On January 21, 2021 Kuur Therapeutics, the leading developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies, reported clinical updates for both the phase 1 GINAKIT2 study of KUR-501 (autologous GD2 CAR-NKT cells) being tested in patients with relapsed/refractory (R/R) neuroblastoma, and the phase 1 ANCHOR study of KUR-502 (off-the-shelf CD19 CAR-NKT cells) being evaluated in patients with R/R CD19 positive malignancies (Press release, Kuur Therapeutics, JAN 21, 2021, View Source [SID1234574184]). Complete responses and evidence of tumor homing have been observed in both trials, and the CAR-NKT cell therapy has been safe and well-tolerated.

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"We are very excited by these results, which help validate the biology and clinical activity of CAR-NKT cells. Although these are phase 1 studies and continue to recruit patients, we are pleased we have been able to demonstrate tumor homing, an important property of CAR-NKT cells, along with an excellent safety profile," said Kurt Gunter MD, Kuur Chief Medical Officer. "We are grateful to the patients and families for their participation in these studies and to the scientists and physicians at Baylor College of Medicine for their scientific leadership."

"We are encouraged by the evidence of clinical activity with an allogeneic approach, especially at such a low dose," said Dr. Carlos Ramos, Principal Investigator of the ANCHOR study, Professor of Medicine at the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine, and member of the Dan L Duncan Comprehensive Cancer Center. "We look forward to advancing the program and treating additional patients."

In the GINAKIT2 study, out of ten evaluable patients and with escalation to a dose level (DL) of 1×108 cells/m2, one complete response (CR) and one partial response (PR) have been observed to date, with stable disease (SD) in three additional patients. The patient with the CR is notable in that a PR was observed after the initial 1×108 cells/m2 dose, and a subsequent single dose at the same level deepened the response to a CR. Tumor biopsies show CAR-NKT cells homing to the neuroblastoma tumor site at all dose levels. KUR-501 has so far demonstrated a promising safety profile, with only one case of grade two cytokine release syndrome (CRS) and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS).

In the ANCHOR study, of the two evaluable lymphoma patients treated to date at the starting DL of 1×107 cells/m2, one patient has experienced a CR and the other a PR. The patient with a CR was initially observed to be in PR four weeks after infusion but subsequently converted to a CR without additional therapy. Biopsy of the patient’s lymph node prior to conversion to CR status revealed viable, allogeneic CD19 CAR-NKT cells. The patient with a PR had previously failed autologous CAR-T cell therapy. KUR-502 has so far demonstrated a promising safety profile with no CRS, no ICANS, and no evidence of graft versus host disease (GvHD).

"We are very pleased to be able to report the first complete response in a patient treated with an allogeneic engineered CAR-NKT cell therapy," said Kevin S. Boyle, Sr., Chief Executive Officer of Kuur. "The clinical activity and safety data from both clinical trials are encouraging for the potential of our innovative CAR-NKT cell platform to create effective therapies for cancer patients."

The trials are being conducted at Baylor College of Medicine (Kuur’s CAR-NKT cell platform partner), Houston Methodist Hospital and Texas Children’s Hospital.

About KUR-501

KUR-501 is an autologous product in which natural killer T (NKT) cells are engineered with a chimeric antigen receptor (CAR) targeting GD2, which is expressed on almost all neuroblastoma tumors. KUR-501 is also designed to address key limitations of current CAR immune cell therapies by secreting the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. KUR-501 is being tested in a phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high-risk neuroblastoma. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target and has extensive potential applications in the treatment of hematological and solid tumors.

About KUR-502

KUR-502 is built on Kuur’s next-generation CAR-NKT platform with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. The NKT cells used in Kuur’s CAR-NKT platform have an invariant T cell receptor that does not distinguish between self- and non-self tissues, making the cells unlikely to induce GvHD when given to another person. Preclinical data generated by Baylor College of Medicine indicate that while human CAR-T cells cause severe GvHD, CAR-NKT cells from the same donor do not.

The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The single-arm study will evaluate three dose levels with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19 positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by delays to get treatment, a requirement for patient leukapheresis, and issues with inferior quality leukapheresis starting material due to prior treatment. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Kuur’s collaborator, Baylor College of Medicine and is currently recruiting participants.

On January 21, 2021 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome, reported its participation in the Microbiome Movement Drug Development Summit – Europe, including the Plenary Session, Microbiome Leaders Industry Review Panel (Press release, 4d Pharma, JAN 21, 2021, View Source [SID1234574182]).

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Plenary Session: European Microbiome Leaders Panel Discussion on Thursday, January 28, 2021 at 8:00am GMT (3:00am ET) with Chief Scientific Officer, Dr. Alex Stevenson, Ph.D.
Clinical Trial Design and Evaluating PK/PD Session: MicroRx and Single Strain Live Biotherapeutics: Proof of Concept Clinical Data and Future Considerations on Thursday, January 28, 2021 at 11:30pm GMT (6:30am ET) with Research Director, Dr. Imke Mulder

On January 21, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its fourth quarter and full year 2020 financial results will be released on Thursday, February 4, after the market closes (Press release, Gilead Sciences, JAN 21, 2021, View Source [SID1234574181]). At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s fourth quarter and full year 2020 financial results and will provide a business update.

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The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 3316988 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, February 6, 2021. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 3316988. The webcast will be archived on www.gilead.com for one year.

On January 21, 2021 Precigen, Inc. (Nasdaq: PGEN) reported it has commenced an underwritten public offering of shares of its common stock (Press release, Precigen, JAN 21, 2021, View Source [SID1234574180]). In addition, Precigen intends to grant the underwriters a 30-day option to purchase additional shares of its common stock. 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 size or terms of the offering.

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Wells Fargo Securities and Stifel are acting as joint book-running managers for the offering with JMP Securities acting as lead co-manager and H.C. Wainwright & Co. acting as co-manager.

The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (SEC) and became effective on July 2, 2020. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and base prospectus relating to this offering may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at 1-800-326-5897, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 21, 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 the pricing of an underwritten public offering of 7,711,284 shares of its common stock at a price of $5.45 per share, with expected gross proceeds to OncoSec of approximately $42.0 million (Press release, OncoSec Medical, JAN 21, 2021, View Source [SID1234574179]). The offering is expected to close on or about January 25, 2021, subject to customary closing conditions.

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

OncoSec has filed a preliminary 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 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.