On March 31, 2022 Gnubiotics Sciences SA, a biotech company pioneering immunomodulatory glycopeptides reported a poster presentation on the use of Glycopeptides to promote anti-cancer immune response against solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, scheduled for April 8-13, 2022 in New Orleans, Louisiana (USA) (Press release, Gnubiotics Sciences, MAR 31, 2022, View Source [SID1234611322]).

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"Our poster presentation at the AACR (Free AACR Whitepaper) will showcase the immunomodulatory and therapeutic potential of our proprietary glycopeptide assets to boost directed anti-tumor immune responses in anti-PD-1 resistant solid tumors. Our innovative Glycopeptides with Tumor and Antigen Associated Delivery (GLAAD) technology has been shown to have the power, through molecular mimicry, to reduce tumor size, either in combination with existing anti-PD-1 treatment or as a monotherapy. The pre-clinical study carried out in collaboration with the University of Zurich indicates that GLAAD treatment may be a safe and effective strategy to potentiate immune checkpoint inhibitor (ICI) therapies in a resistant setting. We expect our GLAAD approach to have a broader utility in immuno-oncology treatments, for example in enabling the efficacy of CAR-T therapies against solid tumors." stated Yemi Adesokan, Ph.D., Gnubiotics` Chief Executive Officer.

The authors on the poster are: Marianne R. Spalinger, Romain Wyss, Sara Vidal, Yong Miao, Michael Scharl, Yemi Adesokan.

The Poster, abstract number 5600, will be made available for browsing on April 8, the first day of the AACR (Free AACR Whitepaper) Annual Meeting 2022 and will remain available for viewing through July 13. Viewers will have the possibility to e-mail questions

On March 31, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma (Press release, JW Therapeutics, MAR 31, 2022, View Source [SID1234611321]).

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B-cell lymphoma is a group of malignant B-cell monoclonal amplified heterogeneous malignancies, accounting for approximately 85% of non-Hodgkin lymphoma (NHL)[1]. Large B-cell lymphoma (LBCL) is the most common subtype of NHL world-wide, accounting for 35% to 50% of all newly diagnosed cases in China[2]. 50% of patients could be cured by current standard of care (R-CHOP) chemotherapy[3]. Nevertheless, R-CHOP was found to be inadequate in 30% to 40% patients[4]. R-CHOP failures were principally due to either primary refractoriness or relapse after reaching a complete response (CR), resulting in little benefit for those failure patients from conventional chemotherapy. Previous study demonstrate that for patients who could not achieve CR or maintain CR less than one year, overall response rate (ORR) of received second-line treatment was about 29%, median progression-free survival (PFS) was about 3 months, and median overall survival (OS) was about 10 months[5]. High unmet medical needs are to be addressed for those patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) from first-line treatment.

This is a multi-centre, randomized, open label phase 3 study to compare the efficacy and safety of Carteyva to standard second-line therapy in adult subjects with relapse/refractory large B-cell lymphoma (r/r LBCL), not reaching CR after first-line therapies (including anthracyclines and rituximab or other CD20-targeted agents) or relapsed within 12 months of CR. Eligible adults will be randomized at the 1:1 ratio to control group and Carteyva group. Subjects in the control group will receive standard second-line therapy. Subjects in the Carteyva group will receive 100×106 CAR+ T cell Carteyva infusion. The primary endpoint is event-free survival (EFS) assessed by Independent Review Board (IRC), and the secondary endpoints include complete response rate (CRR), PFS, OS, duration of response (DOR), pharmacokinetics, and safety.

References

张慕晨;赵维莅;;B细胞淋巴瘤之治疗展望[J];中国肿瘤临床;2016年14期
中华人民共和国国家卫生健康委员会，淋巴瘤诊疗规范，2018年
Sehn, L. H., & Gascoyne, R. D. (2015). Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood, 125(1), 22-32. doi:10.1182/blood-2014-05-577189
Coiffier, B., & Sarkozy, C. e. (2016). Diffuse large B-cell lymphoma: R-CHOP failure-what to do? Hematology Am Soc Hematol Educ Program, 2016(1), 366-378.
van Imhoff, G. W., McMillan, A., Matasar, M. J., Radford, J., Ardeshna, K. M., Kuliczkowski, K., Hagenbeek, A. (2017). Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD Study. J Clin Oncol, 35(5), 544-551. doi:10.1200/JCO.2016.69.0198
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.

