On November 28, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, and I-Mab Biopharma ("I-Mab"), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, reported the establishment of a series of strategic collaborative partnerships for developing multiple immuno-oncology programs, including I-Mab’s proprietary CD73 antibody TJD5, a novel immuno-oncology asset with best-in-class potential from I-Mab’s broad immuno-oncology portfolio, as well as several proprietary bispecific antibodies ("BsAbs") under development by I-Mab (Press release, Tracon Pharmaceuticals, NOV 28, 2018, View Source [SID1234531718]).

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TRACON and I-Mab entered into a cost-sharing product development collaboration whereby TRACON will be responsible for the regulatory and clinical development of TJD5 and up to five of the BsAbs in North America, with the majority of the development effort expected to occur in the U.S. TRACON will bear the costs of early phases of clinical trials and I-Mab will share the costs for more advanced development stages and commercialization. TRACON will also share the North America rights of any selected BsAbs with I-Mab for each collaborative program, with opt-in rights to in-license the BsAbs from I-Mab in certain territories.

"There is a great strategic fit between the two companies. We have complementary development capabilities and share a passion for science. We are pleased to work with TRACON to facilitate clinical development of TJD5 and any selected BsAbs in North America through a capital efficient partnership," said Jingwu Zang, M.D., Ph.D., CEO of I-Mab. "This partnership recognizes and values the potential of our innovative assets and strong drug discovery and development capabilities." "Partnering with TRACON is an important part of our global development strategy to bring innovative biologics to patients worldwide. It further strengthens our presence in North America following the establishment of our US office and is the latest addition to our growing global partnerships spanning from drug candidates to clinical assets," Zang added.

"We are excited to enter into this broad strategic transaction with I-Mab, an innovative biologics company with a broad pipeline of immuno-oncology assets with great potential to impact the treatment of cancer patients. We are particularly impressed with the similarities in corporate cultures between I-Mab and TRACON," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "This agreement expands TRACON’s portfolio of potential first-in-class and best-in-class immuno-oncology therapies and further validates TRACON’s product development solution for companies looking to develop innovative products in the U.S. In particular, we believe our existing in-house drug development expertise can reduce both the cost and time of clinical development for our partners and, when combined with our willingness to cost share, this can be an attractive development option. Given TRACON’s ability to expand our development capacity for additional products, we expect to continue leveraging our platform."

About TJD5

TJD5 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJD5 is currently completing IND-enabling studies and is expected to begin clinical testing in the U.S. in the first half of 2019 in a trial to assess safety and preliminary efficacy as a single agent and when combined with PD-1/PD-L1 checkpoint inhibitors in patients with advanced solid tumors.

On November 28, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported that management will attend the following conferences (Press release, Aclaris Therapeutics, NOV 28, 2018, View Source [SID1234531663]):

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Management will host investor meetings at the 2018 Citi Global Healthcare in New York, NY on Wednesday, December 5, 2018.
Dr. Neal Walker, President and Chief Executive Officer, will present at the 12th Annual Leerink POLARxPRESS Conference in New York, NY on Tuesday, December 11, 2018.

On November 28, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that the U.S. Patent and Trademark Office (USPTO) has issued a new patent protecting the Company’s lead drug candidate, tipifarnib, a potent and selective farnesyl transferase that is currently being studied in multiple solid tumor and hematologic indications, including a registration-directed trial in HRAS mutant head and neck squamous cell carcinoma (HNSCC) and a Phase 2 trial in peripheral T-cell lymphoma (PTCL) (Press release, Kura Oncology, NOV 28, 2018, View Source [SID1234531664]).

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U.S. Patent No. 10,137,121, "Methods of Treating Cancer with Farnesyltransferase Inhibitors," includes multiple claims directed to the use of tipifarnib as a method of treating patients with angioimmunoblastic T-cell lymphoma (AITL), an aggressive form of T-cell lymphoma. The newly issued patent has an expiration date of November 2037, excluding any possible patent term extension. Kura continues to pursue U.S. and foreign patent protection in this and other indications.

"The issuance of this new patent is an important achievement for Kura and reflects our ability to expand the breadth and depth of tipifarnib’s development opportunities," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "This patent comes just six months after the USPTO issued us a patent for the use of tipifarnib as method of treating patients with certain CXCL12-expressing cancers, further strengthening our intellectual property protection for tipifarnib based on genetically defined patient populations and disease indications."

Kura is evaluating, on a prospective basis, the role of the CXCL12 pathway and markers of bone marrow homing as potential biomarkers of clinical activity for tipifarnib in hematologic malignancies. The Company’s ongoing Phase 2 trial of tipifarnib in PTCL is enrolling patients into two expansion cohorts. The first cohort is defined by histology and includes patients with AITL. The second cohort is defined by genetics and includes patients with PTCL not otherwise specified (NOS) who have the absence of a single nucleotide variation in the 3’ untranslated region of the CXCL12 gene. The Company estimates that the combined addressable populations of patients with AITL and CXCL12+ account for approximately 40% of all PTCL cases.

