On November 11, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that it will participate in the Piper Jaffray Annual Healthcare Conference at the Lotte New York Palace in New York City (Press release, Zimmer Holdings, NOV 11, 2019, View Source [SID1234550883]). Bryan Hanson, President and Chief Executive Officer and Suky Upadhyay, Executive Vice President and Chief Financial Officer, will present for the company on Wednesday, December 4, 2019, at 11:30 a.m. Eastern Time.

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A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. The webcast will be archived for replay following the conference.

On November 11, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that its New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic neuroendocrine tumors ("NET") has been accepted for review by the China National Medical Products Administration (Press release, Hutchison China MediTech, NOV 11, 2019, View Source [SID1234551038]).

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The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress on September 29, 2019.

Christian Hogg, Chief Executive Officer of Chi-Med commented, "This NDA filing puts us on track for the potential approval and launch of surufatinib in China, an important development for NET patients with limited treatment options. In order to maximize patient access to surufatinib upon regulatory approval, we are now building our own dedicated commercial oncology organization and expect to be ready to cover all relevant hospitals and clinics in China at the time of launch."

"We believe surufatinib has robust efficacy, tolerability and combinability with a dual angio-immuno kinase inhibition profile, which may make it an attractive treatment in China," Mr. Hogg added.

Chi-Med currently retains all worldwide rights to surufatinib. Surufatinib is under investigation in multiple solid tumors in China, the U.S. and Europe, both as a monotherapy and in combination with immunotherapies.

Surufatinib is Chi-Med’s second in-house discovered novel oncology drug to reach NDA submission in China, following the launch of fruquintinib last year for colorectal cancer under the brand name Elunate.

About Neuroendocrine Tumors (NET)

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or other neuroendocrine tumors. Approved targeted therapies include Sutent and Afinitor for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of neuroendocrine tumors in the U.S. in 2018. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with neuroendocrine tumors in the U.S. in 2018 of which over 90%, or approximately 132,000, were non-pancreatic neuroendocrine tumor patients.

In China, there were approximately 67,600 newly diagnosed neuroendocrine tumor patients in 2018 and, considering the current incidence to prevalence ratio in China, potentially as many as 300,000 patients living with the disease in the country1. It is estimated that approximately 80% of the patients living with neuroendocrine tumors in China are non-pancreatic neuroendocrine tumor patients.

About SANET-ep

SANET-ep is a randomized, double-blind, placebo-controlled, multi-center, Phase III study comparing surufatinib orally daily with placebo in patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors for whom there is no effective therapy. In June 2019, a 198 patient interim analysis was conducted, leading the Independent Data Monitoring

Committee (IDMC) to determine that the study met the pre-defined primary endpoint of progression-free survival ("PFS") and should be stopped early. 84% of the patients in the study had disease with pathological grade 2. 41% of patients had disease originating outside of the gastrointestinal (GI) tract and the lung or with unknown origin.

Surufatinib reduced the risk of progression or death by 67%. Median PFS per investigator assessment was 9.2 months for patients treated with surufatinib, as compared to 3.8 months for patients in the placebo group (hazard ratio [HR] 0.334; 95% confidence interval [CI] 0.223-0.499; p<0.0001). The efficacy of surufatinib was seen across all subgroups, and supported by statistically significant improvement as measured by secondary efficacy endpoints including objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), safety, and tolerability. Efficacy was also supported by Blinded Independent Image Review Committee (BIIRC) assessment. Overall survival (OS) data was not mature, with only 18.7% OS events at data cut-off. The safety profile was consistent with observations in prior clinical studies. Additional details may be found at clinicaltrials.gov, using identifier NCT02588170.

About Surufatinib

Surufatinib (previously known as HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors ("VEGFR") and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies. Surufatinib is in several late-stage and proof-of-concept clinical trials in China and proof-of-concept clinical trials in the U.S.

According to Frost & Sullivan, the market for VEGF/VEGFR inhibitors in China has grown from US$500 million in 2015 to over US$1.5 billion in 2019 and is expected to reach US$5 billion by 2026.

Chi-Med currently retains all rights to surufatinib worldwide.

Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic neuroendocrine tumors in China. The primary endpoint is PFS. We expect an interim analysis in the first half of 2020 and enrollment to complete in 2020 (clinicaltrials.gov identifier: NCT02589821).

