On October 31, 2019 Immunocore Limited, a leading T cell receptor (TCR) biotechnology company, reported that it will present new data on its proprietary ImmTAC platform and from the tebentafusp clinical research programme at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Maryland from 7-10 November (Press release, Immunocore, OCT 31, 2019, View Source [SID1234550132]).

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Immunocore’s TCR technology generates a novel class of bispecific biologics called ImmTAC molecules that are designed to redirect the immune system to recognise and kill cancerous cells. Tebentafusp (IMCgp100), the first investigational ImmTAC molecule developed using this technology, has appeared to demonstrate specific targeting of gp100 a lineage antigen expressed in melanocytes and melanoma.

"We continue to advance the science behind which antigens are presented by cancer cells, to how they are recognized by T cell receptors, to the mechanism of our ImmTAC platform in the clinic. We look forward to sharing these new insights at SITC (Free SITC Whitepaper) this year," said David Berman, Head of Research and Development at Immunocore.

Immunocore poster presentations include:

Friday, 8 November
Posters will be on display from 7 a.m. – 8 p.m.; authors will be present during lunch and the poster reception (6:30 – 8 p.m.).

Poster 73: Large scale multiomics reveals a marked bias in driver mutations toward areas not reliably presented to the immune system
Presented by: Alex Powlesland, PhD, Head of Proteomics, Immunocore
Poster 781: A new approach used to characterise off target peptide repertoires for T cell receptors that target the cancer testis antigen NY-ESO-1-HLA-A*02:01
Presented by: Stephen Harper, PhD, Group Leader, Protein Engineering Research, Immunocore
Saturday, 9 November
Posters will be on display from 7 a.m. – 8 p.m.; authors will be present during lunch and the poster reception (7 – 8:30 p.m.).

Poster 766: The distinct binding footprints of bispecific T cell receptors (TCR) and TCR-mimic antibodies underpin their altered pHLA selectivity
Presented by: David K. Cole PhD, Group Leader, Immunocore
Poster 462: ImmTAC-chemotherapy combination: A preclinical evaluation shows potential benefits
Presented by: Adel Benlahrech, PhD, Principal Scientist, Immunocore
Poster 364: A gp100 targeting TCR-based soluble T cell engaging bispecific induces mobilisation and activation of peripheral T cells in patients with metastatic melanoma
Presented by: Sion Lewis, PhD, Senior Scientist, Immunocore
Poster 706: A TCR-CD3 bispecific fusion protein mediates increased presentation of peptide-HLA which associates with improved T cell activation and tumour cell killing
Presented by: Duncan Gascoyne, PhD, Senior Scientist, Immunocore
Poster 454: Induction of serum CXCL10 by tebentafusp, a gp100-CD3 bispecific fusion protein, was associated with survival in uveal melanoma in a Phase I/II Study
Presented by: Marcus Butler, MD, Ontario Institute for Cancer Research
Poster 828: Cytokine release syndrome (CRS) following treatment with tebentafusp, a novel bispecific TCR–anti-CD3 directed against gp100, in patients with advanced melanoma
Presented by: Alex Shoushtari, MD, Memorial Sloan Kettering Center
– Ends –

About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

About Tebentafusp
Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has Fast Track Designation and Orphan Drug Designation in the US and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment.1,2 Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases/year in the US).3,4,5 Up to 50% of people with uveal melanoma will eventually develop metastatic disease.1,2 When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.6

On October 31, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will present at the following investor conference in November (Press release, Medpace, OCT 31, 2019, View Source [SID1234550148]):

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Credit Suisse Healthcare Conference
Location: Scottsdale, AZ
Date: Tuesday, November 12, 2019
Presentation: 8:35 a.m. MT (10:35 a.m. ET)
Speakers: Dr. August Troendle, President & Chief Executive Officer, and Jesse Geiger, Chief Financial Officer & Chief Operating Officer, Laboratory Operations

A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.medpace.com and will be available for replay following the event.

