On MAY 9, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, reported that, in connection with the $50 million share buyback programme announced on 5 May 2022, it is now commencing purchases of the Company’s ordinary shares of one pence each ("Ordinary Shares") (the "Programme") (Press release, PureTech Health, MAY 9, 2022, View Source [SID1234613864]). The Programme will be carried out in tranches and is in line with the Company’s previously announced capital allocation strategy to balance investment in the continued growth of its business with potential returns of capital to shareholders.1

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PureTech plans to execute the buyback in two tranches. In respect of the first tranche, PureTech announces that it has entered into an irrevocable non-discretionary instruction with Jefferies International Limited ("Jefferies") in relation to the purchase by Jefferies, acting as principal during the period commencing on 9 May 2022 and ending on the earlier of exhaustion of funds associated with the first tranche or 8 May 2023 (subject to any regulatory objections or concerns), of Ordinary Shares for an aggregate consideration (excluding expenses) of no greater than $25 million and the simultaneous on-sale of such Ordinary Shares by Jefferies to PureTech. Jefferies will make its trading decisions in relation to the Ordinary Shares independently of, and uninfluenced by, the Company. Purchases may continue during any close period to which the Company is subject. It is anticipated that the second tranche, subject to a separate instruction, will commence promptly on completion of the first tranche, subject to renewal of the requisite authority at the 2022 AGM.

The maximum number of Ordinary Shares that can be purchased under the first tranche of the Programme is 28,589,874 Ordinary Shares (being the maximum number of shares the Company is authorised to purchase pursuant to the authority granted by shareholders at the Company’s annual general meeting held on May 27, 2021).

The purpose of the Programme is to return capital to shareholders in line with the Company’s capital allocation strategy and to enable the Company to meet obligations arising from employee share option programmes, or other allocations of shares to employees of the Company or to members of the administrative, management or supervisory bodies of the Company, or an associate of the Company. Any shares repurchased for this purpose will be held in treasury.

Any purchase of Ordinary Shares under the first tranche of the Programme will be carried out on the London Stock Exchange and any other UK recognised investment exchange which may be agreed, in accordance with pre-set parameters and in accordance with, and subject to limits, including those limits related to daily volume and price, prescribed by the Company’s general authority to repurchase Ordinary Shares granted by its shareholders at its most recent annual general meeting on May 27, 2021, Chapter 12 of the Financial Conduct Authority’s UK Listing Rules, Article 5(1) of Regulation (EU) No. 596/2014 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018) and Commission Delegated Regulation (EU) 2016/1052 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018).

PureTech will announce any market repurchases of Ordinary Shares no later than 7.30 a.m. BST on the business day following the calendar day on which the repurchase occurred.

On May 9, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinicalstage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported positive interim results from its Phase 2 VB C-02 trial of VB10.16, its wholly-owned therapeutic cancer vaccine, in combination with the PD-L1 inhibitor atezolizumab in patients with HPV16-positive advanced cervical cancer (Press release, Nykode Therapeutics, MAY 9, 2022, View Source [SID1234613862]). Interim results from 39 patients with a median follow up of 6 months show an ORR of 21%—including two patients who achieved a complete response and six who achieved a partial response—and a very high disease control rate of 64%. The trial enrolled a heavily pre-treated patient population with more than two thirds of the patients having received at least two previous systemic lines of treatment.

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Interestingly, anti-tumor activity was observed in both PD-L1 positive (ORR of 27% and DCR of 77%) and PD-L1 negative patients (ORR of 17% and DCR of 58%) indicating a potential clinical benefit also in the PD-L1 negative population. In addition, a DCR of 71% was observed in patients with noninflamed tumors, including both immune desert and T cell excluded tumors. Together these findings suggest a differentiated anti-tumor response pattern of the combination treatment compared to checkpoint inhibitor monotherapy.

"We are thrilled to report these positive interim safety and efficacy results from our Phase 2 trial with VB10.16, which showed evidence of durable anti-tumor activity in a heavily pre-treated population of patients with late-stage cervical cancer," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. "These interim results support Nykode’s unique approach of targeting AntigenPresenting Cells (APCs), designed to produce a robust and long-lasting CD8 killer T cell response against cancer cells. We look forward to reporting updated efficacy data readouts from the Phase 2 trial during the first half of 2023 as we continue to advance our cervical cancer program."

