed in a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MOR210/ TJ210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States (Press release, MorphoSys, JAN 25, 2021, View Source [SID1234574257]).

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MOR210/TJ210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1 (C5aR1). Produced in the tumoral microenvironment, its ligand C5a acts as a chemoattractant to recruit tumor-promoting cells such as myeloid-derived suppressor cells, M2 macrophages and neutrophils. MOR210/TJ210 is designed to induce anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells.

Preclinical studies have shown that targeting the C5aR-C5a axis exerts anti-tumor activity with immune checkpoint inhibitors. Furthermore, in vitro activity was observed for blocking the C5a/C5aR pathway also at very high C5a concentrations leading to a long duration of action. MOR210/TJ210 demonstrated a good safety profile with no observed adverse effects up to the highest dose tested in non-clinical safety studies.

The phase 1 clinical trial is an open-label dose escalation study with multiple doses in multiple centers in the U.S. to evaluate the safety, tolerability, and PK/PD of MOR210/TJ210 in subjects with advanced solid tumors. The development program will evolve into further clinical combination studies of MOR210/TJ210 with checkpoint inhibitors.

"We are encouraged by the data observed in the preclinical studies and believe that TJ210/MOR210 with its unique properties has great potential to target difficult-to-treat cancers," said Dr. Joan Shen, CEO of I-Mab. "The data generated from this study will provide valuable information about TJ210/MOR210’s safety and tolerability profile and its potential benefits in patients with advanced cancers."

"We look forward to progressing with MOR210/TJ210 into clinical studies together with I-Mab to investigate its potential as a novel therapeutic option for patients with advanced solid tumors," said Dr. Malte Peters, Chief Research & Development Officer of MorphoSys.

MorphoSys will receive a $1.5 million payment from I-Mab for achieving this milestone under the license agreement between the two companies. MorphoSys and I-Mab entered into an exclusive strategic collaboration and licensing agreement to develop and commercialize MOR210/TJ210 in November 2018. Under the terms of agreement, I-Mab receives exclusive rights to develop and commercialize MOR210/TJ210 in Greater China and South Korea, while MorphoSys retains rights in other parts of the world. With support from MorphoSys, I-Mab will also fund and conduct all global development activities of MOR210/TJ210, including clinical trials in China and the U.S., towards clinical proof-of-concept (PoC) in oncology.

About MOR210/TJ210
MOR210/TJ210 is a novel human antibody directed against C5aR1 derived from MorphoSys’s HuCAL Platinum(R) technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. MOR210/TJ210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

HuCAL Platinum(R) is a registered trademark of MorphoSys AG.