On October 11, 2018 Spherix Incorporated (Nasdaq: SPEX) reported that it has entered into a merger agreement with CBM BioPharma, Inc. ("CBM") that will transform Spherix into an innovative pharmaceutical company with pioneering drugs and treatments focused on the multibillion dollar oncology therapeutics market.

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CBM is a privately held pharmaceutical company with exclusive drug development rights from world-renowned partners including Wake Forest Innovations and the University of Texas at Austin. CBM has a team of leading drug development scientists who will be joining Spherix as advisors to advance the technology. The CBM platform focuses on the treatment of numerous cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and pancreatic cancer.

Two specific proprietary drugs that are currently being researched are:

KPC34 (Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia)

Developed at Wake Forest School of Medicine, AML and ALL drug, KPC34, is a next generation treatment designed to overcome multiple resistance challenges observed with the current standard of care. KPC34 has also been shown to be more effective in AML relapse cases, notably increasing the lifespan of mice treated with the drug.

One competitive benefit of KPC34 includes its ability to be orally administered. This is critical for patients that are unable to tolerate repeated cycles of chemotherapy. In addition, it has served to double the mean survival time versus the current standard of care treatments in a mouse model of leukemia.
DHA-dFdC (Pancreatic Cancer Drug)

Developed at the University of Texas at Austin, DHA-dFdC has shown positive results in preclinical studies, inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models. DHA-dFdC also overcomes tumor cell resistance to current chemotherapeutic drugs. Pancreatic cancer is a deadly disease that affects millions of people around the world.

The following doctors will be supporting the efforts of Spherix, after the completion of the merger:

Dr. Timothy S. Pardee, MD, PhD, an Associate Professor of Internal Medicine, Section on Hematology and Oncology and Cancer Biology and Director of Leukemia Translational Research at Wake Forest School of Medicine. Dr. Pardee stated, "I am very excited at the possibility of bringing KPC34 to the clinic in early phase clinical trials. As a physician scientist who treats acute leukemia patients, I know firsthand the clear unmet medical need for relapsed patients."

Dr. Gregory Kucera, a Professor of Internal Medicine at the Wake Forest University School of Medicine with over 28 years of research experience on novel therapeutics for cancer treatment. His laboratory has expertise in synthesizing therapeutics, lipid biochemistry, and in vitro drug testing. Dr. Kucera stated, "As a research scientist, the satisfaction of seeing a compound like KPC34 go from the laboratory to an early stage clinical trial is immense. I have a great sense of pride in knowing that the work done by our research team has produced a drug that may benefit cancer patients in the very near future."

Joining Spherix as Chief Science Officer to oversee clinical advancement of these drugs is Dr. Tom Wilkie who is an Associate Professor of Pharmacology at the University of Texas Southwestern Medical Center in Dallas. He earned both his BA at the University of California Berkeley and his PhD with Richard Palmiter at UW Seattle, in biochemistry. Wilkie has published 74 primary research papers and reviews, serves on NIH, CIRM, and AACR (Free AACR Whitepaper) grant review study sections. He reviews manuscripts for multiple journals, and is Director of the first-year graduate student core course at UT Southwestern.

Dr. Wilkie stated, "I’m delighted to join Spherix as Chief Science Officer. The agreement between Spherix Incorporated and CBM BioPharma will advance the exciting potential for improving the lives of patients, family, friends, and ultimately, all of us. Proposals for the next phase of testing are underway."

Dr. Robert J. Vander Zanden, Spherix’s Chairman of the Board, stated, "Spherix is extremely pleased to announce this merger with CBM, as we believe it serves as a necessary step in our transition to a diversified biopharmaceutical company. This deal builds upon our investment in Hoth Therapeutics, which owns several exciting assets in various stages of development."

Anthony Hayes, CEO of Spherix stated, "We are very excited to welcome CBM BioPharma and its team to Spherix. It is an exciting and transformational time for the Company. Spherix will pay $16.5 million in stock for 100% of CBM by issuing 15 million Spherix shares to CBM at a fixed price of $1.10 per share. I look forward to sharing more information with our shareholders about the merger in the upcoming weeks, via investor outreach and our upcoming SEC filings."

On October 11, 2018 Forbius (Formation Biologics) reported that it was nominated in the "Best New Drug Developer" category at the 5thAnnual World ADC Awards (Press release, Forbius, OCT 11, 2018, View Source [SID1234531671]). This competitive nomination process involved over 2,545 casted votes to recognize leaders and innovators in the antibody-drug conjugate (ADC) research field.

