On November 9, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported the launch of its universal cancer immunogenomics platform, ImmunoID NeXT (Press release, Personalis, NOV 9, 2018, View Source [SID1234531186]). This is the first platform to enable comprehensive analysis of both a tumor and its microenvironment from a single sample.

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Personalis CEO, John West, said, "While the success of checkpoint blockade has been hugely promising, it’s increasingly apparent that predicting response to immunotherapies and developing new ones requires a more comprehensive approach to tumor immunogenomics. With ImmunoID NeXT, it’s now possible to characterize the complex interactions between the tumor cells and immune cells of the microenvironment using a single platform. This means researchers no longer have to make the difficult choice of which biomarkers to analyze due to sample limitations, particularly when dealing with FFPE specimens."

The unique design of the ImmunoID NeXT Platform facilitates the delivery of therapeutic and diagnostic biomarker information across ~20,000 genes from DNA and RNA, including:

Neoantigen identification and characterization
Human leukocyte antigens (HLA) typing
Tumor infiltrating adaptive immune cells
T-cell receptor (TCR) repertoire (α, β, γ, and δ chains)
B-cell receptor (BCR) repertoire (heavy and light chains)
Tumor infiltrating innate immune cells
Immune response and tumor escape mechanisms
Neoantigen load and tumor mutational burden (TMB)
Microsatellite instability (MSI) status
Oncoviral detection
Germline genomic variation
Personalis is offering pharmaceutical customers the opportunity to participate in an Early Access Program beginning in January, 2019. The company also anticipates the release of a clinical diagnostic test based on this platform in 2019.

Personalis will be presenting new data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C., November 8-11, 2018. Personalis representatives will also be available to discuss the ImmunoID NeXT Platform at the company’s exhibit (Booth #617).

On November 9, 2018 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, NOV 9, 2018, View Source [SID1234531203]):

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Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Credit Suisse Healthcare Conference on Wednesday, November 14, 2018 at 11:30 a.m. MT in Scottsdale, Arizona.
Shalini Sharp, the company’s Chief Financial Officer, will present at the Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 11:30 a.m. ET in New York.
Dr. Kakkis will present at the Evercore HealthConX on Wednesday, November 28, 2018 at 11:00 a.m. ET in Boston.
The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On November 9, 2018 Synthorx, Inc., a biotechnology company using a first-of-its-kind Expanded Genetic Alphabet platform technology to discover and develop optimized biologics for cancer and autoimmune disorders, reported company researchers will present results of preclinical studies demonstrating the safety and anti-tumor effects of its lead product candidate THOR-707, a "not-alpha" Synthorin of interleukin-2 (IL-2), for the treatment of solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting (Press release, Synthorx, NOV 9, 2018, View Source [SID1234531204]). Marcos Milla, Ph.D., chief scientific officer of Synthorx, will present the poster on Friday, November 9, from 12:45 – 2:15 p.m. and 6:30 – 8:00 p.m. ET at the Walter E. Washington Convention Center in Washington, D.C.

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The study, titled "THOR-707: An engineered IL-2 for the treatment of solid tumors with superior preclinical efficacy and safety evidence," investigates the application of Synthorx’s Expanded Genetic Alphabet platform technology to engineer THOR-707, a variant of recombinant human IL-2 that is pegylated at one specific site and designed to kill tumor cells without inducing vascular leak syndrome (VLS), a toxicity associated with aldesleukin, an approved recombinant IL-2. Aldesleukin was approved by the U.S. Food and Drug Administration over 25 years ago for the treatment of patients with metastatic renal cell carcinoma and metastatic melanoma. However, widespread use of aldesleukin has been limited by toxicities, which include life-threatening and sometimes fatal VLS, as well as by its short half-life, requiring courses of dosing of three times per day over eight days.

In Synthorx’s preclinical studies, THOR-707 induces molecular markers of T cell activation and the proliferation of peripheral NK and CD8+ effector T cells in vivo. However, dosing of THOR-707 has minimal effect on molecular and clinical markers of VLS, even at high exposures. Analysis of the effect of THOR-707 in syngeneic mouse tumor models showed that THOR-707 induced infiltration of CD8+ T effector cells into tumors and elicited anti-tumor effects alone and in combination with a PD-1 immune checkpoint inhibitor.

