On December 5, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the results of a Phase II NK/T-cell lymphoma study of IMC-001, a PD-L1 monoclonal antibody licensed to ImmuneOncia Therapeutics, LLC ("ImmuneOncia") (Seongnam, South Korea) (Press release, Sorrento Therapeutics, DEC 5, 2022, View Source [SID1234624798]). ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and Sorrento. In addition to IMC-001, ImmuneOncia has a wide range of new products in the pipeline, such as IMC-002, a CD47 antibody, and IMC-201, a bispecific antibody.

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The Phase II NK/T-cell lymphoma study was selected for an oral presentation at the Asian Congress of the European Society for Medical Oncology (ESMO Asia 2022) in Singapore on December 4th, 2022. The clinical data demonstrated that in patients with heavily treated NK/T-cell lymphoma, 6 of 10 evaluable patients (60%) not only achieved an objective response, but all 6 patients with an objective response also achieved a complete remission with IMC-001. Additionally, 4 of these 6 patients stayed on treatment for over a year, which provides encouraging indication of long-term IMC-001 treatment safety and durable efficacy.

NK/T-cell lymphoma is a rare cancer that is most prevalent in Asian countries, including China and Korea, and is typically treated with a regimen of radiation and chemotherapy. NK/T-cell lymphoma has a high recurrence rate of 75% within two years. Due to the absence of standard-of-care treatment for relapsed/refractory cases, NK/T lymphoma represents a high unmet medical need and significant market opportunity. To date, no single immuno-oncology drug has obtained approval in this indication.

Professor Won Seog Kim of Samsung Medical Center, the presenter and Principal Investigator of the IMC-001 study, commented, "The complete remission and response rate of 60% of IMC-001 significantly outperformed currently available drugs for the treatment, and very rare adverse events of grade 3 or higher also limit concerns over the side effects, making it a leader among PD-L1 drugs. We expect these results to satisfy the criteria for approval."

Heung Tae Kim, Chief Executive Officer of ImmuneOncia said, "This achievement sets a new standard for the second-line treatment of NK/T-cell lymphoma, which has high unmet needs. ImmuneOncia is preparing additional clinical trials to expand its indications in solid cancer."

Henry Ji, Ph.D., Chief Executive Officer of Sorrento commented, "We expect to leverage these data to create momentum to secure additional partnership and co-development opportunities for IMC-001 in regions with a high incidence of NK/T-cell lymphoma, such as China, as well as in other indications."

IMC-001 is a PD-L1 antibody, a fully human immune checkpoint inhibitor, that serves as the basis of the current immuno-oncology market. This antibody activates the anticancer functions of T cells by strongly inhibiting the binding between PD-1 expressed on T cells and PD-L1 expressed on the surface of cancer cells. Moreover, it can mediate ADCC (antibody-dependent cellular cytotoxicity) against tumor cells, as it maintains the Fc effector function using human IgG1.

On November 30, 2022, Aura Biosciences, Inc. (the "Company") entered into an underwriting agreement (the "Underwriting Agreement") with SVB Securities LLC, Cowen and Company, LLC and Evercore Group L.L.C, as representatives of the several underwriters named therein (the "Underwriters"), pursuant to which the Company agreed to issue and sell 6,700,000 shares of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), to the Underwriters at a public offering price of $12.00 per share (the "Offering") (Filing, 8-K, Aura Biosciences, DEC 5, 2022, View Source [SID1234624797]). Under the terms of the Underwriting Agreement, the Company also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 1,005,000 shares of Common Stock at the same price per share, which was exercised in full on December 1, 2022. The offering closed on December 5, 2022.

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The Company received net proceeds from the Offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, of approximately $86.7 million. The Company intends to use the net proceeds from the Offering, together with its existing cash, cash equivalents and marketable securities to advance the clinical development of belzupacap sarotalocan for the treatment of choroidal melanoma and NMIBC, to develop the platform and for general corporate purposes. The Company believes that the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities, will enable it to fund its operating expenses and capital expenditure requirements into 2025.

The Offering was made pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-268105) (the "Registration Statement"), which was previously filed with the Securities and Exchange Commission on November 1, 2022 and became effective on November 7, 2022, and a related prospectus included in the Registration Statement, as supplemented by a preliminary prospectus supplement dated November 30, 2022 and a final prospectus supplement dated November 30, 2022.

The Underwriting Agreement contains customary representations, warranties and covenants of the Company and also provides for customary indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates and were solely for the benefit of the parties to such agreement. The foregoing summary of the Underwriting Agreement is qualified in its entirety by reference to the Underwriting Agreement, a copy of which is attached hereto as Exhibit 1.1 and incorporated herein by reference.

Goodwin Procter LLP, counsel to the Company, delivered an opinion as to legality of the issuance and sale of the Common Stock in the Offering, a copy of which is attached hereto as Exhibit 5.1 and is incorporated herein by reference.

