3SBio Selects Verseau’s PSGL-1-targeted Antibody VTX-0811 as First Partnered Macrophage Checkpoint Modulator in Immuno-Oncology Collaboration

On November 17, 2019 3SBio Inc. ("3SBio") (HKEX:1530) and Verseau Therapeutics, Inc. ("Verseau") reported the selection of VTX-0811, a monoclonal antibody targeting PSGL-1, as the first licensed program under their partnership agreement focused on the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers (Press release, 3SBio, NOV 17, 2019, View Source [SID1234551402]).

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By targeting PSGL-1, an adhesion molecule that is highly expressed on tumor-associated macrophages across most tumor types, VTX-0811 reprograms macrophages to a pro-inflammatory state, activates T cells and attracts other immune cells to generate a coordinated and powerful antitumor response. Verseau’s PSGL-1 antibodies demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive tumors and non-responsive tumors. PSGL-1 is the first unblinded target from Verseau’s pipeline of macrophage checkpoint modulators (MCMs). Verseau’s MCMs reprogram macrophages to be more inflammatory or more tolerogenic depending on the disease context.

"We are pleased to have achieved our first licensing milestone in our collaboration with 3SBio. Their decision to select VTX-0811 as the first program for development validates that PSGL-1 is an important and novel immuno-oncology target with the potential to expand the number of patients benefitting from immunotherapy," said Dr. Christine Bunt, Chief Executive Officer of Verseau. "Our innovative partnership is enabling Verseau to advance our industry-leading pipeline of macrophage checkpoint modulators with first-in-class potential across a broad range of cancer therapies."

"Early data in patient-derived primary tumors suggests that PSGL-1 antibodies could generate a greater anti-tumor inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumors," said Dr. Jing Lou, Chairman and Chief Executive Officer of 3SBio. "By partnering with Verseau,we are now at the forefront of one of the most promising areas of innovation within immuno-oncology and are making timely progress toward our goal of bringing novel cancer therapies to patients in China. We are eager to begin development on the first program selected under our partnership and look forward to future programs around novel macrophage targets identified by Verseau’s all human translational platform."

Under the terms of the agreement, 3SBio received an exclusive license to develop and commercialize a selected number of MCM antibodies for all human oncology indications in Greater China, including mainland China, Taiwan, Hong Kong and Macau ("Territory"). Verseau retains global rights to all MCM programs outside of Greater China. Verseau is responsible for discovery and optimization of MCM antibodies for each program. 3SBio will fund and conduct antibody development, GMP manufacturing and commercialization in the Territory. Verseau and 3SBio will be eligible to receive certain milestone payments and royalties on product sales both in the Territory and globally. The selection of the first program for co-development under the partnership triggers an undisclosed milestone payment to Verseau. Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., a subsidiary of 3SBio, will be responsible for the development and commercialization of VTX-0811 in the Territory.

About PSGL-1

PSGL-1 (P-selectin glycoprotein ligand-1) is an adhesion molecule that is involved in immune cell trafficking in response to tissue injury or inflammation. Verseau discovered that modulation of PSGL-1 can lead to macrophage reprogramming. Proprietary PSGL-1 monoclonal antibodies induce tumor microenvironment activation, T-cell activation and naïve immune cell recruitment amounting to a coordinated immune attack on tumors. In patient-derived primary tumors, PSGL-1 antibodies demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumors. Given the prominent role of PSGL-1 in many tumor types, Verseau has selected PSGL-1 as the lead macrophage checkpoint modulator (MCM) program for clinical development.

About Macrophage Checkpoint Modulators

Verseau is broadening the therapeutic potential of immunotherapy by developing macrophage checkpoint modulators (MCMs) that regulate the functional shift to make macrophages more inflammatory or more tolerogenic depending on the disease context. While many patients benefit from PD-1 inhibitor therapies, they are only effective in the ~25% of cancers that involve T cell infiltration. By targeting modulation of macrophages, which are present in ~75% of human cancers, Verseau aims to significantly expand the therapeutic benefit of immunotherapy. MCMs cause tumors to turn highly inflammatory and stimulate multiple immune cell types, including T cells. Verseau’s therapies have the potential to significantly expand the number of patients benefitting from immunotherapy, including those unresponsive to PD-1 inhibitor therapies. Through its proprietary all-human translational system Verseau has validated more than two dozen targets amenable to different therapeutic modalities, including monoclonal antibodies.

