On September 18, 2018 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, and NovellusDx, Ltd., a leader in functional genomics, reported the signing of a definitive agreement under which NovellusDx will merge with a newly formed Israeli subsidiary of Cancer Genetics and shareholders of NovellusDx will receive stock equal to approximately 49% of the equity of Cancer Genetics on a fully diluted basis (with certain adjustments) (Press release, Cancer Genetics, SEP 18, 2018, View Source [SID1234531536]). Cancer Genetics will be the surviving entity and expects to remain listed on the Nasdaq Stock Market.

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This transaction will combine Cancer Genetics’ scale, expansive test portfolio and broad data set related to tumor biology, cultivated over more than a decade, with NovellusDx’s proprietary technology and machine learning capabilities to form a leading, oncology-focused precision medicine company. The aim of the combined company is to accelerate and enhance therapeutic development, effectively matching patients to targeted therapies to improve treatment success rates for biopharma companies.

John A. Roberts, Chief Executive Officer of Cancer Genetics commented, "This is truly an exciting day for CGI and its shareholders. We believe that the combination of Cancer Genetics and NovellusDx will result in an organization that is uniquely positioned within the oncology ecosystem. The combined company has an opportunity to become an essential partner for biopharma companies to support their efforts to develop better, more targeted therapeutics and improve patient outcomes in cancer treatment. Over the last several months, we have made significant progress in positioning Cancer Genetics as a value-added partner with biopharma companies. We are confident that this transaction significantly strengthens our value proposition for both existing and potential biopharma partners. We look forward to planning, with the NovellusDx team, the integration of our respective strategic plans to bring innovative product and service offerings as we advance toward closing."

Mr. Roberts will become CEO of the combined company. Dr. Charles Woler, MD, PhD, currently Chairman of the Board of NovellusDx, will serve as Chairman of the Board of the combined company. Dr. Woler has spent the last 30 years in the healthcare industry, in large multinational pharmaceutical companies, SMEs and also in smaller, earlier stage biotech companies. His positions have included CEO of Roche France, CEO of SmithKline Beecham’s European pharmaceutical business (London), CEO of Cadus Pharmaceuticals (US), CEO of Neuro3d & Endotis Pharma (France), and recently Biomnis (France). He holds non-executive chairman and directorship positions in companies in Europe, the United States and Israel.

The Boards of Directors of both companies have approved the proposed merger, which is expected to close in the first quarter of 2019, subject to the approval of Cancer Genetics’ and NovellusDx’s shareholders, tax regulatory approvals, financing, and other customary closing conditions. Existing NovellusDx shareholders, including OrbiMed Israel Partners II, L.P., Pontifax (Israel) IV LP, Helsinn Investment Fund SA, SICAR, and Windham Venture Partners have indicated that they will invest $10 million in additional equity as part of a concurrent PIPE financing, which is expected to close immediately following and in connection with the closing of the merger. NovellusDx will also be providing up to a $2.3 million bridge loan to Cancer Genetics in conjunction with the signing of the definitive merger agreements.

Haim Gil-Ad, Co-founder and Chief Executive Officer of NovellusDx added, "We are pleased to enter into this merger agreement with Cancer Genetics and excited by what the future holds for the combined company and our shareholders. This merger will result in a company offering advanced science and cutting-edge technology to empower oncologists and the biopharma industry to make optimal treatment decisions and develop new therapies to benefit patients in need. We believe that the combined company will have a level of capability and expertise unmatched in the oncology arena and will be well-positioned to compete, particularly in the fast-growing immuno-oncology segment."

Raymond James is serving as exclusive financial advisor to Cancer Genetics and rendered a fairness opinion in connection with the merger. Chardan is serving as exclusive financial advisor to NovellusDx.

On September 18, 2018 Provectus (OTCQB: PVCT) reported that the United States Patent and Trademark Office (USPTO) has allowed the Company’s patent application for the use of adoptive cell transfer (ACT) of PV-10-induced T cells for the treatment of solid tumor cancers (Press release, Provectus Biopharmaceuticals, SEP 18, 2018, View Source [SID1234529473]). Co-inventors include current and former members of a longstanding, PV-10-focused, translational research team at Moffitt Cancer Center (Moffitt) in Tampa, Florida, which has undertaken work in melanoma, breast cancer, and pancreatic cancer starting in 20111.

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PV-10 is Provectus’ lead investigational drug for the treatment of adult and pediatric solid tumor cancers, and is the first small molecule oncolytic immunotherapy. It is administered via intralesional injection directly into superficial or visceral tumors to elicit immunogenic cell death of these injected tumors. PV-10 is the subject of several ongoing clinical trials of adults in melanoma2,3 and cancers of the liver3,4. PV-10 has also been shown to induce cell death in pediatric solid tumor cell lines derived from relapsed neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma6.

