On August 29, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, reported that it will have multiple scientific data presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, held on September 16-21 (Press release, Innovent Biologics, AUG 29, 2021, View Source [SID1234586981]). These presentations include the data from Phase 3 trials of sintilimab in esophageal squamous cell carcinoma and gastric cancer which are disclosed for the first time, as well as results from studies of IBI310 (an anti-CTLA-4 monoclonal antibody) and pemigatinib1 (IBI375, an FGFR1/2/3 inhibitor).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of Innovent’s ESMO (Free ESMO Whitepaper) Congress 2021 presentations are as follows:

Cancer Type: Oesophagogastric Cancer
Topic: Sintilimab plus chemotherapy compared to placebo plus chemotherapy as first-line therapy in patients with advanced or metastatic esophageal squamous cell cancer: First Results of the Phase 3 ORIENT-15 Study
Presentation Type: Mini Oral
Abstract Number: LBA52
Researcher: Professor Lin Shen, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China

Cancer Type: Gastric Cancer
Topic: Sintilimab plus chemotherapy compared to placebo plus chemotherapy as first-line therapy for patients with unresectable or metastatic gastric or gastroesophageal adenocarcinoma: First Results of the Phase 3 ORIENT-16 Study
Presentation Type: Mini Oral
Abstract Number: LBA53
Researcher: Professor Jianming Xu, Department of Oncology, The Fifth Medical Center, Chinese PLA General Hospital

Cancer Type: Melanoma
Topic: IBI310 alone or in combination with sintilimab for advanced melanoma: updated results of a Phase 1 study
Presentation Type: e-Poster
Abstract Number: 1516
Researcher: Professor Jun Guo, Peking University Cancer Hospital & Institute, Beijing, China

Cancer Type: Cholangiocarcinoma
Topic: FGFR2 fusion and/or rearrangement profiling in Chinese patients with intrahepatic cholangiocarcinoma
Presentation Type: e-Poster
Abstract Number: 2064
Researcher: Professor Jian Zhou, Zhongshan Hospital, Fudan University, Shanghai, China

Cancer Type: Cholangiocarcinoma
Topic: Efficacy and safety of pemigatinib in Chinese patients with unresectable, advanced/ recurrent or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement that failed to prior systemic therapy
Presentation Type: e-Poster
Abstract Number: 1810
Researcher: Professor Jian Zhou, Zhongshan Hospital, Fudan University, Shanghai, China

On August 27, 2021 BeiGene (NASDAQ:BGNE) and Immix Biopharma reported a clinical trial and supply agreement to evaluate the safety, tolerability and efficacy of a combination of IMX-110 and tislelizumab for the treatment of various solid tumors (Press release, Immix Biopharma, AUG 27, 2021, View Source [SID1234587963]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, ImmixBio will evaluate the combination of IMX-110 with tislelizumab in a Phase 1/2a trial in patients with advanced solid tumors.

"We have high hopes that IMX-110 in combination with tislelizumab could expand the population of cancer patients experiencing extended remissions," ImmixBio CEO Ilya Rachman said.

On August 27, 2021 Johnson & Johnson reported that The National Institute for Health and Care Excellence (NICE) has published draft guidance stating that it does not recommend it’s Darzalex (daratumumab) plus bortezomib, thalidomide and dexamethasone, as a treatment option for untreated multiple myeloma in adults who are eligible for an autologous stem cell transplant (Press release, Johnson & Johnson, AUG 27, 2021, View Source [SID1234586980]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Currently, most individuals with this condition receive a combination of bortezomib plus thalidomide and dexamethasone (VTd) prior to their stem cell transplant.

Clinical trial evidence suggests that people treated with Darzalex plus bortezomib, thalidomide and dexamethasone live longer and have more time before their tumour progresses, compared to individuals treated with bortezomib plus VTd alone.

However, the UK regulatory body expressed concerns around the long-term effectiveness of the combination treatment, as well as its cost-effectiveness, which is ‘most likely’ higher than what NICE normally considers an acceptable use of NHS resources.

In 2020, the European Commission (EC) granted Darzalex combined with VTd a marketing authorisation for newly diagnosed, transplant eligible patients with multiple myeloma.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells. In Europe, more than 48,200 people were diagnosed with the disease in 2018, with more than 30,800 deaths related to the disease.

On August 27, 2021 Gilead Sciences and Bristol Myers Squibb Company reported that they are competing in the CAR-T space clinically and in the courts (Press release, Gilead Sciences, AUG 27, 2021, View Source [SID1234586979]). And Gilead won the most recent battle when a U.S. appeals court threw out a $1.2 billion ruling against the company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bristol Myers Squibb has alleged that Gilead and its Kite Pharma unit’s Yescarta (axicabtagene ciloleucel) infringed on the patent for its own CAR-T therapy, lisocabtagene maraleucel (liso-cel). BMS acquired Celgene, the parent company of Juno Therapeutics, in 2019 for $74 billion. Juno spun out of the Fred Hutchinson Cancer Research Center in 2013. In 2018, Celgene acquired Juno for $9 billion. The patent battle was over a Juno patent that it licensed from Memorial Sloan Kettering Cancer Center (MSKCC).