About JWCAR029-010 Study

This is a randomized multicenter phase 3 trial to compare the efficacy and safety of Carteyva to standard of care in adult subjects with high-risk, relapsed in 12 months or refractory from first-line treatment (including anthracyclines and rituximab or other CD20-targeted agents), aggressive r/r LBCL.

On March 31, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13, 2022 at 2:15 p.m. Eastern Time (Press release, Personalis, MAR 31, 2022, View Source [SID1234611320]).

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On March 31, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported financial results for the full year ending December 31, 2021 and highlighted its key corporate objectives for 2022 (Press release, 4d Pharma, MAR 31, 2022, View Source [SID1234611319]).

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"2021 was a productive year for 4D pharma. We reported promising signals in the clinic from our lead candidates in immuno-oncology and inflammatory disease, and entered into our second clinical collaboration in oncology, further validating the potential for single strain Live Biotherapeutics to treat systemic disease and the MicroRx platform. Additionally, we completed the merger with Longevity Acquisition Corporation which led to 4D pharma being listed on the NASDAQ exchange, providing us access and visibility across the US capital markets," said Duncan Peyton, Chief Executive Officer of 4D pharma. "Already in 2022 we have continued this progress, and look forward to updating shareholders as we execute on our corporate objectives throughout the year."

Full Year 2021 Financial Highlights

Cash and cash equivalents of $21.0 million as of December 31, 2021
Net assets of $32.4 million as of December 31, 2021
Loss and total comprehensive income for the full year 2021 was $32.1 million
Research and Development Expenses was $21.6 million; General and Administrative Expense was $15.9 million
Listed on the NASDAQ Global Market under ticker symbol ‘LBPS’ after completing the merger with Longevity Acquisition Corporation, a special purpose acquisition company (SPAC) on March 22, 2021
Full Year 2021 Operational Highlights

Provided an update on the ongoing clinical trial portfolio for lead oncology candidate MRx0518. This included the first announcement of signals of anti-tumor activity for the combination of MRx0518 with Keytruda in bladder cancer, adding to the previously reported activity in renal cell carcinoma and non-small cell lung cancer.
Announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., under which 4D pharma will conduct a clinical trial to evaluate MRx0518 in combination with Bavencio (avelumab), an anti-PD-L1 immune checkpoint inhibitor, as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This study is expected to commence in 2022.
Presented additional clinical mechanistic data for MRx0518 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, as both a monotherapy and in combination with Keytruda (pembrolizumab). The results identified baseline biomarkers associated with clinical benefit in patients with solid tumors resistant to immune checkpoint inhibitors (ICIs) treated with MRx0518 in combination with pembrolizumab; and gene and metagene signature changes in solid tumors following treatment with MRx0518 monotherapy.
Presented further analyses of the completed Phase II clinical trial of Blautix in patients with irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D) at Digestive Disease Week (DDW) 2021. The post-hoc analyses revealed strong and statistically significant activity on the key symptom of bowel habit, a potential FDA-approvable primary endpoint. In addition, analysis of the data by geographical region shows that earlier topline results were impacted by an unusually high placebo response in patients in the UK and Ireland, and enhanced positive signals were seen in the larger US population.
Subsequently, the company presented additional mechanistic clinical data for Blautix at Gastro 2021. The results show treatment with Blautix led to structural changes in the gut microbiota and greater increases in interconnectivity between taxa than placebo, in patients with both IBS-C and/or IBS-D.
Reported topline results from Part A of our Phase I/II randomized, double-blind, placebo-controlled clinical trial of MRx-4DP0004 as a treatment for asthma. Part A met the primary endpoint showing MRx-4DP0004 was safe and well tolerated. In addition, MRx-4DP0004 generated promising signals of clinical activity which support progression into Part B of the study.
Published preclinical research relating to second-generation immuno-oncology LBP MRx1299 improving the activity of CAR-T in animal models of cancer, in collaboration with Philipps-University Marburg, Germany, and Universitätsklinikum Würzburg, Germany.
Completed the merger with special purpose acquisition company (SPAC) Longevity Acquisition Corporation and concurrent private placement, raising total gross proceeds of approximately $39.8 million.
Entered into a senior secured credit facility for up to $30 million with Oxford Finance LLC, including the initial drawdown of the first tranche for $12.5 million, with the remaining $7.5 million and $10 million tranches dependent on the achievement of certain milestones.
Announced the appointments of Paul Maier as Non-Executive Director and John Beck as Chief Financial Officer (CFO). Later in the year the Company was saddened to announce the passing of John Beck.
Subsequent Events Since the 2021 Period End