Neuroendocrine tumors in the U.S. and Europe: The encouraging data from the Phase II and Phase III studies of surufatinib in neuroendocrine tumors in China (clinicaltrials.gov identifier: NCT02267967), and the ongoing Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937), have led us to decide to proceed with planning a registration study in neuroendocrine tumors patients.

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is OS (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-programmed cell death protein 1 (PD-1) monoclonal antibodies. This included global collaborations to evaluate the combination of surufatinib with Tuoyi, approved in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt, approved in China by Innovent Biologics, Inc.

On November 11, 2019 Neptune Wellness Solutions Inc. ("Neptune" or the "Corporation") (NASDAQ: NEPT) (TSX: NEPT), reported its financial and operating results for the three-month period ended September 30, 2019 (Press release, Neptune Technologies et Bioressources inc, NOV 11, 2019, View Source [SID1234550884]). All amounts are in thousands of Canadian dollars except specified otherwise.

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Second Quarter Financial and Corporate Highlights:

Total revenues for the three-month period ended September 30, 2019 amounted to $6,512, representing an increase of $2,151 or 49% over the first quarter ended June 30, 2019 and a decrease of $559 or 8% compared to $7,071 for the three-month period ended September 30, 2018.
Revenues from the Cannabis segment reached $1,220, an increase of $1,182 sequentially from the three-month period ended June 30, 2019. Neptune started the commercial operations of its Cannabis segment in March 2019 and hence had no revenues in the prior year period ended September 30, 2018.
Revenues from the Nutraceutical segment for the three-month period ended September 30, 2019 amounted to $5,149, representing an increase of 20% sequentially, over the first quarter ended June 30, 2019 and a decrease of $1,922 or 27% compared to $7,071 for the three-month period ended September 30, 2018. The decrease in revenues was attributable to timing of orders of our nutrition business.
Net loss for the three-month period ended September 30, 2019 amounted to $20,775 compared to $3,050 for the three-month period ended September 30, 2018, an increase of $17,725. The increase is mainly attributable to an increase in stock-based compensation expense, depreciation and amortization and to accretion expense on contingent consideration combined with a lower Adjusted EBITDA1.
Adjusted EBITDA1 decreased by $3,353 for the three-month period ended September 30, 2019 to ($4,581) compared to the three-month period ended September 30, 2018. The decrease in Adjusted EBITDA1 is mainly attributable to investments made in the cannabis segment to grow the workforce in anticipation of increased sales volume as well as an increase in salaries and benefits at the corporate level.
On July 24, 2019, Neptune completed the acquisition of the assets of SugarLeaf. Neptune paid an initial consideration for SugarLeaf of $23.7 million (US$18.1 million), a combination of $15.8 million (US$12 million) in cash and 7.9 million (US$6.1 million) or 1,587,301 in common shares.
On August 14, 2019, Neptune announced the creation of Neptune Ventures, a strategic investment arm and technology incubator which is expected to stimulate innovation and partnerships in the cannabis and wellness industries.
On August 22, 2019, Neptune announced the addition of two new members to its team to support the company’s rapid growth. Neptune appointed Stephen Lijoi, as Vice-President Operations and José Dominguez as Cannabis Sommelier and Formulation Specialist.
In August 2019, Neptune appointed Mr. Philippe Trudeau to its Board of Directors. Mr. Trudeau is a visionary leader with extensive experience in consumer goods. Mr. Trudeau spent 25 years at Trudeau Corporation, a consumer products company marketed in more than 70 countries, where he held many key positions including president from 2010 to 2018.
Subsequent to Quarter-end

