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First Clinical Results Evaluating Allogeneic, Off-The-Shelf, Placental-Derived Cells to be Presented by Celularity at 2019 AACR Annual Meeting

On February 27, 2019 Celularity, Inc., a clinical-stage cell therapeutics company developing allogeneic cellular therapies harnessed from human placentas, reported it will present first-ever clinical and pre-clinical results from its comprehensive placental hematopoietic stem cell derived natural killer (PNK) cells oncology program at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held from March 29 – April 3, 2019 in Atlanta, Georgia (Press release, Celularity, FEB 27, 2019, View Source [SID1234533753]). Investigational PNK-007 is a fully allogeneic, off-the-shelf cell therapy product developed as a potential treatment option for various hematological cancers and solid tumors.

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"Combining the unique biologic properties of placental-derived cells with our proprietary IMPACT cell therapy development platform, Celularity is working to develop next-generation, off-the-shelf immunotherapies that could be safer, more accessible, and more affordable than currently available approaches," said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and CEO. "These data are an important and validating milestone of our IMPACT platform. We believe the emergent positive profile marks the unveiling of a potential new immuno-oncology option, one capable of turning cells from this abundant, highly scalable and versatile source—the placenta leftover after a healthy birth—into meaningful therapies for patients with cancer and other serious diseases."

Data highlights at AACR (Free AACR Whitepaper) include:

Presentation (Abstract #CT108): A Phase I study of PNK‐007, allogeneic, off the shelf NK cell, post autologous transplant in multiple myeloma. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 7.

Presentation (Abstract #CT079): A Phase 1 Study of PNK-007, Allogeneic, Off the Shelf NK Cell in Relapsed/Refractory AML. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 3.

Poster Presentation (Abstract #LB-070): Immune monitoring of PNK-007, an allogeneic, off the shelf NK cell in a Phase I study of acute myeloid leukemia. W. van der Touw, Ph.D. Monday, April 1, 8:00am – 12:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41, Poster Board Number 15.

Oral Presentation (Abstract #5318): Genetic modification potentiates the anti-tumor activity of human placental CD34+ cells-derived NK cells. J. Li, Ph.D. Sunday, March 31, 3:00pm – 5:00pm EST. Location: Georgia World Congress Center, Room B405.

About PNK-007

PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematological cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated for patients with acute myeloid leukemia (AML) and multiple myeloma (MM).

Syros to Present New Preclinical Data on Its Selective CDK7 Inhibitors, SY-1365 and SY-5609, at AACR Annual Meeting

On February 27, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor currently in a Phase 1 clinical trial focused on ovarian and breast cancers, and on SY-5609, its selective oral CDK7 inhibitor that the company has named as its next development candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 29-April 3 in Atlanta (Press release, Syros Pharmaceuticals, FEB 27, 2019, View Source [SID1234533752]).

The presentation on SY-1365 will highlight data showing that alterations in the RB pathway are predictive of response to SY-1365 in patient-derived xenograft models of high-grade serous ovarian cancer, supporting exploration of RB alterations as potential biomarkers of response to SY-1365. The presentation on SY-5609 will describe in vitro and in vivo data on the selectivity, potency and anti-tumor activity of SY-5609 that supported its advancement into investigational new drug application (IND)-enabling preclinical studies.

The abstracts for these presentation are now available online on the AACR (Free AACR Whitepaper) website at View Source

Details on the presentation are as follows:

Presentation Title: Prospective identification of RB pathway alterations predict response to SY-1365, a selective CDK7 inhibitor, in a panel of high-grade serous ovarian cancer (HGSOC) patient derived xenograft (PDX) models
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Nan Ke, Syros
Abstract Number: 4409
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37

Presentation Title: SY-5609, an orally available selective CDK7 inhibitor, demonstrates broad anti-tumor activity in vivo
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Shanhu Hu, Ph.D., Syros
Abstract Number: 4421
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37

ALX Oncology to Present Preclinical Data on SIRPα Antibody Program at Upcoming Conferences

On February 27, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that preclinical data for its SIRPα antibody research program will be presented at the 2019 Keystone Symposia Conference (Keystone), Cancer Immunotherapy in Whistler, British Columbia and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia (Press release, ALX Oncology, FEB 27, 2019, View Source [SID1234533751]).

CD47/SIRPα interaction is a key checkpoint mechanism exploited by cancer cells to escape immunological surveillance. While CD47 is widely expressed in human cells, SIRPα, the CD47 inhibitory receptor, is mainly expressed in myeloid cells and neurons. ALX148, a CD47 blocker with an inactive Fc domain, is generally well tolerated and demonstrates anti-cancer activity in combination with trastuzumab and pembrolizumab in patients with anti-HER2 and checkpoint inhibitor resistant/refractory disease (SITC 2018, P335). Another approach to block this interaction is to target SIRPα.

"Targeting the CD47/SIRPα pathway is an exciting new approach that shows promise in clinical trials. By targeting SIRPα, we can investigate the similarities and differences of an orthogonal strategy to inhibit this axis," said Hong Wan, Ph.D., ALX Oncology’s Chief Scientific Officer. "Our panel of proprietary high affinity monoclonal antibodies provides diverse epitope coverage across the extracellular surface of SIRPα. These antibodies are cross-reactive to human, monkey and rodent SIRPα variants, which enables robust clinical translation. Importantly, these antibodies bind to all human SIRPα variants, a critical attribute for a global patient population."

