On November 1, 2021 Incyte (Nasdaq:INCY) reported that multiple abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, held from November 10-14, 2021 in Washington, D.C and virtually (Press release, Incyte, NOV 1, 2021, View Source [SID1234594002]).

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"We look forward to presenting data from multiple programs within Incyte’s immuno-oncology portfolio at this year’s SITC (Free SITC Whitepaper) conference," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology, Incyte. "Data being presented from the retifanlimab POD1UM clinical program, including a late-breaking poster presentation highlighting results from the POD1UM-101 study; as well as results from a Phase 1 study evaluating an oral PD-L1 inhibitor in immune-checkpoint naïve patients with advanced solid tumors, demonstrate our commitment to addressing the needs of patients with historically difficult-to-treat cancers."

Key abstracts include:

Late-Breaking Poster Presentation

Retifanlimab (INCMGA00012) in patients with recurrent MSI-H or dMMR endometrial cancer: Results from the POD1UM-101 Study (Abstract #956. Saturday, November 13, 7:00 a.m. – 8:30 p.m. ET)

Oral Presentation

Phase 1 study of INCB086550, an oral PD-L1 inhibitor, in immune-checkpoint naive patients with advanced solid tumors (Abstract #529. Session: Concurrent Rapid Oral Abstract Presentation: Clinical. Saturday, November 13, 12:45 – 1:45 p.m. ET)

Poster Presentation

A Phase 2 Study of Retifanlimab in Patients With Advanced or Metastatic Merkel Cell Carcinoma (MCC) (POD1UM-201) (Abstract #545. Friday, November 12, 7:00 a.m. – 8:30 p.m. ET)

Full abstracts will be available on the SITC (Free SITC Whitepaper) website and in the Journal for ImmunoTherapy of Cancer (JITC) on November 9, 2021. More information regarding the conference is available on the SITC (Free SITC Whitepaper) website: View Source

Conference Call and Webcast

Incyte will host an analyst and investor conference call and webcast on Saturday, November 13, 2021 from 6:30 – 7:30 p.m. ET to discuss its oral PD-L1 clinical development program, including data from INCB86550 which has been accepted for oral presentation at the SITC (Free SITC Whitepaper) Annual Congress.

The live and archived webcast will be available via investor.incyte.com.

To access the conference call, please dial 877-407-3042 for domestic callers or +1-201-389-0864 for international callers (conference identification number 13724808). If you are unable to participate, a replay will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1-201-612-7415 (conference identification number 13724808).

On November 1, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that its license partner, China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharma, HKEX: 950) has submitted a NDA (new drug application) for the anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory to treat recurrent or metastatic cervical cancer (Press release, Sorrento Therapeutics, NOV 1, 2021, View Source [SID1234594001]). The NDA application has been accepted by China NMPA.

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In February 2021, Sorrento and Lee’s Pharma announced that socazolimab had been granted breakthrough designation by the NMPA. If approved by NMPA, this will be the first approved fully human antibody discovered and isolated from Sorrento’s proprietary G-MAB library. "This is a major step forward that demonstrates the power of discovery and development engines at Sorrento for producing proprietary biopharmaceuticals for unmet medical needs," said Dr. Henry Ji, Chairman and CEO of Sorrento.

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.
The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.

On November 1, 2021 Curaleaf International (the "Company") (formerly EMMAC Life Sciences Group), part of Curaleaf Holdings (CNSX:CURA), Europe’s largest vertically integrated cannabis company, reported its official rebrand to the European market (Press release, EMMAC Life Sciences, NOV 1, 2021, View Source [SID1234593994]). It has been three years to the day since the UK Government’s landmark decision to legalise cannabis-based products for medicinal use, paving the way for further significant developments to the cannabis sector. In this time Curaleaf International has experienced exponential growth in cannabis revenues, as the demand for premium medicinal cannabis continues to grow.

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Curaleaf International’s cannabis flower products and extracted cannabis-based products now supply five separate markets, including Germany, Europe’s largest market for medicinal cannabis which is expected to be worth over €840 million by 20251. In the UK, specifically over the last 12 months, the number of patients using the Company’s products have increased fivefold.

Building on the momentum within the European medicinal cannabis market, Curaleaf International expects to see significant regulatory change across Europe for adult use (recreational) cannabis over the coming years with expectations that the total European cannabis market will be worth €3.2 billion by 20251. Curaleaf International expects the trends to follow that of Canada and the USA, which both started with the legalisation of medicinal cannabis before moving to legalise cannabis for adult use. With a population of approximately 740 million people, Europe presents a greater market size than that of North America.

The potential commercial impact of cannabis legalisation in Europe is significant. One in 10 Europeans use cannabis every year, while a quarter of people admit to having used cannabis at least once in their lifetime. The annual sales in illicit market cannabis are estimated at around €11 billion1. As highlighted in The European Cannabis Report: 6th Edition1, it is projected that sales of adult-use cannabis will reach €200 million by 2023, coming close to €800 million in 2025. Taking into account growth in the recreational sector due to decreasing stigma and ease of access, Prohibition Partners increased their total market estimate from €800 million to €3.2 billion by 20251.

