Immune Therapeutics Clears Critical Certification Milestone

On February 2, 2017 Immune Therapeutics, Inc. (OTCQB:IMUN), a global specialty pharmaceutical company dedicated to advancing the science of affordable, non-toxic therapies in Emerging Markets, reported that the Dominican Republic’s Ministry of Health and Social Assistance has issued a Certificate of Pharmaceutical Product (COPP) for Lodonal (Naltrexone) (Press release, Immune Therapeutics, FEB 2, 2017, View Source [SID1234517625]). This certificate grants approval for the manufacturing and export of LodonalTM for the treatment of HIV/AIDS, opportunistic infections, inflammatory disease and cancer in the dosages specified in the filings.

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The approval of Lodonal (Naltrexone) was supported by a vast array of research including dossier, certificate of analysis, stability reports, pharmacology and toxicology reports as well as clinical data from several Phase II multi-center, randomized studies. The results of these studies and documents showed patients treated with LodonalTM reported significant improvements when compared with patients receiving placebo.

"We are thrilled with this certification as we are now only one step away of seeing all of our hard work come to fruition," said Noreen Griffin, CEO of Immune Therapeutics. "Before selling into the Nigerian market, we required three main approvals: We received our Drug Approval last year; our Certificate of Pharmaceutical Product which was announced today; and our final approval which is the Marketing Approval from Nigeria."

"The Certificate of Pharmaceutical Product is not just required for Nigeria," Ms. Griffin continued. "It is the cornerstone for exportation into any of the other countries we are engaged in. This certificate is required to follow the World Health Organization format as it provides quality assurance for the pharmaceutical products (LodonalTM) and the facility (Acromax). As we push forward in Nigeria, we are simultaneously leveraging the successful clinical trial results and NAFDAC approval to expedite the approval and distribution into other nations devastated by HIV/AIDS including Malawi, Equatorial Guinea and Senegal."

Vividion Therapeutics, Inc., Launches With $50 Million Series A Financing

On February 2, 2017 – ARCH Venture Partners and Versant Ventures
reported the launch of Vividion Therapeutics, Inc., a biotechnology company
focused on developing innovative therapeutics that treat major unmet clinical needs
using the first platform for proteome-­wide ligand and target discovery. ARCH and
Versant co-­led today’s $50 million Series A financing and were joined by founding
investor Cardinal Partners (Press release, Vividion Therapeutics, FEB 2, 2017, View Source [SID1234520718]).

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Vividion Therapeutics has advanced a novel drug discovery platform that applies
chemical proteomics to expand the druggable proteome and address difficult targets to
bring new, transformative treatments to patients with serious illnesses. Making
accessible the broad set of proteins expressed in human cells, the company’s cutting
edge platform was spun out of the lab of Ben Cravatt, Professor at The Scripps
Research Institute in La Jolla, Calif.

In conjunction with the financing, Tom Daniel will join the Board as Executive Chairman.
"This Series A financing reflects deep commitment to Vividion Therapeutics’ approach
to transform chemical drug discovery and development," stated Dr. Daniel. "The
founders, experienced team and platform are ruthlessly focused on the accelerated
delivery of impactful drugs to serve patients. The platform expands the definition of
druggability on mechanism in serious illnesses, while delivering new routes to address
highly validated disease targets."

Vividion Therapeutics Novel Scientific Approach
Conventional drug discovery is target-­centric;; a compound library is screened using a
target-­specific assay and high-­affinity binding ligands are optimized to develop a drug
candidate. This approach is limited, as research is performed in artificial systems that
fail to account for native protein structure, context and function. Further, conventional
target-­specific assays are applied to a narrow subset of the proteome and selectivity is
assessed later in development.

In contrast, Vividion Therapeutics assesses with high precision and broad coverage
protein-­drug candidate interactions in native biological systems. This eliminates artifacts
and creates proteome-­wide drug interaction maps for simultaneous target engagement
and global selectivity profiling. Through novel chemistry, Vividion Therapeutics’ platform
allows efficient, accelerated optimization of hit fragments into drug candidates. The
company has a robust intellectual property estate that includes the assignment of
numerous, heretofore unrecognized, druggable sites in the human proteome.
"The Vividion Therapeutics’ platform allows human biology to fundamentally drive the
selection of drug targets and to create entry points for targets previously considered to
be undruggable," said Kristina Burow, Managing Director at ARCH. "The team at
Vividion Therapeutics has created a novel platform based on chemical proteomics and
modern synthetic chemistry that will radically expand the druggability of the human
proteome. We believe this will lead to innovative therapeutics that have the ability to
significantly benefit patients."

