On May 18, 2023 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported a publication describing new criteria for antibody-drug conjugate (ADC) development and preclinical efficacy of NAV-001 ADC against mesothelin-expressing tumor types (Press release, Navrogen, May 18, 2023, View Source [SID1234631864]). The publication is presented in the international peer-reviewed PLOS ONE journal and can be accessed at View Source

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NAV-001 ADC targets the cell surface mesothelin protein that is over-expressed by a number of cancers including triple negative breast, metastatic colorectal, non-small cell lung, pancreatic, ovarian and mesothelioma cancers. The publication highlights the negative impact on ADC efficacy caused by direct binding of tumor-produced Humoral Immuno-Oncology (HIO) factors to the ADC antibody component that in turn suppresses its ability to effectively internalize into antigen-expressing target cells thereby lowering its therapeutic efficacy. HIO factor binding to antibody is dependent on its three dimensional structure dictated by amino acids located in the antibody variable domain. Navrogen’s proprietary HIO factor screening platform enables the identification of antibodies that are naturally non-bound by HIO factors while its block-removed immunoglobulin technology (BRITE) platform enables engineering of HIO-refractory ADCs via replacement of amino acids responsible for HIO factor binding. NAV-001 was identified via HIO screening and contains a potent anti-cancer payload with topoisomerase II inhibitory activity. Preclinical studies using patient-derived xenograft (PDX) models have demonstrated NAV-001 single-dose efficacy across a wide array of mesothelin-positive cancers. Based on these data, NAV-001 is advancing towards clinical development as a single agent therapeutic against mesothelin expressing cancers along with a mesothelin diagnostic for patient pre-screening.

"NAV-001 is one of several assets that we have generated overcoming the negative impact that HIO factors can have on antibody-based therapeutics, including ADCs", said Dr. Nicholas Nicolaides, senior author. Implementing HIO screening into ADC development is another feature that may further improve the efficacy of this class of anti-cancer therapeutics".

On May 18, 2023 Shanghai Stock Exchange listed company HitGen Inc. ("HitGen", SSE: 688222.SH) reported that it has entered into a research agreement with ARase Therapeutics, Inc. ("ARase"), a biotechnology company developing first-in-class therapeutics targeting ADP-ribose hydrolases, novel targets that function in therapeutically proven cancer stress pathways (Press release, HitGen, May 18, 2023, View Source [SID1234631863]). HitGen will utilize its DNA-encoded library (DEL) technology platform, centered around the design, synthesis and screening of DELs, to identify novel inhibitors of ARase’s validated oncology targets. HitGen will also support ARase programs from hit-to-lead chemistry to pre-clinical development.

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HitGen is a world leader in the development of DEL technology and applications to early-stage small molecule drug discovery. Their platform includes over 1.2 trillion small molecules generated by the DEL technology and the efficiency of the screening process has made it possible for HitGen to enable drug discovery projects for many organizations around the world.

"We are very excited to work with HitGen. They will be instrumental in progressing our preclinical portfolio and we look forward to leveraging their screening platform and drug discovery capabilities in combination with our deep expertise in ADP-ribosylation and drug development," said Paul Chang PhD. CEO/CSO and founder, ARase Therapeutic.

"I am delighted to see HitGen and ARase enter this drug discovery research collaboration. HitGen’s world leading DEL technologies have enabled generation of novel chemical starting points for many innovative discovery programmes by companies like ARase. We look forward to working together with ARase research teams progressing their therapeutic programmes for serious unmet medical needs," said Dr. Jin Li, Chairman of the Board and CEO of HitGen Inc.

On May 18, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported pre-clinical data demonstrating that using INTASYL to silence TIGIT and CBL-B may be used to improve the anti-tumor response of NK cells, creating a more effective cell therapy for treating cancer (Press release, Phio Pharmaceuticals, May 18, 2023, View Source [SID1234631862]).

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NK cells are the body’s first line of defense against cancer. Unlike T cells, NK cells can recognize and kill tumor cells without prior exposure. Incorporating INTASYL’s RNAi treatment into ex vivo NK cell expansion protocols prior to adoptive cell therapy (ACT) is a strategy to reduce the expression of inhibitory proteins such as TIGIT or CBL-B to improve anti-tumor response.

"These data demonstrate the power of the INTASYL platform to enhance the activity of adoptive cell therapies to better address cancer," said James Cardia, Phio’s VP of Discovery. "Furthermore, these studies in addition to recent studies with PH-762 and PH-894, highlight the multiple applications of INTASYL, for both direct therapeutic applications as well as in combination with ACT therapy. INTASYL has the broad applicability to silence not only extracellular targets (TIGIT) but also intracellular targets that antibodies cannot address (CBL-B)."

On May 18, 2023 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company developing intratumoral immunotherapies to stimulate the patient’s immune system to target cancer cells and eradicate disease, reported the closing of its previously announced registered direct offering of 1,408,384 shares of its common stock, at a purchase price of $0.945 per share, priced at-the-market under Nasdaq rules (Press release, OncoSec Medical, May 18, 2023, View Source [SID1234631861]). The Company also issued in a concurrent private placement unregistered warrants to purchase up to an aggregate of 1,408,384 shares of common stock. The warrants have an exercise price of $0.82 per share, are immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were approximately $1.33 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering as working capital for general corporate purposes.

The securities described above (excluding the warrants and the shares of common stock underlying the warrants) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-260850) that was originally filed with the Securities and Exchange Commission (the "SEC") on November 8, 2021, and declared effective on November 15, 2021. The offering of such securities in the registered direct offering was made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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 May 18, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultra-rare diseases, reported the grant of non-qualified stock options to purchase an aggregate of 810 shares of common stock of the company and 31,690 restricted stock units of the company’s common stock to 23 newly hired non-executive officers of the company (Press release, Ultragenyx Pharmaceutical, MAY 18, 2023, View Source [SID1234631860]). The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of May 16, 2023, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates. The stock options vest over four years, with 25% of the shares underlying the option vesting on the first anniversary of the grant date and the remainder vesting with respect to 1/48th of the shares underlying the options on each monthly anniversary thereafter, subject to the employee being continuously employed by the company as of such vesting dates. The stock options have a ten-year term and an exercise price of $46.69 per share, equal to the per share closing price of Ultragenyx’s common stock on May 16, 2023.