In February 2021, the FDA approved BMS’s liso-cel under the brand name Breyanzi for adults with certain forms of large B-cell lymphoma after two or more previous therapies.

Juno brought the original case against Kite in 2017. In 2019, a jury found that Kite willfully infringed on the Juno and MSKCC patent and awarded them $778 million. U.S. District Judge Philip Gutierrez increased the award to $1.2 billion last year in Los Angeles federal court.

The appeals ruling reversed the decision. BMS stated it disagreed with this ruling and would seek a review of the decision.

Chief U.S. Circuit Judge Kimberly Moore wrote for the three-judge appeals panel, which unanimously decided that the relevant parts of Juno’s patent were invalid. The decision stated that the sections of the patent had insufficient written description and details. The other two judges were Sharon Prost and Kathleen O’Malley.

In an oral argument in July, Judge Moore compared the patent’s description to attempting to identify a specific car by stating it has four wheels.

CAR-T (chimeric antigen receptor T-cell) therapy is where T-cells are isolated from a cancer patient, engineered in the laboratory by adding a gene for a chimeric antigen receptor (CAR), grown, then infused back into the patient. There, they become a living therapy highly tuned to attack the patient’s cancer.

Kite’s argument is built on a written description of the ‘190 patent, specifically around the single-chain antibody variable fragment (scFv). This fragment recognizes and binds to specific tumor antigens in order for a CAR-T cell to attack cancer cells. Kite’s argument was the patent was invalid because it covered "millions of billions of" possible scFv candidates without describing its specific structural features or specifics about which scFvs would function. In their argument, the written description wasn’t detailed enough to meet the requirements of the patent laws. The appeal judges agreed with the argument.

In the judges’ opinion, they wrote that the evidence doesn’t support the jury’s finding that the ‘190 patent "disclosed sufficient information to show the inventors possessed the claimed genus of functional CD19-specific scFvs as part of their claimed CAR. Without more guidance, in a vast field of possible CD19-specific scFvs with so few of them known, no reasonable jury could find the inventors satisfied the written description requirement."

The best-known examples of cell therapies are CAR-T products, such as Gilead Sciences/Kite’s Yescarta (axicabtagene ciloleucel) for non-Hodgkin lymphoma, acute lymphoblastic leukemia, mantle cell lymphoma, and other indications, and Novartis’ Kymriah (tisagenlecleucel), approved for acute lymphoblastic leukemia, chronic lymphoid leukemia, diffuse large B-cell lymphoma, as well as others.

Yescarta was developed by Kite Pharma. Gilead acquired Kite for $11.9 billion in 2017.

On August 27, 2021 Bio-Thera Solutions, Ltd. (688177.SH) and Hikma Pharmaceuticals PLC (LSE: HIK) reported that they have entered into a commercialization and license agreement to commercialize BAT2206, a monoclonal antibody that is a proposed biosimilar referencing Stelara (ustekinumab), in the United States (US) v(Press release, BioThera Solutions, AUG 27, 2021, View Source [SID1234586976]). BAT2206 is currently in a global Phase III clinical trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206. Hikma will have exclusive rights to commercialize the product in the US. The agreement also provides Hikma with a first-right-to-negotiate to add Europe (excluding CIS countries). Bio-Thera is eligible for an upfront payment of $20 million as well as further development and commercial milestones of up to $130 million.

"Partnering with Hikma to commercialize BAT2206, our ustekinumab biosimilar, further validates the high quality of the work performed at Bio-Thera," said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. "We are proud to expand our network of partners to include another great company like Hikma."

"This partnership provides us with a unique opportunity to enter the biosimilar market in the US, building on our position as a leading generic manufacturer in the US," said Siggi Olafsson, Chief Executive Officer of Hikma. "Tapping into the growth of the biosimilar market in the US has been an area of focus for Hikma. Our established commercial presence in the US market and Bio-Thera’s strong technical capabilities for the development and manufacturing of biological products are highly complementary and we are excited by the potential this partnership offers."

About BAT2206 (ustekinumab)

BAT2206 is a proposed biosimilar to Jansen’s Stelara which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis, among many other autoimmune diseases. Stelara is currently approved for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with MTX, the treatment of patients 6 years or older with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease (CD) in adults, and the treatment of moderately to severely active ulcerative colitis (UC) in adults.