Vividion Therapeutics Co-­Founders
The Vividion Therapeutics founding team includes:
• Benjamin F. Cravatt III, Ph.D., Professor and Co-­Chair, Department of Molecular
Medicine, the Skaggs Institute for Chemical Biology at The Scripps Research
Institute
• Phil S. Baran, Ph.D., Professor, Darlene Shiley Professor of Chemistry,
Department of Chemistry, the Skaggs Institute for Chemical Biology at The
Scripps Research Institute
• Jin-­Quan Yu, Ph.D., Frank and Bertha Hupp Professor of Chemistry,
Department of Chemistry, The Scripps Research Institute
• John K. Clarke, Managing General Partner, Cardinal Partners
Vividion Therapeutics Board of Directors
The Vividion Therapeutics scientific team is complemented by a Board of Directors that
has significant experience in creating, leading and growing biopharmaceutical
companies. In addition to Dr. Cravatt and Mr. Clarke, they include:
• Tom Daniel, M.D., Executive Chairman of the Board, formerly President, Global
Research and Early Development, Celgene Corporation
• Kristina Burow, Managing Director, ARCH Venture Partners
• Tom Woiwode, Ph.D., Managing Director, Versant Ventures
• Paul Schimmel, Ph.D., Professor, Department of Cell and Molecular Biology,
Department of Chemistry, The Skaggs Institute for Chemical Biology at The
Scripps Research Institute

About Vividion Therapeutics
Vividion Therapeutics is a biotechnology company focused on developing innovative
therapeutics that treat major unmet clinical needs using the first platform for proteome-­
wide ligand and target discovery. Headquartered in San Diego, CA, Vividion
Therapeutics is a private, biotechnology company founded in 2014 with seed financing
from Cardinal Partners as a spin out from the labs of Dr. Benjamin Cravatt, Dr. Phil
Baran and Dr. Jin-­Quan Yu at TSRI. In 2017, Vividion launched with $50 million in
Series A financing from ARCH Venture Partners, Versant Ventures and founding
investor Cardinal Partners. For more information, please visit www.vividion.com.

About ARCH Venture Partners
ARCH Venture Partners, one of the largest early stage technology venture firms in the
U.S., invests in seed and early stage advanced technology companies. ARCH enjoys
special recognition as a leader in the commercialization of technologies developed at
academic institutions, corporate research labs and national laboratories. Now in its 30th
year, ARCH has over $2.5 billion in committed capital through nine venture funds, and
has co-­founded and provided initial investments for over 200 companies. For more
information, please visit View Source

About Versant Ventures
Versant Ventures is a leading healthcare investment firm committed to helping
exceptional entrepreneurs build the next generation of great healthcare companies. The
firm invests across the healthcare sector and at all stages of company development,
with an emphasis on the discovery and development of novel therapeutics. With $2.3
billion under management and offices in North America and Europe, Versant has built a
team with deep investment, operating, and scientific expertise that enables a hands-­on
approach to company building. Since the firm’s founding in 1999, more than 65 Versant
companies have achieved successful acquisitions or IPOs. For more information,
please visit www.versantventures.com.

About Cardinal Partners
Cardinal Partners, founded in 1996, is one of the leading venture capital partnerships
focused exclusively on healthcare investing. Cardinal specializes in early-­stage
financing rounds. As veteran company-­builders, over the course of their careers, the
Cardinal Partners team has invested in over 100 growth companies. Companies funded
by Cardinal have a cumulative market valuation exceeding $20 billion. Cardinal’s
investors include university endowments, foundations, pension funds, banks, and
insurance companies. Cardinal currently manages funds totaling $400 million. For more
information, please visit View Source

TRILLIUM THERAPEUTICS OUTLINES ANTICIPATED ACTIVITIES AND MILESTONES FOR 2017

On February 2, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported its expected 2017 activities and milestones (Press release, Trillium Therapeutics, FEB 2, 2017, View Source [SID1234517631]).

