FierceBiotech names Kronos Bio as one of its “Fierce 15” Biotech Companies of 2018

On October 2, 2018 Kronos Bio, Inc. (Kronos), a Two River portfolio company, reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry for its pursuit of novel therapies against some of the most important and intractable targets in cancer research (Press release, Kronos Bio, OCT 2, 2018, View Source [SID1234529766]).

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"It is an honor to have Kronos named by FierceBiotech as one of their Fierce 15 biotechnology companies for 2018," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "Fierce adeptly describes our pursuit of targets many have viewed as ‘undruggable.’ We believe our small molecule microarray (SMM) technology will enable us to engage recalcitrant targets and develop innovative therapies for cancer and other life altering diseases."

The foundation of Kronos was built on over a decade of research into high-throughput screening strategies for chemical modulators of transcription factors and other recalcitrant targets in oncology. By combining small molecule microarrays with extensive know-how in biological assay development, Kronos’ technology platform enables high-throughput screens of chemical libraries against target proteins in a more physiologically relevant context. As a result, a single screening assay can identify compounds that bind or interfere with target protein activity directly, disrupt protein-protein or protein-DNA interactions, or indirectly modulate target protein activity by binding to co-factors or
other protein complex members. This approach is ideally suited for rapid discovery of unique ligands that can be utilized in the generation of novel modulators or degraders of historically challenging targets such as transcription factors.

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is FierceBiotech’s 16th annual Fierce 15 selection. An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day’s top stories. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position

Synlogic Appoints Dr. Aoife Brennan as President and Chief Executive Officer

On October 2, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported the appointment of Aoife Brennan, M.B., B.Ch., as president and chief executive officer of Synlogic, effective immediately (Press release, Synlogic, OCT 2, 2018, View Source [SID1234530532]). Dr. Brennan joined Synlogic as chief medical officer in 2016 and has served as interim president and chief executive officer since May 2018.

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"After conducting a thorough search process, it was clear to the board of directors that Aoife is the right person to lead Synlogic at this time in the company’s evolution," said Peter Barrett, chairman of Synlogic’s board of directors. "Aoife stepped into the interim role and rapidly demonstrated her effectiveness. Her broad experience across multiple stages of drug development and therapeutic areas, her demonstrated leadership abilities, and her ambitious vision for Synlogic, make her uniquely qualified for the job. We are confident that under her leadership, Synlogic will be well-positioned to deliver Synthetic Biotic medicines to patients."

"I appreciate the confidence and support of the board of directors and am thrilled to be selected to lead Synlogic as we pioneer the development of a completely new class of living medicines," said Dr. Brennan. "We have made great progress to date, advancing two Synthetic BioticTM programs into the clinic. I look forward to continuing to execute on our plans for the clinical development of our lead candidates while capitalizing on the broad applicability and potential of our novel platform to build a pipeline of therapies for patients with serious and life-threatening diseases."

Prior to joining Synlogic, Dr. Brennan spent six years at Biogen in roles of increasing responsibility, most recently as vice president and head of the Rare Disease Innovation Unit, which included programs ranging from pre-clinical to commercial. She has also led programs across multiple therapeutic areas including the late-phase development of nusinersen for spinal muscular atrophy and treatments for Hemophilia B and Hemophilia A, ALPROLIX and ELOCTATE. Earlier, Dr. Brennan was director of clinical development at Tolerx, a start-up biotech company focused on immunotherapy for Type 1 diabetes. Dr. Brennan holds a medical degree from Trinity College Dublin, Ireland and completed her post-graduate training in internal medicine, endocrinology and metabolism at the Royal College of Physicians in Ireland. Additionally, she completed post-doctoral training in clinical research and metabolism at the Beth Israel Deaconess Medical Center in Boston and is a graduate of the Harvard Medical School Scholars in Clinical Science Program.

NantKwest to Present at 2018 Cantor Global Healthcare Conference

On October 2, 2018 NantKwest (Nasdaq:NK), a leading, clinical-stage natural killer cell based therapeutics company, reported that the company will be presenting at the upcoming Cantor Global Healthcare Conference onTuesday, October 2nd in New York City During the conference, company management will be presenting a corporate overview, as well as conducting one-on-one meetings to provide a corporate update, as well as review R&D and clinical activities (Press release, NantKwest, OCT 2, 2018, http://ir.nantkwest.com/news-releases/news-release-details/nantkwest-present-2018-cantor-global-healthcare-conference?field_nir_news_date_value[min]=2018 [SID1234529706]).

