On February 20, 2020 Biocare Medical, a leading provider of innovative, automated immunohistochemistry (IHC) reagents and instrumentation, reported the launch of seven novel IVD IHC antibody markers for clinical diagnostics and research applications (Press release, Biocare Medical, FEB 20, 2020, View Source [SID1234554588]). The most recent launch focuses on several immuno-oncology markers, critical in aiding early-stage cancer drug developments and patient treatment.

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Biocare re-developed a major antibody marker (S100 Protein), which is expressed in Schwannomas, ependymomas, astrogliomas, and nearly all melanomas (benign and malignant) and their metastases. Biocare’s new marker, S100 [4C4.9], lends a stronger and more robust staining signal for IHC applications vs. previous offerings.

Biocare also releases one mouse monoclonal and five novel rabbit monoclonal antibodies in the immuno-oncology space. Recombinant rabbit monoclonal antibodies are ideal for research applications for use with Multiplex IHC technologies and are not reliant upon hybridomas that may expire. CTLA-4 [CAL49], GITR [CAL8], LAG3 [CAL26], PD-1 [CAL20], CD22 (M) [BLCAM/1796], and E-Cadherin [CDH1/2208R] are now commercially available.

CTLA-4 – Ipilimumab, the first immunotherapeutic drug directed toward CTLA-4 inhibition, has demonstrated overall survival benefit in metastatic melanoma. Another CTLA-4 inhibitor, tremelimumab (IgG2 isotype), has also proven successful in metastatic melanoma and other malignancies1,2.

GITR – GITR modulation in preclinical models has shown promising antitumor activity via significant increase in effector T cells and decrease in Tregs3. Several human monoclonal antibodies that agonize GITR are currently undergoing phase I clinical studies in various solid malignancies. Preliminary results demonstrate an acceptable safety profile without dose limiting toxicities4-5.

LAG3 – Recent studies in a metastatic ovarian cancer mouse model showed that LAG-3 blockade leads to upregulation of other immune checkpoints (PD-1, CTLA4, and TIM-3), and combination therapy targeting LAG-3, PD-1, and CTLA-4 increases functional cytotoxic T cell levels while reducing Tregs and myeloid-derived suppressor cells6,7.

PD-1 – Treatments targeting PD-1 and its ligand, PD-L1, have also shown encouraging results in melanoma, non-small-cell lung cancer, and renal cell carcinoma8-10. This antibody can also be used in multiplex stains with other antibodies such as CD4, CD8, FOXP3, cytokeratin, and melanoma markers11.

CD22 (M) – May be a useful marker for phenotyping mature leukemias, as CD22 membrane expression has been shown to be limited to the late differentiation stages between mature B cells (CD22+) and plasma cells (CD22-)12, 13. CD22 is also strongly expressed in hairy cell leukemia14.

E-cadherin – A decreased expression of E-cadherin is associated with metastatic potential and poor prognosis in breast cancer, prostate, and esophageal cancer.

"We are proud to be able to launch novel, IVD IHC markers that meet the highest standards in cancer diagnostics. This commitment to quality ensures Biocare is providing the best diagnostic and research utility possible," said Dr. Jason Ramos, Vice President – Reagent Research and Development at Biocare Medical.

The new product launches continue Biocare Medical’s long-standing history of providing novel, high-quality reagents to customers looking to advance their research and diagnostic efficiency in the laboratory.

On February 20, 2020 Kyowa Kirin Co., Ltd. (TSE: 4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported that a phase 1 clinical study of automated injection device of G-Lasta [KRN125, generic name: pegfilgrastim (genetical recombination)] *1 was started in Japan, February 19, 2020 (Press release, Kyowa Hakko Kirin, FEB 20, 2020, View Source [SID1234554536]).

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G-Lasta is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product*2. It was licensed from Kirin-Amgen Inc.*3 to Kyowa Kirin, and launched in Japan in 2014 for decreasing the incidence of febrile neutropenia*4 in patients receiving cancer chemotherapy. It is administered at medical institutions at least one day after chemotherapy. This automated injection device has a function to deliver G-Lasta into patient’s body the day after chemotherapy, and is applied to patients on the same day of chemotherapy. Therefore, it is expected to reduce the ambulant burden on patients, and contributes to reducing burden on healthcare professionals.

