On August 19, 2019 Oncoceutics, Inc., reported that it has signed an exclusive, world-wide license for US patent #10,239,877, entitled "Pharmacophore for trail induction", from The Scripps Research Institute ("Scripps"), covering the composition of matter of ONC201 as well as other molecules in the imipridone family (Press release, Oncoceutics, AUG 19, 2019, View Source [SID1234558334]). This patent has been issued in the United States, has received a notice to grant in Europe, and has been filed in most major markets around the world. The earliest expiration for this patent is 2035.

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The license of the composition of matter patent provides Oncoceutics with the highest level of patent protection for its lead molecule. It also resolves a "constitutional isomer issue" that arose following the publication in Angewandte Chemie International Edition entitled "Pharmacophore Reassignment for Induction of the Immunosurveillance Cytokine TRAIL" in May 2014. This article pointed out that a use patent licensed by Oncoceutics in March 2014 for ONC201 detailed an incorrect chemical assignment and noted that Scripps had filed a composition of matter patent application containing the correct structure of ONC201.

Following the publication, Oncoceutics and Scripps pursued parallel patent claims that resulted in a series of issued patents for ONC201, including the composition of matter patent noted above as well as a reissuance of the original Oncoceutics patent, this time with the correct depiction of the chemical structure of the molecule. With the license of the Scripps patent, Oncoceutics now controls all of the issued and pending worldwide patents related to ONC201.

In addition to the composition of matter of ONC201, the license from Scripps also includes a series of additional molecules that share that same core structure as ONC201, named "imipridones", and that are likely to have the same advantageous biological attributes as ONC201, including anti-cancer properties, oral bioavailability and wide therapeutic window.

"With the license from Scripps that covers composiiton of matter, Oncoceutics has added significant patent protection to our lead molecule," said Martin Stogniew, Ph.D., Chief Development Officer of Oncoceutics. "We now have a total of 14 issued patents covering ONC201 and our other imipridone molecules. In addition, we have substantially grown the library of imipridones that Oncoceutics can develop in the future."

On August 19, 2019 Spherix Incorporated, (NASDAQ: SPEX) a technology development company committed to the fostering of innovative ideas, today issued a letter to shareholders (Press release, Spherix, AUG 19, 2019, View Source [SID1234538988])

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Dear Shareholder,

In advance of our Special Meeting on September 5th, I write to update you on certain developments and to encourage you to vote in favor of the proposals recommended by the Board of Directors and set forth in the Special Meeting Proxy.

The acquisition of the CBM BioPharma, Inc. ("CBM") pharmaceutical assets is an integral step in building Spherix into a cutting edge pharmaceutical company. It also builds upon the success we have already realized as a part of the Company’s transformation. Two years ago, Spherix made an investment in Hoth Therapeutics, Inc., which is now estimated to be worth over $10,000,000. In our effort to deliver value to our shareholders and to continue the transformation at Spherix, the Board intends to propose a special dividend of One Hundred Thousand shares (100,000) of Hoth stock. Effectuating the dividend is contingent upon obtaining the necessary votes for the CBM acquisition at the Special Meeting to be held on September 5th. The dividend will be paid upon the consummation of the transaction with CBM to shareholders of record prior to the date of such consummation. Upon closing the acquisition of the CBM assets, the Company expects to focus its efforts on growing and developing its portfolio.

The proposed Hoth dividend represents over $500,000 of value at today’s stock price. Should Spherix not receive the necessary votes to acquire the CBM assets on September 5th, it is unlikely that the Hoth dividend will be declared. The Company would instead retain this stock to use as a valuable resource for other corporate and strategic matters.

There are three ways to vote your shares of Spherix, each only taking a few moments:

By Telephone – Stockholders in the United States can submit their vote by calling the toll-free number indicated on the Special Proxy you received by mail; please have your control number located on the enclosed vote instruction form available when calling;
By Internet – Stockholders can submit their vote via internet at www.proxyvote.com; please have the control number located on the enclosed vote instruction form available; or
By Mail – Stockholders can vote by mail by signing, dating and returning the enclosed vote instruction form in the postage-paid envelope provided.
If you need any assistance in voting your shares or have questions regarding the special meeting of stockholders, please contact Spherix’s proxy solicitor, MacKenzie Partners, Inc., at (800) 322-2885 (toll-free) or (212) 929-5500 (collect), or email at [email protected].

I thank you for your continued support and investment in our Company. We believe with conviction that we are taking the right steps to drive shareholder value, make sound investment decisions, and return capital to shareholders when appropriate.

Sincerely,

Anthony Hayes

On August 19, 2019 Spherix Incorporated (Nasdaq: SPEX) reported that it has filed a Preliminary Proxy Statement with the Securities and Exchange Commission and announced a Special Meeting of Stockholders related to approving various items related to the proposed and previously announced acquisition of substantially all of the assets of CBM BioPharma, Inc. ("CBM") (Press release, Spherix, AUG 19, 2019, View Source [SID1234538984]).

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The acquisition of the CBM assets constitutes another step in Spherix’s continued transformation into an innovative pharmaceutical company with pioneering drugs and treatments focused on the development and commercialization of oncology therapeutics. CBM is a privately held pharmaceutical company with exclusive drug development rights from world renowned partners like Wake Forest University and University of Texas. CBM has a team of leading drug development scientists who will be joining the Spherix Advisory Board. The CBM platform focuses on the treatment of numerous cancers, including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) and pancreatic cancer.

Spherix recently acquired a 20% ownership interest in CBM. That 20% ownership stake puts Spherix in a position to benefit from any dividend distribution made by CBM from any potential sale of Spherix stock that CBM receives from the transaction.

