On August 20, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that an abstract on the company’s CS1001-201 trial has been submitted to the upcoming 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, CStone Pharmaceauticals, AUG 20, 2019, View Source [SID1234538864]). This will mark the first release of CS1001-201 clinical study data since the trial began.

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CS1001 is an investigational anti-PD-L1 monoclonal antibody developed by CStone. CS1001 is currently being evaluated in multiple clinical trials in China, including one multi-arm Phase I study, two registrational Phase II studies, and three Phase III clinical studies. Based on previously released data, CS1001 has shown good overall safety and tolerability, and demonstrated promising clinical utility for combination therapy in various tumor types.

The CS1001-201 trial reported in the abstract is a single-arm, multi-center Phase II clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of CS1001 monotherapy in relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (rr-ENKTL). The primary endpoint of the study is objective response rate (ORR).

ENKTL is a subtype of mature T-cell and NK-cell lymphoma. With its particular geographic predilection, the incidence rate of ENKTL is significantly higher in Asia than it is in Europe or North America. There are around 5,300 new ENKTL cases in China each year, which accounts for approximately 6% of all lymphoma incidences in the country. Approximately 50% of those ENKTL cases progress to rr-ENKTL. ENKTL is an aggressive malignancy with a dismal prognosis. Currently, there is no standard treatment for ENKTL patients in whom the L-asparaginase-based combination therapy has not been effective. CS1001-201 is the first clinical trial investigating an anti-PD-L1 antibody in rr-ENKTL patients, and durable anti-tumor activity has already been observed in the trial.

The abstract submitted to the 2019 ASH (Free ASH Whitepaper) Annual Meeting, if accepted, will highlight the safety and efficacy data from the CS1001-201 Phase II study in rr-ENKTL patients, and it will be the first report of the CS1001-201 trial and the fourth data update on CS1001 at a major scientific conference in 2019, following the ASCO (Free ASCO Whitepaper) Annual Meeting, the ESMO (Free ESMO Whitepaper) Annual Congress, and the CSCO Annual Meeting.

About CS1001

CS1001 is an investigational anti-PD-L1 monoclonal antibody being developed by CStone. Authorized by the U.S.-based Ligand Corporation, CS1001 was generated by the OMT transgenic animal platform, which can produce fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can potentially reduce the risk of immunogenicity and toxicities in patients, a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China and has demonstrated promising anti-tumor activity and tolerability.

CS1001 is currently being evaluated in multiple clinical trials including a bridging phase I trial in the USA, a multi-arm phase Ib dose-expansion study, two pivotal Phase II studies and three Phase III studies in China in various cancer types.

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.