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Processa Pharmaceuticals Announces That It Has Entered Into An Agreement With Aposense, Ltd To License In The Next Generation Irinotecan Drug

On June 01, 2020 Processa Pharmaceuticals reported that it has signed an agreement with Aposense to license in the patent rights and the know-how to develop and commercialize their next generation irinotecan cancer drug, ATT-11T (Press release, Aposense, JUN 1, 2020, View Source [SID1234583953]).

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Irinotecan metabolizes to SN-38, the active anti-cancer moiety, and is used as first and second line therapy in many types of cancer (e.g., metastatic colorectal, small cell lung, pancreatic). Although irinotecan has a narrow therapeutic window and dose limiting adverse effects, including a FDA "Black Box" warning for both neutropenia and severe diarrhea, irinotecan achieved peak annual sales of US$1.1 billion.

ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Aposense molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.

"The licensing of this product from Aposense fits with our strategy to continue to bring innovative products to patients with an unmet medical need condition. With the addition of this product to our pipeline, the Processa team is excited about moving into the cancer arena," said Dr. David Young, Chief Executive Officer of Processa.

The licensing agreement is a Condition Precedent License Agreement conditioned upon: (i) Processa’s closing of the Satisfactory Financing Round and the listing of the Company’s shares on the NASDAQ or NYSE and (ii) Aposense obtaining the approval of the Israel Innovation Authority for the consummation of the transactions set forth in the agreement. Subject to the terms of the Agreement and upon satisfaction of the conditions, Aposense will grant Processa a worldwide (excluding China), royalty-bearing right and license, including the right to sublicense. Under the terms of the License Agreement, Aposense will receive shares in Processa with an aggregate value of $2.5 M and could receive up to $125 M in potential development and sales milestones, as well as royalties of 7% based on net sales.

Turning Point Therapeutics to Participate in Goldman Sachs 41st Annual Global Healthcare Conference Webcast

On June 1, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that President and CEO Athena Countouriotis, M.D., will participate via webcast in a question and answer session at the 41st annual Goldman Sachs Global Healthcare Conference on June 9 (Press release, Turning Point Therapeutics, JUN 1, 2020, View Source [SID1234564370]).

Dr. Countouriotis’ session is scheduled to begin at 4:40 p.m. ET and will be accessible via audio webcast through the Investors page of www.tptherapeutics.com.

Ayala Pharmaceuticals to Present at Upcoming Investor Conferences

On June 1, 2020 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported Ayala management will present at two upcoming investor conferences (Press release, Ayala Pharmaceuticals, JUN 1, 2020, View Source [SID1234563987]):

Jefferies Virtual Global Healthcare Conference: Wednesday, June 3, 2020 at 10:30 am ET.
Raymond James 2020 Human Healthcare Innovation Conference: Thursday, June 18, 2020 at 8:20 am ET.
A live webcast of each presentation may be accessed by visiting the Investors and News section of Ayala’s website at www.ir.ayalapharma.com. An archived replay of each webcast will be available on the website for 90 days following the presentations.

Orgenesis to Collaborate with The Edith Wolfson Medical Center to Conduct Clinical Study Using Orgenesis’ Proprietary POCare Technologies for the Generation and Expansion of Tumor Infiltrating Lymphocytes

On June 1, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, reported that it has entered into a Clinical Study Agreement with The Edith Wolfson Medical Center, a leading public hospital in Israel (Press release, Orgenesis, JUN 1, 2020, View Source [SID1234561702]). Under the agreement, the parties will conduct a clinical study with a goal of utilizing and validating a number of Orgenesis’ proprietary POCare Technologies, including a novel, automated cell culturing system, designed to enable a faster, safer and metabolically optimized culturing and expansion process for the generation and expansion tumor infiltrating lymphocytes (TIL) for use in adoptive T-cell therapies.

The goal of the cell culturing system is to provide an innovative and simplified method for TIL generation and expansion in an automated and controlled system from the initial TIL production to final product with minimal human operation.

Vered Caplan, CEO of Orgenesis, stated, "Partnering with Edith Wolfson Medical Center, an established and well-respected medical institution, to conduct this clinical trial will further validate our cell processing system for TIL generation and expansion. These POCare Technologies are not only highly versatile, but also highly expandable and as a result, could increase our ability to grow various types of cells for a broad range of customer needs. This latest collaboration is a further illustration of Orgenesis’ commitment to advance novel cell therapies and develop new approaches to immune-oncology in a cost effective, high quality and scalable manner through our CGT Biotech Platform. Orgenesis will deploy these solutions across its POCare Network. This network includes a growing number of leading medical institutions around the world, including our newly formed collaboration with Hospital Infantil Universitario Niño Jesús, Madrid."

Dr. Ronen Brenner, Head of the Oncology Division at The Edith Wolfson Medical Center, commented, "We look forward to collaborating with Orgenesis on this important clinical trial to advance and validate this breakthrough Orgenesis proprietary TILs technology, with the joint goal of reducing manufacturing costs and bringing new, cell and gene therapy products to cancer patients worldwide."

Allogene Therapeutics Announces Commencement of Public Offering of Common Stock

On June 1, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), reported the commencement of an underwritten public offering of $450.0 million of shares of its common stock (Press release, Allogene, JUN 1, 2020, View Source [SID1234560836]). In addition, Allogene expects to grant the underwriters a 30-day option to purchase up to an additional $67.5 million of shares of its common stock offered in the public offering. All of the shares of common stock to be sold in the offering will be sold by Allogene. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Goldman Sachs & Co. LLC, Jefferies LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The securities described above are being offered by Allogene pursuant to a shelf registration statement (including a prospectus) filed on November 5, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926, or by email at [email protected].

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.