On August 2, 2021 Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, reported that it has received a $200 million strategic investment from Roivant Sciences (Press release, Roivant Sciences, AUG 2, 2021, https://investors.immunovant.com/news-releases/news-release-details/immunovant-receives-200-million-strategic-investment-roivant [SID1234585515]). Immunovant intends to use the proceeds from this investment to advance the development of IMVT-1401 in multiple indications.

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Roivant has purchased 17,021,276 shares of Immunovant’s common stock at a price of $11.75 per share, which purchase has been approved by a special committee of Immunovant directors not affiliated with Roivant. This represents approximately a 15% premium to Immunovant’s 20 trading day volume weighted average price. After giving effect to the investment, Immunovant has a pro forma cash balance of approximately $600 million and Roivant has increased its ownership stake in Immunovant from 57.5% to 63.8%, based on Immunovant’s cash balance and share count as of March 31, 2021.

"We are excited to announce this significant investment by Roivant, which will expedite our development of IMVT-1401 for a wide range of autoimmune disorders," said Dr. Pete Salzmann, Chief Executive Officer of Immunovant. "Over the next 12 months, we plan to initiate a pivotal trial for myasthenia gravis, resume our trials in WAIHA and TED and initiate at least two additional clinical studies, including another pivotal trial in 2022."

"Roivant and Immunovant explored a range of possible transactions over the past few months, including a potential acquisition by Roivant of the minority interest in Immunovant, and ultimately agreed on this significant investment in order to support a robust development plan for IMVT-1401 and increase our stake in the company," said Matt Gline, Chief Executive Officer of Roivant Sciences. "We are incredibly excited about the prospects for IMVT-1401, and we are eager to support Immunovant through this investment. We look forward to continuing to work closely with Dr. Salzmann and the Immunovant management team to help develop IMVT-1401 to maximize benefit for patients with high levels of unmet medical need."

On August 2, 2021 Oncternal Therapeutics (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that management will participate in the BTIG Virtual Biotechnology Conference being held August 9-10, 2021 (Press release, Oncternal Therapeutics, AUG 2, 2021, View Source [SID1234585536]).

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BTIG Virtual Biotechnology Conference – August 9-10, 2021

James Breitmeyer, President and Chief Executive Officer will present a corporate overview on Monday, August 9th at 12:00pm (ET), and the company will be available for one-on-one meetings.

On August 2, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced translational genomics and diagnostics for cancer, reported the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"(1) in Clinical Cancer Research, a journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Personalis, AUG 2, 2021, View Source [SID1234585551]).

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The study details the development of the Personalis Neoantigen Presentation Score (NEOPS), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients. In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational burden. Performance of this composite biomarker was initially tested on a cohort of late-stage melanoma patients receiving immune checkpoint blockade therapies and later validated on an independent dataset of similarly treated late-stage melanoma patients.

"Given the varied response to immunotherapy as well as the potential toxicities associated with treatment, there is a need for improved biomarker approaches to better predict which patients will respond to therapy," said Richard Chen, MD, Personalis CMO. "Our findings suggest that integrative, multi-omic biomarkers like NEOPS can be stronger predictors of response than simpler, single-analyte approaches, especially in the setting of new cancer therapies where the underlying biological mechanisms governing response are highly complex. We feel that NEOPS and other composite biomarkers will be important, sharper tools for enabling precision oncology."

NEOPS utilizes technology that Personalis has been developing since 2015 to better predict neoantigens and identify associated escape mechanisms such as HLA LOH. Our ImmunoID NeXT, and clinical NeXT Dx tests make this advanced capability, including NEOPS, available to pharmaceutical researchers and clinicians for clinical trials and investigational use, and additional clinical studies with other tumor types are planned.

On August 2, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate in the following upcoming investor events and conferences (Press release, Xencor, AUG 2, 2021, View Source [SID1234585569]):

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Bernstein CD28 Day
Presentation: Monday, August 9, 1:00 p.m. ET (10:00 a.m. PT)
2021 Wedbush PacGrow Healthcare Virtual Conference
Panel: Tuesday, August 10, 1:10 p.m. ET (10:10 a.m. PT)
BTIG Virtual Biotechnology Conference 2021
Presentation: Tuesday, August 10, 3:30 p.m. ET (12:30 p.m. PT)
Canaccord Genuity 41st Annual Growth Conference
Presentation: Wednesday, August 11, 4:30 p.m. ET (1:30 p.m. PT)
Piper Sandler Virtual West Coast Bus Tour
Presentation: Thursday, August 12, 4:00 p.m. ET (1:00 p.m. PT)
A webcast of the presentation at the Canaccord conference will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Following the webcast, a replay will be archived on the website approximately for at least 30 days.