The Company expects that over the next three to four years significant regulatory changes will occur across the continent. Recent progress has notably occurred in Switzerland, the Netherlands, Italy and Germany. Since May 2021, Switzerland allows the sale of adult use cannabis under a trial basis. In Zurich, the country’s largest city, consumers will be allowed to buy cannabis products from pharmacies and social clubs.3 In the Netherlands, 10 licences have been issued for a recreational cannabis pilot project to supply 79 "coffee shops" in 10 municipalities. In Germany, the largest market in Europe for medical cannabis, the likely new coalition Government under the SPD, Greens and FDP parties are all in favour of legalising adult use cannabis. Additionally, Italy could be the first European nation to make adult use cannabis legal. The country is due to have a referendum proposing the legalisation of adult use cannabis in 2022, with an expected result of 57% voting in favour of legalising4, the potentially €8 billion market presents a lucrative opportunity for first movers such as Curaleaf International.

With the anticipated regulatory changes across Europe, Curaleaf International believes this is a pivotal moment for the European cannabis industry. The Company is uniquely positioned within Europe with a fully vertically integrated model, handling every aspect of the process from seed to shelf. The Company has two operating EU-GMP processing facilities and import and distribution capabilities in place in the UK and Germany.

Commenting on the European opportunity, Antonio Costanzo, CEO of Curaleaf International, said: "We have seen good growth in medicinal cannabis across Europe, and building on this momentum, the official launch of Curaleaf International has been designed to create a European cannabis platform to capitalise on the rapidly emerging opportunities that are accelerating in line with regulatory change and cultural acceptance. The landscape in Europe is changing and we can see similar clear patterns to the progress in North America for adult use cannabis. As the only established fully integrated cannabis company in Europe, our first mover advantage gives us complete control over the supply chain, and this, coupled with our science led approach leaves Curaleaf International best positioned to capitalise on this potentially enormous market."

On November 1, 2021 United Therapeutics Corporation (Nasdaq: UTHR) reported that Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, will provide an overview and update on the company’s business during a fireside chat session at the Credit Suisse 30th Annual Healthcare Conference (Press release, United Therapeutics, NOV 1, 2021, View Source [SID1234593988]).

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The session will take place virtually on Monday, November 8, 2021, from 8:50 a.m. to 9:30 a.m., Eastern Standard Time, and can be accessed via a live webcast on the United Therapeutics website at View Source An archived, recorded version of the session will be available approximately 24 hours after the session ends and can be accessed at the same location for 90 days.

On November 1, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported a collaboration with Guardant Health, a leading precision oncology company, focused on characterizing the prevalence of patients with advanced solid tumors bearing BRAF Class I, II and III alterations (Press release, Kinnate Biopharma, NOV 1, 2021, View Source [SID1234593987]). The study will also assess real-world clinical outcomes stratified by BRAF alteration class and by treatment type.

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"Currently, patients with Class II and III BRAF alterations have no available targeted therapies and represent a significant and potentially greater unmet clinical need than previously understood," said Richard Williams, MBBS, Ph.D., Chief Medical Officer at Kinnate. "With a focus on metastatic disease and longitudinal genomics data, GuardantINFORM has provided valuable insights into this important biomarker that will help us to guide the development of our lead BRAF candidate. We believe that this collaboration with Guardant Health will enable a deeper look at the occurrence rates of functionally distinct classes of BRAF alterations across patient groups and help advance our efforts to develop novel targeted therapies that improve their lives."

Preliminary analyses conducted utilizing the GuardantINFORM platform suggest that the prevalence of Class II and III alterations across patients with advanced and metastatic solid tumors screened via liquid biopsy-based comprehensive genomic profiling (CGP) is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations across all tumor types. When looking across common tumor types – Non-Small Cell Lung Cancer (NSCLC), Melanoma and Colorectal Cancer (CRC) – approximately 65%, 20% and 30% of oncogenic BRAF alterations, respectively, are BRAF Class II and III. In addition to NSCLC, Melanoma, and CRC, BRAF Class II and III alterations are also detected at substantial rates in other common and rare tumor types such as prostate, breast, duodenal adenocarcinoma, renal pelvis urothelial carcinoma, and cholangiocarcinoma. These findings, as well as other studies that will assess real-world clinical outcomes stratified by BRAF Class and by treatment, are planned for presentation at a future date.

"Analysis of large-scale, real-world clinical-genomic datasets has become a critical approach for our biopharmaceutical partners like Kinnate to gain unique insights into disease biology, prevalence, and clinical outcomes across diverse patient populations," said Daniel Simon, Senior Vice President of Biopharma Solutions at Guardant Health. "Through GuardantINFORM, we can provide our partners like Kinnate with a unique perspective into biomarkers such as BRAF that drive tumors for patient populations where there is greatest unmet need."

Kinnate is utilizing the GuardantINFORM platform which combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test which has been provided to more than 175,000 patients to date in the United States. Its robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers including NSCLC, Melanoma, Breast, CRC and Prostrate.