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Forbius’ lead program, AVID100, is an ADC targeting EGFR. AVID100 is undergoing Phase 2 clinical trials in patients with confirmed EGFR overexpression in squamous cell carcinoma of the head and neck, squamous non-small cell lung cancer, and triple negative breast cancer. Phase 2a development of AVID100 is supported by the recently announced $18.75M peer-reviewed grant from the Cancer Prevention Research Institute of Texas (CPRIT).

On October 11, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of an abstract on pelareorep (formerly known as REOLYSIN) for the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich (Press release, Oncolytics Biotech, OCT 11, 2018, View Source [SID1234530639]).

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The abstract, authored by Sanjay Goel, Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, et al., "Dose finding and safety study of Reovirus (Reo) with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC): Final results", outlines positive clinical trial results for pelareorep in the treatment of patients with KRAS mutant metastatic colorectal cancer. Thirty-six patients received treatment with FOLFIRI/B and pelareorep, and the results demonstrated that the combination is not only safe and well tolerated, but that progression free survival (PFS) and overall survival (OS) are significantly superior to historical data.

The patients receiving the recommended phase 2 dose had a 50 percent response rate (3 of 6 patients) and the median PFS and OS were 65.6 weeks and greater than 98.3 weeks (as of May 9, 2018), respectively.

"The noted improvement in both PFS and OS compared to historical results are meaningful for Oncolytics and for the patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "The favorable results reported from this clinical trial demonstrate the potential of pelareorep to be a compelling treatment choice for a patient population that otherwise has limited therapeutic options after they have progressed on current standard-of-care chemotherapy."

The complete Abstract can be found online at View Source Full details from the poster presentation will be announced after it is presented.

Presentation Number:
565P
Date:
October 21, 2018
Lecture Time:
1:05 pm CEST
Location:
Hall A3 – Poster Area Networking Hub, ICM München, Munich, Germany
Speakers:
Sanjay Goel
Session Name:
Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The

compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On October 11, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported results from an FDA End of Phase 2 meeting and provided a corporate update (Press release, Iovance Biotherapeutics, OCT 11, 2018, View Source;p=RssLanding&cat=news&id=2371343 [SID1234530323]).

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The company reported that an End of Phase 2 meeting with the FDA was held. FDA has acknowledged the potential acceptability of a single-arm cohort for registration. FDA has further acknowledged that conduct of a randomized Phase 3 trial may not be feasible in its intended population of advanced melanoma patients who have been treated with at least one systemic therapy including a PD-1 blocking antibody and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor and is not required for initial registration of lifileucel. A new cohort of 80-100 patients in C-144-01 will be enrolled with a prospective definition of the primary endpoint of ORR to be read out by a Blinded Independent Review Committee (BIRC) to support registration of lifileucel. This new cohort, which the company refers to as Cohort 4, will be initiated in early 2019 and is expected to be fully enrolled by late 2019/early 2020. BLA submission to FDA is expected in the second half of 2020.

The company also reported that Iovance was granted a Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel in advanced melanoma based on data provided to the U.S. Food and Drug Administration (FDA) from the company’s C-144-01 study. RMAT designation is granted for regenerative medicine drugs and allows for increased access to FDA during development. Under this designation, surrogate endpoints can be used to receive approval for a product, accelerated approval may be granted, and a rolling review of a Biologics License Application (BLA) may be possible for the Center for Biologics Evaluation and Research (CBER).

"We are very excited with the progress made at Iovance during 2018. Specifically, we are pleased to have alignment with FDA regarding acceptability of a single-arm cohort to support registration of our lead product. In addition, we have greatly optimized our manufacturing process with Gen 2, leading to a scalable, commercial manufacturing process. We now have a global footprint with our clinical sites resulting in increased clinical enrollment and have produced sufficient data to discuss our registration path with FDA. As part of the recent interactions, we have also received an RMAT designation allowing for more frequent interactions with the FDA, benefiting from the agency’s guidance during development of lifileucel," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics.