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Phase 1 trials of TTI-621:
During the year, Trillium expects to make progress in the Phase 1b TTI-621-01 study (NCT02663518) of its anti-CD47 checkpoint inhibitor TTI-621 (SIRPaFc), which is designed to evaluate safety, pharmacokinetics and preliminary anti-tumor activity across a broad range of hematologic malignancies. One cohort of lymphoma patients is receiving TTI-621 in combination with rituximab, and the company will consider additional combination cohorts based on emerging preclinical data. Furthermore, given the good safety profile of the agent, further dose intensification is planned with the goal of achieving increased blockade of CD47.

In a second Phase 1 trial, TTI-621-02 (NCT02890368), patients with percutaneously accessible solid tumors are receiving intratumoral injections of TTI-621 with the goal of achieving a high level of localized CD47 blockade. The company expects to complete the dose escalation phase, and potentially begin an expansion phase in 2017. This trial provides a unique opportunity to closely characterize local anti-tumor immune responses and to assess the impact of TTI-621 treatment on the tumor microenvironment. Combination cohorts are also under consideration for this trial.

"We are aggressively advancing the TTI-621 clinical program through multiple efforts. After completing the phase 1a dose escalation trial in patients with lymphoma, where we observed preliminary evidence of anti-tumor activity at well-tolerated doses, we finished the year with robust enrollment in the 10-cohort expansion phase and recruitment continues to progress well. As our data mature, we intend to explore the addition of other cohorts to this trial. The TTI-621-02 solid tumor trial has enrolled its first patient and we expect this study to provide key scientific data for charting the course of our clinical development program, especially as it relates to combination therapies," said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. "In TTI-621 we believe that we have a potent CD47-targeting agent, and we aim to identify cancers that depend upon the CD47 ‘do not eat’ signal to evade the immune system."

Trillium intends to provide an update on both ongoing TTI-621 trials by year-end. There may be additional opportunities to report on individual cohorts in both trials throughout the year.

Expanding the CD47 Franchise with TTI-622:
In 2017, Trillium is also planning to advance its second SIRPaFc fusion protein, TTI-622, into clinical testing. TTI-622 contains an IgG4 Fc region and is thus anticipated to have a different pharmacologic profile and enable greater exposures in patients than TTI-621 (IgG1 Fc). Like TTI-621, TTI-622 does not bind erythrocytes, and the company believes that this property could give TTI-622 best-in-class status among IgG4-based CD47 blocking agents currently in development. The company plans to submit an IND by the end of 2017 and begin enrolling patients in early 2018, with the goal of rapidly advancing this agent into combination studies.

"With the introduction of TTI-622, we are specifically targeting opportunities for drug combinations that are complementary to TTI-621. Our two SIRPaFc fusion proteins allow us to block CD47 and achieve different levels of Fc receptor engagement on macrophages, which we believe represents a diversified approach to targeting the CD47 axis in the treatment of cancer," said Dr. Bob Uger, Trillium’s Chief Scientific Officer. "CD47 is in its infancy as a therapeutic cancer target and we have chosen to apply a broad, science-driven investigative approach to maximize our chances of defining patient populations that will derive clinical benefit from TTI-621 or TTI-622 therapy."

Additional Preclinical Data and Small Molecule Pipeline:
In 2017 Trillium intends to continue investigating SIRPaFc in relevant preclinical models, focusing on combination strategies and mechanism of action studies. The company expects to report data at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Washington D.C., as well as at other international scientific conferences throughout the year.

The company is actively investigating the competitive advantages and positioning of its orally available small molecule bromodomain and EGFR inhibitor programs and expects to provide guidance on the next steps in the first half of 2017. In addition, Trillium recently launched a discovery program against an undisclosed immuno-oncology target using its proprietary fluorine-based chemistry platform.

Trillium’s cash balance at the end of 2016 was approximately $50 million. A major component of the company’s business strategy continues to be a focus on evaluating potential partnering opportunities across all programs, which may help fund future growth.

The company also announced that its ticker symbol on the Toronto Stock Exchange changed to "TRIL" effective Feb. 1, 2017.

Baxter Reports 2016 Fourth-Quarter and Full-Year Results

On February 1, 2017 Baxter International Inc. (NYSE:BAX) reported results for the fourth quarter ended December 31, 2016, and provided its guidance for the first quarter and full-year 2017 (Press release, Baxter International, FEB 1, 2017, View Source [SID1234517613]).

