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.

Sun Pharmaceutical agrees to acquire Japan’s Pola Pharma

On November 28, 2018 India-based drugmaker Sun Pharmaceutical Industries reported the company has signed a definitive agreement to acquire Pola Pharma, a Japan-based pharma firm involved in the research, development, manufacture, and sale of branded and generic products.

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India-based drugmaker Sun Pharmaceutical Industries has signed a definitive agreement to acquire Pola Pharma, a Japan-based pharma firm involved in the research, development, manufacture, and sale of branded and generic products.

The $1m deal will enable Sun to bolster its global dermatology business. Pola Pharma’s portfolio primarily consists of dermatology products.

Pola Pharma, a part of Pola Orbis Group, reported a net loss of $7m on consolidated revenue of $108m in fiscal year 2017. It has two manufacturing facilities in Saitama and has capabilities to manufacture topical products and injectables.

The deal is slated to close by 31 January 2019 subject to closing conditions.

Sun Pharma executive vice-president Kirti Ganorkar said: "This acquisition is in line with our strategy to strengthen our global dermatology presence.

"Pola Pharma is a leading dermatology company and it will help us to launch our speciality and generic dermatology products in the Japanese market in future. We also get access to local manufacturing capability enabling us to serve the Japanese pharmaceutical market more effectively."

Sun Pharma country head of Japan Junichi Nakamichi said: "By combining Sun Pharma’s global strengths with Pola Pharma’s local expertise, we will have a great opportunity to further strengthen our presence in Japan, especially in the area of dermatology."

Sun Pharma entered into the Japanese prescription market in 2016 with the purchase of 14 prescription brands from Novartis.

The Japanese pharmaceutical market is estimated to be worth $84.8bn according to IQVIA Market Prognosis of September 2017.

Sun Pharma owns 42 manufacturing units located in India, Canada, US, Russia, Israel, Bangladesh, Hungary, Romania, South Africa, Malaysia, Nigeria and Australia. Approximately 68% of its sales come from overseas markets.