On August 2, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that the FDA has authorized Sorrento’s IND application for the Phase 1 clinical testing of its allogeneic anti-CD38 Dimeric Antigen Receptor (DAR) – T Cell therapy for relapsed or refractory multiple myeloma (Press release, Sorrento Therapeutics, AUG 2, 2021, View Source [SID1234585537]). The proprietary CD38 DAR-T cell therapy candidate demonstrated strong cytotoxic activity in preclinical studies. DAR-T product candidates are produced using Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology, which potentially allows for improved specificity, stability and potency, and enables an off-the-shelf treatment approach, thereby eliminating the need for patients to undergo leukapheresis and undesirable treatment delays to perform cell harvesting, manufacturing and release prior to treatment for each individual cancer patient.

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Sorrento’s KOKI-enabled DAR-T platform uses DAR-modified T cells from a normal healthy donor which are engineered to be specific to the cell surface marker of interest, in this case CD38, a clinically validated antigen in myeloma, to target tumor cells. The combination of KOKI and DAR-T technologies offers potential advantages over conventional CAR-T therapies, including removing the ability for DAR-expressing T cells to illicit undesired immune reaction to the cancer patient, thereby reducing or eliminating the possibility of graft versus host disease (GvHD) following treatment. Additionally, once DAR-T cells are manufactured, they can be stored at the clinic site, allowing patients to be screened and treated within days. This is compared to existing approved CAR-T therapies, which typically require 6-8 weeks of screening, cell production and qualification before a patient can receive treatment. Because of this timeframe, it is not unusual for cancer patients to no longer be eligible for CAR-T treatment due to disease progression. Also, autologous CAR-T cells pose several manufacturing challenges, including issues that relate to quality control and single-lot-release, and often do not meet the release criteria following the manufacturing process. DAR-T technology is designed to potentially provide a significant advancement to the timeliness and potency of treatments for patient populations who have already undergone multiple rounds of chemotherapy and are suffering from persistent disease.

DAR-T technology is readily adaptable to dozens of cancer targets and Sorrento has developed a preclinical product pipeline with specific fully human antibodies discovered from Sorrento’s G-MAB library. Sorrento expects to file additional IND applications now that the first DAR-T Phase 1 trial has been cleared to proceed by the FDA.

"This FDA clearance of our first allogeneic DAR-T cell therapy is a seminal event for our cutting-edge KOKI and DAR-T technologies," said Henry Ji, Ph.D., Chairman and CEO of Sorrento. "We foresee the first "Off-the-Shelf" DAR-T trial will open the door to numerous other DAR-T cell therapies for other indications to follow."

About the DAR-T Platform

Sorrento’s DAR-T technology is a proprietary, next-generation cell therapy platform that offers potential advantages over conventional Chimeric Antigen Receptor (CAR) T cell therapy:

The proprietary DAR construct utilizes a natural antibody Fab (antigen-binding fragment) structure instead of an artificial scFv (single-chain variable fragment) sequence.
Preclinical in vitro and in vivo studies have demonstrated that DAR-T cells provide better target specificity and functionality, due to higher inherent stability of the Fab and stronger affinity of DAR vs. CAR receptors on the T cell surface.
DAR-T cells may reduce potential undesirable side effects, such as CAR-T induced cytokine release syndrome (CRS) and graft-versus-host disease (GvHD).
About KOKI Technology

Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology provides DAR-T cells with several potential benefits over virus-based transduction currently used for CAR-T therapies:

"Off-the-Shelf": DAR-T cells are cryo-preserved engineered T cells designed to be delivered to patients on-demand without delays in treatment due to the lengthy and individualized manufacturing process for CAR-T.
"Allogeneic": DAR-T cells are produced from pre-screened healthy volunteers; while autologous CAR-T cells are patient-specific and made from and for individual cancer patients.
"Mass Production": DAR-T cell manufacturing is scalable (potentially hundreds to thousands of doses per manufacturing run) and can meet high demand while autologous CAR-T cell therapy requires a single-lot-release process that can only be performed one patient at a time.