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 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, reported its financial results for the third quarter ended September 30, 2019 (Press release, Momenta Pharmaceuticals, OCT 31, 2019, View Source [SID1234550130]).

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"Our focus in 2019 is on the execution of our clinical programs as they advance toward proof of concept," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Looking ahead to 2020, we anticipate key readouts across our novel auto- and alloimmune programs, including proof-of-concept data from M254 in ITP and nipocalimab in MG. Importantly, both of these agents have the potential to reshape the treatment landscape for a range of large market, IgG-mediated diseases."

Third Quarter 2019 Highlights, Recent Events and Anticipated Upcoming Milestones

Novel Therapeutics Pipeline:

Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

•Vivacity-MG, the Company’s Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG), continues to enroll patients. The Company expects to report top-line data from this study in the second or third quarter of 2020.

•Unity, the Company’s global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), is active and enrolling patients. Nipocalimab has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for this indication and the Company expects to report top-line from this study data in 2021.

•Energy, the Company’s adaptive Phase 2/3 clinical study of nipocalimab in Warm Autoimmune Hemolytic Anemia (wAIHA) commenced in the third quarter 2019. The Company is activating clinical sites in both the United States and European Union and is actively recruiting patients. Nipocalimab has been granted Fast Track designation by the FDA in this indication and the Company expects to report top-line data from this study around the end of 2021.

M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)

•The Company’s multi-part Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP) has completed Part A and is progressing through Part B, which is evaluating M254 in a single ascending dose (SAD) cohort of ITP patients. Parts C and D include a randomized cross-over study comparing M254 to IVIg and a multiple ascending dose (MAD) study of M254, respectively. Enrollment is ongoing and the Company expects to report preliminary data from this study in the first half of 2020.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

•A Phase 1 clinical trial to evaluate the safety and tolerability of M230 in healthy volunteers is ongoing and Momenta’s partner, CSL, looks forward to introducing a subcutaneous formulation into the phase 1 program. We expect to have data regarding this formulation in the next calendar year.

Legacy Products:

Glatopa 20 mg and 40 mg: FDA approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz

•In the third quarter of 2019, Momenta recorded $5.6 million in product revenue from Sandoz’s sales of Glatopa products.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

•Iylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA.

Corporate:

•In September 2019, the Company announced the appointment of Donna Grogan, M.D. to its Board of Directors.

Third Quarter 2019 Financial Results

Revenue:

In the third quarter of 2019, the Company recorded $5.6 million in product revenue from Sandoz’s sales of Glatopa. In the third quarter of 2018, the Company recorded $13.6 million in product revenue, net a deduction of $0.2 million for legal fees and includes 1.7 million received by Momenta for the Pfizer settlement. The decrease in product revenue from the prior year period was primarily due to continued competition.

Research and development revenue for the third quarter of 2019 was $0.8 million, compared to $1.3 million in the same quarter in 2018. The decrease in research and development revenue of $0.4 million, or 34%, was primarily due to lower reimbursement revenue for Glatopa expenses.

Total revenue for the third quarter of 2019 was $6.4 million compared to $14.9 million for the same period in 2018.

Operating Expenses:

Research and development expenses for the third quarter of 2019 were $46.1 million, compared to $30.7 million for the same period in 2018. The increase of $15.3 million, or 50%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254, offset in part by lower personnel costs following the Company’s workforce reduction in the fourth quarter of 2018 and lower lease costs.

General and administrative expenses for the third quarter of 2019 were $20.1 million, compared with $20.4 million for the same period in 2018. The decrease of $0.4 million, or 2%, was primarily due to lower depreciation costs.

In July 2019, Momenta entered into an amendment to its office and laboratory space lease at 320 Bent Street in Cambridge, Massachusetts, reducing the Company’s footprint at the location. During the quarter, the company recognized a noncash gain of $13.7 million, reflecting the reduction in the lease liability and the related right-of-use asset.

Total GAAP operating expenses were $52.5 million in the third quarter of 2019. Third quarter 2019 non-GAAP operating expense was $45.7 million. Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Income (Loss): The Company reported a net loss of $44.5 million, or $0.45 per share for the second quarter of 2019 compared to a net loss of $50.3 million, or $0.65 per share for the same period in 2018.

Liquidity: At September 30, 2019, Momenta had $325.9 million in cash, cash equivalents, marketable securities, and reflects the addition of $36.1 million related to the release of a bond following a settlement agreement with Amphastar Pharmaceuticals. This compares to $449.4 million at December 31, 2018 in cash, cash equivalents, and marketable securities.

2019 Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Non-GAAP operating expense is total operating, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. Momenta is providing quarterly non-GAAP operating expense guidance of $50 – $60 million for the fourth quarter 2019.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense, restructuring expense and collaborative reimbursement revenue. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company has provided the estimated reconciling information that is available without unreasonable effort in the section of this press release above entitled "2019 Financial Guidance."

Conference Call Information

Management will host a conference call and webcast today at 8:30 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 3067995.

On October 31, 2019 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Thursday, November 14 at 8:30am Eastern Time to report third quarter and nine-months ended September 30, 2019 financial results and to provide a corporate update (Press release, VBL Therapeutics, OCT 31, 2019, View Source [SID1234550129]).

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Thursday, November 14th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13696234
Webcast: View Source

On October 31, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report third quarter 2019 financial results and provide a corporate update before market open on Thursday, November 7, 2019 (Press release, Jounce Therapeutics, OCT 31, 2019, View Source [SID1234550128]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. ET.

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Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3379867. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

On October 31, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune system recognition of solid cancers, reported that the first patient has been dosed with a combination of INT230-6, the Company’s lead investigational product, and Keytruda (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy (Press release, Intensity Therapeutics, OCT 31, 2019, View Source [SID1234550127]). The combination is being studied in a series of cohorts within IT-01, Intensity’s ongoing Phase 1/2 international clinical study (NCT03058289).

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The first part of the combination cohort of IT-01 expects to enroll approximately six patients with different types of advanced solid tumors in order to test safety of the combination. The second part will evaluate the safety and efficacy of the combination in several Phase 2 cohorts of patients with different types of cancer, including cancers that are not immunogenic.

"Bringing INT230-6 into human testing in combination with Keytruda is a major milestone for Intensity Therapeutics," commented Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Our preclinical and clinical data to date have already demonstrated good safety for INT230-6 as a single agent, with evidence of patient benefit and immune activation in highly refractory cancer patients. We believe the immune activation potential of INT230-6 can be increased when combined with Keytruda, and are excited to have initiated human testing of the combination."

"Our Phase 1/2 study will continue to accrue patients with multiple tumor types in the INT230-6 monotherapy portion while concurrently exploring this combination," said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "We are optimistic that our trial design enables us to quickly evaluate safety and efficacy. Tumor types of interest in the Phase 2 cohorts include pancreatic, cholangiocarcinoma, and non and microsatellite unstable colorectal cancer, which are all difficult to treat and historically nonresponsive to a PD1/PDL1 antibody alone. Physicians desperately need improved treatments for these patients and evidence of tumor response in any one of these patient populations would be validation of our approach of releasing tumor antigens derived from the patient’s own tumors to enable an immune attack on the cancer, an effect that can be amplified by blocking a checkpoint signal."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity collaborative research, published in July 2019, showed that there was also strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.