On October 31, 2019 Hansa Biopharma reported Positive results from a pooled analysis of Phase 2 trials with imlifidase for desensitization in highly sensitized kidney transplant patients were presented for the first time at the European Society of Organ Transplantation’s (ESOT) Congress on September 17 (Press release, Hansa Biopharma, OCT 31, 2019, View Source [SID1234550164]). Imlifidase enabled kidney transplantation in 46 sensitized patients. The data presented was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

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– Hansa Biopharma continued to advance imlifidase towards a potential marketing approval in the EU. A Marketing Authorization Application (MAA) for imlifidase for enabling kidney transplantation in highly sensitized patients is currently under review by the European Medicines Agency, EMA. An opinion from the Committee for Medicinal Products for Human Use is expected during the first half of 2020.

– In the United States, a follow-up meeting with the U.S. Food and Drug Administration (FDA) has been scheduled. At the meeting, the Company intends to continue the discussion from the December 2018 meeting regarding the path forward for a regulatory filing for imlifidase in kidney transplantation of highly sensitized patients in the U.S. The meeting will take place on November 20th, 2019. Minutes from the FDA meeting expected by end-of-December 2019.

– Our pipeline has advanced with the first patient treated within our Phase 2 study in acute Antibody Mediated Rejection (AMR). In the Anti-GBM study we enrolled 11 patients at the end of the third quarter.

– Hansa Biopharma continued building its’ medical and commercial organization to support a potential commercial launch of imlifidase in 2020: Investments in R&D and SG&A increased in the third quarter to SEK 47m (Q3’18: SEK 36m) and SEK 46m (SEK 24m) respectively.

– Cash flow from operating activities for the third quarter ended at SEK -80m (SEK -54m); the Company’s cash position was SEK 680m at the end of September 2019.

Søren Tulstrup, President and CEO, comments

"Hansa Biopharma’s evolution into a fully integrated, commercial biopharmaceutical company continues according to plan. During the first nine months of 2019 we made solid progress across the organization with the expansion of our global footprint, advancements in our pipeline and continued engagements with the healthcare community in transplantation, autoimmune diseases and beyond.

Our top priority is advancing our lead candidate, imlifidase, through market authorization to enable kidney transplants for highly sensitized patients. At the same time, we continue to develop our proprietary enzyme technology platform in rare autoimmune diseases, where there is a significant unmet medical need.

In September, Hansa Biopharma presented positive imlifidase data at the ESOT Congress in Copenhagen, Denmark. The data was based on a pooled analysis of highly sensitized kidney transplant patients from four single arm, 6-month, open label, Phase 2 trials of imlifidase treatment prior to deceased and living donor transplantation in sensitized patients. The analysis included 46 patients, of which 50% had a cPRA of 100%, 85% were crossmatch positive and 70% were re-transplanted. Following the treatment of imlifidase, the donor specific antibodies (DSA) levels rapidly decreased and all positive crossmatches were converted to negative, thus enabling transplantation of all patients. The data was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

In Europe, the regulatory review process for imlifidase is progressing as planned, following the acceptance of our Marketing Authorization Application end of February. We expect to receive an opinion from the committee for medical products of European Medicines Agency in the first half of 2020.

In the U.S., we recently confirmed a follow-up meeting with the FDA. The purpose of the meeting will be to continue the discussion from our December 2018 meeting regarding the path forward for a regulatory filing of imlifidase in kidney transplantation of highly sensitized patients in the U.S.

Talking about the U.S., we welcome the initiative by the current administration in the United States, who recently issued an executive order to improve the care of people with end stage renal disease (ESRD). Following the executive order, the U.S. Department of Health and Human Services (HHS) set out three specific goals for ESRD:

1) Reducing the number of Americans developing ESRD by 25 percent by 2030

2) Having 80 percent of new ESRD patients in 2025 either receiving a transplant or homecare dialysis

3) Doubling the number of kidneys available for transplant by 2030

In the U.S., approximately 37 million people have chronic kidney disease and more than 700,000 have ESRD. There are nearly 100,000 Americans waiting to receive a kidney transplant, and approximately 20% of the money spent on traditional Medicare in the U.S. are related to kidney disease. If approved, imlifidase may have the potential to help highly sensitized patients getting off dialysis by enabling transplantation.