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"Baxter’s solid operational performance in 2016 was fueled by strong sales and disciplined execution across the organization," said José (Joe) E. Almeida, chairman and chief executive officer. "We’ll continue to build on this momentum in 2017 and beyond, driven by new product launches, effective portfolio management and further progress on our business transformation initiatives – all in support of delivering sustainable top-quartile results for our shareholders, and advancing our mission to save and sustain lives."

Fourth-Quarter Financial Results

Baxter reported income from continuing operations of $240 million, or $0.44 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the fourth quarter. These results included special items totaling $134 million ($72 million net after-tax), primarily related to business optimization initiatives and intangible asset amortization.

On an adjusted basis, excluding special items, Baxter’s fourth quarter income from continuing operations totaled $312 million, or $0.57 per diluted share, exceeding the company’s previously issued guidance of $0.49 to $0.52 per diluted share.

Baxter’s worldwide sales totaled $2.6 billion in the fourth quarter, an increase of 2 percent on both a reported and constant currency basis as compared to the prior-year period. Sales within the U.S. were $1.1 billion, advancing 5 percent, while international sales totaled $1.5 billion, representing a 1 percent decrease on a reported basis, and an increase of 1 percent on a constant currency basis. Adjusting for the impact of foreign exchange and generic competition for cyclophosphamide, Baxter’s sales increased 7 percent in the U.S. and rose 3 percent globally in the fourth quarter.

By business, Hospital Products sales of $1.6 billion in the fourth quarter increased 1 percent on a reported basis, and 1 percent on a constant currency basis. Adjusting for the impact of foreign exchange and cyclophosphamide, Hospital Products sales advanced 2 percent from the prior-year period. Hospital Products performance in the quarter benefited from strong sales of IV therapies, infusion pumps and related IV access administration sets in the U.S., along with favorable demand for anesthesia and critical care products globally. This performance was partially offset by lower sales of IV solutions internationally, as the company implements actions to optimize its global product portfolio, as well as lower manufacturing service revenues from Shire, under the company’s manufacturing and supply agreement with Baxalta.

Baxter’s Renal sales totaled $1 billion in the fourth quarter, representing a 3 percent increase on a reported basis, and a 5 percent increase on a constant currency basis. U.S. sales grew 7 percent to $222 million, and international sales totaled $793 million, representing growth of 2 percent on a reported basis, and an increase of 4 percent on a constant currency basis. Growth continued to be driven by robust sales of peritoneal dialysis products as well as increased demand for the company’s acute renal care products.

During the quarter, Baxter repurchased $247 million worth of common stock or approximately 5.4 million shares outstanding.

Summary of Full-Year 2016 Results

For full-year 2016, Baxter reported income from continuing operations of approximately $5 billion, or $9.01 per diluted share, on a GAAP basis. These results included a gain of $4.4 billion (on a pre and post-tax basis), related to the company’s disposition of its retained Baxalta shares. Partially offsetting these results were special items of $817 million ($557 million net after-tax) related to business optimization initiatives, intangible asset amortization, debt extinguishment costs, Baxalta-related spin-off costs and asset impairments.

On an adjusted basis, excluding special items, Baxter’s full-year income from continuing operations totaled $1.1 billion, or $1.96 per diluted share.

Baxter’s worldwide sales totaled $10.2 billion in 2016, an increase of 2 percent on a reported basis and 4 percent on a constant currency basis as compared to the prior year. Sales within the United States totaled $4.3 billion, improving 6 percent over the prior year. International sales totaled $5.9 billion, representing a 1 percent decrease on a reported basis, and an increase of 3 percent on a constant currency basis. Adjusting for the impact of foreign exchange and generic competition for cyclophosphamide, Baxter’s sales increased 9 percent in the U.S. and rose 5 percent globally.

Full-year sales for Hospital Products totaled $6.3 billion, reflecting growth of 2 percent on a reported basis and 4 percent at constant currency. Adjusting for the impact of foreign exchange and cyclophosphamide, sales increased 5 percent. Baxter’s Renal sales totaled $3.9 billion, increasing 2 and 5 percent on a reported and constant currency basis, respectively.