Immunological analyses of the peripheral T cell responses demonstrated an increased HPV16-specific IFN T cell immune response post-vaccination in the majority of subjects and were associated with clinical efficacy indicating the induction of clinically relevant T cell responses. Clearance of circulating HPV16 DNA was significantly correlated with clinical response and progression free survival suggesting ctDNA may be an early marker of response to treatment in cervical cancer. VB10.16 is potentially a first-in-class therapeutic vaccine against HPV16-positive cervical cancer.

"The patients who were treated with VB10.16 in combination with atezolizumab in the C-02 trial were heavily pre-treated and are prone to progress quickly," said Professor Peter Hillemanns, Director of the Departments of Gynecology, Obstetrics and Breast Cancer at Hannover University Hospital, Germany and principal investigator of the C-02 trial. "It is very encouraging to see that a majority of patients experienced a clinical benefit and that many patients had durable responses. The combination of VB10.16 and atezolizumab was also well tolerated by patients."

"Treatment advances within the area of advanced cervical cancer have been limited though checkpoint inhibitors have demonstrated clinical efficacy in some patients. The unmet need is still high, and we are very pleased to see a high disease control rate and durable responses in these heavily pre-treated HPV16+ cervical cancer patients. The anti-tumor activity seen in both noninflamed and PD-L1 negative populations may potentially open up a new subset of patients for treatment. These findings indicate that VB10.16 may give a meaningful added clinical benefit compared to the existing standard of care treatment in this setting. We would like to thank all the investigators, patients and their relatives for participating in this trial. Without all of you the advances of VB10.16 would not have been possible," added Siri Torhaug, Chief Medical Officer of Nykode Therapeutics.

VB10.16 was generally safe and well tolerated, with 10% of patients experiencing Grade 3 or more treatment-related adverse events, indicating no increased toxicity compared with atezolizumab monotherapy and a favorable safety profile that is consistent with previously published data for the Nykode DNA vaccine technology platform. Nykode expects to report updated efficacy data read-outs from VB C-02 during the first half of 2023. Webcast Investors and analysts are invited to join a webcast presentation of the interim results conducted by CEO Michael . The slide presentation will be available in the Investors section of the Company’s website at View Source following the event. The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website at View Source/financial-reports-and-presentations.

About the VB C-02 trial VB C-02 is a multi-center, single arm, open-label Phase 2 trial of patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. Patients received treatment with VB10.16 in combination with the PD-L1 inhibitor atezolizumab for up to one year. The main aim of the trial was to assess the efficacy, immunogenicity and safety of VB10.16 when given in combination with atezolizumab. The trial is now fully enrolled with 52 patients enrolled at sites in Europe, and the preplanned second interim analysis was performed at the cut-off date of 14 February 2022. Nykode has previously reported positive interim safety data from the trial. Additional information about the VB C-02 trial is available at clinicaltrials.gov (NCT04405349).

About VB10.16
VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody technology platform of targeting antigens to antigen presenting cells. The candidate has demonstrated favorable clinical data in a Phase I/IIa study in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. VB10.16 is currently being investigated in the VB C-02 trial in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer.

About cervical cancer
Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma (arising from cells lining the bottom of the cervix) and most other patients have adenocarcinomas (arising from glandular cells in the upper cervix). Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread.

On May 9, 2022 Eurofins Scientific (EUFI.PA), a global scientific leader in bioanalytical testing, reported that it has successfully signed an agreement with Stichting PAMM Laboratoria voor Pathologie en Medische Microbiologie ("PAMM"), a medical microbiology and pathology laboratory diagnostics company in The Netherlands (Press release, Eurofins Scientific, MAY 9, 2022, View Source [SID1234613848]).

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PAMM serves 6 hospitals in The Netherlands, including 2 top-rated clinical oncology centers, general practitioners and independent treatment centers. The lab specializes in medical microbiology and pathology and was the first in The Netherlands to have implemented full digital pathology. PAMM employs over 265 employees and pathologists and will complement Eurofins’ industry-leading global clinical testing offering. Through combining forces, PAMM will be able to further improve quality to clients and service to patients in the Dutch healthcare system.