We have also continued advancing our pipeline during the first 9 months of 2019, with the initiation of two Phase 2 studies in Guillain-Barré Syndrome (GBS) and acute Antibody Mediated Rejection (AMR) in kidney transplantation. In AMR, the first patient has now been treated with imlifidase. Our Anti-Glomerular Basement Membrane (Anti-GBM) program is also progressing as expected, with 11 patients enrolled so far and it’s our aim to complete enrollment in this study by year-end.

With the continued progress across the organization and significant progress for our lead candidate and pipeline activities, we are well-positioned to become a global biopharmaceutical company that brings lifesaving and life altering therapies to patients with rare diseases who need them and generate value to society at large. I look forward to updating you on our continued progress."

Søren Tulstrup

President and CEO of Hansa Biopharma

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on October 31, 2019.

On October 31, 2019 Ipsen (Euronext: IPN; ADR: IPSEY) reported that results from a network meta-analysis (NMA) in advanced renal cell carcinoma (aRCC), and a UK-focused budget impact study assessing long-acting somatostatin analogues (LA-SSAs) for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP NET) will be presented at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2019 Annual Conference (Press release, Ipsen, OCT 31, 2019, View Source [SID1234550095]). ISPOR takes place in Copenhagen, Denmark from 2 – 6 November 2019.

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Key studies to be presented at ISPOR Europe 2019:

An assessment of the budget impact of LA-SSAs in the treatment of acromegaly and GEP NET, considering attributes related to the drug delivery of LA-SSAs in the UK.
An NMA analyzing cabozantinib versus standard-of-care comparators in progression free survival (PFS) and overall survival (OS) in the first-line treatment of advanced renal cell carcinoma.

"We’re excited to be sharing two interesting sets of results – namely a comparison of first-line therapies and budget impact of a treatment approach for acromegaly and gastroenteropancreatic neuroendocrine tumors," said Ulf Staginnus, Senior Vice President, Head Global Market Access and Pricing, Ipsen. "With more than 5,000 global healthcare leaders, seeking robust health solutions and new insights, ISPOR Europe 2019 is the perfect stage to share these results."

The delivery attributes of both LA-SSAs were considered in the UK-focused study assessing the budget impact of the LA-SSAs, lanreotide versus octreotide in the treatment of acromegaly and GEP-NET. Model inputs (including drug acquisition and administration costs) were based on publicly available sources. The analysis compared the current and hypothetical market share scenarios from three perspectives in the UK: the National Health Service (NHS), a regional clinical commissioning group (CCG), and a local institution (hospital). Results suggested that increasing the use of lanreotide to a hypothetical 80% market share for lanreotide in the UK would reduce overall LA-SSAs patient treatment expenses by £2.9 million annually in the UK (a reduction of 3.6% from the current budget estimate of £80.6 million).

In the area of treatment provision in aRCC, Ipsen used an NMA to respond to the challenge presented to healthcare professionals by the introduction of targeted therapies in the last year with no way to objectively compare them. While randomized trials are the gold standard for comparative effectiveness research, they are not always available for clinically and economically important treatment comparisons. In this case, the NMA may offer some helpful insights as it suggests that cabozantinib significantly increases progression free survival (PFS) in intermediate and poor-risk patients when compared with standards-of-care and concludes that cabozantinib may be considered as an efficient treatment option in first-line aRCC.

"Modern quantitative data reviews of available agents offer additional insights into existing healthcare," said Bartek Bednarz, Senior Vice-President, Global Product and Portfolio Strategy, Ipsen. "The network meta-analysis (NMA) for cabozantinib and budget impact model for somatostatin analogues shared at ISPOR Europe 2019 are just part of Ipsen’s ongoing commitment to demonstrating benefit for payers and improving options for patients with high unmet needs."

