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Vertex to Announce Second-Quarter 2021 Financial Results on July 29

On July 16, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its second-quarter 2021 financial results on Thursday, July 29, 2021 after the financial markets close. The company will host a conference call and webcast at 5:30 p.m. ET (Press release, Vertex Pharmaceuticals, JUL 16, 2021, View Source [SID1234584921]). To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

Celldex Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On July 16, 2021 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported the closing of its previously announced underwritten public offering of 6,845,238 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 892,857 shares, at a public offering price of $42.00 per share (Press release, Celldex Therapeutics, JUL 16, 2021, View Source [SID1234584920]). The gross proceeds to Celldex from this offering were approximately $287.5 million, before deducting underwriting discounts and commissions and offering expenses.

Jefferies, SVB Leerink, Guggenheim Securities and Cantor acted as joint book-running managers for the offering. LifeSci Capital LLC and H.C. Wainwright & Co. acted as co-lead managers for the offering.

The securities described above were offered and sold by Celldex pursuant to a prospectus supplement and an accompanying base prospectus forming part of a shelf registration statement on Form S-3 (File No. 333-249917), which was deemed effective by the Securities and Exchange Commission ("SEC") on November 6, 2020, and are available on the SEC’s website located at View Source Copies of the prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by e-mail at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

This press release does not constitute an offer to sell or the 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.

Grit Bio Closes Series A+ Round for its Cell Therapy Oncology Therapies

On July 16, 2021 Grit Biotechnology, a two-year-old Shanghai cell therapy company, reported that it closed a Series A+ round to develop its Tumor Infiltrating Lymphocytes (TIL) therapies (Press release, Grit Bio, JUL 16, 2021, View Source [SID1234584915]). Its leading program is GT101, a genetically unmodified TIL product that is currently being tested at a multi-centered clinical trial in China for solid malignancy indications. The round was led by GL Ventures, the VC arm of Hillhouse Group, with participation from Apricot Capital and Junshi Bio, as well as continued support from existing shareholders, Decheng Capital and Matrix Partners.

Aluda Pharmaceuticals announces peer-reviewed publication on ALD-R491, an Exosome Release Inhibitor and novel oncology mechanism

On July 16, 2021 Aluda Pharmaceuticals, a private company, reported the publication of an article in a peer reviewed journal describing a novel mechanism of Exosome Release Inhibition (ExoRI) for the treatment of a broad range of cancers (Press release, Aluda Pharmaceuticals, JUL 16, 2021, View Source [SID1234584913]). Over the past decade, tumor exosomes have been studied extensively in academia for their roles carrying signals that make tumors invasive, create a tumor microenvironment (TME) that enables evasion from immune detection, and promote metastases . Tumor cells upregulate their release of exosomes to promote these roles throughout all stages of cancer, across many types of cancers, transporting multiple pro-cancer signals, many of which are existing drug targets. Inhibition represents a way to block many signals at once, even as they change over time. Research has shown that PD-L/PD-L1, the important immune checkpoint targets, avoid detection by their transport in exosomes, so exosome inhibitors may also address the large rate of non-response for that class of agents.

Aluda’s paper, entitled A Small Vimentin-Binding Molecule Blocks Cancer Exosome Release and Reduces Cancer Cell Mobility, appears in the journal Frontiers in Pharmacology, and describes the exosome release inhibition action of ALD-R491 through multiple in vitro models. Further in studies with ALD-R491 show exosome-driven tissue changes consistent with diminished signaling and a lowered TME.

The essential role of vimentin in enabling exosome movement was discovered by Aluda.

Aluda CEO Dr. Ruihuan Chen said, "These results show exosome inhibition can block the messages sent by tumors to drive metastases, reduce the TME, and increase systemic dysregulation. It enables tumors to be detected and attacked by native immunity, and is a non-cytotoxic mechanism that is oral so we expect exosome release inhibition (ExoRI) will be an effective, safe, and patient-friendly anti-cancer therapy with new and significant benefits to patients, and complementarity to existing drugs."

About ALD-R491

ALD-R491 is an intracellular protein that forms dynamic and flexible filaments which play an essential role in disease to mobilize, become invasive, and activate process, including the release of tumor exosomes. Many different types of diseases, from autoimmune and fibrosis to cancer, rely on vimentin filaments for these steps. ALD-R491 binds to a specific domain on vimentin, changing its physical properties and interrupting its role in disease. As a first-in-class "vimentin binder", ALD-R491 showed wide efficacy against disease. ALD-R491 has completed all IND filing requirements including complete two-species GLP tox.

Kiromic BioPharma Provides Update on IND Filings on its Off-the-Shelf, Allogeneic CAR-T for Solid Tumors

On July 16, 2021 Kiromic BioPharma, Inc. (Nasdaq: KRBP) reported that Two INDs were submitted to the FDA in May 2021 for the first-in-human off-the-shelf allogeneic CAR-T for Solid Tumors (Press release, Kiromic, JUL 16, 2021, View Source [SID1234584912]).

FDA returned with comments on the Company’s allogeneic CAR-T products with respect to:

— Tracing of all reagents used in manufacturing

— Flow chart of manufacturing processes

— Certificate of Analysis (COA) for the Company’s CAR-T products (allogeneic CAR-T)

The company has an FDA response taskforce, staffed with 30 yr industry veterans, working on answering the FDA comments above.

Our CMC processes are rigorous.

Our product is allogeneic gamma delta T cell manufacturing which few companies have mastered.

The company’s timeline for commencement of the dosing of its first in human clinical trial is expected to be tighter but we still plan on delivering in 3Q 2021.

June 2, 2021, Kiromic announces the closing of public offering