The agreement includes a commitment by Eurofins to invest in the laboratory, R&D, innovation, employee development and job security. The agreement has been approved by the Dutch Healthcare authority (NZa) and The Netherlands Authority for Consumers and Markets (ACM, Merger Control).

Comment from Dr. Gilles Martin, Eurofins CEO: "We are very pleased to welcome PAMM and its team of outstanding specialists and laboratory technicians to the Eurofins Group. This agreement reinforces the Group’s broad innovative test offering to hospitals and practitioners in The Netherlands, strengthens Eurofins geographic offering in the clinical testing market, and enhances our ability to deploy the latest scientific advances to benefit patients."

On May 8, 2022 InxMed Co., Ltd, a clinical-stage biotechnology company dedicated to developing innovative therapies targeting stroma microenvironment and drug resistance for hard-to-treat solid tumors, reported that it had completed $15 million in Series B+ Financing (Press release, InxMed, MAY 8, 2022, View Source [SID1234614002]). The Series B+ was funded by Hyfinity Investments.

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InxMed will use the funds to accelerate ongoing clinical trials of IN10018 for multiple cancer types in both US and China, including the initiation of pivotal trials in the second half year, and advance more stroma targeting pipelines into clinics in both US and China this year, and strengthen the R&D capabilities in Nanjing.

IN10018 is a potent and highly selective adenosine triphosphate competitive FAK inhibitor, and InxMed has its exclusive global development and commercial operation rights. InxMed Nanjing Translational Medicine Center has conducted extensive original exploratory research on IN10018 and FAK targets and has published research results in renowned academic journals. Early clinical data on IN10018 showed its safety and efficacy in multiple tumor types, and the latest research results and preclinical data demonstrated that IN10018 can also be effective in combination therapies. It is expected to overcome the tumor-associated fibrosis barrier and improve local immunity, and therefore has the potential to act as an important anchor molecule in synergy with different therapeutic modalities including immunotherapy, chemotherapy, and targeted therapy.

IN10018 received fast track designation from the U.S. Food and Drug Administration (FDA) in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA) for the treatment of patients with platinum-resistant ovarian cancer. The company plans to disclose more data on IN10018 at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June 2022.

"InxMed is focused on the development of innovative treatments to address the true global unmet medical needs. Our strategy is targeting the ecosystem fostered by tumor cells including tumor microenvironment to develop effective therapeutic regimens to combat or even cure cancer. We have built robust pipelines with different, yet complementary Mechanism of Actions, and promising preliminary efficacy data. Building partnership is also our important strategy to maximize the value of our assets, and we are actively exploring global partnership opportunities to accelerate more value inflections of IN10018 and other programs," said Dr. Zaiqi Wang, Founder and Chief Executive Officer of InxMed.

Dr. Xin He, managing partner of Hyfinity Investments, added, "InxMed’s vision and pipeline strategy aligns with the purpose of our fund. In past three years, InxMed has proven its value and potential through its capability of global innovation, strong execution, highly synergistic pipeline and encouraging clinical efficacy of IN10018. We think InxMed is well positioned to become the first-tier China-based biotechnology innovator with a global impact and we are pleased to partner with InxMed and provide our unreserved support all along."

On May 8, 2022 JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that it will present the latest clinical study data for Carteyva via poster presentations and online publication at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, JW Pharmaceutical, MAY 8, 2022, View Source [SID1234613850]).

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Title: Two-year follow-up result of RELIANCE study, a multicenter phase 2 trial of relmacabtagene autoleucel (Carteyva) in Chinese patients with relapsed/refractory large B-cell lymphoma
Format: Poster Presentation
Abstract number: 7529
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Presenter: Dr. Zhitao Ying

Title: Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) as second-line therapy for primary refractory Chinese patients with large B-cell lymphoma (LBCL): Results from an open-label, multicenter, single-arm phase I study
Format: Online publication
Abstract number: e19509
First author: Dr. Zixun Yan

Title: Relma-cel (JWCAR029) in relapsed and refractory B-cell non-Hodgkin lymphoma: A two-year survival update of a phase I study
Format: Online publication
First author: Dr. Zhitao Ying

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.