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ISPOR Europe 2019 Conference news and updates by using the hashtag #ISPOREurope.

Overview of key Ipsen presentations at ISPOR Europe 2019:

Medicine Abstract title Abstract number/timing (CEST)
Cabometyx

(cabozantinib)

Cabozantinib versus standard-of-care comparators: a network meta-analysis of progression free survival and overall survival in the first-line treatment of advanced renal cell carcinoma
PCN42; Board D5

RESEARCH POSTER SESSION 2

CANCER

Monday, November 4, 2019

Display Hours: 15:30 – 19:00

Somatuline Autogel (lanreotide autogel/depot) Budget impact analysis of somatostatin analogues in the treatment of GEP-NET and acromegaly in the UK
PDG23; Board J3

RESEARCH POSTER SESSION 4

DRUGS & GENERICS

Tuesday, November 5, 2019

Display Hours: 15:45 – 19:00

N/A Retrospective Gesetzliche Krankenversicherung (statutory health insurance) (GKV) research study on the initial treatment of bladder carcinoma (BCA) by transurethral bladder resection (TURB) – a comparative analysis of costs and urological follow-up therapies using standard white light- (WL-) vs. Blue light- (WL-)TURB
PCN502; Board W12

RESEARCH POSTER SESSION 2

CANCER

Monday, November 4, 2019

Display Hours: 15:30 – 19:00

N/A Assessing the human and economic burden of short stature: a systematic literature review
PMU142; Board V19

RESEARCH POSTER SESSION 4

MULTIPLE DISEASES

Tuesday, November 5, 2019

Display Hours: 15:45 – 19:00

On October 31, 2019 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the third quarter of 2019 (Press release, Cytokinetics, OCT 31, 2019, View Source [SID1234550117]). Net loss for the third quarter was $29.6 million, or $0.50 per share, compared to net loss for the third quarter of 2018 of $22.0 million, or $0.40 per share. Cash, cash equivalents and investments totaled $166.0 million at September 30, 2019.

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"In the third quarter of 2019, we achieved major milestones in both our cardiovascular and neuromuscular programs representing progress on key priorities across our pipeline of muscle-directed therapies," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Completion of enrollment of GALACTIC-HF represents a significant step forward towards the completion of this important trial which holds promise for advancing the treatment of millions of patients suffering from heart failure. Additionally, recently presented Phase 1 data for CK-274 reaffirms its next-generation profile and supports advancing this program into a Phase 2 trial in patients with obstructive hypertrophic cardiomyopathy this year. Furthermore, additional analyses of results from FORTITUDE-ALS, as well as ongoing regulatory interactions, provide support for a potential Phase 3 trial of reldesemtiv in patients with ALS next year. We believe this progress positions us well to leverage our leadership in muscle pharmacology to benefit a wide array of patients suffering from varied diseases of muscle dysfunction."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Completed patient enrollment in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. GALACTIC-HF enrolled over 8,200 patients in 35 countries. We expect GALACTIC-HF to continue throughout 2019 and the second planned interim analysis of GALACTIC-HF to occur in the first quarter of 2020.

Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. We expect to continue enrollment of METEORIC-HF throughout 2019.
AMG 594 (cardiac troponin activator)

Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under our joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Presented data from the Phase 1 study of CK-274 at the Heart Failure Society of America’s 23rd Annual Scientific Meeting in Philadelphia. The study met its primary and secondary objectives to assess the safety and tolerability of single and multiple oral doses of CK-274, describe the pharmacokinetics of CK-274 and its pharmacodynamic effects as measured by echocardiography, as well as to characterize the PK/PD relationship with regards to cardiac function. These data support the advancement of CK-274 into a Phase 2 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM) which is expected to begin in Q4 2019.