On October 4, 2019, Neptune announced a new strategic partnership with American Media LLC ("American Media") which will provide US$12 million in advertising and creative services to Neptune to support the marketing and commercialization of Neptune’s consumer-facing brands in the U.S. Neptune will issue 3,000,000 warrants to AMI, each warrant allowing the holder to purchase one common share of Neptune at an exercise price of US$8.00 per share and with a 5-year expiration date.
On October 17, 2019, Neptune announced that it entered into an agreement to provide extraction services to a large U.S.-based farming services operation. Under the contract terms, Neptune will receive hemp biomass to be processed and transformed into crude oil extracts. The 2-year agreement could reach a total value in excess of US$20 million.
On October 17, 2019, the Corporation announced the appointment of Brett DuBose as Vice-President of Sales for the U.S. Region. Brett has more than 20 years of sales experience, most recently with Lonza Consumer Health and Nutrition where he was Associate Director Sales, for the Eastern U.S and Canada.
On November 11, 2019, Neptune announced that it has entered into a definitive agreement with International Flavors & Fragrances Inc. (NYSE: IFF) to co-develop hemp-derived CBD products for the mass retail and health & wellness markets. Under this strategic product development partnership, IFF will leverage its intellectual property (IP) for taste, scent, nutrition, and ingredients to provide essential oils and product development resources. Neptune will leverage its proprietary cold ethanol extraction processes and formulation IP to deliver high quality, full and broad-spectrum extracts for the development, manufacture and commercialization of hemp-derived products, infused with essential oils, for the cosmetics, personal care and home care markets. The initial launch will include a variety of topical products across the aromatherapy category, a market estimated at approximately $3 billion annually. Neptune will issue 2,000,000 warrants to IFF, each warrant allowing the holder to purchase one common share of Neptune at an exercise price of US $12.00 per share and with a 5-year expiration date.
"We have a strong opportunity in the consumer market, and in recent months I have been focused on developing our B2B and B2C strategy for the U.S. market. According to most estimates, the U.S. hemp-derived CBD market is expected to exceed US$20 billion at retail in the next five years. This market size is roughly three to four times larger than the expected size of the Canadian cannabis market and represents our largest opportunity today. The collaboration agreement with IFF and the American Media partnership will help raise the awareness of our CBD brand, Forest Remedies. We expect to introduce our first consumer products at retail locations and online with rollout commencing in the first half of CY2020," stated Michael Cammarata, CEO of Neptune.

"We achieved a significant milestone in mid October when we completed our Phase II capacity expansion. This additional capacity will alleviate our constraints in the near-term and help accelerate the company’s revenue growth in the cannabis segment. However, the start-up of our ethanol process has been longer than initially expected which has delayed the full ramp-up by one month to the end of December. With regards to our CO2 operations, we have been running seven days a week since the end of July and we are pleased with our yields and quality of extracts." Said Stephen Lijoi, VP Operations.

"I believe we have created a very solid foundation to grow our company with a well capitalized balance sheet. Moreover, we are at an inflection point in terms of profitability. The dynamics of the legal cannabis and hemp extraction markets remain favorable with a scarcity of biomass extraction capacity in both Canada and the U.S., which should lead to continued sustained demand for our extraction services. We expect our revenue growth to accelerate for the remainder of the FY2020 based on the strong demand witnessed for extraction services. Lastly, we have a comprehensive strategy based on geographic diversification, and a wide scope of value-added services, as well as unique and distinctive products," concluded Mr. Cammarata.

Financial Results

Total revenues reached $6,512 for the three-month ended September 30, 2019, down versus last year’s revenues of $7,071. The majority of the revenues during the quarter were generated in the Nutraceutical segment. The decline in total revenues was attributable to timing of orders of our nutrition business.

For the three-month ended September 30, 2019, Adjusted EBITDA1 was a loss of $4,581 compared with a loss of $1,228 last year. The increased Adjusted EBITDA1 loss is due to investments made in the cannabis segment to grow the workforce in anticipation of increased sales volume as well as an increase in salaries and benefits at the corporate level. The decrease can also be explained by an increase in litigation legal fees and additional SG&A coming from SugarLeaf.

Neptune reported a net loss of $20,775 for the three-month ended September 30, 2019, an increase compared to a net loss of $3,050 last year. The increase in net loss is mainly attributable to an increase in stock-based compensation expense, depreciation and amortization and accretion expense recognized on contingent consideration as well as for the same reasons as stated in the Adjusted EBITDA1 section above.

Cash and cash equivalents were $24,399 as of September 30, 2019. On November 6, 2019, Neptune closed a revolving line of credit with a large Canadian financial institution for an amount of $5 million to support the nutraceutical segment.

Management Update

This summer Neptune initiated a search process to hire a new CFO. This process is well underway and the Corporation’s new CFO is expected to be announced in the coming months. Following the departure of Mario Paradis, Claudie Lauzon has been appointed interim CFO of the Company. Ms. Lauzon is the Corporate Controller of Neptune and has been employed by the Corporation for 10 years.

