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CytomX Announces the First Patient Treated in Phase 1/2 PROCLAIM-072 Trial

On February 2, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the treatment of the first patient in the PROCLAIM (Probody Clinical Assessment In Man) CX-072 study, a Phase 1/2 clinical trial evaluating CX-072, a PD-L1-targeting Probody therapeutic, as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers (Press release, CytomX Therapeutics, FEB 2, 2017, View Source;p=irol-newsArticle&ID=2241629 [SID1234517635]).

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"Treating the first patient with CX-072 marks a key milestone as we advance our broad pipeline of innovative Probody therapeutics into clinical development within the PROCLAIM program," said Rachel W. Humphrey, M.D., chief medical officer of CytomX Therapeutics. "Advancement of this potentially transformational treatment, derived from our Probody technology platform, would not be possible without the patients who are willing to engage with the scientific community by enrolling in clinical trials. We thank them for their participation."

About the PROCLAIM-072 Trial
The first clinical trial under the international umbrella program PROCLAIM is the open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers. As part of the study, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.

More information about the trial is available at clinicaltrials.gov.

TapImmune Completes Scale-Up and GMP Manufacturing of TPIV 200 Vaccine to Supply Additional Phase 2 Clinical Trials

On February 2, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, reported it has successfully completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, the company’s multi-epitope T-cell vaccine targeting folate receptor alpha (Press release, TapImmune, FEB 2, 2017, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=%5B%5Brssitem_title%5D%5D [SID1234517634]). The manufactured vaccine product will be used to supply an ongoing Phase 2 study of TPIV 200 for the treatment of platinum-sensitive ovarian cancer, as well as a planned Phase 2 study sponsored by the Mayo Clinic for treating triple-negative breast cancer.

"The successful release of our second lot of TPIV 200 represents another important milestone in the progression of our product pipeline and technologies," said Dr. Glynn Wilson, Chairman and CEO of TapImmune. "Improvements to the manufacturing process include a process change to improve scalability and a formulation change to improve the physical appearance and consistency of the final vialed product. The end result is a superior formulation that is more amenable to large scale manufacturing and commercialization."

"Our first TPIV 200 lot was manufactured in early 2016 to fully supply a TapImmune-sponsored Phase 2 trial evaluating the vaccine for the treatment of triple-negative breast cancer as well as a Phase 2 trial evaluating the vaccine in combination with a checkpoint inhibitor for platinum-resistant ovarian cancer, both of which are currently enrolling patients," said Dr. John Bonfiglio, President and COO of TapImmune. "The current, larger clinical batch of TPIV 200 will fully supply the first TapImmune-sponsored Phase 2 trial in platinum-sensitive ovarian cancer, for which a number of clinical sites are currently being screened and initiated. The batch will also supply a planned Mayo Clinic-sponsored Phase 2 trial for triple-negative breast cancer, which is fully funded by a grant from the Department of Defense."

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]).

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.

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.

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]).

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