On April 26, 2021 InnoCare Pharma reported The 2021 edition of the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines (hereinafter referred to as the "Guidelines") was released recently (Press release, InnoCare Pharma, APR 26, 2021, View Source [SID1234578432]). InnoCare’s novel BTK inhibitor orelabrutinib was listed as a Level I recommended treatment for relapsed or refractory (r/r) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and r/r mantle cell lymphoma (MCL).

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In addition, for r/r diffuse large B-cell lymphoma (DLBCL), the Guidelines recommend that BTK inhibitors be considered to be used in combination with chemotherapy, and specifically mentioned that innovative drugs such as orelabrutinib be recommended for single or combinational therapy for r/r DLBCL based on preliminary efficacy in clinical studies. For primary central nervous system lymphoma (PCNSL), BTK inhibitor orelabrutinib demonstrates good blood-brain barrier penetration. The Guidelines recommend BTK inhibitors to be used in combination with chemotherapy, and specifically pointed out that orelabrutinib is expected to show efficacy in the treatment of PCNSL.

The Guidelines are aimed at further promoting the standardization of lymphoma diagnosis and treatment in China.

Professor Jun Ma, Chairman of the CSCO Board of Supervision and Director of the Harbin Institute of Hematology, said: "Lymphoma is one of the top ten most common tumors in China, and it is also the fastest growing hematological malignant tumor in recent years. The five-year survival rate of lymphoma patients in China still lags behind that of U.S. and Europe. Therefore, it is very important to standardize the diagnosis and treatment. The CSCO Guidelines not only reflect the continuous improvement of drug research and development in China, but also contribute to the standardization of lymphoma diagnosis and treatment, which will benefit patients."

Professor Jun Zhu, Executive Director of the CSCO, Director of the Lymphoma Department of Peking University Cancer Hospital, said: "As the principal investigator of orelabrutinib, I am very pleased that orelabrutinib has been recognized by the experts and recommended by the Guidelines. As a lymphoma physician, we can provide Chinese patients with better anti-tumor drugs, so that our patients can obtain greater benefit. This is what we have been striving for."

"Orelabrutinib was recommended by the CSCO Guidelines four months after its approval, which demonstrates the recognition for orelabrutinib by CSCO experts. With the further improvement of research and development, we believe that our lymphoma diagnosis and treatment can be further refined and standardized to better benefit patients in China." said Dr. Jasmine Cui, co-founder, chairwoman and CEO of InnoCare.

Orelabrutinib is a novel BTK inhibitor with high target selectivity. It was approved for marketing by the National Medical Products Administration (NMPA) of China on December 25, 2020 for the treatment of patients with r/r CLL/SLL and r/r MCL.

On April 25, 2021 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization and TG Therapeutics (NASDAQ: TGTX), reported an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody (Press release, Samsung BioLogics, APR 25, 2021, View Source [SID1234578437]). TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQ (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with CLL, based primarily on the positive results from the UNITY-CLL Phase 3 trial. Ublituximab was also the subject of two successful Phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS) and a BLA is currently being prepared for this indication.

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Samsung Biologics and TG Therapeutics Expand Collaboration for the Large Scale Manufacture of Ublituximab
"We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities," John Rim, CEO of Samsung Biologics, commented. Rim added, "By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world and getting a step closer to our vision of bringing about a better life for humanity."

Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics, stated, "Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications. With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our long-standing relationship with Samsung."

In order to support all its current and potential clients around the world, Samsung Biologics is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire bio-CMO capacity globally. The company provides contract manufacturing, contract development, and testing services all from a single location, offering end-to-end services for its clients.

ABOUT UBLITUXIMAB
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

On April 25, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported the initiation of the Phase 2b study of the company’s lead drug candidate, STP705, for the treatment of squamous cell skin cancer (Press release, Sirnaomics, APR 25, 2021, View Source [SID1234578436]).

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The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of intralesional injection of STP705 in 100 adult patients with squamous cell carcinoma in situ (isSCC). This is a two-part dose escalation trial; in the run-in period, the 30 ug and 60 ug dosing regimens from the Phase 2a study of STP705 will be further evaluated, in addition to a third new dose level. The second part of the trial will further evaluate the two most efficacious dosing regimens. The primary endpoint of this trial is the proportion of participants with histological clearance of treated isSCC lesion at the end of treatment. Histological clearance will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

"In the recently concluded Phase 2a clinical trial of STP705 in isSCC, a high rate of patients achieved histological clearance in a dose dependent manner, which is the gold standard for skin cancer," said Patrick Lu, Ph.D., the founder, President and CEO of Sirnaomics. "As we initiate the Phase 2b trial, we are hopeful to learn more about the potential of this non-surgical, non-invasive treatment for common non-melanoma skin cancer, and more broadly the promise of RNAi therapeutics in oncology."

"isSCC continues to be a disease with high unmet therapeutic need where surgery is still considered the only viable treatment option for many patients," said Michael Molyneaux M.D., Chief Medical Officer of Sirnaomics. "We hope to build on the success we have seen in the Phase 2a study, where we achieved 90% histological clearance rates in the 30 ug and 60 ug dosing groups. We anticipate having an interim data readout late second half of 2021 that will guide our clinical development for this indication."

Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04844983.

About Non-melanoma Skin Cancer and Squamous Cell Carcinoma In Situ
Skin cancer is the most common type of all cancers diagnosed each year in the United States. It is estimated that nearly half of cancers diagnosed every year will be skin cancers. Over the past decade, the incidence of skin cancers has increased dramatically. According to the JAMA Dermatology paper (Rogers, et. al. JAMA Dermatol. 2015151(10):1081-1086), an estimated 3.3 million people in the US suffer from non-melanoma skin cancer (NMSC) along with 5.43 million people that are currently living with cancer lesions. Data on specific types of NMSC were 2.55 million cases for basal cell carcinoma (47%): 2.57 million cases for squamous cell carcinoma including squamous cell carcinoma in situ (46.7%), plus another 332,000 cases of unspecified type of skin cancers.

A World Health Organization authorized report from "International Agency for Research on Cancer" (2019) has demonstrated that the number of deaths in 2018 globally for both men and women from NMSC is 65,155, where the mortality of Asia NMSC patients represents 41.9% of the global total, significantly more than other individual areas.

Squamous cell carcinoma in situ, also called Bowen disease, is the earliest form of squamous cell skin cancer (SCC). Along with basal cell carcinoma, SCC is one of two major subtypes of NMSC. The key driver for development of SCC is ultraviolet rays from the sun. It is believed that development of SCC is linked closely to genomic perturbations, genetic mutations, and altered expression of key molecules (e.g., overexpression of TGF-β1 and COX-2) that impacts squamous cell lineage commitment and terminal differentiation.

Surgery is the currently the most common treatment option for the treatment of NMSC. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. Surgery can also have a significant recurrence rate. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective.

About STP705
Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of cholangiocarcinoma, nonmelanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma and primary sclerosing cholangitis. STP705 is currently in four clinical trials for different indications. A Phase 2a study of STP705 for treatment of squamous cell skin cancer (isSCC) in adult patients demonstrated positive efficacy and safety results, with 76% of all patients (19/25) achieving complete histologically clearance and the two optimal dosing ranges achieving 90% histological clearance of tumor cell in the lesion. No significant or serious adverse events, including no significant cutaneous skin reactions, were reported in the study, and the company was able to define a clear therapeutic window in advance of later stage studies.

On April 24, 2021 CiMaas reported that it is successful in expanding Natural Killer cells obtained from a small population in peripheral blood into very high numbers in just 2 weeks (Press release, CiMaas, APR 24, 2021, View Source [SID1234578431]). This is directly applicable for clinical application in anti-cancer therapy.

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CiMaas is actively working on multiple myeloma and breast cancer, but realises the NK cells can be used for many indications outside its’ own expertise where people are also desperately awaiting new therapies.

As CiMaas believes in collaboration, CiMaas would like to provide these cells to research groups that are interested in studying them in their in vitro cancer research and in vivo tumour models. CiMaas is also open for clinical partnerships to embark on other cancer types using NK cells produced under GMP compliancy.

On April 23, 2021 Prescient Therapeutics (PTX) reported that it will progress to the next dose level of its Phase 1b clinical study of PTX-200 and cytarabine in patients with acute myeloid leukemia (AML) (Press release, Prescient Therapeutics, APR 23, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-continues-to-advance-ptx-200-aml-trial [SID1234578472]).

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In August last year, the company announced patients had successfully completed the first round of dosing at 25 milligrams per square metre (mg/m2) PTX-200.

Now, the second cohort at 35 mg/m2 PTX-200 has also passed with no dose limiting toxicities observed.

Under a revised study protocol, the treatment is administered on day one, and cytarabine is administered by continuous infusion on days three to seven of a 21-day cycle.

Following a review of the safety data from this cohort with the study investigators, the next cohort is open for enrolment which will be an increased dose level of 45 mg/m2 PTX-200.

AML is a cancer of the bone marrow that prevents formation of normal blood cells.

Around 158,000 patients globally suffer from this type of cancer, which has poor survival rates.

Prescient’s Chief Medical officer Dr Terrence Chew says the disease is very difficult to treat, especially after relapse when patients are often too sick to endure vigorous treatment.

"It is therefore pleasing to see the completion of this cohort without dose limiting toxicities, suggesting that AML patients are able to better tolerate the combination of PTX-200 and cytarabine under the modified protocol," he said.

PTX-200 is a novel PH domain inhibitor that blocks an important tumour survival pathway known as Akt, which plays a key role in the development of many cancers, including leukemia.

PTX-200 is different to other drug candidates as it has a novel mechanism of action that specifically inhibits Akt and is said to be safer.

The study is led by world-renowned leukemia expert Professor Jeffrey Lancet at the H. Lee Moffitt Cancer Center in Florida, Associate Professor Tara Lin at the University of Kansas Medical Center is also participating in the study.

Shares are 8.2 per cent higher trading at 10.5 cents each at 10:08 am AEST.