On November 12, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH), reported exploratory subgroup analyses and preliminary translational data from the Phase II trial evaluating the combination of monalizumab and cetuximab (anti-EGFR) in previously treated patients with recurrent and/or metastatic squamous cell carcinoma of the head & neck (R/M SCCHN) (Press release, Innate Pharma, NOV 9, 2018, View Source [SID1234531226]). Monalizumab is a first-in-class checkpoint inhibitor targeting NKG2A inhibitory receptors expressed on tumor-infiltrating cytotoxic CD8 T lymphocytes and NK cells.

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"The subgroup analysis revealed very interesting durable responses in both IO-naïve and IO-pretreated patients," commented Pierre Dodion, Chief Medical Officer of Innate Pharma. "Patients who have failed on IO-therapy currently have no other treatment option. The fact that they appear to benefit with prolonged survival is rather remarkable and prompted us to advance our clinical program. Discussions are taking place in parallel with regards to the next steps in IO naïve patients".

"The high disease control rate that we observed in this study along with the favorable trends in progression-free and overall survival, including a preliminary estimate of median overall survival of 10.3 months, are very encouraging," commented Professor Roger B. Cohen, Principal Investigator of the study. "We also saw evidence of clinical activity in both IO-naive and IO-pretreated patients. If confirmed, these data would provide support for a highly novel immunotherapeutic combination with a unique mechanism of action for the treatment of patients with head & neck cancer."

Data from the cohort of 40 patients were reported at 2018 ESMO (Free ESMO Whitepaper) congress in October. Exploratory subgroup analysis revealed encouraging responses, durability of response, PFS and OS in IO-naïve and IO-pretreated patients.

Cut-off August 31, 2018

All patients

(n=40)

IO-naïve

(n=23)

IO-pretreated

(n=17)

ORR [95% CI]

27.5% [16-43]

35% [19-55]

18% [6-41]

Median PFS [95% CI]

5.0 m [3.7-6.9]

4.0 m[3.7-10.6]

5.0 m [3.5-NR]

Median OS [95% CI]

10.3 m [7.3-NR]

10.3 m [7.2-NR]

12.8 m [6.0-NR]

DCR 24 weeks

35% [22-51]

39% [22-59]

29% [13-53]

Median time to response [range]

1.6 m [1.5-3.9]

1.7 m [1.5-3.9]

1.6 m [1.6-3.1]

Median duration of response [95% CI]

5.6 m [3.8-NR]

5.3 m [3.8-NR]

5.6 m [3.7-NR]

Eric Vivier, Chief Scientific Officer of Innate Pharma, said: "We are combining the use of state-of-the-art technologies including high-dimensional flow cytometry, single cell RNA seq and computational pathology, to monitor the immune response in patients. Data support the mode of action of monalizumab as unleashing a multilayered immune response involving both NK and T cells. As such, monalizumab appears as a first-in-class second generation immune checkpoint inhibitor with a large spectrum of immune targets. He added: "While preliminary, translational results suggest that the combination of monalizumab and cetuximab is associated with a reshaping of "cold tumors" into "hot tumors" prone to sustain tumor immunity".

Preliminary biomarker analysis show indeed that while the combination did not impair the distribution or absolute counts of peripheral NKG2A+ NK and CD8+ T cells, an infiltration of NK cells and CD8+T cells is detected very early upon treatment (day 15) at the tumor bed. Further, tumor-infiltrating NK and CD8+ T cells may be predictive of RECIST response, tumor reduction and PFS.

Importantly, the activity of the monalizumab and cetuximab combination appears to occur across HPV status, tumor burden and PD-L1 expression.

On November 9, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) reported that it will present at the Stifel 2018 Healthcare Conference in New York, NY on Tuesday, November 13th at 9:30 a.m. ET (Press release, Seres Therapeutics, NOV 9, 2018, View Source [SID1234531102]).

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A live audio webcast of the presentation will be available under the "Investors and Media" section of Seres’ website. A replay will become available approximately one hour after the event and will be archived for 21 days.