On November 18, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that results from a number of studies from across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS), from 10-14 December 2019 (Press release, Hoffmann-La Roche, NOV 18, 2019, View Source [SID1234551405]). These data include new results in HER2-positive breast cancer and studies of new molecules in hormone receptor-positive (HR-positive) breast cancer.

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"For the past three decades we have remained dedicated to improving outcomes for people with breast cancer," said Levi Garraway, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "This sustained commitment is exemplified by new data for our approved and investigational medicines across the spectrum of breast cancer being presented at SABCS this year."

Key presentations
New data will be presented from a second interim overall survival (OS) analysis of the phase III APHINITY trial evaluating Perjeta (pertuzumab) and Herceptin (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC). This latest interim OS analysis also includes updated descriptive invasive disease-free survival (iDFS) and cardiac safety data.

Roche will also present data from the primary analysis of the phase III FeDeriCa study which evaluated a new investigational fixed-dose combination (FDC) of Perjeta and Herceptin administered as a single subcutaneous (SC) formulation in combination with intravenous (IV) chemotherapy. The FDC is administered under the skin in just minutes, significantly reducing the time spent receiving treatment and providing people with HER2-positive breast cancer a potential new treatment option for faster delivery of the Perjeta-based regimen.

Data will also be presented from studies in HR-positive breast cancer, including findings from early studies investigating Roche’s pipeline molecules GDC-9545, a selective oestrogen receptor degrader, and GDC-0077, a selective PI3Kα inhibitor.

Overview of Roche studies to be presented at SABCS 2019

About the APHINITY study1,2
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy, compared to Herceptin and chemotherapy, as adjuvant therapy in 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is iDFS, which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, OS, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.

About the FeDeriCa study3
FeDeriCa is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the pharmacokinetics, efficacy and safety of SC injection of the FDC of Perjeta and Herceptin in combination with chemotherapy, compared with standard IV infusions of Perjeta and Herceptin in combination with chemotherapy, in people with HER2-positive eBC who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough). Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pCR, meaning there is no tumour tissue detectable at the time of surgery.

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer which have changed the natural history of the disease. As our understanding of breast cancer biology has rapidly evolved, we have expanded our focus to identify new biomarkers and approaches to treatment for other types of breast cancer, such as triple-negative and HR-positive disease, where there remains a significant unmet need.

Our HER2-targeted medicines Herceptin, Perjeta and Kadcyla continue to transform the treatment of early and advanced HER2-positive breast cancer and now, through our large clinical trial programmes with Tecentriq and ipatasertib and recent approvals for Tecentriq, we are bringing new treatment options to people with TNBC.

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.

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.

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.

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.