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Conference Details:

Event: Cantor Global Healthcare Conference
Date/Time: Tuesday, October 2, 2018 at 4:00pm
Location: New York, NY

BioInvent presents slow-eliminating checkpoint blocking antibody for tumor directed oncoviral immunotherapy at the SITC conference

On October 2, 2018 BioInvent International AB (OMXS: BINV) reported that the company will present two posters together with its transgender for a new checkpoint blocking antibody optimized for slow elimination and its targeted oncolytic virus vector at Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)s (SITC) (Free SITC Whitepaper) annual meeting that will be held November 7-11 in Washington DC (USA) (Press release, BioInvent, OCT 2, 2018, View Source [SID1234529707]). The anti-CTLA-4 antibody encoding oncolytic virus product candidate is developed for tumor localized cancer immunotherapy.

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Generation and characterization of a CTLA-4 antibody with improved Fc γ R -dependent Treg deletion of tumor microenvironment-targeted oncolytic virotherapy of cancer

Author: Monika Semmrich, Jean-Baptiste Marchand, Petra Holmkvist, Linda Mårtensson, Ulla-Carin Tornberg, Laetitia Fend, Mathilda Kovacek, Ulla-Carin Tornberg, Ingrid Teige, Andre McAllister, Eric Quéméneur, Björn Frendéus.
Poster number: P602
Antibody-armed oncolytic vaccinia virus to block immunosuppressive pathways in the tumor microenvironment

Author: Jean-Baptiste Marchand, Monika Semmrich, Laetitia Fend, Ulla-Carin Tornberg, Nathalie Silvestre, Björn Frendéus, Eric Quéméneur
Poster number: P615
The posters will be shown on Friday and Saturday, November 9-10 in the poster (hall E).

Björn Frendéus, BioInvents Chief Scientific Officer, said: "We are pleased to announce a potentially safe and more effective strategy for combining anti-CTLA 4 and anti-PD-1 / PDL1 checkpoint inhibition in oncolytic viral therapy. By building on the extensive clinical validation of checkpoint blockers, onkoviral tumor localized administration of our monoclonal antibody optimized for slow elimination potential has improved the therapeutic window for CLTA-4 targeted checkpoint intervention, enabling a better tolerated and more effective combination therapy with approved antibodies directed against the PD-1 / PD-L1 axis. "

Cellectar Announces Overall Survival Exceeding 19 Months in Phase 1b Trial with CLR 131 in Relapsed/Refractory Multiple Myeloma

On October 2, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported its updates interim overall survival (OS) data from the company’s ongoing Phase 1b clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Cellectar Biosciences, OCT 2, 2018, View Source [SID1234530173]).

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The results to date show that OS is currently at 19.4 months. Cellectar continues to monitor these patients and intends to update OS results as data become available. All 15 patients from the Phase 1b, single-dose cohorts were heavily pretreated, receiving an average of 5 previous lines of multidrug therapy including anti CD38, immunomodulating drugs and proteasome inhibitors. All patients were relapsed or refractory to at least one proteasome inhibitor and IMiD. Most patients presented with advanced stage 2 or 3 disease and 67% had previously received at least 1 stem cell transplant.

"We are extremely pleased to announce that CLR 131 has achieved OS of 19.4 months in our Phase 1b trial in R/R MM. We view this outcome as impressive considering all patients were heavily pretreated and presented with high tumor burden," said James Caruso, president and chief executive officer of Cellectar Biosciences. "Most drugs currently approved for third-line or later R/R MM average approximately 12 months of survival, including several recent approvals. We believe extending OS to beyond 19 months with a more patient-friendly dosing regimen provides both a unique product profile and potential for beneficial patient outcomes."

The objective of this multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 administered as a single-dose, 30-minute infusion in patients with R/R MM. Patients received doses of 12.5 mCi/m2 up to 31.25 mCi/m2. All doses were deemed safe and well tolerated by an independent data monitoring committee.

Data from a fifth cohort, released in August, evaluated a split or fractionated dose of 31.25 mCi/m2 for tolerability and safety. The dosing schedule provided higher average drug exposure but lower peak serum levels than non-fractionated dosing potentially reducing adverse events and improving efficacy. The independent Data Monitoring Committee (DMC) determined the fractionated dose used in Cohort 5 to be safe and well tolerated and recommended advancement to a higher dose cohort.

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a Phase 2 clinical study in R/R MM and a range of B-cell malignancies and a Phase 1b clinical study in patients with R/R MM exploring fractionated dosing. The objective of the multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 received single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2. All study doses have been deemed safe and well tolerated by an independent Data Monitoring Committee. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.