On September 25, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported the company will present at the Ladenburg Thalmann 2018 Healthcare Conference on October 2, 2018 at 12:00 pm Eastern Time in New York, NY (Press release, Alpine Immune Sciences, SEP 25, 2018, View Source [SID1234529574]).

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A live webcast of the presentation will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast.

On September 25, 2018, Aduro Biotech, Inc. ("we" or the "Company")reported it received written notices of termination from Janssen Biotech, Inc. ("Janssen") for its Research and License Agreements pertaining to the Company’s proprietary attenuated strains of Listeria for treatment of lung and prostate cancers (Filing, 8-K, Aduro Biotech, SEPT 25, 2018, View Source [SID1234529939]). Specifically, Janssen delivered notice for the following agreements (the "Janssen Agreements"): (i) the Research and License Agreement, dated as of October 13, 2014, as amended by that certain Amendment to Research and License Agreements, dated as of November 11, 2015 (the "Amendment"); (ii) the Research and License Agreement, dated as of May 27, 2014, as amended by the Amendment; and (iii) the GVAX Prostate License Agreement, dated as of May 27, 2014. The terminations are effective December 24, 2018.

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Under the terms of the Janssen Agreements, the Company granted Janssen an exclusive, worldwide license to research, develop, manufacture, use, sell and otherwise exploit products containing ADU-214, ADU-741 and GVAX Prostate for any and all uses. Additionally, the Company granted Janssen exclusive rights to develop products utilizing the Company’s proprietary attenuated strains of Listeria for treatment of lung and prostate cancers. The Company previously received upfront license fees and milestone payments upon completion of various development activities and was eligible to receive future contingent payments based on development, regulatory and commercial milestones as well as royalties on any net sales of licensed products by Janssen under each of the Janssen Agreements. Pursuant to the terms of the Janssen Agreements, upon Janssen’s termination, the Company regains worldwide rights for the development and commercialization of products containing ADU-214, ADU-741 and GVAX Prostate for any and all uses. In addition, Janssen will have certain obligations as set forth in the Janssen Agreements, including (i) immediately ceasing its use of any Company intellectual property and (ii) promptly returning or destroying any materials related to the development or manufacturing of the products containing ADU-214, ADU-741 and GVAX Prostate.

The foregoing descriptions of the Janssen Agreements do not purport to be complete and are qualified in their entirety by the full text of the agreements. The Janssen Agreements were filed as Exhibits 10.18, 10.19 and 10.20 to the Company’s Registration Statement on Form S-1, filed with the Securities and Exchange Commission on March 11, 2015, and the Amendment was filed as Exhibit 10.41 to the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 8, 2016.

On September 24, 2018 Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, reported the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials (Press release, Epizyme, SEP 24, 2018, View Source [SID1234529538]). Epizyme is now in the process of reopening enrollment in all of its company-sponsored trials in the U.S., including the follicular lymphoma (FL) EZH2 activating mutation cohort of its Phase 2 non-Hodgkin lymphoma trial.

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Epizyme’s formal response to the FDA included a comprehensive assessment of the risk of secondary malignancies, including T-cell lymphoblastic lymphoma (T-LBL) potentially associated with tazemetostat, which took into account both published literature and the company’s clinical experience to date. This followed a report of a single case of T-LBL in its tazemetostat pediatric study. Epizyme provided a thorough assessment of efficacy and safety data across all of its trials in hematological malignancies and solid tumors, in both adults and children, and convened a panel of external scientific and medical experts who reviewed and validated the findings.

"The Epizyme team has worked diligently to provide a comprehensive response back to the FDA, and through constructive dialogue, we successfully resolved the partial clinical hold. This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL," said Robert Bazemore, president and chief executive officer of Epizyme. "We, along with our investigators and the global experts we consulted to support our complete response, continue to believe in the positive benefit/risk of tazemetostat as we move forward in our clinical development program. We remain steadfast in our commitment to bringing this potential therapeutic option to cancer patients in need of safe and effective new treatments."

Epizyme will now engage with regulators in France and Germany to resolve the partial clinical holds and resume enrollment in those countries. The company is also working closely with its study partners to reach a similar resolution for their respective trials in which tazemetostat is being studied in combination with other therapies.

Investor Conference Call Notice
Company management plans to host a conference call and webcast at 8:30 a.m. EDT today to discuss the resolution of the partial clinical hold. To participate, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 3499753. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast also will be archived on the website for 60 days.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).

On September 24, 2018 Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, reported that Douglas M. Fambrough, Ph.D., president and chief executive officer, will participate in two investor conferences in October (Press release, Dicerna, SEP 24, 2018, View Source [SID1234529539]).

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2018 Cantor Fitzgerald Global Healthcare Conference, Monday, October 1, 2018 at 7:45 a.m. ET at the InterContinental New York Barclay in New York. Dr. Fambrough will present a corporate update and overview of the Company’s most advanced GalXC pipeline programs, including DCR-PHXC, an investigational RNAi therapeutic in development for the treatment of all forms of primary hyperoxaluria. A live webcast of the presentation can be accessed on the Investors & Media section on the Dicerna website at www.dicerna.com. An archived replay of the webcast will be available on the Company’s website after the conference.

Leerink Partners Roundtable Series: Rare Disease and Oncology, Tuesday, October 2, 2018 at 2:30 p.m. ET at the Lotte New York Palace in New York. Dr. Fambrough will participate in an analyst-moderated fireside chat. A live webcast of the fireside chat can be accessed on the Investors & Media section on the Dicerna website at www.dicerna.com. An archived replay of the webcast will be available on the Company’s website after the conference.

On September 24, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that President and Chief Executive Officer Guy Macdonald will present a corporate overview at the Cantor Global Healthcare Conference on Monday, October 1, 2018 at 5:15 p.m. Eastern Time at InterContinental New York Barclay Hotel in New York City (Press release, Tetraphase, SEP 24, 2018, View Source [SID1234529560]).

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A live webcast of the presentation will be available on the Company’s website at View Source The archived presentation will be available for 30 days