In 2016, Baxter generated $1.6 billion in operating cash flow, an increase of $371 million driven by improved operational performance and implementation of new programs focused on improving the company’s working capital. In addition, through disciplined management of expenditures Baxter reduced capital spending by $192 million to $711 million. As a result, the company generated an increase of $563 million in free cash flow to $905 million (operating cash flow less capital expenditures).

"We are extremely pleased with the significant improvements Baxter has made in free cash flow generation. Our progress in 2016 represented an increase of more than 2.5 times as compared to 2015, and further supports our ability to reinvest in the business both organically and inorganically to drive accelerated growth," said Jay Saccaro, Baxter’s chief financial officer.

Business Highlights

In 2016 Baxter continued delivering meaningful innovation for patients and expanded access to life-sustaining therapies through a combination of more than 20 new product launches, line extensions and geographic expansions, including: NUMETA G13E, the only triple-chamber commercially prepared parenteral nutrition system approved for vulnerable neonatal patients; HEMOPATCH, an advanced surgical patch; premix generic drugs such as VANCOMYCIN injection in 0.9% Sodium Chloride; new applications and features for the SIGMA SPECTRUM infusion system; and HDx therapy enabled by THERANOVA to provide high performance hemodialysis treatments.

Additionally, the company saw continued momentum with its new Automated Peritoneal Dialysis (APD) systems, AMIA in the U.S. and HOMECHOICE CLARIA outside the U.S., both featuring Baxter’s SHARESOURCE Connectivity Platform, the first and only two-way remote patient management system for home dialysis therapy.

In December, Baxter announced plans to expand its presence in the generic injectables space with the proposed acquisition of Claris Injectables Limited (Claris). The acquisition of Claris, which is expected to close in the second half of 2017, will provide Baxter with a currently marketed portfolio of molecules in anesthesia and analgesics, renal, anti-infectives and critical care in a variety of presentations including bags, vials and ampoules, along with a robust pipeline and high-quality manufacturing capabilities. This acquisition will provide Baxter with a platform to establish a leadership position in generic injectables.

Over the course of the year, the company also took actions to significantly improve its balance sheet position and return value to shareholders through the disposition of the Baxalta retained stake, a $1.6 billion debt offering to retire existing higher coupon rate bonds and pay off outstanding commercial paper, a 13 percent increase in its shareholder dividend and share repurchases of approximately $300 million.

Financial Outlook

Baxter is providing its outlook for the full-year and first quarter of 2017:

For full-year 2017, Baxter expects sales to be comparable to the prior-year period on a reported basis and to increase approximately 2 percent on a constant currency basis. Adjusting for the impact of generic cyclophosphamide competition (an estimated one percent) and selected strategic product exits the company is undertaking (an estimated one percent), Baxter expects underlying constant currency sales growth of approximately 4 percent. The company expects earnings from continuing operations, before special items, of $2.10 to $2.18 per diluted share. This guidance does not include any impact from the company’s proposed acquisition of Claris, which is expected to close in the second half of 2017.
For the first quarter, the company expects sales growth of approximately 2 to 3 percent on a reported basis, or 3 to 4 percent on a constant currency basis. Adjusting for the impact of generic cyclophosphamide competition (an estimated one-half percent) and selected strategic product exits the company is undertaking (an estimated one and a half percent), Baxter expects underlying constant currency sales growth of 5 to 6 percent. The company expects earnings from continuing operations, before special items, of $0.50 to $0.52 per diluted share.
The reconciliations between the projected 2017 adjusted diluted earnings per share and projected GAAP diluted earnings per share follows:

2017 Earnings per Share Guidance Q1 2017 FY 2017
Diluted Earnings per Share – Adjusted $0.50 – $0.52 $2.10 – $2.18
Estimated intangible asset amortization $0.04 $0.18
Estimated business optimization charges $0.05 – $0.06 $0.31 – $0.38
Estimated Baxalta separation-related expenses $0.01 $0.02
Diluted Earnings per Share – GAAP $0.39 – $0.42 $1.52 – $1.67
These estimates are based on information reasonably available at the time of this release and future events or new information may result in different actual results.

