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.

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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.

On August 27, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the following conferences (Press release, PTC Therapeutics, AUG 27, 2021, View Source [SID1234586962]):

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Morgan Stanley Virtual 19th Annual Global Healthcare Conference
Friday, September 10th at 11:00 a.m. ET

2021 Cantor Virtual Global Healthcare Conference
Monday, September 27th at 3:30 p.m. ET

The presentation will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

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.

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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 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]).

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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 Immix Biopharma, Inc. ("ImmixBio") reported a clinical trial and supply agreement with BeiGene, Ltd. to evaluate the safety, tolerability and efficacy of combining IMX-110, a Tissue Specific Therapeutic with TME Normalization Technology, with BeiGene’s anti-PD-1 antibody tislelizumab, for the treatment of various solid tumors, in the U.S. and internationally (Press release, Immix Biopharma, AUG 27, 2021, View Source [SID1234586965]).

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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.

"ImmixBio is proud to showcase our Tissue Specific Therapeutics (TSTx) platform to the world. Promising data from our ongoing IMX-110 clinical trial, from pre-clinical studies in a genetic mouse model of pancreatic cancer showing IMX-110 turning "cold" tumors "hot," and IMX-110 in combination with murine anti-PD-1 demonstrating extended survival in a genetic mouse model of pancreatic cancer versus multi-drug combinations in the literature, have demonstrated substantial rationale to combine IMX-110 and tislelizumab," said Ilya Rachman, MD, PhD – ImmixBio CEO. "We have high hopes that IMX-110 in combination with tislelizumab could expand the population of cancer patients experiencing extended remissions."

About IMX-110

IMX-110 is a Tissue-Specific Therapeutic built on ImmixBio’s TME Normalization Technology encapsulating a poly-kinase inhibitor and apoptosis inducer delivered deep into the tumor micro-environment, or TME. ImmixBio’s TME Normalization Technology enables IMX-110 to circulate in the bloodstream, then exit through porous tumor blood vessels, and accumulate in the TME. IMX-110 then simultaneously attacks all 3 components of the TME (cancer associated fibroblasts, or CAFs; tumor-associated macrophages/immune cells, or TAMs, and cancer itself), severing the critical lifelines between the tumor and its metabolic and structural support. IMX-110’s TME Normalization Technology causes tumor apoptosis, a non-inflammatory tumor-cell death (vs. necroptosis, which results in repeat reignition of the inflammatory cascade leading to tumor progression).

IMX-110 is currently being evaluated in a phase 1b/2a open-label, dose-escalation/dose-expansion safety, tolerability and pharmacokinetic study in patients with advanced solid tumors in the United States and Australia.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab market authorization in four indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab is not approved for use outside of China.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.