"Burden on patient’s body is heavy after chemotherapy, and it is very important to reduce it." said Takeyoshi Yamashita, Ph.D., Executive officer, Director of Corporate Strategy & Planning Department of Kyowa Kirin. "We believe that this device contributes to reducing the burden on patients." Kyowa Kirin will file an application for manufacturing and marketing approval with Japan’s Ministry of Health, Labor and Welfare (MHLW) using this phase 1 clinical study’s data which is objected to evaluate safety of G-Lasta. This device is co-developed with a domestic medical equipment manufacturer.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Indication Decrease the incidence of febrile neutropenia in patients receiving cancer chemotherapy
Phase Phase 1
Design Multicenter open-label single-arm study
Administration group KRN125 group
Primary evaluation items Safety
Sample size 30
Countries Japan *1:

About G-Lasta
G-Lasta is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product, which is produced by PEGylation*5 of filgrastim, for decreasing the incidence of febrile neutropenia in patients receiving cancer chemotherapy. Pegfilgrastim, originally generated by Amgen, Inc., was licensed from Kirin-Amgen Inc., to Kyowa Kirin. *

2: About Granulocyte Colony-Stimulating Factor (G-CSF) product G-CSF is a protein produced by using gene recombination. G-CSF selectively stimulates production of neutrophils and also enhances the neutrophil function. Based on this mechanism, G-CSF is used to accelerate recovery from chemotherapy-induced neutropenia, and it reduces various risks associated with neutropenia. *

3: About Kirin-Amgen Inc. At the time of its licensing, it was a joint venture between Amgen and Kirin Holdings. In 2017, they have agreed to terminate the joint venture. And it is now a subsidiary of Amgen. *

4: About febrile neutropenia Myelosuppressive chemotherapy causes low neutrophil count, i.e. neutropenia, which can raise risk of infections. Neutropenia with fever, known as febrile neutropenia, can be a sign of a serious infection and the patient needs to be given appropriate treatments. *

5: About PEGylation PEGylation is a chemical modification of protein bound by polyethylene glycol. PEGylation enables protein to suppress degradation and to reduce clearance in human body, resulting in improving retention of the protein in the blood stream and prolonging the duration of its activities.

On February 20, 2020 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $1.18 per share (Press release, AbbVie, FEB 20, 2020, View Source [SID1234554555]).

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The cash dividend is payable May 15, 2020 to stockholders of record at the close of business on April 15, 2020.

Since the company’s inception in 2013, AbbVie has increased its dividend by 195 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On February 20, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that company management will host a conference call & webcast to report topline results from DeCidE1, an ongoing Phase 2 study evaluating its lead compound, DPX-Survivac, in patients with advanced recurrent ovarian cancer, on Tuesday, February 25, 2020 at 8:00 am EST (Press release, IMV, FEB 20, 2020, View Source [SID1234554573]).

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IMV aims to make immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer. Patients with advanced, recurrent ovarian cancer have limited treatment options. The five-year survival rate for women with advanced disease is less than 30%1.

In 2020, the standard of care for recurrent cancer is single-agent chemotherapy, which elicits a response rate of ~12% with limited duration of benefit and severe adverse effects. There is a significant need for more effective and better-tolerated therapies in recurrent ovarian cancer.

Conference Call & Webcast Information

Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (International).

All interested parties are able to register and access the live audio webcast by clicking the link available under the Investors section of the company’s website: "Events, Webcasts & Presentations".

The webcast will be recorded and available on the IMV website for 30 days following the call.

About the DeCidE1 Study

"DeCidE1" is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac with intermittent low dose cyclophosphamide. This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. Patients received two subcutaneous injections of DPX-Survivac three weeks apart and every eight weeks thereafter, and intermittent low dose CPA, one week on, and one week off for up to one year. Paired tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of targeted immunotherapies designed to elicit antigen-specific functional, robust and sustained de novo T cell response. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of five unique HLA-restricted survivin peptides formulated in IMV’s proprietary DPX drug delivery platform and known to induce a cytotoxic CD8+ T cell response against survivin expressing cancer cells.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

Company has recently published data with DPX-Survivac (as single regimen or in combination with Merck’s Keytruda) at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019 (see poster) and at the ASCO (Free ASCO Whitepaper)-SITC symposium in February 2020 (see poster).

