Burzynski Research Institute has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Burzynski Research Institute, 2018, MAY 22, 2018, View Source [SID1234526849]).

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On May 22, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for CX-2029, a first-in-class CD71-directed Probody drug conjugate being co-developed by CytomX and its partner AbbVie (Press release, CytomX Therapeutics, MAY 22, 2018, View Source [SID1234527069]). CD71, also known as the transferrin receptor 1, is a highly expressed protein present in a number of solid and hematologic cancers that possess attractive molecular properties for the efficient delivery of cytotoxic payloads to tumor cells. The achievement of this milestone triggers a $25 million payment to CytomX from AbbVie.

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"CD71 has long been considered a high potential but challenging target for antibody drug conjugates given its high expression in tumors but ubiquitous expression in normal tissues. However, we see CD71 is an attractive candidate for a Probody drug conjugate approach, since our technology can potentially localize treatment directly to tumor tissue," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With CX-2029 now clear to advance into Phase 1, CytomX and our partners now have four clinical-stage Probody programs with anticipated initial data readouts later this year from our two wholly-owned programs, CX-072 and CX-2009. It is also noteworthy that this milestone comes just two years following the signing of our agreements with AbbVie, reflecting the efficiency of this collaboration."

"The IND clearance of CX-2029 marks an important step in our partnership with CytomX," said Steve Davidsen, Ph.D., vice president, oncology drug discovery, AbbVie. "Our partnership has the potential to advance emerging areas of science with the hope of providing additional options for people living with cancer."

About the Collaboration
AbbVie and CytomX are co-developing CX-2029, a Probody drug conjugate against CD71, with CytomX leading pre-clinical and early clinical development. AbbVie will lead later development and commercialization, with global late-stage development costs shared between the two companies. CytomX is eligible to receive up to $470 million in development, regulatory and commercial milestones, pending the achievement of pre-determined outcomes. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S.

AbbVie also received exclusive worldwide rights to develop and commercialize Probody drug conjugates against up to two additional, undisclosed targets. Should AbbVie ultimately pursue these targets, CytomX is eligible to receive additional milestone and royalty payments per target on any resulting products.

On May 22, 2018 Immunocore Limited, a leading T cell receptor (TCR) company focused on delivering first-in-class biological therapies that have the potential to transform lives, reported that new data from its phase I/II dose escalation trial of its wholly-owned, lead programme, IMCgp100, in metastatic uveal melanoma (mUM) will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on 4 June 2018 (Press release, Immunocore, MAY 22, 2018, View Source [SID1234526841]).

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Redirected T cell lysis in patients with metastatic uveal melanoma with gp100-directed TCR IMCgp100: Overall survival findings (abstract 9521, poster #348) will be presented by Takami Sato, MD, PhD, Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, in the melanoma/skin cancers poster session on Monday 4 June, 13:15-16:45 CDT. The poster presentation will include updated data and additional findings from the IMCgp100-102 clinical trial.

"Patients with metastatic uveal melanoma have an extremely rare form of eye cancer and there are currently few treatment options that can address their needs," said Dr. Chris Coughlin, Chief Medical Officer at Immunocore. "We are actively recruiting for our pivotal trials in metastatic uveal melanoma, and are looking forward to sharing updated overall survival data from our IMCgp100-102 study at this year’s ASCO (Free ASCO Whitepaper) meeting."

On May 22, 2018 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on rare brain and solid tumors, reported that it will feature one clinical poster presentation and three online publications at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 1-5 in Chicago, IL.

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The ASCO (Free ASCO Whitepaper) Annual Meeting brings together more than 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.

Bexion’s representation:

Abstract # 2517: First-in-class Phase Ia Study of BXQ-350 for Solid Tumors and Gliomas

Olivier Rixe, MD, PhD, will participate in a Q&A panel presenting data from this study during a Poster Discussion Session on Monday 4 June 2018 from 3:00-4:15 pm. Dr. Rixe’s comments will include that BXQ-350 met its Phase I Safety endpoint with no significant DLT or SAE attributed to drug at the highest planned dose. In addition, it was observed that BXQ-350 showed promising clinical activity in heavily pre-treated patients with recurrent brain cancer and advanced solid tumors.

