Positive recommendation of IDMC to Zepsyre® to continue the Phase III trial with in small-cell lung cancer (ATLANTIS)

On May 29, 2018 PharmaMar (MSE:PHM) has reported that the Independent Data Monitoring Committee (IDMC) has notified the Company of its recommendation that the Phase III (ATLANTIS) trial currently under way with Zepsyre (lurbinectedin, PM1183) in combination with doxorubicin in small-cell lung cancer patients should continue without any changes (Press release, PharmaMar, MAY 29, 2018, View Source [SID1234527441]).

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The IDMC’s recommendation came after an analysis of the safety data obtained with more than 500 patients treated in the trial. This pivotal randomized Phase III trial assesses the efficacy of PM1183 in combination compared with the standard treatment for this indication: investigator’s choice of either Topotecan or CAV (cyclophosphamide, doxorubicin, and vincristine).

About Zepsyre
Zepsyre (lurbinectedin, PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

About small-cell lung cancer
SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%i

About 18% of all the lung
cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded every year. This tumor is strongly associated with tobacco smoking, posing an important public health problemii.

After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.

Avid Bioservices to Participate at BIO International Convention 2018

On May 29, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that the company will participate at the upcoming 2018 BIO International Convention(Press release, Avid Bioservices, MAY 29, 2018, View Source [SID1234526916]). The company’s activities will include hosting of a corporate booth (#1073) in the conference’s exhibit hall, delivering a presentation on single-use manufacturing of biopharmaceuticals, participating in a roundtable discussion on the topic of capacity strategies for the utilization of single-use systems vs. traditional stainless steel technology, and taking part in the conference’s one-on-one partnering meetings. The company will also hold a reception at its booth on the evening of Tuesday, June 5th as part of the exhibit hall activities taking place on opening day. BIO 2018 is being held June 4-7, 2018 in Boston, MA.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of Avid’s activities at BIO 2018 are as follows:
Avid will host corporate booth #1073 showcasing the company’s comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services. Company representatives will provide a virtual tour of Avid’s 42,000 square foot state-of-the-art commercial biomanufacturing suite (Myford facility), which is in the unique position of being a validated facility with immediately available 2,000-liter scale bioreactor capacity. The company will also discuss the ongoing expansion of its process development capabilities and laboratories.

The Myford facility, located in Tustin, California, incorporates a variety of cutting-edge, single-use equipment with the goal of ultimately accommodating a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into the facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics drug substance manufacturing.

Additionally, Avid will dedicate a portion of its booth to celebrating the company’s 25 years of experience in biopharmaceutical development and manufacturing, which dates back to 1993. This anniversary coincides with the 25-year anniversary of the Biotechnology Innovation Organization (BIO), which is also being celebrated this year.
Joining the Avid team at BIO 2018 will be Sandra C. Carbonneau, the company’s newly appointed director of business development for the East Coast. Mrs. Carbonneau has more than 26 years of relevant industry experience, including a 22-year tenure with Lonza, a global integrated solutions provider to the pharmaceutical and biotechnology industries. During her time with Lonza, she held positions of increasing responsibility spanning areas of manufacturing, quality assurance, compliance and contract management, culminating in her overseeing the company’s global commercial development for its mammalian business unit. Mrs. Carbonneau most recently served as director of business development in the New England region at Integrated Project Services (IPS), a leading consulting firm for technically complex facilities worldwide. At Avid, she will play a key role in the company’s new customer acquisition efforts on the east coast of the US, while supporting all its existing clients in the eastern half of the country.

Roger Lias, Ph.D., Avid’s president and chief executive officer, will participate in a roundtable discussion titled, "Capacity Strategies – The Strategy Behind the Large Scale SUS vs. Stainless Steel Investment." The roundtable discussion will take place from 1:00 – 2:00 p.m. Eastern on Wednesday, June 6th at booth #375 within the BioProcess Zone’s BPI Theatre. It will be part of the BPI Theatre’s "Emerging Techniques, Technologies and Strategies" track.

Sun Ra Bullins, director of manufacturing at Avid, will make a presentation titled, "The Perks and Pitfalls of a Single-Use Biopharmaceutical Facility." The presentation will take place from 3:40 – 4:00 p.m. Eastern on Wednesday, June 6th at booth #375 within the BioProcess Zone’s BPI Theatre. It will be part of the BPI Theatre’s "Emerging Techniques, Technologies and Strategies" track.

ATARA BIOTHERAPEUTICS TO PARTICIPATE AT TWO UPCOMING INVESTOR CONFERENCES

On May 29, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Isaac Ciechanover, M.D., the Company’s President and Chief Executive Officer, will participate at two upcoming investor conferences in June (Press release, Atara Biotherapeutics, MAY 29, 2018, View Source [SID1234526936]):

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Jefferies 2018 Global Healthcare Conference
Company Presentation: Tuesday, June 5, 2018 at 11:00 a.m. ET
Grand Hyatt in New York, NY

Goldman Sachs 39th Annual Global Healthcare Conference
Fireside Chat: Tuesday, June 12, 2018 at 1:20 p.m. PT
Terranea Resort in Rancho Palos Verdes, CA

Live audio webcasts of the presentations will be available by visiting the Investors section of the Atara website at www.atarabio.com. Archived replays of the webcasts will be available on the Company’s website for 14 days following each presentation.

Sesen Bio to Present at the Jefferies 2018 Global Healthcare Conference

On May 29, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate therapies for the treatment of cancer, reported that Stephen Hurly, president and chief executive officer of Sesen Bio, will present a company overview at the Jefferies Global Healthcare Conference on Tuesday, June 5, 2018 at 8:30 a.m. ET in New York City (Press release, Eleven Biotherapeutics, MAY 29, 2018, View Source [SID1234526917]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the company’s presentation will be accessible from the Investors & Media section of Sesen Bio’s website, www.sesenbio.com. An archived replay of the webcast will be available on the company’s website for 90 days after the conference.

ATARA BIOTHERAPEUTICS TO PARTICIPATE AT TWO UPCOMING INVESTOR CONFERENCES

On May 29, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Isaac Ciechanover, M.D., the Company’s President and Chief Executive Officer, will participate at two upcoming investor conferences in June (Press release, Atara Biotherapeutics, 29 29, 2018, View Source [SID1234526936]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies 2018 Global Healthcare Conference
Company Presentation: Tuesday, June 5, 2018 at 11:00 a.m. ET
Grand Hyatt in New York, NY

Goldman Sachs 39th Annual Global Healthcare Conference
Fireside Chat: Tuesday, June 12, 2018 at 1:20 p.m. PT
Terranea Resort in Rancho Palos Verdes, CA

Live audio webcasts of the presentations will be available by visiting the Investors section of the Atara website at www.atarabio.com. Archived replays of the webcasts will be available on the Company’s website for 14 days following each presentation.