TESARO Announces Participation at Three Investor Conferences

On August 27, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported its participation in three upcoming investor conferences. The three conferences are (Press release, TESARO, AUG 27, 2018, View Source [SID1234529154]):

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Citi’s 13th Annual Biotech Day at the Four Seasons Hotel in Boston on Wednesday, September 5, 2018.Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President and COO of TESARO, will discuss the Company’s business and development programs in an analyst-led fireside chat, and importantly, will review recent progress of the Company’s lung cancer strategy for ZEJULA and its immuno-oncology programs. The fireside chat will be webcast on September 5 from 12:15 to 1:15 PM ET, and TESARO will also host meetings with investors.

The Baird 2018 Global Healthcare Conference at the InterContinental New York Barclay in New York City on Wednesday, September 5. Tim Pearson, Executive Vice President and CFO of TESARO, and Grant Bogle, Senior Vice President and Chief Commercial Officer of TESARO, are scheduled to participate in an analyst-led fireside chat from 12:15 to 12:45 PM ET on September 5, and will also host meetings with investors.

The Wells Fargo Global Healthcare Conference at the Westin Copley Place in Boston on Thursday, September 6. Lonnie Moulder and Mary Lynne Hedley, Ph.D., are scheduled to present an overview of the Company’s business and development programs at 11:30 AM ET on September 6, and will also host meetings with investors.
Live webcasts of the presentations at the Citi, Baird, and Wells Fargo conferences will be available by visiting the Investors section of the TESARO website at www.tesarobio.com. Archived replays of these webcasts will be available on the Company’s website for 14 days following the conferences.

Bio-Path Holdings Announces First Patient Dosed in Expansion of Phase 2 Trial of Prexigebersen in Acute Myeloid Leukemia

On August 27, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported it has commenced Stage 2 of the company’s Phase 2 trial of prexigebersen in acute myeloid
leukemia (Press release, Bio-Path Holdings, AUG 27, 2018, View Source [SID1234529151]).

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The open-label Phase 2 study is evaluating the efficacy and safety of prexigebersen in conjunction with LDAC, a therapeutic regimen well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than would be expected with LDAC alone in this de
novo patient population.

"We are delighted to announce the expansion of our ongoing Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia using a dosing schedule that administers a greater amount of prexigebersen to the patient prior to commencing LDAC dosing than in the first part of the trial. Based on compelling new data, we are also
including a cohort of patients who will be treated with a combination of prexigebersen and decitabine," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "Results from the planned interim analysis of the first part of this Phase 2 study were particularly encouraging, with 47% of treated patients demonstrating a response. Consequently, we remain enthusiastic about prexigebersen’s potential and believe these protocol changes
will optimize the drug’s impact in AML cancer patients with high unmet need."

Based on recommendations from the study’s principal investigators, the Company amended the study’s protocol to change the dosing schedule in Stage 2 to that used in the Phase 1b study in relapsed and refractory AML patients as announced in April 2018. In the Phase 1b study, a greater amount of prexigebersen was administered prior to LDAC
treatment starting at day 10 versus LDAC treatment starting on day four as was the case in Stage 1 of the current Phase 2 study. Importantly, Stage 2 of the study includes a cohort of patients treated in combination with decitabine based on relatively new and positive data with this compound. Bio-Path plans to perform an interim analysis of each cohort once approximately 19 evaluable patients are reached in the cohort.

As previously announced, a planned interim analysis of Stage 1 of the study was performed on 17 evaluable patients, with four patients achieving complete responses and four patients achieving stable disease, including one patient achieving a morphologic leukemia free state and one patient who showed significantly reduced bone marrow blasts. In total, 47% of the evaluable patients showed some form of response, including stable disease, to
the combination treatment. The average patient in Stage 1 of the study was 73.5 years of age

Affimed Announces Collaboration with Genentech to Develop Novel NK Cell Engager-based Immunotherapeutics for Multiple Cancer Targets

On August 27, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells), reported that it has entered into a strategic collaboration agreement with Genentech, a member of the Roche Group, to develop and commercialize novel NK cell engager-based
immunotherapeutics to treat multiple cancers (Press release, Affimed, AUG 27, 2018, View Source [SID1234529117]).

