On January 19, 2021 Kite Pharma reported that The UK’s National Centre for Health and Care Excellence (NICE) has recommended its CAR-T therapy Tecartus (autologous anti-CD19 transduced CD3+ cells) for the treatment of certain adult patients with relapsed or refractory mantle cell lymphoma (MCL) on the NHS (Press release, Kite Pharma, JAN 19, 2021, View Source [SID1234574191]).

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NICE’s technology appraisal committee has recommended Tecartus for use through the Cancer Drugs Fund (CDF) for patients in England and Wales.

The managed access agreement will allow NICE to collect more data on the therapy while patients can access the ‘cutting-edge’ cancer treatment.

NICE has asked for this further data because it found that there is not enough evidence on whether lymphoma patients receiving the CAR-T therapy can be cured.

The additional data will be collected on markers including progression-free survival, overall survival and the age of patients when treatment starts.

"This will help to reduce the uncertainty in the evidence while the treatment is used on NHS patients," said NICE.

NICE added that NHS England had received a confidential discount for use of the therapy from Kite.

The recommendation covers MCL patients who have previously received two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

Tecartus uses patient’s own white blood cells – which are re-engineered in a laboratory to enable them to recognise and attack cancer cells. These re-engineered white blood cells are then infused back into the patient.

"We are pleased to be able to recommend another revolutionary CAR T-cell therapy, this time for adults with mantle cell lymphoma, which represents a step forward for personalised medicine. Clinicians will be able to consider this innovative therapy for their patients because of joint working between NICE, NHS England and NHS Improvement and the company," said Meindert Boysen, deputy chief executive and director of NICE’s centre for health technology evaluation.

"CAR T-cell therapy is expensive. The treatment is specific to each individual and could be a potential cure for some, although it is early days. Our recommendation for Tecartus, on the Cancer Drugs Fund, means people can benefit while more data is collected," he added.

On January 19, 2021 WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, and Oxford BioTherapeutics Ltd. ("OBT"), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate based therapies, reported that OBT has selected a second bispecific program that will combine an anti-PD-L1 antibody with OBT’s immuno-oncology (IO) candidate, OX003 (Press release, Oxford BioTherapeutics, JAN 19, 2021, View Source [SID1234574189]). OBT will research and develop OX003/PD-L1, which employs WuXi Biologics’ proprietary bispecific antibody platform WuXiBody.

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"We are pleased to extend our IO partnership with WuXi Biologics, by combining a second bispecific antibody from WuXi Biologics’ proprietary bispecific platform with one of our leading clinical IO assets, OX003," said Dr. Christian Rohlff, CEO of Oxford BioTherapeutics. "This designation represents the second advancement of our immuno-oncology partnership with WuXi Biologics, in which we will research, develop and commercialize five novel bispecific antibodies for the treatment of several cancer types. Combining the potent immune stimulatory activity of OX003 with the ability to block PD-L1 in a single agent, OX003/PD-L1 has the potential to achieve broad utility across many solid and liquid tumor types while simultaneously improving the risk/benefit ratio, reducing costs and maximizing future commercial potential. This product is the second molecule with WuXiBody in our partnership, following the design of OX001/PD-L1, which is now entering pre-clinical development."

"We are glad that significant progress has been made from our strategic partnership with OBT, one of the earlier adopters of our proprietary WuXiBody platform," said Dr. Chris Chen, CEO of WuXi Biologics. "Globally the first WuXiBody based bispecific is in a phase I clinical trial. Broad applications of this innovative non-specific platform further validate our beliefs that this platform addresses most technical limitations of current bispecific technologies and has the potential to tremendously expedite bispecific development and reduce the cost of making these biologics. WuXi Biologics will continue to invest in developing next-generation technologies to transform biologics discovery, development and manufacturing."

About OX003R
OX003R is a unique immuno-modulatory receptor discovered by OBT to be highly expressed in tumor infiltrating lymphocytes (TILs) of ten different solid tumor types and in activated T cells. OBT has developed anti-OX003 as a humanized first-in-class antibody directed against the human extracellular domain of OX003R antigen. It shows a strong agonistic effect on activated CD8+ T cells promoting their proliferation, cytokine secretion, and cytolytic ability, and suppresses Treg function. The antitumor activity of OX003 is demonstrated by enhancement of cytotoxicity of tumor cells (including HCT116, MDA-MB-231, and BT474). OBT plans to investigate the safety, pharmacokinetics and efficacy of OX003 antibody therapy as a single agent in a Phase I clinical study in patients across a range of solid tumors, especially in human cancers that show the presence of TILs, including small cell lung cancer, non-small cell lung cancer, skin cancer, breast cancer.

