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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On December 5, 2022 M2GEN, an oncology-focused health informatics solutions company, reported that its participation as a presenter, exhibitor, and research partner at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition December 10th through 13th, 2022 in New Orleans, Louisiana (Press release, M2Gen, DEC 5, 2022, View Source [SID1234624789]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Five poster presentations will be presented at ASH (Free ASH Whitepaper) utilizing the rich longitudinal clinicogenomic data from M2GEN’s Oncology Research Information Exchange Network (ORIEN) Avatar program, and showcase the collaboration of scientists across ORIEN, M2GEN, and other leading cancer centers across the nation. These projects highlight research discoveries in multiple myeloma and mantle cell lymphoma. Partnering with our 18 ORIEN members, M2GEN enables breakthrough scientific research to advance patient care.

We look forward to meeting with colleagues, researchers, partners, and future clients individually and at our booth #3628 during the conference. To inquire about partnering with M2GEN and the Oncology Research Information Exchange Network (ORIEN), or to learn more about how our rich longitudinal clinicogenomic ORIEN Avatar dataset could support your research efforts, contact [email protected].
Learn more about how ORIEN investigators are collaborating with fellow Network members and M2GEN to leverage the expansive clinical and molecular Avatar database, for the research being featured at ASH (Free ASH Whitepaper) 2022. The schedule of M2GEN supported poster presentations at ASH (Free ASH Whitepaper) 2022 includes:

Saturday, December 10

Lymphoid Oncogenesis poster session
Rafael Renatino-Canevarolo, PhD, of H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "Multiple Myeloma Evolution Is Characterized By Dynamic Epigenetic Landscapes" (Abstract: 1306, Full Text).

Multiple Myeloma and Plasma Cell Dyscrasias poster session
Praneeth Reddy Sudalagunta, PhD, of H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "A Multiomic Approach to Reversing Therapy Resistance in Multiple Myeloma Using Paired Ex Vivo Drug Sensitivity Measures and RNA Sequencing Data" (Abstract: 1848, Full Text).

Sunday, December 11

Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms poster session
Ryan T Bishop, PhD, of the H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "Acid Ceramidase (ASAH1) Is a Key Mediator of Drug Resistance in Refractory Multiple Myeloma" (Abstract: 2661, Full Text).

Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological poster session
David A. Bond, MD, BS, of Ohio State University will present a poster entitled "Favorable Overall Survival Following First and Second Relapse of MCL with Availability of Novel Therapies: Results from the Lion Prospective Observational Registry" (Abstract: 2897, Full Text).

The abstract presented by Dr. Bond will feature research completed by seven ORIEN institutions working together to study relapse/refractory Non-Hodgkin’s lymphoma. This group is also a recipient of a Novel Oncologic Visionary Award (NOVA) from the ORIEN Foundation.

Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Prognostic Markers in Multiple Myeloma oral program
Francesco Maura, MD, of Sylvester Comprehensive Cancer Center at University of Miami will present an oral presentation entitled "Individualized Treatment-Adjusted Risk Stratification in Newly Diagnosed Multiple Myeloma" (Abstract: 646, Full Text).

On December 5, 2022 Jazz Pharmaceuticals Ireland Limited ("Jazz"), a subsidiary of Jazz Pharmaceuticals plc (the "Company"), and Zymeworks BC Inc. ("Zymeworks"), a subsidiary of Zymeworks Inc., reported it has entered into a License and Collaboration Agreement (the "License and Collaboration Agreement") granting Jazz the exclusive rights to develop and commercialize zanidatamab, a HER2-targeted bispecific antibody with novel mechanisms of action, in the United States, Europe, Japan and other territories except for those Asia/Pacific territories that Zymeworks previously licensed to BeiGene, Ltd. (the territories subject to the License and Collaboration Agreement are referred to as the "Territory") (Filing, 8-K, Jazz Pharmaceuticals, DEC 5, 2022, View Source [SID1234624787]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The effectiveness of the License and Collaboration Agreement was subject to customary closing conditions, including all relevant antitrust clearances and the expiration or termination of all applicable waiting periods under any antitrust laws. On November 29, 2022 (the "Effective Date"), the Agreement became effective following expiration of the waiting period under the United States Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended.

Under the terms of the License and Collaboration Agreement, Jazz was granted an exclusive, royalty-bearing license, with the right to grant sublicenses, under certain of Zymeworks’s intellectual property, to research, develop, manufacture, and commercialize in the Territory pharmaceutical products containing or incorporating zanidatamab or certain related antibodies (such antibodies, collectively, "Licensed Antibodies" such pharmaceutical products, "Licensed Products"). Licensed Antibodies and Licensed Products expressly exclude all antibody-drug conjugates, including Zymeworks’s proprietary antibody-drug conjugate, zanidatamab zovodotin (also known as ZW49). Zymeworks also granted to Jazz a non-exclusive license, with the right to grant sublicenses, under certain of Zymeworks’s intellectual property, to research, preclinically develop and manufacture Licensed Products outside the Territory for the sole purpose of furthering the development and commercialization of Licensed Products in the Territory.

Pursuant to the License and Collaboration Agreement, Jazz will pay Zymeworks an upfront, non-refundable cash payment of $50.0 million. In addition, should Jazz decide to retain its licenses and other rights under the License and Collaboration Agreement following the delivery to Jazz of top-line data from Zymeworks’ ongoing study of zanidatamab in subjects with advanced or metastatic HER2-amplified biliary tract cancers (HERIZON-BTC-01), then it will be required to make a second, one-time payment of $325.0 million to Zymeworks. Jazz also agreed to pay to Zymeworks potential regulatory milestone payments of up to an aggregate of $525.0 million, and potential commercial milestone payments of up to an aggregate of $862.5 million. Pending approval, Zymeworks is eligible to receive tiered royalties between 10% and 20% on annual net sales of Licensed Products in the Territory.

The foregoing description of the terms of the License and Collaboration Agreement is not complete and is qualified in its entirety by reference to the full text of the License and Collaboration Agreement, a copy of which is filed as Exhibit 2.1 hereto and is incorporated herein by reference.