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

On February 20, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported interim data from its ongoing Phase II TACTI-002 study (Press release, Immutep, FEB 20, 2020, View Source [SID1234554592]). The results are being presented today at the 34th German Cancer Congress in Berlin by Principal Investigator, Dr. Bernhard Doger of START Madrid, Spain. The Company will also present this interim data and provide a further update on its clinical programs in a global webcast, details below.

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The data relates to use of the Company’s lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3 protein, as part of a combination treatment with pembrolizumab. The activation of antigen-presenting cells (APC) and subsequent T cell recruitment with efti may lead to stronger anti-tumour responses than observed with pembrolizumab alone.

Immutep CSO and CMO, Dr Frederic Triebel said: "The results we are seeing from our TACTI-002 trial are highly encouraging, with 47% of first line non-small cell lung cancer patients responding. These results are remarkable given that usually only 20% of patients respond to pembrolizumab monotherapy, if not pre-selected for high PD-L1 expression. Interestingly, patient responses are being seen in all three PD-L1 expression level groups, meaning the combination treatment seems to work even in patients not expected to respond to pembrolizumab monotherapy.

The initial overall response rate of 33% of second line head and neck squamous cell carcinoma patients is also very exciting, albeit from a smaller patient group. It compares well to an expected pembrolizumab monotherapy response rate of 15-18%, especially taking into account that three patients could not yet be assessed."

Immutep CEO, Marc Voigt stated: "We are very excited by the results from TACTI-002 as pembrolizumab monotherapy is approved only for PD-L1 subgroups in first line NSCLC. Seeing substantial response rates also in low PD-L1 expression groups from the combination therapy is very encouraging, particularly in light of the good safety profile to date for efti."

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

Overview of the Trial

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients. All patients receive 200 mg of pembrolizumab every three weeks, along with 30 mg of efti every two weeks for the first eight cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).

The trial is a Simon’s two-stage, open-label, single-arm study, with patients participating in three Parts:

Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

Part B – Second line NSCLC, PD-X refractory

Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

Key Findings

Stage 1 Part A (1st line NSCLC):

Overall Response Rate (ORR) of 47% and no patient with a response had progressive disease thus far

Distribution of the PD-L1 subgroups is as expected (see table) ~30% with ³ 50% PD-L1

Tumour responses are reported across all three PD-L1 expression level groups (< 1%, 1-49% and ³50%) for NSCLC. 5 out of the 8 responders had a PD-L1 expression <50%

Majority (10/17; 59%) of NSCLC patients are still under treatment and median PFS is not yet reached with all patients having passed the 7+ months mark already

PD-L1 status of stage 1 of Part A (n=17) are detailed below:

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

Interim ORR of 33% with 6 out of 18 patients reporting a response according to iRECIST (3 patients are not yet re-staged after initiation of therapy and PD-L1 results are currently being evaluated)

More detailed data will be provided as patient treatment duration advances.

Safety:

No new safety signals for this combination therapy reported thus far.

Recruitment Update

Recruitment is ongoing for stage 1 of Part B, along with stage 2 of Parts A and C. The table below summarises the number of patients recruited to date for the TACTI-002 cohorts.

The presentation entitled, ‘Initial results from a Phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab’ will be made available on the Company’s website at View Source

Webcast Details

The Company will also present this interim TACTI-002 data and provide a further update on its clinical programs in a global webcast. The details for the webcast are as follows:

Date & Time:
Wednesday, February 26, 2020, 8:00 am Australian Eastern Daylight Time /

Tuesday, February 25, 2020, 4:00 pm US Eastern Daylight Time

Register:
Interested parties can register via a link to the webcast on the Company’s website or via the following link:

View Source

Questions: Investors are invited to submit questions in advance via [email protected].
A replay of the webcast will also be available at www.immutep.com from the day after the event.

About the TACT-002 trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.