Official Launch of the Forest Remedies Brand

Our CBD consumer brand, Forest Remedies, was acquired along with the purchase of SugarLeaf Labs. Initially, Forest Remedies was used to gain consumer insights on CBD finished product forms. Since its beginning in the fall of 2018, the brand has gained traction locally. The increasing demand for high quality hemp-derived products has led Neptune to recently rebrand Forest Remedies to appeal to a wider audience. Forest Remedies offers finished products such as tinctures, balms, massage oils, soft gels, and pet soothers. Additional products are currently in development. Forest Remedies products will continue to be available online (www.forestremedies.com) and could enter mass market retailers in calendar 2020. With innovation and a focus on quality, Neptune is confident in its ability to successfully grow the Forest Remedies brand. The company will deploy a marketing campaign and will be launching a new online platform in early calendar 2020.

Research and Development Initiatives

Neptune is undergoing and/or planning 10 research and clinical studies to further elucidate the benefits of its MaxSimil omega-3 licensed technology. Among the several initiatives underway is a clinical study that is a follow-up on a successful nonclinical study to determine if MaxSimil fish oil, when used as a carrier oil, can increase the absorption of cannabinoids in humans. In another study Neptune will try to establish if our proprietary formulation of MaxSimil fish oil and CBD can help with occasional anxiety from everyday life events. We also have an upcoming clinical study which will look at the use of our proprietary formulation of MaxSimil fish oil and CBD for workout recovery to determine if athletes will benefit from its use. This builds on the findings of our mitochondrial activity and inflammation resolution studies. We have increased our clinical activity because of the benefits we see in combining our omega-3 formulations with cannabinoids and have increased the size of our R&D team accordingly.

Outlook

"We continue to see strong demand for extraction services in Canada. We have provided extraction services to five clients in Canada and expect to continue to diversify our client base in the coming months. While the ramp-up of our phase II ethanol extraction is slower than originally anticipated, once running at full capacity by the end of December, this custom-built specialized equipment should provide Neptune with low operational costs," said Stephen Lijoi, VP Operations at Neptune.

The construction of our Phase IIIa is ongoing and is being adapted to our customers’ needs and changes in the Canadian Federal and Provincial regulatory requirements for Cannabis 2.0. This process is expected to be completed before fiscal year-end, subject to Health Canada approval. The expansion of our packaging capabilities is tracking as planned along with the installation of security measures for our warehouse to comply with Health Canada’s requirements. We expect to send a license amendment to Health Canada for the certification of those areas early in calendar 2020.

The next few months will be very active at Neptune. We have several projects ongoing in Canada such as obtaining our organic certification, applying for our sales license and further down the road, seeking our EU GMP certification. These future catalysts should help the company accelerate its revenue growth in Canada.

Our U.S. operations are scaling up as planned and our facility in North Carolina should reach a processing capacity of 1,500,000 kg of biomass annually by the end of December, as expected. The recent changes implemented by the USDA are expected to increase the cultivation of hemp in the US and could translate into increased demand for biomass extraction in the coming years. The recent client wins are an endorsement of our ability to provide superior extraction services. Our talent pool continues to grow with the addition of key personnel such as a VP Sales – U.S. Region and a Head – Quality Assurance both of which should help support additional growth.

On November 11, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that Christian Hogg, Chief Executive Officer, will present at the following conferences (Press release, Hutchison China MediTech, NOV 11, 2019, https://www.chi-med.com/chi-med-to-attend-upcoming-investor-and-industry-conferences/ [SID1234552848]):

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Deutsche Bank Depositary Receipts Virtual Investor Conference (dbVIC) webcast on Wednesday, November 13, 2019 at 8:30 am (EST) / 1:30 pm (GMT) / 9:30 pm (China Time);
BioCentury & Bayhelix China Healthcare Summit on Wednesday, November 20, 2019 at 1:30 pm (China Time) in Shanghai; and
Presentation at Piper Jaffray Annual Healthcare Conference on Tuesday, December 3, 2019 at 8:50 am (EST), and investor meetings on Tuesday, December 3, 2019 in New York.

In addition, members of the management team will attend the following investor conferences:

Presentation at Jefferies University Specialist Speakers Summit on China Disruption & Innovation on Friday, November 15, 2019 in Hong Kong;
Investor meetings at Jefferies London Healthcare Conference on Wednesday, November 20, 2019 and Thursday, November 21, 2019 in London;
Investor meetings at Morgan Stanley Annual Asia Pacific Summit on Thursday, November 21, 2019 in Singapore; and
Presentation at Goldman Sachs Asia Pacific Healthcare Forum on Monday, November 25, 2019 at 11:30 am (Hong Kong Time), and investor meetings on Monday, November 25, 2019 and Tuesday, November 26, 2019 in Hong Kong.

