Geron to Host Analyst and Investor Event on December 10, 2018

On November 28, 2018 Geron Corporation (Nasdaq: GERN) reported that the Company’s analyst and investor event will take place in New York, N.Y., on Monday, December 10, 2018 (Press release, Geron, NOV 28, 2018, View Source [SID1234531717]). Management will be joined by clinical investigators from both IMerge and IMbark who will reprise oral presentations from the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting occurring in early December, as well as discuss the unmet medical need in hematologic myeloid malignancies. The event will begin at 8:00 a.m. ET.

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Azra Raza, M.D., Chan Soon-Shiong Professor of Medicine and Director of the MDS Center in New York, will review data from Part 1 of the ongoing Phase 2/3 IMerge clinical trial of the telomerase inhibitor imetelstat in patients with lower risk myelodysplastic syndromes, including more mature efficacy and safety data from the combined initial and expansion cohorts presented at ASH (Free ASH Whitepaper).

John Mascarenhas, M.D., Associate Professor of Medicine in the Myeloproliferative Disorders Program of the Tisch Cancer Institute, Division of Hematology/Oncology at the Icahn School of Medicine at Mount Sinai, will review data from IMbark, the ongoing Phase 2 clinical trial of imetelstat in patients with Intermediate-2 or High-risk myelofibrosis, including more mature data from the extension phase of IMbark presented at ASH (Free ASH Whitepaper), including median overall survival.

Analysts and investors in attendance will be able to ask questions of the investigators during the question and answer session following the presentations. In addition, the Company will also discuss its development plans for imetelstat, including the start of the Phase 3 portion of IMerge by mid-year 2019.

A live audio webcast of the event will be available on Geron’s website, www.geron.com/investors/events. If you are unable to listen to the live event, an archived webcast of the event will be available on the Company’s website for 30 days

Vor Biopharma Announces Issuance of Foundational U.S. Patent Broadly Covering Compositions and Methods to Treat Hematologic Malignancies

On November 28, 2018 Vor Biopharma, an immuno-oncology company pioneering hematopoietic stem cell (HSC) therapies for the treatment of hematological malignancies and affiliate of PureTech Health plc (LSE: PRTC), reported that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 10,137,155 related to the Company’s technology platform (Press release, Vor BioPharma, NOV 28, 2018, View Source [SID1234531678]). This foundational patent is the first of its kind in the immuno-oncology field and broadly covers compositions and therapeutic methods related to using novel modified HSCs to enable targeted immunotherapies. The platform technology underlies Vor’s pipeline of immuno-oncology candidates, including lead candidate VOR33.

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The now patented technology is designed to address the fundamental limitations of traditional targeted therapies, including antibody-drug conjugates, bispecific antibodies, and chimeric antigen receptor (CAR) T cells, for the treatment of hematologic malignancies. These existing therapies target antigens on malignant cells that also appear on healthy cells, which can result in mass depletion of critical life-sustaining cells. Vor’s approach employs the use of antigen-modified hematopoietic stem cells (amHSCs), which are designed to repopulate a patient’s blood with cells that have a benign genetic modification to a specific surface antigen that escapes targeting and protects the cells from depletion by targeted immunotherapies. By sparing healthy blood cells, this approach may potentially improve patient safety, enable maximal dosing of cancer-targeted therapies, increase the number of potential patient populations that could benefit from these therapies, and expand the reach of targeted immunotherapies beyond B-cell cancers to a broad range of hematological malignancies, including acute myeloid leukemia (AML).

"The USPTO’s allowance of these broad claims provides validation that our approach and intellectual property are novel and first-in-class," said Aleks Radovic-Moreno, Ph.D., PureTech Health Vice President and Vor program lead. "The compositions and methods covered in the patent protect our lead product candidate as we continue development of our technology towards the clinic. This technology has the potential to provide a novel therapeutic approach for patients with aggressive blood cancers that otherwise have very few treatment options and poor prognoses."

The relevant intellectual property is exclusively licensed to Vor Biopharma and is based on technology developed by Siddhartha Mukherjee, M.D., D. Phil, Associate Professor of Medicine at Columbia University and a Staff Physician at Columbia University Medical Center, and his colleagues.

"This approach has the potential to broaden the use of targeted immunotherapies beyond B-cell cancers, and to help patients who have very limited treatment options," said Dr. Mukherjee.

About VOR33
Vor’s lead product candidate, VOR33, is designed to enable maximal CD33-targeted immunotherapy. CD33, a target that is present in the vast majority of acute myeloid leukemia (AML) patients, is also expressed in normal myeloid progenitor cells. Depletion of normal myeloid progenitor cells prevents the beneficial use of several CD33-targeted therapies at important stages throughout the treatment process, at higher doses, and for longer periods of time. By enabling new CD33-targeted therapies, VOR33 has the potential to overcome these challenges and improve treatment for AML. Vor anticipates initiating IND-enabling studies for VOR33 in early 2019.

TRACON Pharmaceuticals And I-Mab Biopharma Announce Strategic Partnerships For Multiple Immuno-Oncology Programs

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.

Aclaris Therapeutics to Attend Upcoming Investor Conferences

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.

Kura Oncology Announces New Patent for Tipifarnib in Angioimmunoblastic T-Cell Lymphoma

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.