ALX Oncology’s SIRPα antibodies enhance the antitumor activity of immune checkpoint inhibitors, with reduction of metastases, eradication of tumors, and acquisition of memory immune response in tumor-bearing mice with intact immune systems. The cellular immune response in syngeneic models shows that these SIRPα antibodies enhance innate and adaptive anti-cancer immunity, providing a rationale for combination with other immunotherapies. In an exploratory toxicology study in monkeys, the selected SIRPα antibodies demonstrate a favorable pharmacokinetic, target occupancy and tolerability profile.

Together, these preclinical data provide a compelling rationale to advance the development of anti-SIRPα therapy for patients with cancer.

Keystone Presentation Information
Title: Discovery of monoclonal antibodies targeting myeloid checkpoint SIRPα to enhance anti-tumor immunity
Session: Poster session 3
Session Date: Wednesday, March 13, 2019
Location: Whistler Conference Centre
Poster Number: 3022

AACR Presentation Information
Title: Antibodies to SIRPα enhance innate and adaptive immune responses to promote anti-tumor activity
Session Category: Immunology
Session Title: Therapeutic Antibodies 1
Session Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23
Abstract Number: 562

Tetraphase Pharmaceuticals to Present Data on Preclinical Activity of TP-2846 in Acute Myeloid Leukemia

On february 27, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat life-threatening conditions, reported it will present three posters on TP-2846, the Company’s newly revealed pipeline candidate for acute myeloid leukemia (AML) (Press release, Tetraphase Pharmaceuticals, FEB 27, 2019, View Source [SID1234533750]). The posters will be presented at the 2019 American Association for Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place March 29 – April 3 at the Georgia World Congress Center in Atlanta. The poster presentations will include in vitro and in vivo data supporting TP-2846’s potential as a novel tetracycline antileukemia agent.

"Decades of research have shown that tetracyclines hold potential as anticancer agents, but to date, optimizing a tetracycline for oncology has proven elusive," said Guy Macdonald, President and Chief Executive Officer. "Leveraging our proprietary and productive discovery platform, we identified TP-2846, a structurally diverse tetracycline and potential new antileukemia agent with potent in vitro and in vivo activity. We look forward to further discussing the potential of TP-2846 at AACR (Free AACR Whitepaper) and building on this encouraging preclinical dataset."

"TP-2846 represents a new mechanism of action with potential application for AML patients regardless of mutation status," said Jacques Dumas, Ph.D., Chief Scientific Officer. "By using our fully synthetic technology for building tetracyclines, we have been able to optimize TP-2846 for AML, warranting its further study in this patient population."

The details for the data presentations at AACR (Free AACR Whitepaper) are as follows:

Abstract Number: 3857
Title: Discovery and structure-activity relationship studies of TP-2846: a novel tetracycline antileukemia agent
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 2
Session Date and Time: Tuesday, April 2, 2019 from 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 12

Abstract Number: 3880
Title: In vivo activities of TP-2846: a novel tetracycline antileukemia agent
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 2
Session Date and Time: Tuesday, April 2, 2019 from 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 12

Abstract Number: 4802
Title: In vitro characterization of TP-2846: a novel tetracycline antileukemia agent
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Session Date and Time: Wednesday, April 3, 2019 from 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 13

Patrick Baeuerle Recognized for Contributions to Cancer Immunotherapy

On February 27, 2019 Cullinan Oncology is reported that its co-founder and Chief Scientific Officer, Biologics, Patrick Baeuerle, has been honored by the European Molecular Biology Laboratory (EMBL) (Press release, Cullinan Oncology, FEB 27, 2019, View Source [SID1234533749]). The EMBL has presented Baeuerle with the 2019 Lennart Philipson Award for his pivotal role in developing cancer immunotherapies.

The award focuses on Baeuerle’s many contributions to the field of immuno-oncology, including his efforts at Micromet and subsequently Amgen where he developed bispecific antibodies known as BiTEs (Bispecific T cell Engagers). BiTEs engage the body’s T cells to facilitate the destruction of cancer cells. Baeuerle led the development of Blincyto, the first bispecific antibody approved by the FDA, for relapsed/refractory acute lymphoblastic leukemia (ALL).

"Patrick’s contributions to the fight against cancer have been significant and this recognition is well deserved. We are fortunate to have his knowledge, expertise, and leadership at Cullinan as we work to develop the next breakthroughs for patients," said Owen Hughes, CEO at Cullinan Oncology.

In addition to his role at Cullinan, Patrick Baeuerle is an Executive Partner at MPM Capital. He is also the founder of MPM-funded cancer immunotherapy companies Harpoon Therapeutics (NASDAQ: HARP), TCR2 Therapeutics (NASDAQ GS: TCRR), iOmx Therapeutics, and Maverick Therapeutics.

To access the EMBL announcement click here.

About the Lennart Philipson Award

The Lennart Philipson Award (LPA) was created to honor EMBL’s second Director General, Lennart Philipson (1982-1993). The Award recognizes outstanding and validated contributions in translational research in human health and/or technology innovation in the life sciences.