On October 16, 2018 Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, reported it welcomed the approval of Verastem Oncology’s COPIKTRA (duvelisib) capsules by the U.S. Food and Drug Administration (FDA) (Press release, Catalent, OCT 16, 2018, https://www.catalent.com/index.php/news-events/news/Catalent-and-Verastem-Oncology-Partner-on-Newly-Launched-FDA-Approved-COPIKTRA-duvelisib-Capsules [SID1234530088]). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.

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COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Catalent has had a multi-year collaboration with Verastem Oncology, initially providing development and analytical support, and later clinical development and manufacturing services from its facility at Kansas City, Missouri.

"We are proud to partner with Verastem as part of the team delivering COPIKTRA capsules to patients. Catalent’s Kansas City facility is focused on oral and biologic programs, primarily with smaller pharmaceutical firms, to deliver products to patients with poorly met or unmet disease states," commented Matt Mollan, Catalent’s General Manager at Kansas City. "Like Verastem, Catalent is committed to advancing therapies with the potential to make a significant impact for patients, their caregivers and physicians. We look forward to building on this strong relationship through supplying clinical trial materials as well as commercial manufacturing and testing."

Robert Forrester, President and Chief Executive Officer of Verastem Oncology, added, "We selected Catalent as our development partner because of their experience and record of bringing similar therapies through clinical trials and on to successful commercialization. We are pleased to partner with Catalent in order to deliver this important new medicine to patients."

Catalent’s 450,000 square-feet Kansas City, Missouri facility provides a range of fully integrated support services, from formulation development and analytical testing, to clinical- and commercial-scale manufacturing and packaging of various oral dose forms.

Use of COPIKTRA is associated with a BOXED WARNING for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is also associated with adverse reactions which may require dose reduction, treatment delay or discontinuation of COPIKTRA. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity. The most common ADVERSE REACTIONS (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

On October 16, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that it initiated patient dosing in the dose exploration cohort of its ongoing Phase 1 clinical trial of FPA150 (FPA150-001; NCT03514121), a targeted, first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, OCT 16, 2018, View Source [SID1234529927]).

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"We’re excited to be ahead of schedule in opening up our dose exploration basket cohort for FPA150, our first-in-class B7-H4 antibody, in patients whose tumors overexpress B7-H4," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "B7-H4 is generating excitement in investigators because it’s expressed in tumor types that are currently not well served by immunotherapy, including breast and gynecologic cancers. We’re hopeful that a targeted therapy like FPA150 will provide clinical benefit in these patients who have limited treatment options."

B7-H4 is in the same family of checkpoint molecules as PD-L1 and, like PD-L1, appears to inhibit T-cells in preclinical models. FPA150 has a dual mechanism of action: it blocks a T cell checkpoint pathway and delivers antibody-dependent cell-mediated cytotoxicity (ADCC) against B7-H4-expressing tumor cells.

FPA150-001 is an ongoing Phase 1a/1b dose escalation and expansion clinical trial of FPA150 monotherapy in patients with advanced solid tumors. The exploratory basket cohort is a part of that trial and will include up to 10 patients whose tumors overexpress B7-H4, as assessed by an immunohistochemistry (IHC) assay. The objective of this cohort is to evaluate a range of FPA150 doses to gain additional data on safety, pharmacokinetics (PK) and potential preliminary clinical activity. All patients will undergo pre- and on-treatment biopsies to assess the pharmacodynamic effects of FPA150 on the tumor and the tumor microenvironment.

The Phase 1a dose-escalation portion of FPA150-001 in unselected patients with any solid tumor is currently ongoing. The primary objective of this portion of the trial is to identify a maximum tolerated dose (MTD) or recommended dose (RD) for FPA150 monotherapy.

Once the MTD/RTD has been identified, the company will initiate a Phase 1b dose-expansion portion of the trial in B7-H4 positive tumors, including in breast cancer, ovarian cancer and endometrial cancer. The Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering ADCC against tumor cells expressing B7-H4.

The European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2018) congress takes place in Munich, Germany between 19 Oct – 23 Oct 2018.

