Entry into a Material Definitive Agreement

On March 10, 2020, Rexahn Pharmaceuticals, Inc. ("Rexahn") and BioSense Global LLC ("BioSense") reported that it has entered into an amendment (the "Amendment") to the Collaboration and License Agreement, dated as of February 25, 2019, by and between Rexahn and BioSense, as previously amended (the "Original Agreement" and, as amended by the Amendment, the "Amended Agreement") (Filing, 8-K, Rexahn, MAR 10, 2020, View Source [SID1234555611]). Under the terms of the Amended Agreement, the aggregate upfront payments were reduced to $1.65 million, $1.5 million of which had previously been paid as part of the upfront payment under the Original Agreement. Upon payment in full of the remaining unpaid portion, Rexahn will (i) grant an exclusive license to develop and commercialize pharmaceutical products containing RX-3117 ("Licensed Products") for any indication in the Republic of Singapore, China, Hong Kong, Macau and Taiwan (the "Territory") and (ii) assign and transfer to BioSense all of Rexahn’s patents and patent applications related to RX-3117 in the Territory.

Pursuant to the Amendment, BioSense has agreed to use commercially reasonable efforts to develop a Licensed Product in the Territory, file an investigational new drug application relating to a Licensed Product in China, and take certain other actions relating to commercialization upon any regulatory approval.

The Amendment reflects the agreement of the parties to terminate and remove collaboration provisions under the Original Agreement, reflects the intention of Rexahn not to conduct or sponsor any additional trials with RX-3117, and reduces the milestone payments and royalties payable under the Original Agreement. Under the Amended Agreement, Rexahn is eligible to receive milestone payments in an aggregate of up to $74.5 million upon the achievement of development, regulatory and commercial goals and will also be eligible to receive tiered royalties in the mid-single digits to low tens on annual net sales in the Territory.

Until March 31, 2020, pursuant to the Amended Agreement, BioSense has the option to obtain an exclusive license to develop and commercialize Licensed Products outside the Territory upon the payment of an additional upfront fee.

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Axial Biotherapeutics to Present at the Chardan 2nd Annual Microbiome Medicines Virtual Summit

On March 10, 2020 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, reported that David H. Donabedian, Ph.D., Co-founder and Chief Executive Officer of Axial Biotherapeutics will present a virtual company overview and participate in a virtual panel on "Modulating the Microbiome" at the Chardan 2nd Annual Microbiome Medicines Summit on Monday, March 16, 2020 at 8:45 AM ET and 12:40 PM ET, respectively (Press release, Axial Biotherapeutics, MAR 10, 2020, View Source [SID1234555563]).

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Pascal Biosciences Announces Private Placement and Potential Transaction with S?RSE Technology for Cannabinoid Research Programs

On March 10, 2020 Pascal Biosciences Inc. (TSX.V: PAS) ("Pascal") is reported that it has entered into a non-binding term sheet (the "Term Sheet") with SōRSE Technology Corporation ("SōRSE"), pursuant to which it has agreed to exclusively negotiate a potential transaction (the "Potential Transaction") with SōRSE (Press release, Pascal Biosciences, MAR 10, 2020, View Source [SID1234555447]). In exchange for the exclusive right to negotiate a definitive agreement, SōRSE has agreed to purchase units of Pascal, each unit consisting of one share and one warrant of Pascal, for gross proceeds of US$250,000 on a private placement basis (the "Private Placement").

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Pascal intends to use the proceeds of the Private Placement for working capital purposes. Further details regarding the Private Placement, including the price of the units, the terms of the warrants and proposed closing date, will be announced. Completion of the Private Placement remains subject to the approval of the TSX Venture Exchange. All securities issued pursuant to the Private Placement will be subject to a statutory four month hold period.

Pursuant to the Term Sheet, Pascal has agreed to exclusively negotiate the terms of the Potential Transaction with SōRSE until May 27, 2020. Although Pascal and SōRSE have not yet finalized the binding terms of the Potential Transaction, Pascal expects that:

SōRSE will purchase Pascal’s cannabinoid programs in exchange for common shares of SōRSE valued at US$9.5 million.
Upon closing of the Potential Transaction, Pascal will hold at least 15.8% of the outstanding shares of SōRSE.
The Potential Transaction will be structured as a share purchase agreement whereby SōRSE will purchase all of the shares of Pascal Biosciences US, Inc. ("US SubCo"), a wholly-owned subsidiary of Pascal which, in addition to other assets, holds all of Pascal’s cannabinoid assets and employs certain personnel responsible for researching and advancing Pascal’s scientific programs.
Upon closing of the Potential Transaction, Pascal will focus on the advancement of its leukemia program which will not be transferred to SōRSE as part of the Potential Transaction.
As additional consideration for the sale of the cannabinoid assets, SōRSE will permit US SubCo’s employees to support Pascal’s retained intellectual property and scientific programs at no additional cost to Pascal, in accordance with a work program to be determined in the definitive agreement.
Upon closing of the Potential Transaction, SōRSE will invest an additional US$250,000 in Pascal on a private placement basis.
A binding commitment with respect to the Potential Transaction will result in an enforceable agreement only if Pascal and SōRSE negotiate and execute terms and conditions of a definitive agreement prior to the expiry of the exclusivity period, which is May 27, 2020. If entered into, the definitive agreement, and any ancillary transaction agreements, will contain representations and warranties, conditions relating to regulatory approvals, TSX Venture Exchange approvals and any required shareholder approvals, and other terms as are customary in comparable transactions of this nature. In addition, if the Potential Transaction results in the sale of more than 50% of Pascal’s assets, business or undertaking, as an additional condition to closing of the Potential Transaction, Pascal will be required to obtain approval of the Potential Transaction from its shareholders in accordance with Policy 5.3 of the TSX Venture Exchange. If a definitive agreement is not entered into and the Potential Transaction is not completed, Pascal will retain ownership of US SubCo and all rights to its cannabinoid assets.