Under the treatment concept of the allowed patent application, which is entitled "Method of Ex Vivo Enhancement of Immune Cell Activity for Cancer Immunotherapy with a Small Molecule Ablative Compound," PV-10 is injected into solid tumors and the resulting immune products – T cells trained via PV-10 oncolytic immunotherapy to be functional against treated tumors – are harvested, banked, and amplified. Amplified T cells may be administered via ACT, if needed. The allowed patent application also covers the ACT treatment of either the original patient or other immunologically-suitable patients.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Hundreds of patients have received intralesional PV-10 for a variety of solid tumor types. One of several logical paths for expanding our clinical development program is to explore harnessing functional immunologic activation produced by PV-10 oncolytic immunotherapy via the use of adoptive cell transfer. Protecting Provectus’ intellectual property in this regard was an important and necessary task."

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

On September 18, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its partner, Austrianova, has successfully performed an additional pre-production "engineering run" using the Cell-in-a-Box encapsulated cells that will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, SEP 18, 2018, View Source [SID1234529474]).

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On the advice of PharmaCyte’s Chief Scientific Officer and Austrianova, who will be performing the full production process of PharmaCyte’s clinical trial material, it was decided that the first production run would be deemed an engineering/pre-production run to be conducted before the production run to produce clinical trial material begins.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are happy to report that the encapsulation portion of the process during the pre-production run went flawlessly. Our decision has proven to be the correct course of action. We have much more information on how the cells from the Master Cell Bank (MCB) perform during and after encapsulation. The experience we have gained allowed Austrianova to make minor, but important, changes to the cell culture portion of the full production process. Completing the full production process and testing the final product now are the major items that remain to be accomplished before submitting our IND to the FDA."

The full production process consists of several steps with the most important being (i) the encapsulation process and (ii) the subsequent culturing of the encapsulated cells. PharmaCyte’s Cell-in-a-Box technology, with the live cells inside, must be placed in a "culture bath" long enough for the capsules to become filled with about 10,000 living cells that stop dividing upon contact with neighboring cells. If the capsules contained dividing cells, those cells would be killed (and rendered useless for cancer therapy) within the capsules when the ifosfamide prodrug was administered.

The decision to regard the run as an engineering run before the final production run occurs resulted, partly, due to learning that the cells from the MCB produced by Eurofins show slightly altered growth properties when compared to the cells that were previously tested and then used to prepare the MCB. This finding is not unusual when a new cell bank is established. However, since any alterations in the growth characteristics of the cells from the MCB that were used for the current encapsulation run might impinge on aspects of the overall production process, to have any anomalies well characterized and in line with regulatory guidelines, this additional engineering run was performed.

The knowledge gained from the two engineering runs should allow for the final production run to produce clinical trial material to begin. Austrianova completed the entire production process a few weeks ago and since then has successfully filled syringes with capsules that were produced during this pre-production run. This process was carried out to mimic what will be done in the final production run from encapsulation to preparing for direct shipment of PharmaCyte’s live-cell product to clinical trial study sites

On September 18, 2018 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that the first patient has started treatment in the company’s Phase II BRIDGE trial designed to study the Pharmacokinetics (PK), safety and efficacy of Ygalo in combination with dexamethasone in multiple myeloma patients with renal impairment (Press release, Oncopeptides, SEP 18, 2018, View Source [SID1234529532]).

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Multiple myeloma commonly results in deteriorating renal function. This makes BRIDGE an important study to show treating physicians how Ygalo can be used in Relapsed Refractory Multiple Myeloma (RRMM) patients with renal impairment.

CEO comment

"In addition to our pivotal study OCEAN, this is the third ongoing clinical trial to gather information about Ygalo in different groups of myeloma patients. It is important to map out Ygalo’s efficacy and side effect profile in myeloma patients at various stages of the disease to guide treating physicians about Ygalo’s clinical benefit profile. The BRIDGE study is an important positioning study since it seems Ygalo’s treatment profile does not vary with kidney function in the same way as for other multiple myeloma treatments that has limitations in use or effect in these patients" said Jakob Lindberg, CEO of Oncopeptides.

Ygalo in clinical development

Ygalo has been investigated in the treatment of late-stage relapsed refractory multiple myeloma (RRMM) patients. This was done in the clinical study O-12-M1 where strong final results were reported in December 2017. Currently, four clinical studies, including BRIDGE, are ongoing with Ygalo.

In the BRIDGE study the pharmacokinetics (PK), safety and also efficacy will be evaluated in RRMM patients, also suffering from renal impairment, a common complication in MM patients, Ygalo is administered together with dexamethasone.

