On June 29, 2021 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported the pricing of an underwritten public offering of 4,137,931 shares of its common stock at a public offering price of $145.00 per share (Press release, Intellia Therapeutics, JUN 29, 2021, View Source [SID1234584471]). Intellia also granted the underwriters a 30-day option to purchase up to an additional 620,689 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $600 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares in the offering are to be sold by Intellia.

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Goldman Sachs & Co. LLC, Jefferies, SVB Leerink, and Barclays are acting as joint book-running managers for the offering. Truist Securities is acting as co-manager for the offering. The offering is expected to close on or about July 2, 2021, subject to customary closing conditions.

The shares of common stock are being offered by Intellia pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on June 28, 2021. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; or Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Barclays Capital Inc., by mail at c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the 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 June 29, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM) (Press release, CNS Pharmaceuticals, JUN 29, 2021, View Source [SID1234584489]). As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

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"Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease," commented John Climaco, CEO of CNS Pharmaceuticals.

Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.

CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme. For more information about this study, please visit ClinicalTrials.gov and reference Identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On June 29, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported clinical data for its tumor infiltrating lymphocyte (TIL) therapy LN-145 in patients with metastatic non-small cell lung cancer (mNSCLC) who enrolled in Cohort 3B of the ongoing basket study IOV-COM-202 (Press release, Iovance Biotherapeutics, JUN 29, 2021, View Source [SID1234584453]). Cohort 3B enrolled patients that had progressed on prior immune checkpoint inhibitor (ICI) therapy, including patients with oncogene-driven tumors who received prior tyrosine kinase inhibitor therapy. The initial clinical results are available in a slide presentation on the Iovance website here.

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The overall response rate (ORR) by investigator per RECIST 1.1 was 21.4% (n=28, one complete response and five partial responses) and the disease control rate (DCR) was 64.3% following one-time treatment with LN-145 monotherapy, including two responders with PD-L1 negative tumors. Median duration of response was not reached at a median study follow up of 8.2 months. The treatment-emergent adverse event profile was consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2. All patients treated in Cohort 3B received prior anti-PD-1/L1 therapy and all six responding patients also received prior chemotherapy. Historically, ORRs of approximately 20% were reported with ICIs as second-line therapy in ICI-naïve patients who progressed on front-line chemotherapy. Iovance anticipates presenting additional Cohort 3B data at a medical meeting in the second half of 2021.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "There remains a very significant unmet need to increase response rates and prolong survival in the second line non-small cell lung cancer treatment setting. The initial data for LN-145 in this difficult to treat patient population is very promising."

The Cohort 3B data using Iovance’s TIL cell therapy are the first reported clinical data on TIL administered as a one-time monotherapy in mNSCLC from a prospective, multi-center study, and add significantly to the existing scientific data previously reported by Iovance’s collaborator H. Lee Moffitt Cancer Center.

Iovance also announced today that it dosed the first patient in IOV-LUN-202. Iovance previously opened the IOV-LUN-202 trial to investigate LN-145 in second-line mNSCLC where patients have progressed on one prior ICI and chemotherapy. This trial is designed to be supportive of registration.

Dr. Graf Finckenstein also stated: "We are excited to share our initial results for LN-145 in non-small cell lung cancer, a new potential indication for Iovance TIL cell therapy, which show positive outcomes in patients with high unmet medical need. We see a substantial opportunity to advance LN-145 in the post-ICI setting for patients with lung cancer. These data also have the potential to drive momentum with enrollment in our registration supporting study, IOV-LUN-202, as well as in two additional non-small cell lung cancer cohorts in IOV-COM-202, and we move ahead with great enthusiasm."

On June 29, 2021 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company")reported its Financial
Report for the Year Ended 31 March 2021 (Press release, Amplia Therapeutics, JUN 29, 2021, View Source;[email protected] [SID1234584472]).

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This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On June 29, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported its participation in the following conference in July. Details of the conference are as follow:

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CMBI Healthcare Corporate Day (Virtual)

Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Mr. Tianyi Zhang, Executive Director Investor Relations

One-on-one and small group meetings: July 7-9, 2021

For more information, please contact your CMBI representative.