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 Lumicell, Inc., an innovation leader in image guided cancer surgery, reported that it has completed enrollment in its Phase C feasibility clinical trial of the Lumicell Imaging System for breast cancer (Press release, Lumicell Diagnostics, AUG 19, 2019, View Source [SID1234538862]). With results from the Phase C feasibility trial expected in late 2019, Lumicell expects to begin the pivotal trial by the end of 2019 before applying for FDA approval.

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Breast-conserving surgery is a critical first step of treatment for many women with breast cancer. The goal is to remove all the cancer cells, leaving behind only healthy tissue. However, today, surgeons do not have adequate tools to determine if all cancer has been removed during the initial surgery; instead, patients must wait until days after surgery to find out if all the cancer has been removed. Unfortunately, in as many as 20-40% of cases, cancer cells are found at the margins of the removed tissue, typically requiring patients to undergo a second surgery to remove the remaining cancer.

Lumicell has developed a novel system intended to enable surgeons to see and remove residual cancer cells in real-time during the initial surgery, with the ultimate goal of reducing the risk of second surgeries and cancer recurrence, while also minimizing healthy tissue removal and improving efficiency in the operating room.

"My goal is to provide the best outcomes for patients under our care at Novant Health. One of the most important ways we do that is through innovative technology. The Lumicell System gives me increased confidence during my lumpectomy procedures; for numerous patients enrolled in the Phase C trial, my team was able to avoid a second surgery by identifying and removing tissue highlighted by the Lumicell System. I’m encouraged by our experiences with the system thus far, and I’m eager to have this as an option available for all of our breast cancer patients," said Dr. David Carr, MD, General Surgeon at Novant Health Salem Surgical Associates and principal investigator for the Lumicell breast cancer trial at Novant Health.

The Lumicell Phase C trial is a multi-center, prospective clinical study of 234 patients across 16 sites, comprised of both academic medical centers and community hospitals. Dr. Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School, is the lead investigator of the Lumicell breast cancer trials. Findings from this trial — the third feasibility study of the Lumicell System for Breast Cancer — will be published at the end of 2019. Lumicell is also expecting to initiate the pivotal trial stage later this year to support an FDA submission for approval of the Lumicell System for the treatment of breast cancer.

"With the Lumicell Phase C trial now fully enrolled, we are quickly moving forward with the data review, and finalizing the design and plans for the pivotal study to begin later this year," said Andrey Zarur, PhD, Executive Chairman at Lumicell. "We’re confident that we have developed a pivotal trial design that is compelling to patients and surgeons. And we’re optimistic that the pivotal trial will deliver results clearly demonstrating the clinical value of the Lumicell System in the treatment of breast cancer and benefits to the patients."

The Lumicell System is also in early feasibility trials for treatment of prostate, brain, colorectal, esophageal and pancreatic cancers, as well as peritoneal metastases from primary ovarian and colon cancers.

On August 19, 2019 Siamab Therapeutics, Inc., a biopharmaceutical company developing novel glycan-targeted cancer therapeutics, reported that it has entered into a strategic agreement valued at up to $202 million with an undisclosed, large commercial-stage biopharmaceutical company under which such company will develop and commercialize antibody-based products targeting a tumor-associated carbohydrate antigen (TACA) identified by Siamab’s proprietary TACA discovery platform (Press release, Siamab Therapeutics, AUG 19, 2019, View Source [SID1234538863]). Under the terms of the agreement, Siamab will receive a multimillion-dollar initial payment and is eligible to receive additional payments when specific milestones are achieved. No additional terms are being disclosed.

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"We’re pleased to have inked a deal with a leading biopharma that will accelerate the development of our glycan-targeted therapeutics so that cancer patients will be able to benefit more quickly," said Jeff Behrens, President and Chief Executive Officer of Siamab. "This validates our TACA discovery platform technology and its potential to develop promising new approaches in treating solid tumors. We’ve made tremendous progress advancing our discovery platform and pre-clinical programs on modest funding."

Siamab is the rare biotech that made significant progress without traditional venture capital funding. The company has raised just over $12 million from angel investors and has leveraged $7 million in grants and corporate partnerships. Alongside angel investors and several angel groups including Mass Medical Angels (MA2), Launchpad Ventures, and Boston Harbor Angels, funding came from National Institutes of Health (NIH) grants, an early investment from Momenta Pharmaceuticals, and a collaboration with Boehringer Ingelheim.