Personalis, Inc. to Present New Data at the AACR Tumor Immunology and Immunotherapy Conference

On November 17, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will participate in the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy conference at the Boston Marriott Copley Place in Boston, MA, November 17-20, including poster presentations on November 18th and 19th (Press release, Personalis, NOV 17, 2019, View Source [SID1234551401]).

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The company will showcase ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Following is a list of abstracts that will be presented at the meeting.

Scientific Poster Presentations

Poster Number


Title & Presenter


Day & Time


Location

A19

HLA allele-specific loss of heterozygosity detection
using augmented exome capture approach

Presenter: Rachel Marty Pyke, Ph.D.

November 18:
12:30 PM – 3:00 PM

Back Bay

B18

Exome scale liquid biopsy monitoring of putative
neoantigens and genomic biomarkers in patients
on anti-PD-1 therapy in squamous cell carcinoma of
the head and neck

Presenter: Charles Abbott, Ph.D.

November 19:
4:30 PM – 7:00 PM

Back Bay

Personalis will also be exhibiting during the conference (Exhibit # 10). Representatives will be available to answer questions about the company’s cancer immunogenomics services.

LIDDS Liproca® Depot Phase IIb study results presented at EMUC19 showing both primary and secondary endpoints being met

On November 16, 2019 LIDDS AB (publ) reported that Phase IIb clinical data from the LPC-004 prostate cancer study on LIDDS Liproca Depot were presented in an oral session at the 11th European Multidisciplinary Congress on Urological Cancers, EMUC19 (Press release, Lidds, NOV 16, 2019, View Source [SID1234555900]). The study met both its primary and secondary endpoints as well as demonstrated that a larger proportion of intermediate risk patients, which is the Liproca Depot target group, are PSA responders. The presentation can be accessed through LIDDS webpage and are also attached to this release.

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The phase IIb results from the LPC-004 prostate cancer study was presented as "Late Breaking News" at EMUC in Vienna on November 16, 2019 by Professor Laurence Klotz, a world leading expert in Active Surveillance of prostate cancer patients. Professor Klotz was one of the LPC-004 study investigators and is Professor at the University of Toronto Division of Urology at the Sunnybrook Health Sciences Centre in Canada.

The preliminary data recently released from the phase IIb study, LPC-004, confirms that 90 % of patients receiving 16 ml intraprostatic injection of Liproca Depot experienced a PSA reduction and also that 16 ml is the optimal dosage for future Phase III studies. Further, the study showed no systemic hormonal adverse reactions, that Liproca Depot is safe and well tolerated by the patients, and that 84 % of patients being treated were amenable to a second injection of Liproca Depot.

As LIDDS advances Liproca Depot towards late-stage clinical development, LIDDS intends to target intermediate risk patients in its phase III trial. The LPC-004 study showed that a larger proportion of intermediate risk patients are PSA responders and that this group display a stronger mean PSA decrease compared to low risk patients.

– The results confirm that Liproca Depot can offer a completely novel approach to complement active surveillance in intermediate risk prostate cancer patients. Liproca Depot is well tolerated without the hormonal side effects associated with anti-androgen therapy, and is equally easy to administer as performing a prostate biopsy. Liproca Depot treatment could contribute to the benefit of prostate cancer patients in the future, says Professor Laurence Klotz, a world leading expert and one of the study investigators and Professor at the University of Toronto Division of Urology.

– The results regarding the intermediate risk patients further validate the continued clinical development of Liproca Depot. As announced recently, our licensing partner, Jiangxi Phuong, has decided to progress with the phase III trial in China and we will continue the commercial activities in order to sign further licensing agreements in other major markets, says Monica Wallter, CEO, LIDDS.