On January 3, 2022 announced the appointment of John Doyle as Chief Financial Officer (CFO)
On February 22, 2022, the Company announced that the U.S. Food and Drug Administration (FDA) has cleared investigational new drug (IND) applications for MRx0005 and MRx0029 for the treatment of Parkinson’s disease. The Company expects to initiate a first-in-human Phase I clinical trial in people with Parkinson’s disease in mid-2022.
On March 23, 2022, the company announced that in Part B of the ongoing Phase I/II study of MRx0518 and Keytruda in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group met its primary efficacy endpoint ahead of enrolment completion.
Anticipated Development Milestones and Key Objectives for 2022

First patient dosing in our Phase II study of MRx0518 & Bavencio as a first-line maintenance therapy for urothelial carcinoma expected in Q2 2022
Complete enrollment of Phase I study of MRx0518 in pancreatic cancer expected to be Q2 2022
Presentation of data from the Phase I/II Part A Study in Asthma at The American Thoracic Society conference in May 2022
Part B of ongoing Phase I/II trial of MRx-4DP0004 in asthma, expected to commence in 2H 2022
Phase I trial of MRx0005 and MRx0029 in people with Parkinson’s disease expected to commence in 2H 2022
Provide update and guidance on Phase II study of Blautix in patients with irritable bowel syndrome (IBS)
Provide update on next steps in Phase I/II study of MRx0518 and Keytruda in the Renal Cell Carcinoma (RCC) group

On March 31, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that unaudited net revenue for 2021 of $61.2 million and cash and cash equivalents as of December 31, 2021 of approximately $28 million (Press release, Biocept, MAR 31, 2022, View Source [SID1234611318]).

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"Revenue reached a record high in 2021, up 123% over the prior year driven primarily by RT-PCR COVID-19 testing. As anticipated, we are currently experiencing a decline in COVID-19 testing demand as the unpredictable pandemic begins shifting to an endemic stage. Also, in the fourth quarter of 2021 we once again achieved sequential-quarter volume growth for CNSide, our proprietary cerebrospinal fluid assay for the detection and monitoring of cancer involving the central nervous system," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "We anticipate reporting positive cash flow from operations for 2021 and ended the year with a cash balance of approximately $28 million."

As a result of the restatement of financial results for the quarter ended September 30, 2021, the implementation of additional accounting review and control procedures, and resource constraints, the accounting review of Biocept’s financial statements as of and for the year ended December 31, 2021 is ongoing. Biocept is filing a notification of late filing on Form 12b-25 with the Securities and Exchange Commission, which provides an automatic 15-day extension of the filing deadline for its Annual Report on Form 10-K for the year ended December 31, 2021, to April 15, 2022. The net revenue and cash and cash equivalent data presented in this news release should be considered preliminary and could be subject to change as the company’s independent registered public accounting firm has not completed its audit. Biocept anticipates filing its Form 10-K for the year ended December 31, 2021 by April 15, 2022 or as soon as practicable.