On November 11, 2019 Immunocore Limited, a leading T cell receptor (TCR) biotechnology company, reported new findings from its Phase 1/2 tebentafusp (IMCgp100) clinical trial programme demonstrating a correlation between treatment-induced immune response and improvement in overall survival and tumour shrinkage, in patients with advanced uveal and cutaneous melanoma (Press release, Immunocore, NOV 11, 2019, View Source [SID1234550869]). The new analyses from two clinical trials (IMCgp100-101, IMCgp100-102) were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Maryland.

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"We are gaining valuable insights from our clinical data to further our understanding of the mechanism of action of our bispecific, soluble TCR," said Bahija Jallal, Chief Executive Officer of Immunocore. "Advancing the science underlying TCR recognition of antigens supports our efforts to further develop our platform and maximize its value on behalf of patients."

Tebentafusp is an investigational novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. It is engineered to specifically target 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. Pivotal tebentafusp clinical trials are currently underway in metastatic uveal melanoma (UM), a rare form of eye cancer.

"When using a therapy designed to induce an immune response, it’s not unexpected to see inflammatory events like rash or cytokine response syndrome," said Alexander N. Shoushtari, M.D., study investigator and medical oncologist at Memorial Sloan Kettering Cancer Center in New York. "While these were general low-grade events that resolved with treatment and time, it was interesting to see their potential connection to overall survival and other clinical outcomes. These findings are encouraging and will help to inform future research and treatment protocols."

SITC Presentation Highlights:

Induction of serum CXCL10 by tebentafusp, a gp100-CD3 bispecific fusion protein, was associated with survival in uveal melanoma in a Phase 1/2 study

The goal of this analysis was to increase understanding of the biological effects of tebentafusp and association between rash seen with treatment, CXCL10 and clinical outcomes in UM. Researchers focused on the initial 42 patient cohort enrolled in IMCgp100-102, a Phase 1/2 study in patients with HLA-A2+ positive advanced UM. Patients were treated using a weekly intra-patient dose-escalation regimen and the occurrence of rash within 21 days following treatment initiation was evaluated as a predictor of overall survival.

The findings showed a transient increase in peripheral cytokines after treatment with tebentafusp, reaching maximal changes at 8-24 hours post treatment, with CXCL10 having the greatest increment between 12-24 hours. Patients treated with tebentafusp experienced induced type 1/2 IFN pathways and neutrophil, eosinophil signatures and reduced CD4, CD8 and NK cell signatures in the blood. Tebentafusp-treated patients with rash and those with a greater increase in serum CXCL10 following the first treatment dose appeared to be associated with improved overall survival. In a multivariate Cox proportional hazards model, both rash (p<0.001) and CXCL10 induction (p=0.01) were independent predictors of survival.

Cytokine release syndrome following treatment with tebentafusp, a novel bispecific TCR-anti-CD3 directed against gp100, in patients with advanced melanoma

The goal of this analysis was to better understand the incidence, severity and resolution of cytokine release syndrome (CRS) following tebentafusp treatment, an adverse event commonly associated with CD3-bispecifics, and its association with clinical outcomes in advanced melanoma. Researchers analysed data from IMCgp100-101, a Phase 1 first-in-human clinical trial assessing the safety and tolerability of tebentafusp in 84 HLA-A2+ patients with metastatic melanoma (n=61 cutaneous, n=19 uveal, n=4 other) resistant to standard treatment regimens or for which no standard treatments exist. This post-hoc analysis evaluated adverse events, serious adverse events, vital signs, and concomitant medications reported by investigators to identify episodes of CRS.

The findings show that patients treated with tebentafusp experienced a low incidence of severe CRS. Despite no corticosteroid pre-treatment, CRS occurrence was generally low grade, reversible with standard management (i.e., IVF and short course corticosteroids), decreased in frequency and severity after the initial doses, and infrequently led to the discontinuation of treatment. The most frequent CRS adverse events were mild-to-moderate fever, fatigue, nausea, hypotension and headache. Patients with a < 1°C increase in body temperature eight hours following treatment were less likely to develop subsequent moderate or higher-grade CRS. Consistent with tebentafusp’s hypothesized mode of action, transient increases in peripheral cytokines occurred within hours of treatment administration, and tended to be greater in patients with higher grade CRS. The incidence of CRS following the first dose of tebentafusp appeared to be associated with the greatest reductions in tumour size.

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.[i],[ii] 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).[iii],[iv],[v] 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.[vi]