Kura plans to report preliminary data from both expansion cohorts in its Phase 2 trial of tipifarnib at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego on Sunday, December 2, 2018. A copy of the poster will be available on the Company’s website at www.kuraoncology.com following presentation at the meeting.

About Tipifarnib

Kura Oncology’s lead candidate, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. Tipifarnib was previously studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets with a manageable side effect profile. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. Based on positive results from a Phase 2 clinical trial in HRAS mutant HNSCC and feedback from the U.S. Food and Drug Administration, Kura recently initiated a global, registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC.

On November 28, 2018 HOOKIPA Pharma Inc. ("HOOKIPA"), a clinical stage biopharmaceutical company developing a new class of immuno-therapeutics targeting infectious diseases and cancers based on its proprietary technology platform, reported that it entered into a research collaboration and license agreement with DarwinHealth to develop novel immunotherapies based on the systematic discovery and prioritization of the next generation of immunogenic, tumor-specific cryptic antigens (Press release, Hookipa Biotech, NOV 28, 2018, View Source [SID1234531680]). DarwinHealth is a precision-focused cancer medicine company, utilizing systems-biology derived algorithms to identify appropriate therapies for cancer patients and to systematically discover and prioritize the next generation of immunogenic, tumor-specific antigens.

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Under the terms of the agreement, DarwinHealth will utilize a combined single-cell transcriptome analysis and bioinformatics-based approach using both mouse and human cancerous and non-cancerous tissues to identify the next generation of shared "off-the-shelf" tumor-specific antigens. HOOKIPA will perform the validation experiments and be granted exclusive rights to the development, manufacturing and commercialization of products arising from the collaboration.

"Immunotherapy is one of the areas of greatest potential for future cancer treatment. Arguably, all antigen-specific immunotherapy is limited by the scarcity of known antigens. The current group of shared tumor self-antigens has been established for many years, and while more recent efforts have been aimed at identifying patient-specific neo-antigens, systematic attempts to identify the next generation of tumor self-antigens have not been pursued as aggressively," said Dr. Igor Matushansky, Chief Medical Officer and Global Head of Research and Development of HOOKIPA. "This is why the primary objective of our next generation, antigen discovery program – entitled HIDE [Human Immunotranscript Discovery initiativE]" – with DarwinHealth is to identify a novel constellation of shared self-antigens for multiple tumor subtypes. Our goal is that following a successful completion of the two-year program, antigens with validated immunogenicity will be deployed clinically as antigen-specific, vector-mediated immunotherapy using our TheraT* vector."

"DarwinHealth utilizes proprietary, systems biology-generated algorithms to match cancer patients with the drugs and drug combinations that are most likely to produce a successful treatment outcome. These same algorithms can also be used to prioritize investigational drugs and compound combinations of unknown potential against a full spectrum of human malignancies, as well as novel cancer targets," explained Andrea Califano, Dr. co-founder of DarwinHealth and Clyde and Helen Wu Professor of Chemical Systems Biology and Chair, Department of Systems Biology at Columbia University, "and importantly, for immuno-oncology applications, DarwinHealth can apply proprietary bioinformatics- and experimentally-based methodologies to identify human, cryptic immunogenic transcripts (crypto-antigens) that can be optimally delivered using HOOKIPA’s highly innovative vector."

Commenting on this immuno-oncology-focused collaboration, Gideon Bosker, CEO and co-founder of DarwinHealth said: "Combining HOOKIPA´s proprietary viral vector technology with DarwinHealth´s novel, systems-based approach to identifying next generation, shared antigens shows immense promise, potentially enabling cancer research to leap forward and transform patients´ lives."

On November 28, 2018 Oncorus, Inc., an oncolytic virus company focused on driving innovation to transform outcomes for cancer patients, reported the nomination of ONCR-177, a next-generation locally administered oncolytic virus clinical candidate for multiple solid tumor indications (Press release, Oncorus, NOV 28, 2018, View Source [SID1234531681]). ONCR-177 utilizes Oncorus’ proprietary, next-generation oncolytic herpes simplex virus (oHSV) platform. In addition, Oncorus has created a unique synthetic oncolytic virus platform, which will enable the company to develop multiple oncolytic viruses for repeated, systemic administration. Proprietary innovations in potency and safety engineered by Oncorus into both platforms enable best-of-class potential for the company’s portfolio programs and the opportunity to pursue multiple cancer types.

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"While we’ve seen early promise of the ability of oncolytic virus therapies to improve the response rates of checkpoint inhibitors, many patients still do not respond to these agents. Our team is committed to changing this fact," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We are driving multiple proprietary innovations across two distinct platforms that are enabling a portfolio of oncolytic virus product candidates with best-in-class potential. We intend to become the leaders in realizing the full potential of this exciting treatment modality to dramatically transform outcomes for cancer patients."