Mr. Anthony Hayes, CEO of Spherix stated, "We are moving methodically and expeditiously to complete this transformative merger, wherein we will become a diversified biopharmaceutical company with a compelling portfolio of potential compounds to develop and commercialize. The deal is structured in a way as to minimize the cash outlay and create a structure that we hope will allow Spherix to be paid back a portion of its CBM investment. As a 20% owner of CBM, Spherix will be in a position to receive 20% of all dividends that CBM may make if CBM sells any portion of its Spherix stock. These dividends can be used to further advance the newly purchased CBM technology, without any additional dilution to shareholders."

On August 19, 2019 Genmab A/S (Nasdaq: GMAB) reported that 13 Janssen Research & Development, LLC (Janssen)-sponsored abstracts regarding daratumumab were accepted for presentation at the 17th International Myeloma Workshop, taking place in Boston, Massachusetts from September 12 to 15, 2019 (Press release, Genmab, AUG 19, 2019, View Source [SID1234538874]). Data from the Phase II GRIFFIN study (MMY2004) and data from the Phase II PLEIADES (MMY2040) study were both accepted for presentation during oral sessions at the conference. The abstracts are available on the conference website and may be accessed via View Source

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"We look forward to the first presentation of data from the Phase II PLEIADES and GRIFFIN studies and are pleased to see that key updates from the Phase III MAIA, CASSIOPEIA and COLUMBA studies, have all been selected for presentation at a prestigious medical conference," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Abstracts submitted by Janssen include:

Daratumumab, Lenalidomide, Bortezomib and Dexamethasone Improves Depth of Response in Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN – Oral presentation, Sunday, September 15, 8:45 AM EDT

Concordance of Post-consolidation Minimal Residual Disease Rates by Multiparametric Flow Cytometry and Next-generation Sequencing in CASSIOPEIA – Oral presentation, Friday, September 13,10:45 AM EDT

Daratumumab Plus Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma: Subgroup Analysis of High-risk Patients in CASSIOPEIA -Oral presentation, Friday, September 13, 10:30 AM EDT

Subcutaneous Daratumumab in Combination with Standard Multiple Myeloma (MM) Treatment Regimens: An Open-label, Multicenter Phase 2 Study (PLEIADES) – Oral presentation, Friday September 13, 1:45 PM EDT

Greater Treatment Satisfaction in Patients Receiving Subcutaneous Versus Intravenous Daratumumab for Relapsed or Refractory Multiple Myeloma: COLUMBA – Poster discussion presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Brazil with Relapsed or Refractory Multiple Myeloma – Poster discussion presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

Daratumumab, Lenalidomide, and Dexamethasone Delivers a Reduction and Delay in Worsening of Pain Symptoms for Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplant – Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Matching-adjusted Indirect Comparison of Bortezomib-Thalidomide-Dexamethasone and Daratumumab Plus Bortezomib-Thalidomide-Dexamethasone Versus Bortezomib-Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma who are Transplant Eligible – Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Matching-adjusted Indirect Comparison of Daratumumab-Bortezomib-Thalidomide-Dexamethasone Versus Bortezomib-Lenalidomide-Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma who are Transplant Eligible – Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Matching-adjusted Indirect Comparison of Bortezomib-Thalidomide-Dexamethasone and Daratumumab Plus Bortezomib-Thalidomide-Dexamethasone Versus Bortezomib-Cyclophosphamide-Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma who are Transplant Eligible – Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

Subcutaneous Daratumumab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma: An Open-label, Multicenter, Phase 2 Study (PLEIADES) – Trial-in-progress poster presentation, Friday, September 13, 6:30 PM – 8:30 PM EDT

Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma After Frontline Transplant: A Multicenter, Randomized, Phase 3 Study (AURIGA) – Trial-in-progress poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Randomized Phase 2 Study of Subcutaneous Daratumumab Plus Carfilzomib/Dexamethasone Versus Carfilzomib/Dexamethasone Alone in Patients with Multiple Myeloma who have been Previously Treated with Intravenous Daratumumab to Evaluate Retreatment (LYNX) – Trial-in-progress poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

On August 19, 2019 On Target Laboratories, Inc., a privately held biotechnology company that is developing tumor-targeted fluorescent imaging agents to improve cancer surgery, reported that it has completed its Phase 2, multi-center, open-label clinical trial for OTL38 in the detection of lung cancer nodules in lung cancer patients during surgery (Press release, On Target Laboratories, AUG 19, 2019, https://www.prnewswire.com/news-releases/on-target-completes-otl38-phase-2-clinical-trial-in-lung-cancer-300903646.html [SID1234538872]). Top-line data from the trial are expected to be reported in the first half of 2020.

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The Phase 2 study assessed the efficacy, safety and tolerability of OTL38 used intraoperatively in patients with suspected lung cancer. OTL38 is an imaging agent consisting of a folate receptor targeting ligand linked to a highly fluorescent near-infrared dye, which specifically targets folate receptors overexpressed in multiple cancers, including non-small cell lung cancers. For more information on the trial refer to www.clinicaltrials.gov, using the NCT identifier NCT02872701.

"Completing the OTL38 Phase 2 trial in lung cancer is a major milestone for On Target Laboratories," said Chris Barys, newly appointed CEO of On Target Laboratories, who recently succeeded outgoing CEO Martin Low. "The completion of this study propels us one step closer to FDA approval and commercialization which will bring a much-needed advancement in imaging for patients undergoing image-guided surgery for lung cancer."

About OTL38

OTL38, which is being evaluated in clinical trials in ovarian cancer and lung cancer, is a novel compound consisting of a folate receptor targeting ligand, linked to a near-infrared dye which specifically targets folate receptors overexpressed in multiple cancer types.