The following three abstracts will be included online in the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings, a Journal of Clinical Oncology supplement, publicly released on May 16, 2018.

Absence of Indicators of Hypercoagulability and Anti-Phospholipid Syndrome in BXQ-350 First in Human Study

Therapeutic BXQ-350 nanovesicles, comprised of a lysosomal activator protein and a phosphor- lipid, did not cause anti-phospholipid syndrome (APS) or clinically significant hypercoagulability in humans.

Allometric Scaling of Preclinical Pharmacokinetic and Toxicokinetic Parameters to Predict Clinical Pharmacokinetics of BXQ-350 Saposin C Protein-Phosphatidylserine Nanovesicles

Allometric scaling of animal PK/TK data provided reasonable estimates of human PK and exposure for BXQ-350 and can be expected to have good predictive utility for extrapolating drug dose and pharmacokinetic parameters.

Combined Effect of Gemcitabine (GEM) and SapC-DOPS Nanovesicles on Pancreatic Ductal Adenocarcinoma (PDAC) in Mice

The combination of Gemcitabine and SapC-DOPS demonstrated enhanced antitumor activity in Pancreatic Ductal Adenocarcinoma (PDAC) in mice.

"These abstracts highlight the excitement we have on the potential of BXQ-350 to treat brain and multiple solid tumors; and potentially opening new avenues to treat CNS tumors" stated Dr. Ray Takigiku, Founder and CEO of Bexion.

"The University of New Mexico Comprehensive Cancer Center is pleased to take part in these Phase 1A clinical trials," said Rixe, who is the Principal Investigator at that site and author of the Phase I protocol. "I am honored to present the preliminary results to the scientific community on Bexion’s BXQ-350 and share these exciting new developments."

About BXQ-350

BXQ-350 is a unique formulation of a synthetically produced, human lysosomal protein, Saposin C (sphingolipid activator protein, or SapC), and the phospholipid dioleoylphosphatidylserine (DOPS).

On May 22, 2018 CoBioRes NV, an early stage biotech company that valorises promising academic research in the field of medicine by translating it into innovative therapeutic approaches, reported that it has received a € 1.7 million R&D grant from Flanders Innovation and Entrepreneurship (VLAIO) (Press release, Collaborative Biotech Research, MAY 22, 2018, View Source [SID1234526842]). This grant will allow CoBioRes to further develop and to select a lead Tetra-doxo candidate (doxorubicin prodrug) for treatment of Triple Negative Breast Cancer (TNBC) based on in vivo efficacy and toxicity testing. Furthermore, potential new biomarkers will be investigated.

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Approximately 12% of all breast cancers are triple negative. In TNBC the growth of the cancer is not supported by the hormones estrogen and progesterone, nor characterised by the presence of many HER2 receptors. Therefore, TNBC does not respond to hormonal therapy or therapies that target HER2 receptors, such as trastuzumab (Herceptin). There’s a clear need for new effective treatments in this large patient population.

"We are very pleased to receive this support from VLAIO. This will enable the company to obtain in vivo proof-of-concept of its Tetra-doxo prodrugs and to identify new biomarkers for patient selection. This will pave the way for initiation of further preclinical and clinical development," said dr. Nele Kindt, CEO at CoBioRes.

About Tetra-prodrugs technology
Use of traditional chemotherapeutic drugs is restricted by severe side effects and lack of tumour specificity. CoBioRes has designed a tumour-specific activation system by chemically linking a cap and a specific oligopeptide to a chemotherapeutic drug, rendering the modified drug inactive and blocking systemic toxic side effects of the drug. The chemotherapeutic prodrugs are activated by selective proteases available in the tumour microenvironment. This leads to a precise control of drug activation and release, circumventing distribution of native active drugs in other tissues. This finally leads to a combination of selective efficacy and reduced systemic toxicity, resulting in an improved therapeutic index.