About WuXiBody
WuXiBody is a leading proprietary bispecific antibody platform developed by WuXi Biologics. It can effectively break through the CMC barriers for many bispecific antibodies development with high expression yield, high stability, good solubility, and easy purification to homogeneity, expedite the process by 6-18 months and significantly reduce manufacturing costs, a limitation still faced by many other current bispecific platforms. WuXiBody Platform enables almost any mAb sequence pairs to be assembled into bispecific constructs, which are expected to have low immunogenicity risk and longer in vivo half-life. WuXiBody Platform also has a unique structural flexibility, which makes it convenient to build various formats with different combination of valencies (1+1, 1+2, 2+2) to meet the requirements of different target biologies.

On January 19, 2021 Pascal Biosciences, Inc. ("Pascal" or the "Company") (TSXV: PAS) (OTC:BIMUF), a biotechnology company that specializes in cancer drug discovery and development, reported that it has amended the terms of the non-brokered private placement (the "Private Placement") previously announced on November 2, 2020 (Press release, Pascal Biosciences, JAN 19, 2021, View Source [SID1234574141]). The new terms provide for issuance of up to 7,500,000 Units at a price of $0.10 per unit (each a "Unit") for gross proceeds of up to $750,000.00. Each Unit will consist of one common share and one common share purchase warrant (each a "Warrant"). Each Warrant will entitle the holder to purchase one additional common share of the Company at a price of $0.25 for a period of twelve months from the date of closing, subject to an acceleration clause which the Company may exercise once the Units are free of resale restrictions and if the Company’s shares are trading at or above a volume weighted average price of $0.40 for 10 consecutive trading days. The Warrants will expire upon 30 days from the date the Company provides notice in writing to the Warrant holders via a news release. Proceeds of the Private Placement may be subject to finder’s fees.

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Certain directors and officers of the Company intend to acquire the Units under the Private Placement. Any such participation would be considered to be a "related party transaction" as defined under Multilateral Instrument 61 -101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any shares issued to, or the consideration paid by such persons, will exceed 25% of the Company’s market capitalization.

The proceeds from the sale of Units will be added to working capital in furtherance of the Company’s business. The securities to be issued under the placement will be subject to a four-month hold period and the Private Placement is subject to the acceptance of the TSX Venture Exchange.

On January 19, 2021 Suzhou Sinovent reported that it completed a pre-IPO financing of at least $30 million in a round led by Oceanpine Healthcare Fund (Press release, Sinovent, JAN 19, 2021, View Source [SID1234574119]). Founded in 2016, Sinovent is a global biopharma that has 12 biologic products in development, five in clinical trials and another three molecules preparing to file INDs in China. Its lead program is a Wnt pathway porcupine inhibitor aimed at cancers of the digestive system, including colon cancer, esophageal cancer and gastric cancer. In August of last year, Sinovent completed a $145 million C round.

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On January 19, 2021 Turret Capital Management, a global investment and venture building firm focused on the healthcare industry, reported that it has signed a Definitive License Agreement with Genexine, inc.(KOSDAQ 095700), a South Korea-based Biotechnology company (Press release, Genexine, JAN 19, 2021, View Source [SID1234574118]). Under the terms of the agreement, Turret Capital has obtained global rights for selective indications to GX-P1. GX-P1 is a Phase I ready novel immunosuppressant agent that reduces the immune response by binding to PD-1 on activated T cells and thus inhibiting T cell activation; a mechanism that is opposite to that of an anti-PD-L1 immune checkpoint inhibitor typically used to treat cancer.

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The compound will be housed and developed within Egret Therapeutics, a subsidiary of Turret Capital, and will target clinical areas of unmet need in the area of acute subarachnoid hemorrhage. Daniel Chai, M.D., Executive Chairman of Egret Therapeutics and Managing Partner of Turret Capital, stated, "Our firm strives to develop and market the most compelling and innovative technologies to address large market opportunities in healthcare. We are excited to partner with Genexine on this Phase I ready asset and leverage our scientific and clinical expertise in Neurological diseases to better help patients that suffer from the debilitative and life-threatening conditions of stroke."

Sung Yung-Chul, Ph.D., Founder and CEO of Genexine stated, "We are excited about working with the team at Egret Therapeutics and leadership at Turret Capital. Through our partnership, we believe we can achieve maximal value for innovative products that have been developed within Genexine."

Under the terms of the agreement, Genexine will receive 5% of underlying Egret Therapeutics outstanding shares and be eligible to receive development and commercial milestones payments of up to $200 million USD.