About the Phase IIb Liproca Depot clinical trial
The single blind, two-part dose finding study aimed to determine the highest tolerable dose of Liproca Depot in part I and to determine the level of PSA reduction for part II patients at month 5. The study was conducted at eight specialist urology clinics in Canada; Lithuania and Finland. The study involved 61 patients diagnosed with localized non-aggressive prostate cancer who were on Active Surveillance. Patients were followed for six months to assess response and tolerability. Three previous clinical trials (LPC-001, LPC-002 and LPC-003) involved a total of 57 patients and showed promising results for tolerability and effect on tumor tissue, prostate volume and the PSA biomarker.

About prostate cancer and the market
Of the 1.2 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard drug treatment for these cancer patients and many treating doctors see an unmet need.

According to market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca Depot’s target group is an untapped market potentially exceeding USD 3 billion per year.

About Liproca Depot and NanoZolid
NanoZolid is a safe, flexible and functional method of delivering drugs. When injected, NanoZolid forms a solid depot releasing the active drug over periods of potentially more than six months. As it releases its drug load, the NanoZolid depot dissolves and is absorbed harmlessly into the body.
Liproca Depot combines NanoZolid and 2-HOF (2-hydroxyflutamide), a well-established antiprostate cancer drug. Liproca Depot’s target group is patients under Active Surveillance (AS) with intermediate risk of cancer progression.

Carisma Therapeutics Announces Investor Conference Participation

On November 16, 2019 Carisma Therapeutics Inc., a preclinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies based on engineered macrophages, reported that it will be participating in three upcoming investor conferences (Press release, Carisma Therapeutics, NOV 16, 2019, View Source [SID1234551403]).

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Stifel 2019 Healthcare Conference, November 19-20, 2019 – Carisma’s management will deliver a presentation on Wednesday, November 20, at 4:45 pm EDT and host one-on-one meetings at the venue. The conference will be held at the Lotte New York Palace Hotel, New York, NY.
Jefferies 2019 London Healthcare Conference, November 20-21, 2019 – Carisma will host one-on-one meetings on November 20 and 21 at the conference venue, at the Waldorf Hilton, London, UK.
Piper Jaffray 31st Annual Healthcare Conference, December 3-5, 2019 – Carisma’s management team will present on Tuesday, December 3, at 4:50 pm EDT. The company will host one-on-one meetings at the conference venue, at the Lotte New York Palace Hotel in New York, NY.
Carisma Therapeutics is pioneering the development of engineered macrophages to transform the treatment of cancer and other serious illnesses through the engagement of both the innate and adaptive immune responses. Carisma’s proprietary chimeric antigen receptor (CAR)-macrophage cell therapy platform is designed to address key challenges involved in the treatment of solid tumors by actively trafficking to the tumor, selectively killing tumor cells through phagocytosis, "warming up" the tumor microenvironment, and triggering a durable response from other immune cells.

Carisma’s first product in development is an autologous HER2-targeted CAR-macrophage expected to enter clinical studies in 2020. Additional CAR-macrophages targeting other solid tumor antigens are in early development.

Skyhawk’s $80M Celgene deal expands remit to autoimmune

On November 15, 2019 Skyhawk reported its fifth deal of the year, the company is moving into a new therapeutic area and adding $80 million to its cash reserve (Press release, Skyhawk Therapeutics, NOV 15, 2019, View Source [SID1234626570]). Skyhawk partnered with Celgene to discover and develop small molecules for autoimmune disease and cancer against hard-to-drug targets that have been clinically validated, or genetically associated with a disease.

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Skyhawk Therapeutics Inc. uses its SkySTAR platform to discover and develop small molecules capable of modulating RNA splicing within the spliceosome, dictating which exons are included in the final mRNA transcript and offering drug developers a mechanism to control protein expression at the level of mRNA. The therapeutic approach can be applied broadly to indications where attempts at drugging a target at the protein level have been unsuccessful (see "Splice Time")