On December 22, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that it received a positive determination from the Nasdaq Stock Market granting approval of the Company’s request to transfer its listing to the Nasdaq Capital Market from the Nasdaq Global Select Market (Press release, Advaxis, DEC 22, 2020, View Source [SID1234573207]). The Company’s securities will begin trading on the Nasdaq Capital Market effective at the start of trading on December 24, 2020. The Company’s shares will continue to trade on Nasdaq under the symbol "ADXS."

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The Company’s stock price has traded below the minimum bid price necessary to maintain its listing on the Nasdaq Global Select Market (and now, the Nasdaq Capital Market). On December 22, 2020, Advaxis received notification from Nasdaq that the Company has been granted an additional 180-day compliance period, or until June 21, 2021, to regain compliance with the minimum $1.00 bid price per share requirement of Nasdaq’s Marketplace Rule 5550(a)(2) (the "Rule"). Nasdaq’s determination to grant the additional 180-day compliance period was based on the Company meeting the continued listing requirements of the Nasdaq Capital Market with the exception of the bid price requirement, and the Company having provided written notice of its intention to cure the deficiency during the additional compliance period, including effecting a reverse stock split if necessary.

According to Nasdaq, if at any time before June 21, 2021 the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Company will regain compliance with the Rule and the matter will be closed.

If the Company does not meet the minimum bid requirement during the additional 180-day grace period, Nasdaq will provide written notification to the Company that its common stock will be subject to delisting. At such time, the Company may appeal the delisting determination to a Nasdaq Hearings Panel ("Panel"). The Company would remain listed pending the Panel’s decision. There can be no assurance that, if the Company does appeal a subsequent delisting determination by the Staff to the Panel, that such appeal would be successful.

On December 22, 2020 Genprex, Inc. (Nasdaq: GNPX) ("Genprex" or the "Company"), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into a securities purchase agreement with a single healthcare-dedicated institutional investor for the purchase and sale of 3,116,884 shares of its common stock at a purchase price of $3.85 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Genprex, DEC 22, 2020, View Source [SID1234573206]). No warrants will be issued in connection with the transaction. The closing of the offering is expected to occur on or about December 24, 2020, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239134) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement 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 Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the 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 December 22, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the publication of a manuscript on MGD019, an investigational PD-1 × CTLA-4 bispecific DART molecule, in Cell Reports Medicine (Press release, MacroGenics, DEC 22, 2020, View Source [SID1234573205]). MacroGenics’ DART platform allows for the creation of bispecific antibody-based molecules with the ability to bind to two distinct targets in contrast to a single target as supported by traditional monoclonal antibodies.

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The publication, Development and Preliminary Clinical Activity of PD-1-Guided CTLA-4 Blocking Bispecific DART Molecule, highlights key findings from the ongoing Phase 1 trial of MGD019 first-in-human study of patients with advanced solid tumors (NCT03761017) as well as data from mechanistic studies. Findings in mechanistic studies demonstrated that cells co-expressing PD-1 and CTLA-4 are abundant in the tumor microenvironment (TME) compared to normal tissues, supporting PD-1 and CTLA-4 co-blockade in treating solid tumor cancers. This observation suggests that targeting dual PD-1/CTLA-4-expressing cells may also provide an opportunity for increased selectivity of checkpoint blockade in the TME, while relatively reducing effects in normal tissues.

In vitro studies demonstrated that MGD019 may provide complete blockade of PD-1 together with tunable inhibition of CTLA-4, with greatly enhanced blockade of CTLA-4 activity on dual-antigen expressing cells, a potential advantage over PD-1 or CTLA-4 blockade with individual monoclonal antibodies. In addition, MGD019 was well tolerated in non-human primates following repeated intravenous (IV) administrations (four weekly doses) of MGD019 at dose levels of 10, 40 and 100 mg/kg, well exceeding the highest non-severely toxic dose reported for the combination of nivolumab and ipilimumab in this species.

These mechanistic data formed the basis for the on-going, first-in-human study demonstrating clinical activity and correlated pharmacodynamics. At the cutoff date of April 1, 2020, 33 patients representing 21 different advanced solid tumor types were treated, including 13 patients (39.4%) who had previously received checkpoint inhibitor therapy. Objective responses were reported in four patients (including one unconfirmed response) with tumor types typically unresponsive to conventional checkpoint inhibition. MGD019 was generally well-tolerated up to the top predefined dose level of 10 mg/kg, with no dose limiting toxicities (DLTs) observed and a safety profile generally consistent with that of anti-PD-1 monotherapy.