SignalRx Pharmaceuticals Announces Breakthrough Results on Novel Anti-Cancer Dual PI3K-BRD4 Inhibition Paradigm in PNAS Publication

On January 31, 2018 SignalRx Pharmaceuticals Inc., a clinical-stage company focused on developing new and more effective oncology drugs with designed multiple target-selected inhibition profiles, reported the publication of key research in the journal Proceedings of the National Academy of Sciences (doi: 10.1073/pnas.1613091114 PNAS January 30, 2017) (Press release, SignalRx, JAN 31, 2017, http://www.ireachcontent.com/news-releases/signalrx-pharmaceuticals-announces-breakthrough-results-on-novel-anti-cancer-dual-pi3k-brd4-inhibition-paradigm-in-pnas-publication-612341103.html [SID1234527325]).

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SignalRx Pharmaceuticals Inc., in collaboration with researchers at the University of California, San Diego School of Medicine and Moores Cancer Center, led by Dr. Donald L. Durden, Professor and Associate Director of Pediatric Oncology at the Moores UCSD Cancer Center, and senior scientific advisor at SignalRx along with Dr. Tatiana Kutateladze, Professor at the University Colorado, Department of Pharmacology, report on key preclinical findings using the small molecule SF2523 designed to inhibit the key cancer targets PI3K and BRD4.

Key results include:

Designed dual inhibition: The dual inhibitor SF2523 inhibits the acetyl-lysine binding of the epigenetic reader protein BRD4 as well the kinase activity of PI3K thus simultaneously disrupting two orthogonal cancer driving mechanisms that promote undesirable effects from the oncogene MYC which is responsible for activating the immuno-oncology targets CD47 and PD-L1. X-ray crystal structures of SF2523 bound to BRD4 isoforms were obtained and are consistent with in silico modeling predictions and thus provide insights for further investigations.
Mode of action: SF2523 blocks both PI3K and BRD4 signaling in vitro and in vivo promoting maximal MYC down-regulation.
Anticancer activity in vivo: SF2523 markedly inhibits cancer cell growth and metastasis in mouse models of neuroblastoma and an orthotopic pancreatic metastatic tumor model.
Safe in vivo profile: Most importantly, the dual PI3K/BRD4 inhibitor SF2523 is dramatically much safer in vivo than the administration of two separate inhibitors in combination (PI3K and BRD4). This proof of concept shows that designing 1 drug with the attributes of 2 distinct drugs (2 drugs in 1) can eliminate or significantly reduce unwanted added toxicity of combination drugs providing an exciting opportunity for the exploration of more sophisticated combinations for maximal anticancer efficacy.
SF2523, as discussed in the manuscript, inhibits phosphatidylinositol 3-kinase (PI3K) which, in addition to drive cancer on its own, also inhibits the epigenetic reader bromodomain-containing protein 4 (BRD4). This new anticancer paradigm harnesses the synergistic impact of inhibiting simultaneously PI3K and BRD4 to maximally inhibit MYC activity by enhancing MYC degradation (PI3K inhibition) and blocking MYC production (inhibition of MYC transcription via BRD4 inhibition). MYC inhibition is an important oncology outcome of this new anticancer paradigm because inactivation of MYC down-regulates immuno-oncology targets CD47 and PD-L1. This down-regulation offers a novel immune-oncology approach alone or in combination with checkpoint inhibitors.

SF2523 has arisen from SignalRx’s platform technology for cancer therapeutics that enables the engineering of one small molecule to inhibit two or more molecular targets in the cancer and stromal cell for maximum anticancer efficacy and unprecedented safety in vivo. While most anti-cancer drugs are made with a single cancer target in mind, the lead compound SF2523 was designed to inhibit two or more key orthogonal signaling biomolecules simultaneously within the cancer cell.

The cancer targets for this new technology approach are selected based on forward genetics and the discovery of important cancer synthetic lethalities for therapeutic exploitation. This effective engineering approach is in contrast to the industry paradigm which relies on random screening efforts of large collections of compounds hoping to find interesting dual-target activities. With SignalRx’s technology, it is possible now to molecularly design dual and triple inhibitory chemotypes for maximum in vivo antitumor activity while maintaining a safety advantage over using combinations of drugs to attempt similar attacks on cancer targets.

SignalRx is seeking a partner to accelerate the development of SF2523 and SF2535 into first-in-man clinical trials based on the promising profile of its PI3K/BRD4 inhibitors shown so far. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to develop them as single therapeutics and streamline their development in combination therapies focused on companion diagnostics built around synthetic lethality discoveries in human cancers such as kinome adaptation mediated by BRD4.