This conference features more than 2000 abstracts and a global presence of companies ranging from big pharma to startups like Arcus Biosciences (USA), CStone Pharmaceuticals (China), Neon Therapeutics (USA), NEOMED Therapeutics 1 (Canada) and Oblique Therapeutics (Sweden).

Read more below on the latest and hottest from companies like Arcus, AstraZeneca, Merck & Co or any of the other 40+ selection of companies generating heat about their presence at ESMO (Free ESMO Whitepaper) 2018.

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On October 15, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the phase III KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin (trastuzumab) as an adjuvant (after surgery) treatment in people with HER2-positive early breast cancer (eBC) who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant (before surgery) treatment (Press release, Hoffmann-La Roche, OCT 15, 2018, View Source [SID1234529895]). The safety profile of Kadcyla in the KATHERINE study was consistent with previous clinical trials and no new safety signals were identified. [1,2]

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"We are highly encouraged by these positive results with adjuvant Kadcyla treatment in people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible."

Full results will be submitted to health authorities around the world, and will be presented at the 2018 San Antonio Breast Cancer Symposium on Wednesday 5 December at 11.00 am CST.

The KATHERINE trial investigated a population of people with HER2-positive eBC who did not achieve a pathological complete response to neoadjuvant treatment. This state of residual disease is associated with a worse prognosis.[3,4]

The goal in treating early breast cancer is to provide people with the best chance for a cure. [5] While we come closer to this goal with each advance, many people still have a disease recurrence in the long-term. [6] Neoadjuvant treatment is given before surgery with the goal of shrinking tumours and helping to improve surgical outcomes. [7,8,9] Adjuvant treatment is given after surgery as part of a complete eBC treatment regimen and is aimed at eliminating any remaining cancer cells in the body, to help reduce the risk of the cancer returning. [7]

About the KATHERINE study[10]
KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which, in this study, is defined as the time from randomisation to invasive breast cancer recurrence or death from any cause. Secondary endpoints include disease-free survival and overall survival.

About Kadcyla
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. [1,2] It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. [11] Kadcyla is the only ADC approved as a single agent in 104 countries including the US and EU for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients. [12] Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.

On October 15, 2018 HiFiBiO Therapeutics, a world leader in the discovery of therapeutic antibodies through single-cell screening and analysis, reported the acquisition of H-Immune Therapeutics, an early-stage biotechnology company engaged in the discovery and development of novel immuno-oncology therapeutics (Press release, HiFiBiO Therapeutics, OCT 15, 2018, View Source [SID1234555288]). The acquisition strengthens HiFiBiO Therapeutics’ strategic focus on identifying first-in-class targets for multiple immune cell types, as well as applying industry-leading technologies to develop diverse antibody therapeutics. Specific financial terms of the transaction were not disclosed.

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Established in late 2016 as a spin-out of the French Atomic Energy Commission, H-Immune was founded by Luc Boblet, PhD, Former Co-founder and CEO of Institute Pasteur spin-out PathoQuest, and Michel Léonetti, PhD, Senior Immunologist. H-Immune has pioneered a unique in vitro immunization-based fully human antibody generation platform (IVI), which complements HiFiBiO’s world-leading single-cell platform, and has developed an early-stage novel pipeline through translational collaborations with leading cancer centers in Europe. Following the acquisition, Dr. Boblet has joined the HiFiBiO Therapeutics’ leadership team as Executive Vice President, Business Development.

"Over the past several months, we have made significant strides in our evolution as a biotherapeutics pioneer with this acquisition of H-Immune Therapeutics, collaborations with major pharmaceutical companies including Takeda and Kite, and fast progression of our own internal projects through our open innovation model," said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. "This acquisition not only adds a pipeline of promising novel therapeutics, but also strengthens our team of world-class immunologists and immune assay scientists. Together, we will accelerate the development of a full repertoire of innovative antibody drugs that will soon transform patient care."

"HiFiBiO Therapeutics is well known for its expertise with immune modulation antibody therapies and unprecedented drug discovery engine," said Dr. Boblet. "My team and I are excited to join this group of experienced, enthusiastic drug hunters. Together, with our synergies, we will be able to bring innovative immuno-oncology drugs to patients in need, faster and more effectively than before."