"We are very pleased with the hard work of the Siamab team and the outcome they have achieved, and thrilled that our investment may make a difference for cancer patients," said Richard Anders, MA2 Founder and Executive Director. "It is extremely difficult to successfully exit an early-stage drug company, and I expect this exit will encourage angel investors to further invest in biotech and biotech cures for humankind’s afflictions."

Siamab was founded by Dr. Ajit Varki, a professor at the University of California, San Diego (UCSD) based on his early work on the TACA discovery platform technology. The company moved to Massachusetts in 2015 with a semi-virtual model that enabled high-quality scientific progress with a focused team and capital efficient operations. This transaction demonstrates that lean biotech companies can successfully launch innovative science into the biopharma pipeline.

On August 19, 2019 BerGenBio reported Results for the Second Quarter and First Half 2019 (Press release, BerGenBio, AUG 19, 2019, View Source [SID1234538837]).

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-Acute Myeloid Leukaemia (AML): Preliminary Phase II clinical shows promising efficacy for bemcentinib in combo with low-intensity chemo in elderly AML patients unfit for intensive therapy

– Non small cell lung cancer (NSCLC): Phase II clinical data continues to show promising clinical activity and improved overall survival, particularly in patients with AXL positive tumours including those with low or no PD-L1 expression.

– Recruitment completed for second stage Phase II bemcentinib and KEYTRUDA combo trial in patients with advanced NSCLC (BGB008)

– Private placement completed, raising gross proceeds of NOK 74.2 million

– Cash and Cash equivalents at end of Q2 2019 NOK 324.4 million

– Operating loss of NOK 52.0 million in Q2 2019 (NOK 50.7 in Q2 2018) and NOK 97.1 million in H1 2019 (NOK 105.5 H2 2018).

BERGEN, Norway, Aug. 19, 2019 /PRNewswire/ — BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces its results for the second quarter and first half 2019.

A presentation and live webcast by the Company’s management will take place today at 10.00 am CEST in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"We are pleased to report a period of continued encouraging clinical data and validation of our lead candidate bemcentinib in our AML and NSCLC programmes. We are particularly excited by the LDAC combination data in second line AML patients.

Our focus is now on refining and preparing our late stage clinical trials in light of our recent clinical data and emerging market opportunities, as we continue to leverage our significant scientific and R&D leadership to develop this potentially transformative therapy. We are committed to progressing bemcentinib through to regulatory approval and, in turn, addressing the significant unmet need among AML and NSCLC patients in order to improve outcomes for these patients and create value for stakeholders."

Operational Highlights – second quarter and first half 2019

Acute Myeloid Leukaemia (AML)

– Preliminary Phase II clinical data from AML trial presented at EHA (Free EHA Whitepaper) 24 and ASCO (Free ASCO Whitepaper) 2019

Phase II trial evaluating bemcentinib in combination with low-intensity chemotherapy in elderly AML patients unfit for intensive therapy shows promising efficacy
6 out of 14 patients receiving LDAC combination achieved an Overall Response Rate (ORR) of 43%, with encouraging duration of response – this data is still maturing.
ORR significantly higher than previously reported/historical benchmarks (18%) with single-agent low dose cytarabine
Favourable safety profile continues to be seen in LDAC combination
Initiated preparation of expansion cohort to confirm the clinical signal from bemcentinib in combination with LDAC in elderly relapse/refractory AML patients.
Non-Small Cell Lung Cancer (NSCLC)

– New clinical data from BGB324 in NSCLC presented at ASCO (Free ASCO Whitepaper) 2019

Completed recruitment for second stage of Phase II trial evaluating bemcentinib and KEYTRUDA in previously treated NSCLC patients post chemotherapy (NCT03184571 (BGB008, cohort A)
First stage previously met efficacy endpoint, and reported encouraging median overall survival of 12.2 months
Preliminary Overall Response Rate of 40% continues to be seen in patients with AXL positive tumours including those with weak or no PD-L1 expression
Encouraging safety profile continues to be seen in combination
– Initiation of additional cohort in combination with KEYTRUDA in previously treated NSCLC patients post immunotherapy (NCT03184571, BGB008, cohort B)

Completed private placement, raising gross proceeds of NOK 74 million

Net proceeds from the Private Placement to be used to advance the Company’s clinical programs in AML and lung cancer, as well as for general corporate purposes
The Private Placement attracted strong interest from existing shareholders and new specialist institutional investors
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CEST at:

Carnegie AS
Fjordalleen 16, 5. floor,
Aker Brygge,
Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

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."