ANCHOR is a Phase I/II study, where Ygalo is administered in combination with either bortezomib+dexamethasone or daratumumab+dexamethasone in RMM or RRMM patients. The results from this study aim to create understanding and knowledge among treating physicians for how Ygalo can be used in combination with these drugs. In addition, the results could open up for the use of Ygalo in earlier lines of treatment.

HORIZON is a Phase II study that studies the effect of Ygalo in late-stage RRMM patients with few or no remaining established treatment options. Interim data from this study was reported in June 2018 at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting (EHA) (Free EHA Whitepaper).

OCEAN is Oncopeptides´ pivotal Phase III study where Ygalo is compared directly head-to-head with current standard of care, pomalidomide, in late-stage RRMM patients.

FACTS – BRIDGE

Performed in Europe
Phase II study that will include 25 patients
A PK study in which Ygalo is administered together with dexamethasone (steroid)
The study will show how Ygalo should be used in patients with renal impairment
Results are expected late 2019
BRIDGE will increase Ygalos market opportunity by opening up for use in patients with renal impairment, which is a common complication in patients with multiple myeloma
For further information, please contact or visit www.oncopeptides.se:

Jakob Lindberg, CEO of Oncopeptides
Phone: +46 (0)8 615 20 40
E-mail: [email protected]

Rein Piir, Head of Investor Relations at Oncopeptides
Cell phone. +46 708 537 292
E-mail: [email protected]

The information was submitted through the agency of the contact person above for publication at 11.30 CET on September 18, 2018.

About Ygalo

Ygalo, an alkylating peptide, belongs to a novel class of peptidase-enhanced compounds (PEnCs) and targets the multiple myeloma (MM) tumor transformation process with a unique mechanism of action. Aminopeptidases are heavily over-expressed in MM and are key to the transformational process of the tumor cells. Ygalo selectively targets MM through aminopeptidase-driven accumulation; in vitro experiments show a 50-fold enrichment of alkylating metabolites in MM cells. The enrichment results in selective cytotoxicity (increased on-target potency and decreased off-target toxicity), and that resistance pathways of existing myeloma treatments (including alkylators) is overcome. Ygalo also demonstrates strong anti-angiogenic properties.

About Multiple Myeloma

Multiple myeloma is a hematological cancer of the B-cells (antibody producing cells) with no cure. Currently, the median overall survival is roughly 5 years and improving (Source: National Cancer Institute).

Today, approximately 170,000 patients live with multiple myeloma in the EU and the US while 57,000 patients get diagnosed and 26,000 patients die from the disease annually (Source: American Cancer Society, Global Data 2015 and National Cancer Institute). The underlying increase in number of multiple myeloma patients is slightly more than 1% per year where an aging population is the main reason for growth. However, the growth in late-stage multiple myeloma patients, which is studied in the OCEAN trial with Ygalo, is more than 10% per year due to improvements in earlier lines of therapy, i.e. more patients survive the first years with multiple myeloma and become late-stage multi-refractory patients with a significant medical need for more treatment options.

Treating Multiple Myeloma

Multiple myeloma is mainly treated through five different treatment modalities – alkylators, CD-38 binding antibodies, IMiDs, proteasome inhibitors and steroids. Due to the high mutation frequency of myeloma cells, patients have several different active cancers (cancer cell clones) at the same time with different protein expression patterns. Because of this heterogeneity of the disease in each patient, broad spectrum agents such as alkylators, IMiDs, proteasome inhibitors and steroids are the back-bone in multiple myeloma treatment. In the case of the new targeted agents, they will predominantly be used in combination with broad spectrum agents to ensure that all the patient’s cancer cells get appropriately treated. Immuno-oncological compounds have so far had limited success in the treatment of multiple myeloma.

On September 17, 2018 Shuwen Biotech reported that it is the first in China to launch a locally manufactured proprietary PD-L1 test kit, which can accurately determine the expression status of PD-L1 in tumor tissues, and to provide laboratory testing services for anti-PD-L1/PD-1 drug development (Press release, Shuwen Biotech, SEP 17, 2018, View Source [SID1234529452]).

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Recently, The investigation of the safety, efficacy and molecular marker efficacy of Hengrui Medicince’s anti-PD-1 drug, SHR1210, in the treatment of patients with advanced esophageal squamous cell carcinoma who failed conventional therapy was published in the March 2018 issue of Clinical Cancer Research, in which one of Shuwen Biotech’s PD-L1 detection kits was used and clinical results showed that patients positive for PD-L1 (PD-L1 expression ≥5%) have a higher objective response rate.

Shuwen Biotech’s PD-L1 kits and testing services have been used by leading pharmaceutical companies for dozens of clinical trials against PD-1 immunotherapeutics, contributing to the development of tumor immunotherapy drugs. Shuwen Biotech’s CAP-certified Shuwen Guanz Diagnostic Laboratories also successfully passed CAP’s multi-site, multi-country proficiency testing for PD-L1 testing.