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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.

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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

CytRx Corporation Announces Closing of $10 Million Offering to Healthcare-Focused Institutional Investor

On July 16, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported the closing of its previously announced sale of its securities pursuant to a securities purchase agreement (the "Purchase Agreement") to a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million (Press release, CytRx, JUL 16, 2021, View Source [SID1234584911]). The Investor is independent of the Company’s Board of Directors and management team. The Company intends to use the net proceeds of the offering for working capital purposes.

Under the terms of the Purchase Agreement, CytRx sold 2,000,000 shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering and 8,240 shares of Series C 10.00% Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share for total gross proceeds of approximately $8.24 million, in a concurrent private placement. The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. The Preferred Stock includes beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock.

CytRx also issued to the Investor an unregistered preferred investment option (the "Investment Option") that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Investment Option is exercised in full. The exercise price for the Investment Option is $0.88 per share. The Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval (the "Authorized Share Increase").

H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

As described above, the issuance of the shares of common stock underlying the Preferred Stock and the Investment Option sold in the private placement is subject to the Authorized Share Increase. Pursuant to the Purchase Agreement, the Company must hold a meeting of its stockholders no later than September 25, 2021 to seek shareholder approval.

The shares of common stock sold in the registered direct offering were offered and sold in the registered direct offering by CytRx pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255431), including a base prospectus, previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on July 12, 2021. The registered direct offering was made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering has been filed with the SEC and is available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained from H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022 or via telephone at (212) 856-5711 or email at [email protected].

The Series C Preferred Stock and Investment Options sold in the private placement and the shares of common stock issuable thereunder were offered pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and have not been registered under the Act, or applicable state securities laws, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

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.

Aptevo Therapeutics’ Chief Scientific Officer, Jane Gross, PhD, to Present at Upcoming Cambridge Health Institute PEGS Virtual Conference

On July 16, 2021  Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that Dr. Jane Gross, Senior Vice President of Research and Development and Chief Scientific Officer of Aptevo, will give a presentation and participate in a live interactive panel discussion at the Cambridge Health Institute PEGS Virtual Conference being hosted from Monday, July 19, 2021 – Thursday, July 22, 2021 (Press release, Aptevo Therapeutics, JUL 16, 2021, View Source [SID1234584910]).

Dr. Gross’ talk, entitled "Generating Immuno-Modulatory Bispecific Therapeutic Candidates for the Treatment of Hematologic and Solid Tumors," will occur on Monday, July 19, 2021 at 11:25 am Eastern time. This presentation will focus on those aspects that are unique to the Aptevo ADAPTIR and ADAPTIR-FLEX platforms and enable the generation of bispecific and multi-specific therapeutic candidates with anti-cancer potential.

The live, interactive panel session, to include Dr. Gross and entitled "Bispecifics vs CAR T Therapy for T Cell Engagement: Competing or Complementary?" will occur on Monday, July 19, 2021 at noon Eastern time. The panel discussion will focus on the benefits of bispecific antibodies vs. CAR T therapies and the potential role of either or both treatment modalities for the treatment of cancers.

"We are excited about Jane’s participation in the upcoming PEGS conference because it provides an important platform from which we can share the accomplishments and potential of our ADAPTIR and ADAPTIR-FLEX technologies," said Marvin White, President and CEO of Aptevo. "There is a growing body of evidence that tells us the fight against cancer will require many kinds of therapies that are both cancer specific and patient specific. Robust discussion around these needs, and the relative benefits and challenges associated with them, is critical to our collective success."

MorphoSys Concludes a US$ 100 Million Capital Increase to Implement the Purchase of 1,337,552 shares by Royalty Pharma

On July 16, 2021 MorphoSys reported a US$ 100 Million Capital Increase to Implement the Purchase of 1,337,552 shares by Royalty Pharma (Press release, MorphoSys, JUL 16, 2021, View Source [SID1234584909])

MorphoSys AG (FSE: MOR; NASDAQ: MOR) ("MorphoSys") reported that its Management Board, with the approval of the Supervisory Board, has passed a resolution to increase the share capital of MorphoSys AG by issuing 1,337,552 new ordinary shares from the Authorized Capital 2021-II, excluding pre-emptive rights of existing shareholders, to implement the purchase of 1,337,552 new ordinary shares by Royalty Pharma Investments 2019 ICAV, a subsidiary of Royalty Pharma plc (NASDAQ: RPRX) ("Royalty Pharma"). The new ordinary shares represent 3.9% of the registered share capital of MorphoSys following the capital increase.

"We’re pleased that Royalty Pharma is taking an equity position in MorphoSys as part of the long-term strategic finance partnership the two companies entered into this year," said Sung Lee, Chief Financial Officer of MorphoSys.

Royalty Pharma’s share purchase in the aggregate amount of US$ 100 million is part of the funding agreement with MorphoSys for the now completed acquisition of Constellation Pharmaceuticals; the agreement has become effective upon the completion of the merger on 15 July 2021. Royalty Pharma has purchased the 1,337,552 new ordinary shares at a price of € 63.35 per share, the volume-weighted average price of MorphoSys shares five trading days on the Frankfurt Stock Exchange (Xetra) prior to the merger, representing a premium of 12.1% to today’s closing market price on the Frankfurt Stock Exchange (Xetra). The new MorphoSys shares will be listed on the Frankfurt Stock Exchange. Royalty Pharma has agreed, subject to limited exceptions, not to sell or otherwise transfer any of the new ordinary shares for a period of twelve months.