Presented preclinical data at the American Heart Association’s Basic Cardiovascular Sciences Scientific Sessions in Boston demonstrating that CK-274 produces exposure related effects on cardiac contractility in healthy animals and mouse models of HCM and support the therapeutic hypothesis relating to onset of action and reversibility.
Skeletal Muscle Program

reldesemtiv (next-generation, fast skeletal muscle troponin activator (FSTA))

Presented post-hoc analyses from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), at the 2019 Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting in Clearwater Beach, FL. The analyses demonstrated that, in the combined middle and faster progressing tertiles of patients, the decline in the ALSFRS-R total score from baseline to week 12 in patients who received any dose of reldesemtiv was significantly smaller than the decline on placebo, while no significant difference between reldesemtiv and placebo was observed in slower progressing patients.

Held regulatory interactions and conducted feasibility and other planning activities in preparation for the potential advancement of reldesemtiv to a Phase 3 trial in patients in ALS in 2020.

Received European Orphan Designation for reldesemtiv for the potential treatment of spinal muscular atrophy (SMA) by the European Medicines Agency (EMA).
Pre-Clinical Development and Ongoing Research

Announced the publication of "Fast Skeletal Muscle Troponin Activator CK-2066260 Increases Fatigue Resistance by Reducing the Energetic Cost of Muscle Contraction," in The Journal of Physiology, demonstrating that a FSTA can decrease skeletal muscle fatigue by increasing the metabolic efficiency of muscle contraction. CK-2066260 is a preclinical FSTA tool compound.

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA, under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; Astellas is sponsoring Cytokinetics’ research activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

We and Astellas have agreed in principle to revise the terms of our collaboration agreement so that Cytokinetics would have the exclusive right to develop and commercialize all FSTAs, including reldesemtiv and CK-601. Astellas’ future contributions would be to provide partial co-funding for certain Phase 3 clinical trial costs for reldesemtiv in ALS and to provide other in-kind support. In exchange, Astellas would receive a low- to mid- single digit royalty on reldesemtiv to be payable by Cytokinetics. We have also agreed in principle to extend our joint research program for another year with Astellas sponsoring research at Cytokinetics through 2020.

The above agreements in principle are non-binding and contingent upon our finalizing amendments to our collaboration agreement and, absent such agreement, the terms of the existing agreement remain in place.

Announced the continuation of our partnership with Cure SMA to increase education, awareness, public policy and fundraising for SMA. The partnership includes support for several of Cure SMA’s national initiatives as well as local community events.

Announced a call for proposals for the second annual Cytokinetics Communications Fellowship Grant program. The program provides $100,000 in grants to five selected patient advocacy organizations serving the ALS, heart failure, HCM, or SMA communities, and is intended to support increased capacity in communications, awareness building and community engagement.
Financials

Revenues for the three and nine months ended September 30, 2019 were $6.1 million and $21.7 million, respectively, compared to $10.6 million and $22.1 million for the corresponding periods in 2018. The decrease in revenues for the three and nine months ended September 30, 2019 was due primarily to the winding down of FORTITUDE-ALS in addition to a lack of license revenue in 2019. License revenues in the third quarter and first nine months of 2018 were related to the Phase 2 trial of reldesemtiv in spinal muscular atrophy completed in 2018.

Research and development expenses for the three and nine months ended September 30, 2019 were $20.2 million and $67.8 million, respectively compared to $21.4 million and $65.9 million for the same periods in 2018, respectively. The changes were primarily due to reduced spending for reldesemtiv as well as tirasemtiv following suspension of development of tirasemtiv in late 2017 offset by increased spending related to METEORIC-HF and the development of CK-274.

General and administrative expenses for the three and nine months ended September 30, 2019 increased to $9.8 million and $29.0 million, respectively, from $7.2 million and $23.7 million for the same periods in 2018, respectively, due primarily to an increase in outside legal counsel and personnel related costs including stock-based compensation.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s third quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9440838.

An archived replay of the webcast will be available via Cytokinetics’ website until November 7, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9440838 from October 31, 2019 at 7:30 PM Eastern Time until November 7, 2019.