Corporate Update

Regulatory

Iovance held an End of Phase 2 meeting with FDA during which the agency acknowledged that a single-arm cohort as part of C-144-01 could be supportive of initial registration and conduct of a randomized Phase 3 trial in the patient population being enrolled may not be feasible.
Iovance was granted an RMAT designation for advanced melanoma.
Iovance intends to continue consultation with FDA under the RMAT designation and enroll a new cohort of patients to support registration of lifileucel. The new cohort will have a prospective definition of the primary endpoint of ORR by BIRC and release criteria for lifileucel.
Clinical

The Company also reported that data from 46 patients of Cohort 2 of trial C-144-01 will be provided at SITC (Free SITC Whitepaper) 2018. For these 46 patients, an objective response rate (ORR) of 37% has been observed in the cohort, with duration of response (DOR) ranging from 1.3+ to 14+ months depending on time of enrollment. The ORR includes one (1) complete response and 16 partial responses, six (6) of which are unconfirmed and pending patient’s upcoming second assessments.
Enrollment in the global Phase 2 metastatic melanoma study, C-144-01, has reached the predefined sample size. Enrollment into the existing Cohort 2 will be closed and a new Cohort 4 will be initiated in early 2019. The company plans on initiating enrollment into Cohort 4 in early 2019 and expects to fully enroll the necessary patients into Cohort 4 by late 2019/early 2020.
BLA submission is expected in the second half of 2020.
Enrollment continues in other Iovance studies. Patient dosing in EU was initiated in the C-145-04 study of cervical carcinoma. The study design is based on Simon’s two-stage design. Stage one has now been completed and enrollment in the study continues. To date, preliminary data for 15 patients yields an ORR of 27% with an early look at the DOR ranging from 2.4 to 2.5+ months. In the C-145-03 study of head and neck cancer, to date, preliminary data for 13 patients yields an ORR of 31% with a DOR ranging from 2.8 to 7.6 months. The safety findings from these studies remain consistent with previous reports.
Data referenced above is from a data cut as of October 4, 2018.
Manufacturing

In support of the ongoing studies in EU, in addition to Lonza, Netherlands, a second European manufacturing collaboration was initiated.
IP

Two U.S. patent applications covering therapeutic methods based upon Generation 2 manufacturing, developed at Iovance, have been recently allowed.

On October 11, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported the pricing of $150 million aggregate principal amount of its 3.00% convertible senior notes due 2025 (the "Notes") (Press release, Karyopharm, OCT 11, 2018, View Source [SID1234530278]). The Notes will be sold in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Karyopharm also granted to the initial purchasers of the Notes a 13-day option to purchase up to an additional $22.5 million aggregate principal amount of the Notes. The offering is expected to close on or about October 16, 2018, subject to satisfaction of customary closing conditions.

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The Notes will be unsecured, senior obligations of Karyopharm, and will bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, beginning on April 15, 2019. The Notes will mature on October 15, 2025, unless earlier repurchased, redeemed or converted in accordance with their terms. Subject to certain conditions, on or after October 15, 2022, Karyopharm may redeem for cash all or a portion of the Notes at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The Notes will be convertible at the option of holders of the Notes, upon satisfaction of certain conditions and during certain periods, into cash, shares of Karyopharm’s common stock, or a combination of cash and shares of Karyopharm’s common stock, at Karyopharm’s option. The conversion rate for the Notes will initially be 63.0731 shares of Karyopharm’s common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $15.85 per share. This represents a premium of approximately 27.5% over the last reported sale price of $12.435 per share of Karyopharm’s common stock on The Nasdaq Global Select Market on October 10, 2018. The conversion rate will be subject to adjustment upon the occurrence of certain events.

Karyopharm estimates that the net proceeds from the sale of the Notes will be approximately $145.1 million (or approximately $167.0 million if the initial purchasers exercise their option to purchase additional Notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Karyopharm. Karyopharm intends to use the net proceeds from the sale of the Notes: to continue establishing the infrastructure to support the potential commercial launch of selinexor; to support continued clinical development of selinexor in hematologic malignancies and solid tumors; to conduct ongoing activities to support regulatory submissions for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma and, if the results of Karyopharm’s SADAL trial are positive, as a new treatment for patients with relapsed/refractory diffuse large B-cell lymphoma; for clinical trials of two of Karyopharm’s pipeline drug candidates in oncology, eltanexor and KPT-9274; and for working capital and other general corporate purposes.

The Notes will be offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the Notes and the shares of common stock issuable upon conversion of the Notes, if any, have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction, and the Notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Any offer of the Notes will be made only by means of a private offering memorandum.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the Notes or any other securities, nor shall there be any offer, solicitation or sale of the Notes or any other securities (including the shares of Karyopharm’s common stock issuable upon conversion of the Notes, if any) in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful