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MEI Pharma to Present at Two Upcoming Investor Healthcare Conferences

On November 9, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported its participation in the following upcoming virtual investor conferences (Press release, MEI Pharma, NOV 9, 2020, View Source [SID1234570313]):

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Stifel 2020 Virtual Healthcare Conference on Monday, November 16, 2020 at 4:40 p.m. ET.
Evercore ISI HealthCONx Conference on Thursday, December 3, 2020 at 11:45 p.m. ET.
A live webcast of each presentation providing a company overview and business update can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

Replimune Announces Poster Presentations at the SITC 2020 Annual Meeting and a Presentation at the SITC 2020 Annual Meeting Virtual Press Conference

On November 9, 2020 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that the posters being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting being held virtually from November 9-14, 2020 are now available on the Company’s website (Press release, Replimune, NOV 9, 2020, View Source [SID1234570312]). In addition, the Company has been selected to participate in the SITC (Free SITC Whitepaper) 2020 Virtual Press Conference being held on Monday, November 9, 2020 at 7:45 AM ET where the principal investigator will discuss the Company’s poster titled "An Open-label, multicenter, Phase 1/2 clinical trial of RP1, an enhanced potency oncolytic HSV, combined with nivolumab: Updated results from the skin cancer cohorts".

Details of Replimune’s poster presentations:

Title: (647) Initial results of a phase 1 trial of RP2, a first in class, enhanced potency, anti-CTLA-4 antibody expressing, oncolytic HSV as single agent and combined with nivolumab in patients with solid tumors:

Abstract Authors: Mark Middleton1, Joseph J. Sacco2, Kevin Harrington4, Anna Olsson-Brown2, Pablo Nenclares4, Francesca Aroldi1, Suzanne Thomas3, Robert S. Coffin, etc.

Presentation times: Wednesday, Nov. 11 from 5:15–5:45 p.m. EST and Friday, Nov. 13 from 4:40–5:10 p.m. EST

Location: Virtual Poster Hall

The poster is also available on the Replimune website linked here.
Title: (650) An Open-label, multicenter, Phase 1/2 clinical trial of RP1, an enhanced potency oncolytic HSV, combined with nivolumab: Updated results from the skin cancer cohorts

Abstract Authors: Mark R. Middleton, Francesca Aroldi, Joseph J. Sacco, Mohammed M. Milhem, Brendan D. Curti, Ari M. Vanderwalde, Scott Baum, Adel Samson, Anna C. Pavlick, Jason Alan Chesney, Jiaxin Niu, Terence Duane Rhodes, Tawnya Lynn Bowles, Robert Conry, AnnaOlsson-Brown, Douglas Earl Laux, Praveen Bommareddy, Alex Deterding, Robert S. Coffin, Kevin Harrington

Presentation times: Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST

Location: Virtual Poster Hall

The poster is also available on the Replimune website linked here. Supporting slides with patient examples are linked here.

Data from Incyte’s Oncology Portfolio Accepted for Presentation at the Society for Immunotherapy of Cancer 2020 Annual Meeting

On November 9, 2020 Incyte (Nasdaq:INCY) reported that abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, held virtually from November 11-14, 2020 (Press release, Incyte, NOV 9, 2020, View Source [SID1234570311]).

"We are excited to join the oncology community at the SITC (Free SITC Whitepaper) 35th anniversary annual meeting and look forward to sharing data from our immuno-oncology portfolio," said Lance Leopold, Group Vice President, Immuno-Oncology, Incyte. "In particular, initial translational data from the ongoing clinical trial support further development of our orally administered PD-L1 inhibitor INCB86550 — a novel small-molecule discovered at Incyte."

E-Poster Presentations:

Pharmacodynamic Biomarkers Demonstrate T-Cell Activation in Patients Treated with the Oral PD-L1 Inhibitor INCB086550 in a Phase 1 Clinical Trial [Poster #419]

Retrospective Pooled Analysis of Epacadostat Clinical Studies Identifies Doses Required for Maximal Pharmacodynamic Effect in Anti-PD-1 Combination Studies [Poster #28]

MCLA-145 (CD137xPD-L1): A Potent CD137 Agonist and Immune Checkpoint Inhibitor That Does Not Show Signs of Peripheral Toxicity [Poster #814] 1

MCLA-145 is a Bispecific IgG1 Antibody that Inhibits PD-1/PD-L1 Signaling While Simultaneously Activating CD137 Signaling on T Cells [Poster #820]1

A Phase 1 Study of Retifanlimab (INCMGA00012), a PD-1 Inhibitor, in Patients with Advanced Solid Tumors: Preliminary Results in Recurrent MSI-High or dMMR Endometrial Cancer (POD1UM-101) [Poster #268]

A Phase 2 Umbrella Study of Retifanlimab (INCMGA00012) Alone or in Combination with Other Therapies in Patients with Advanced or Metastatic Endometrial Cancer (POD1UM-204, GOG 3038, ENGOT-en12/NOGGO) [Trial in Progress; Poster #348]2

All posters will be on display from Monday, November 9, 2020 until the virtual poster hall closes on December 31, 2020.

Abstracts are available on the SITC (Free SITC Whitepaper) 2020 website at View Source

Seagen Highlights Immuno-Oncology Data from Broad Portfolio During SITC Virtual Annual Meeting 2020

On November 9, 2020 Seagen Inc. (Nasdaq:SGEN) reported the presentation of immuno-oncology data from its broad pipeline of therapies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting 2020, taking place virtually November 9-14, 2020 (Press release, Seagen, NOV 9, 2020, View Source [SID1234570310]). Six abstracts will highlight the company’s continued progress in advancing innovative research for marketed and late-stage antibody-drug conjugates (ADCs) and innovative empowered antibody pipeline utilizing its proprietary sugar-engineering antibody (SEA) technology.

Data presented at SITC (Free SITC Whitepaper) will demonstrate how Seagen’s monomethyl auristatin E (MMAE)-based ADCs induce immunogenic cell death (ICD) by activating the innate immune cells and changing the tumor microenvironment to a more inflammatory state thereby enhancing the efficacy of other cancer immunotherapies. These findings will be presented for tisotumab vedotin, ladiratuzumab vedotin and across vedotin-based ADCs (Abstracts #617, #618 and #323).

"Our vedotin-based ADC research at SITC (Free SITC Whitepaper) illustrates the impact of immunogenic cell death on the tumor microenvironment," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Importantly, these data support the mechanistic rationale for combining vedotin-based ADCs with immuno-oncology therapies in the clinic."

Data will also be presented utilizing Seagen’s proprietary SEA technology, which produces nonfucosylated antibodies that uniquely enhance activity targeting key immune modulating receptors. Preclinical data will be presented from SEA-TGT (Abstract #250), a novel investigational nonfucosylated human IgG1 TIGIT antibody. SEA-TGT is in an ongoing phase 1 clinical trial for patients with solid tumors and lymphoma (NCT04254107). In addition, preclinical data will be presented for SEA-CD40 (Abstract #438), a novel investigational, nonfucosylated human IgG1 antibody targeted to CD40, an immune stimulatory receptor found on antigen-presenting cells. SEA-CD40 is in a phase 1 trial for pancreatic cancer in combination with chemotherapy and a PD-1 inhibitor (NCT02376699).

"We believe our immuno-oncology candidates have a best-in-class potential, creating a strong foundation for our immunotherapy pipeline," said Scott Peterson, Ph.D., Senior Vice President of Research at Seagen. "Data presented at SITC (Free SITC Whitepaper) demonstrate that our sugar-engineered antibodies are differentiated and have the potential to improve efficacy and address unmet needs in cancer."

Data regarding ADCETRIS (brentuximab vedotin) will be presented demonstrating its ability to selectively target and kill CD30-positive T regulatory cells (Tregs) that contribute to resistance to cancer immunotherapies (Abstract #696). These data support that ADCETRIS may have an immunomodulatory effect through selective depletion of highly active Tregs.

The abstracts published in advance of the SITC (Free SITC Whitepaper) Annual Meeting can be found here. All data presentations will be available on-demand starting on November 11, 2020.

Details of Seagen Presentations at SITC (Free SITC Whitepaper) Annual Meeting 2020:

Abstract Title

Abstract No.

Presentation

Type / Date

Presenter

Brentuximab vedotin, a CD30 targeting antibody-drug conjugate, selectively depletes activated Tregs in vitro and in vivo

#696

E-Poster /

November 11-14

B. Grogan

Tisotumab vedotin shows immunomodulatory activity through induction of immunogenic cell death

#617

E-Poster /

November 11-14

E. Gray

Systemic administration of ladiratuzumab vedotin alone or in combination with pembrolizumab results in significant immune activation in the tumor microenvironment in metastatic breast cancer patients

#323

E-Poster /

November 11-14

L. Pusztai

Synergy between SEA-CD40 and chemotherapeutics drives curative anti-tumor activity in pre-clinical models

#438

E-Poster /

November 11-14

W. Zeng

SEA-TGT is a nonfucosylated antibody with distinct and amplified effector function activity that leverages the dependencies of anti-TIGIT anti-tumor activity upon FcγR engagement

#250

E-Poster /

November 11-14

A. Smith

Vedotin ADCs induce ER stress and elicit hallmarks of ICD across multiple cancer indications

#618

E-Poster /

November 11-14

K. Klussman

RTX-240, an Allogeneic Engineered Red Blood Cell Expressing 4-1BBL and IL-15TP, Promotes NK Cell Functionality In Vitro and In Vivo

On November 9, 2020 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported the presentation of new preclinical data supporting its lead clinical oncology program, RTX-240, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Rubius Therapeutics, NOV 9, 2020, View Source [SID1234570309]). The meeting is being held virtually from November 9-14, 2020.

RTX-240 is an allogeneic, off-the-shelf Red Cell Therapeutic that is engineered to mimic the human immune system by stimulating adaptive and innate immunity to generate an anti-tumor immune response. Rubius Therapeutics is currently enrolling patients in the Phase 1/2 clinical trial of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors. In addition, RTX-240 is being evaluated in a second Phase 1 arm of the clinical trial for the treatment of patients with relapsed/refractory acute myeloid leukemia.

"The preclinical data presented at SITC (Free SITC Whitepaper) indicate that RTX-240 has the ability to potently activate and expand CD8 T cells and natural killer (NK) cells in vitro and in vivo," said Laurence Turka, M.D., chief scientific officer of Rubius Therapeutics. "In addition, the preclinical data demonstrated that RTX-240 promotes NK cell killing of a myeloid leukemia cell line, giving us confidence that these promising preclinical results may translate into clinical benefit for patients with relapsed/refractory acute myeloid leukemia, where the activation status of the NK cells is linked to clinical outcomes. Finally, our surrogate model of RTX-240 demonstrated significant expansion of CD8 T cells and NK cells in a colorectal cancer model and potent anti-tumor activity in a melanoma model – giving us added conviction that RTX-240 may be an effective treatment for relapsed/refractory or locally advanced solid tumors."

Data Summary

RTX-240, an Allogeneic Engineered Red Blood Cell Expressing 4-1BBL and IL-15TP, Promotes NK Cell Functionality In Vitro and In Vivo

RTX-240 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BBL and IL-15TP (trans-presentation of IL-15 on IL-15Rα) on the cell surface in their native forms. RTX-240 is designed to stimulate innate and adaptive immunity by activating NK cells and T cells inside the patient’s body to generate an anti-tumor immune response. RTX-240 preclinical data demonstrated:
° RTX-240 led to increased CD8 T cell and NK cell expansion and activation in vitro compared to the combination of a 4-1BB agonist antibody plus recombinant IL-15 which was directly correlated with the percentage of 4-1BBL and IL-15TP expressed on the cell surface
° RTX-240 expanded CD56dim NK cells, a cell population with high cytotoxicity
° RTX-240 promoted NK cell-killing of a myeloid leukemia cell line, K562, and this was accompanied by increased NK cell degranulation and activation
° A murine surrogate for RTX-240, mRBC-240, promoted significant expansion of CD8 T cells and NK cells in vivo in a murine model of colorectal cancer (CT26)
° mRBC-240 demonstrated potent antitumor activity in a B16F10 melanoma model that was directly correlated with the expansion of terminally differentiated NK cells in the tumors
About the RTX-240 Clinical Trial
Rubius Therapeutics is enrolling patients in a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study of RTX-240. The study contains two Phase 1 dose escalation arms: one in patients with relapsed/refractory or locally advanced solid tumors and another in patients with relapsed/refractory acute myeloid leukemia. These two Phase 1 arms will determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended Phase 2 dose and dosing regimen of RTX-240 in patients with solid tumors as well as in patients with relapsed/refractory AML. The trial will also assess the pharmacodynamics of RTX-240 measured by changes in T and NK cell number and function relative to baseline and anti-tumor activity in both patient populations. The study will include an expansion phase in specified tumor types during the Phase 2 portion of the solid tumor arm. The extent to which the COVID-19 pandemic may impact Rubius’ ability to enroll patients in the trial will depend on future developments.

About RTX-240
RTX-240 is an allogeneic cellular therapy product candidate that is being evaluated for the treatment of patients with relapsed/refractory or locally advanced solid tumors or relapsed/refractory acute myeloid leukemia. RTX-240 is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BBL and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms and is designed to stimulate innate and adaptive immunity by activating NK cells and T cells inside the patient’s body to generate an anti-tumor immune response.