Dr. Ashburn will give an update on the company’s pipeline and business at a presentation today at 7:30 AM EST at the Piper Jaffray 30th Annual Health Care Conference in New York City, highlighting key accomplishments from 2018 to date and outlining near- and long-term value drivers for the company.

Key 2018 Accomplishments:

Nomination of lead clinical candidate, ONCR-177. Oncorus recently nominated a lead clinical candidate, ONCR-177, a locally administered oncolytic virus therapy. ONCR-177 features key innovations engineered into Oncorus’ next-generation oHSV platform, including the largest number of immunomodulatory payloads in the class. These payloads include IL-12, FLT3L, CCL4 and antagonists of the clinically proven checkpoint inhibitors, CTLA-4 and PD-1, to enable the recruitment and activation of T cells, natural killer (NK) cells and dendritic cells and increase the likelihood of productive anti-tumor responses. ONCR-177 is also a fully-replication competent virus in that it retains the ability to expresses γ34.5, which allows the virus to replicate in the presence of host antiviral immune responses, a feature unique among oHSVs that have been developed to date or are being developed currently. ONCR-177 also features Oncorus’ proprietary microRNA-attenuation strategy, which leverages the differential expression of microRNA sequences to allow robust viral replication in tumor cells, while preventing replication in healthy tissue. In addition, Oncorus has developed a complementary and orthogonal approach to protecting neurons from viral infection by engineering mutations in UL37, an HSV protein, which prevent both axonal retrograde transport and latency.
The company intends to file an investigational new drug application (IND) and start a first-in-human study by the end of 2019 in order to evaluate ONCR-177 in multiple solid tumor indications.

"The promise of oncolytic viruses as a therapeutic tool in the fight against cancer has been clear for some time. However, a fundamental challenge to date has been the need to sacrifice potency to ensure safety," said Christophe Quéva, Ph.D., Oncorus’ Chief Scientific Officer. "Our team has been working diligently to enhance our oHSV platform in a number of innovative ways to successfully overcome this ‘potency versus safety’ tradeoff. We are very encouraged by our progress to date and look forward to seeing how our innovations improve outcomes in clinical studies involving ONCR-177."

Achieved in vivo proof-of-concept for synthetic virus program for repeat, systemic administration. Oncorus has made notable progress advancing its research programs for systemic intravenous delivery for its breakthrough synthetic virus platform. Systemic delivery of oncolytic viruses offers the promise of targeting indications not amenable to locally administered oncolytic virus therapy such as cancers of the lung. The company recently achieved in vivo proof-of-concept for its systemic virus platform and aims to nominate a lead clinical candidate synthetic virus by the end of 2019.
Solidified leadership with key hires. Oncorus made key management hires in 2018 that helped expand the company’s expertise, solidify its leadership team, and position it for rapid growth. In September, the company announced that Theodore (Ted) T. Ashburn, M.D., Ph.D., was appointed President and CEO. Dr. Ashburn brings a wealth of experience in immuno-oncology drug development and commercialization to Oncorus. Mitchell H. Finer, Ph.D., Oncorus’ co-founder, founding CEO and MPM Capital Managing Director, assumed the role of Executive Chairman. Other key hires include John Goldberg, M.D., Senior Vice President, Clinical Development; Brett Belongia, Ph.D., Senior Director of CMC; Brian Haines, Ph.D., Senior Director Pharmacology, Toxicology; and Tooba Cheema, Ph.D., Director of Biomarkers and Translational Medicine.
Closed the third and final tranche of Series A round of financing. Oncorus closed a third and final tranche of its Series A financing, which raised a total of $61.4 million. The company’s blue-chip investor syndicate includes founding investor MPM Capital, as well as MPM’s UBS Oncology Impact Fund (OIM), Deerfield Management, Arkin Bio Ventures, Long March, Astellas and Celgene.
Continued to build a robust intellectual property (IP) estate. Oncorus continued to pursue a broad IP strategy and augment its current patent estate surrounding its proprietary innovations for both its oHSV and synthetic virus platforms and respective applications.
2019 Goals:

Oncorus’ key goals and upcoming value drivers include:

Filing an IND and initiating a first-in-human Phase 1 study involving ONCR-177
Nominating a lead synthetic virus clinical candidate for repeat systemic administration, and
Continuing to expand its team with the recruitment of key talent across multiple disciplines
"It’s an exciting time to be in the oncolytic virus therapy space, given the continued progress of this modality and its potential to become an important addition to the arsenal of immuno-oncology therapies available to cancer patients," said Dr. Finer. "2018 has been a year of important growth for Oncorus on both the scientific and business fronts. We have clear momentum as we approach 2019 and look forward to transitioning into a clinical stage company, progressing our portfolio of best-in-class products and, above all, realizing the promise of oncolytic virus therapy for cancer patients."