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Affimed will apply its proprietary Redirected Optimized Cell Killing (ROCK) platform, which enables the generation of both NK cell and T cell-engaging antibodies, to discover and advance innate immune cell engager-based immunotherapeutics of interest to Genentech. The collaboration includes candidate products generated from Affimed’s ROCK platform and multiple undisclosed solid and hematologic tumor targets. Affimed and Genentech will collaborate on the discovery, early research and late-stage research phases. Genentech will be responsible for clinical
development and commercialization worldwide.

"We are incredibly excited to work with Genentech, a leader in oncology with a long history of excellence in the discovery and development of medicines to treat cancer," said Dr. Adi Hoess, Affimed’s CEO. "This strategic partnership marks an important step on our path to leverage the full potential of innate immune cells in oncology."

Under the terms of the agreement, Affimed will receive $96 million in an initial upfront payment and other near-term committed funding. Affimed may be eligible to receive up to an additional $5.0 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones, and royalties on sales. The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust
Improvements Act, and closing is expected to occur in the third quarter of 2018.

"This collaboration is based on Affimed’s innate immune cell drug discovery and development expertise and our team’s deep understanding of cancer immunology," commented James Sabry, M.D., Ph.D., Global Head of Partnering, Roche. "Our partnership with Affimed provides an opportunity to enhance our existing efforts to understand how the immune system can be activated to help people living with cancer."

About Affimed’s ROCK Platform
Affimed’s proprietary, versatile and modular ROCK (Redirected Optimized Cell Killing) platform enables the generation of first-in-class, tetravalent, multi-specific immune cell engagers. Based on its modularity, ROCK allows for antibody engineering of highly customizable NK and T cell engagers to generate clinical candidates tailored to multiple disease indications and settings, including generation of molecules against validated oncology targets to address the limitations of existing treatments of hematologic and solid tumors.

Generex Biotechnology to Present Overview of Immuno-Oncology Development Program at Summit in Boston, MA

On August 27, 2018 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (View Source) reported to announce that Richard Purcell, the Company’s Executive Vice President of Research & Development will participate in a panel discussion at the Cambridge Healthtech Institute’s Immuno-Oncology Summit at the Seaport World Trade Center in Boston, MA (https://www.immuno-oncologysummit.com/) on August 30, 2018. The panel discussion will focus on current trends and future prospects for immunotherapy in the treatment of cancer. Additionally, Mr. Purcell will provide an overview of the relaunched clinical development program of the HER2/neu immunotherapeutic vaccine, AE37, together with strategies to advance the proprietary Ii-Key technology under development at the Company’s wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).

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"The introduction of checkpoint inhibitors has been revolutionary in the practice of clinical oncology, but is only effective in roughly 30% of patients across a variety of cancers," said Mr. Purcell. "The complementary mechanism of action of AE37 (T-cell activation), and encouraging results obtained in triple negative breast cancer patients, strongly suggest that the combined use of AE37 with pembolizumab (Keytruda) will provide significantly greater efficacy than either alone."

The Immuno-Oncology Investing & Partnering Forum is taking place on Thursday, August 30th and the session Novel Therapeutics in Cancer Immunotherapy will take place at 1:30 pm EDT and consist of company presentations followed by Q&A with the audience. The conference is taking place at the Seaport World Trade Center in Boston, MA, and the session room is Beacon Hill 1

ImmunoGen Announces Webcasts of Presentations at Upcoming Conferences

On August 27, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, AUG 27, 2018, View Source [SID1234529086]):

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20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC September 5 at 12:30pm ET

Morgan Stanley 16th Annual Global Healthcare Conference September 13 at 3:30pm ET

A webcast of each presentation will be accessible live through the "Investors" section of the Company’s website, www.immunogen.com; a replay will be available in the same location for approximately two weeks.