"Treatment with PD-1 and CTLA-4 inhibitors such as nivolumab and ipilimumab has been effective in several cancer indications; however, the combination is associated with significant toxicity," said Paul Moore, Ph.D., MacroGenics’ Vice President of Cell Biology and Immunology and the senior author on the paper. "The pre-clinical and clinical results published today demonstrated that MGD019 can mediate complete blockade of PD-1 with tunable blockade of CTLA-4, which is enhanced on dual-expressing cells, a potential advantage over blockade by combining individual monoclonal antibodies to PD-1 and CTLA-4. The early clinical data from the Phase 1 trial of MGD019 appear to indicate an acceptable safety profile and support further clinical investigation of MGD019 in cancer treatment."

About MGD019

MGD019 is an investigational, bispecific DART molecule that was designed to enable blockade of two immune checkpoint molecules expressed on T cells, PD-1 and CTLA-4. Based upon the establishment of a recommended Phase 2 dose (RP2D) from a dose escalation study, MGD019 is initially being evaluated in a dose expansion study in microsatellite-stable colorectal cancer and non-small cell lung cancer. MacroGenics retains global rights to MGD019.

On December 22, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the closing of its previously announced underwritten public offering of common stock, resulting in gross proceeds to the Company of $26.4 million (Press release, Greenwich LifeSciences, DEC 22, 2020, View Source [SID1234573204]).. The Company intends to use the net proceeds for completion of all manufacturing and all clinical trial activities to complete an interim analysis and data readout of the GP2 Phase III clinical trial, for the submission of a Biologics Licensing Application to the FDA seeking conditional marketing approval of GP2, for the in-licensing or acquisition and development of additional products, including the coronavirus vaccine program, and for working capital and general corporate purposes.

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The Company has also granted the underwriters a 45-day option to purchase up to an additional 99,000 shares of common stock offered in the public offering to cover over-allotments, if any, at the public offering price, which would increase the total gross proceeds of the offering to approximately $30.4 million, if exercised in full.

Aegis Capital Corp. acted as sole bookrunner for the offering.

This offering was made pursuant to a registration statement on Form S-1 (File No. 333-251366) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and subsequently declared effective on December 17, 2020 and a registration statement on Form S-1 (File No. 333-251438) previously filed with the SEC and immediately declared effective on December 17, 2020. A final prospectus related to the offering was filed and is available on the SEC’s website. Electronic copies of the final prospectus may be obtained by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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 December 22, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the issuance of a U.S. patent (US 10,450,340) covering compositions of matter for a novel family of camsirubicin analogs (Press release, Monopar Therapeutics, DEC 22, 2020, https://ir.monopartx.com/news/detail/23/monopar-announces-issuance-of-u-s-patent-covering-compositions-of-matter-for-a-novel-family-of-camsirubicin-analogs [SID1234573202]). The patent, which expands the Company’s camsirubicin intellectual property portfolio, is expected to expire in 2038 not including any patent term extensions.

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"The analogs covered in this patent have been designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin and the potent broad-spectrum antitumor activity of doxorubicin; further, preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active in doxorubicin-resistant tumor cells. This may enable us to address additional cancer types beyond those possible with camsirubicin," said Andrew Mazar, PhD, Monopar’s Chief Scientific Officer.

Doxorubicin is FDA approved in 14 different types of cancers including soft tissue and bone sarcomas; metastatic stomach, ovarian, thyroid, lung, and breast cancer; acute myeloid and lymphoblastic leukemia; Hodgkin and non-Hodgkin lymphoma; and neuroblastoma. However, cumulative dose effects of doxorubicin can result in irreversible heart damage and death, which is why a restrictive lifetime cumulative dose limitation has been placed on its use.

"If successful, camsirubicin and its analogs could overcome the restrictive dose limitation and be administered at higher doses and for longer periods of time than doxorubicin," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "This could lead to improved efficacy and better patient outcomes."

Monopar’s clinical trial collaboration partner, Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcomas, is on track to initiate an open-label Phase 2 clinical study in early 2021 evaluating camsirubicin head-to-head against doxorubicin in advanced soft tissue sarcoma (ASTS), where doxorubicin is currently the first-line treatment.