On December 5, 2022 IVERIC bio, Inc. (Nasdaq: ISEE) (the "Company"), reported that the pricing of an upsized underwritten public offering of 13,350,000 shares of its common stock at a price to the public of $22.50 per share, less underwriting discounts and commissions (Press release, Ophthotech, DEC 5, 2022, View Source [SID1234624793]). In addition, in connection with the offering, the Company has granted the underwriters an option for a period of 30 days to purchase up to an additional 2,002,500 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by the Company.

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The gross proceeds from the offering are expected to be approximately $300.4 million, before underwriting discounts and commissions and offering expenses payable by the Company, and without giving effect to any exercise by the underwriters of their option to purchase additional shares.

Morgan Stanley, BofA Securities, Cowen and Stifel are acting as the book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering. The offering is expected to close on or about December 5, 2022, subject to customary closing conditions.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of an automatically effective registration statement. A final prospectus supplement related to the offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on 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, when available, by contacting: Morgan Stanley, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by telephone: 1-866-718-1649, or by email at [email protected]; BofA Securities, 200 North College Street, 3rd floor, Charlotte, NC (28255-0001), Attn: Prospectus Department, by telephone: 1-800-294-1322, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: 1-833-297-2926, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone: 1-415-364-2720, or by email at [email protected].

This press release does 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 5, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the patient’s own immune system to target and eradicate cancer, reported that Robert Arch, Ph.D., President and CEO of OncoSec, will be participating at the RHK Capital Disruptive Growth Conference in New York City (Press release, OncoSec Medical, DEC 5, 2022, View Source [SID1234624792]).

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The RHK Capital Disruptive Growth Conference will feature leading C-suite executives and senior management of approximately 30 growth-oriented and disruptive companies to meet with seasoned institutional investors, accredited investors, representatives of family offices, market analysts and financial advisors, as well as broker-dealer wealth managers, and select RHK clients.

OncoSec’s’s webcast will be held on December 6, 2022 at 1:40 pm ET.

On December 5, 2022 Novartis announced the pivotal Phase III PSMAfore study with PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint (Press release, Novartis, DEC 5, 2022, View Source [SID1234624790]). Pluvicto demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) in patients with PSMA–positive metastatic castration- resistant prostate cancer (mCRPC) after treatment with androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI1. No unexpected safety findings were observed in PSMAfore; data are consistent with the already-well established safety profile of Pluvicto.

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This is the second positive read-out for Pluvicto in a Phase III trial following the VISION study, where patients with PSMA–positive mCRPC who received Pluvicto plus standard of care after being treated with ARPI and taxane-based chemotherapy had a statistically significant reduction in risk of death1,3. The PSMAfore results continue to support the important role of Pluvicto1 in treating patients with prostate cancer. The Phase III data will be presented at an upcoming medical meeting and discussed with the US Food and Drug Administration (FDA) in 2023 for regulatory approval.

"With the announcement of these positive topline Phase III results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane- based chemotherapy," said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. "We look forward to discussing the data with healthcare authorities in order to bring this innovative new early treatment option to many more prostate cancer patients sooner after their diagnosis."

The vast majority of patients diagnosed with CRPC already present with metastases at time of diagnosis4, patients with metastatic prostate cancer have an approximate 3 in 10 chance of surviving 5 years5. Despite recent advances, outcomes for those who progress after standard of care second-generation ARPI remain poor, and there is an urgent need for new targeted treatment options to help improve long-term outcomes6,7,8,9.

Pluvicto is already approved for treatment in adult patients with PSMA–positive mCRPC who have been treated with ARPI and taxane-based chemotherapy in the United States and several other countries10-12.

About the PSMAfore Study

PSMAfore is a Phase III, open-label, multi-center, 1:1 randomized study comparing the efficacy and safety of Pluvicto to a change in ARPI in patients with PSMA–positive mCRPC13. Patients enrolled must have progressed only once after receiving a second-generation ARPI13. There were 469 participants enrolled in the study13. The primary endpoint is rPFS, defined as the time from randomization to radiographic progression by PCWG3-modified RECIST v1.1 (as assessed by blinded independent central review) or death13. Evaluation of overall survival, the key secondary endpoint, is ongoing as data remain immature.

About PluvictoTM (lutetium (177Lu) vipivotide tetraxetan)

Pluvicto is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)3. After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein3. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

Pluvicto is approved in the US and other countries to treat adults with a type of advanced cancer called PSMA–positive mCRPC and who have already been treated with other anticancer treatments (ARPI and taxane-based chemotherapy)10-12. More specifically, in March 2022, the United States Food and Drug Administration (US FDA) approved Pluvicto10. In August and September 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada approved Pluvicto in Great Britain and Canada, respectively11,12. In October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorization for Pluvicto14. These regulatory decisions are supported by the results from the pivotal Phase III VISION study, where patients with pre-treated PSMA– positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in the risk of death; both alternate primary endpoints of radiographic progression free survival and overall survival were met.

Novartis is also evaluating opportunities to investigate Pluvicto radioligand therapy in earlier stages of prostate cancer.