If completed, the Potential Transaction would leverage SōRSE’s industry-leading formulation technology with Pascal’s cannabinoid programs for clinical trials. Pascal is the first company to identify a mechanism for cannabinoids to directly benefit cancer immunotherapy, and is also developing PAS-403, a cannabinoid-derived drug targeting glioblastoma. In addition, both of these programs would be funded and developed by SōRSE, which would expedite their path to human clinical trials.

SōRSE has developed a proprietary water-soluble cannabinoid emulsion technology (patent-pending) that enables increased bioavailability, accurate dosing, and over 12 months shelf stability. SōRSE is science and data-driven, with 53 employees, 30 of whom specialize in R&D and Quality Assurance. In 2019, SōRSE secured a $5 million raise and a $10 million strategic partnership with a third party and currently has multiple partnerships which provide profitable revenue streams.

"The potential of Pascal’s cannabinoid programs for clinical applications in cancer in combination with SōRSE’s proprietary emulsification methods offers a promising path for future medical applications of cannabinoid products," said Dr. Patrick Gray, CEO of Pascal Biosciences. "If a definitive agreement is entered into with SōRSE in connection with the Potential Transaction, it would come on the heels of recent, successful collaborative efforts with SōRSE that allowed Pascal to examine SōRSE formulations in several Pascal ongoing studies."

This press release will not constitute an offer to sell or the solicitation of an offer to buy nor will there be any sale of the securities in any state in which such offer, solicitation, or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

China Immunotech Completes $6.5 Million Series A for TCR-T and CAR-T Candidates

On March 10, 2020 China Immunotech Biotech of Beijing completed a $6.5 million Series A financing, led by Jianxin Capital with Grower Venture Capital and Huacheng Group participating (Press release, Immunotech, MAR 10, 2020, View Source [SID1234555396]). Founded in March 2018, China Immunotech is developing TCR-T and CAR-T products that target hematological tumors, solid tumors and virus-related diseases. It has two unique technology platforms, STAR-T and TCR-T. The STAR-T platform uses a proprietary structure of antigen receptor complexes. The company believes the platform provides multi-targeted molecules with better efficacy, fewer side effects and easier development than traditional CAR-T products.

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Kuur Therapeutics Launches to Develop and Commercialize “Off-the-shelf” CAR-NKT Cell Therapies Targeting Hematological and Solid Tumors

On March 10, 2020 Kuur Therapeutics reported the launch of its new business in partnership with Baylor College of Medicine and Baylor’s Center for Cell and Gene Therapy (Press release, Kuur Therapeutics, MAR 10, 2020, View Source [SID1234555391]). Houston-based Kuur Therapeutics will advance the work of its predecessor, Cell Medica, to develop anti-cancer therapies using its innovative chimeric antigen receptor natural killer T cell (CAR-NKT) therapy platform.

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IP Group, Baylor College of Medicine and Schroeder Adveq are investing to support two phase 1 studies: GINAKIT 2 (autologous CAR-NKT cells in neuroblastoma) and ANCHOR (allogeneic CAR-NKT cells in CD19 malignancy). The ongoing GINAKIT2 study is now enrolling patients at the third dose level and the ANCHOR study IND has recently been approved by the FDA, with first patient treatment expected in 1H 2020. The funding will also support the preclinical development of an allogeneic CAR-NKT product for treatment of hepatocellular carcinoma, ahead of an IND submission anticipated in 1H 2021.

In conjunction with the new investment, Kevin S Boyle, Sr, was named CEO of Kuur, succeeding Chris Nowers. Mr Boyle joined Cell Medica as CFO in February 2018. Kevin previously held senior finance roles at both NASDAQ-listed and private equity backed companies. He is an accomplished capital markets professional, having raised over $2.0 billion in equity and debt capital.

Kuur’s novel CAR-NKT platform is a next-generation technology of engineered immune cells with enhanced functions for the treatment of hematological and solid tumors. It utilizes the unique properties of NKT cells, a specialized type of innate lymphocyte, which shares properties with both T and NK cells. This platform, developed in the laboratory of Baylor Principal Investigator Leonid Metelitsa, is exclusively licensed to Kuur by its partner and collaborator, Baylor College of Medicine.

Annalisa Jenkins, Chair of Kuur’s Board, said: "We are fortunate to have Kevin step up to the role of CEO. He will act as a change agent, leading the company during a crucial period for our clinical trials and working to secure the additional capital required to progress our two lead CAR-NKT products through the clinic.

"The Board would also like to thank Chris for his exceptional leadership during a transition period that has resulted in a company on the right path forward for its investors, with a focus on its important collaborations."

Kevin S Boyle, Sr, Kuur’s CEO, said: "I am excited to lead Kuur Therapeutics at such a pivotal moment. We are making final preparations to take our off-the-shelf program into the clinic and believe the allogeneic approach holds huge promise for unlocking the potential of CAR therapies for large patient populations. Compared with patient-specific autologous CAR products, it is immediately available for treatment and less expensive to manufacture."

Leonid S. Metelitsa, BCM Principal Investigator, said: "My goal is to make a difference in the lives of cancer patients, especially children, and I’m excited to be working with the Kuur team to make this goal a reality. I believe that the NKT-cell platform technology, developed in my laboratory and progressed to first-in-human clinical testing in close collaboration with colleagues at BCM and Texas Children’s Hospital, offers a unique route to next-generation off-the-shelf CAR therapies for a broad range of malignancies."