On February 8, 2021 Longevity Acquisition Corporation (NASDAQ: LOAC) (the "Company"), a publicly-traded special purpose acquisition company, reported that on February 8, 2021, 4D pharma plc (AIM: DDDD) ("4D pharma"), a pharmaceutical company leading the development of Live Biotherapeutic products ("LBPs") – a novel class of drug derived from the microbiome, and a business combination target of LOAC, has announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. for BAVENCIO (avelumab), the first and only immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (Press release, Longevity Biotech, FEB 8, 2021, View Source [SID1234574762]). BAVENCIO is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

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Under the collaboration, 4D pharma intends to commence a clinical trial in 2021 to evaluate BAVENCIO in combination with MRx0518 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.

"With this second clinical trial collaboration for MRx0518 with a leading immune checkpoint inhibitor, 4D is able to evaluate MRx0518 in a new combination and earlier treatment setting. Following the promising data already generated in combination with checkpoint inhibitor pembrolizumab in refractory patients, and MRx0518 monotherapy data demonstrating single agent immuno-modulation presented last year at SITC (Free SITC Whitepaper), this collaboration allows us to continue to build a broad understanding of the safety and efficacy of MRx0518 across a range of solid tumors and stages of disease," said Duncan Peyton, Chief Executive Officer, 4D pharma. "The combination of MRx0518 with BAVENCIO has the potential to further enhance the positive clinical outcomes achieved by BAVENCIO for the significant number of patients in this treatment setting."

About MRx0518

MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumours. It is currently being evaluated in three clinical trials in patients with cancer. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumours and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients whose disease has previously progressed on anti-PD-1 therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. A fourth clinical trial of MRx0518 in combination with BAVENCIO (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc., is expected to initiate in 2021.

Avelumab Approved Indications

Avelumab (BAVENCIO) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis including fatal cases, colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib which can be severe and have included fatal cases), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib which can be severe and have included fatal cases, and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO monotherapy include lymphopenia; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

On February 8, 2021 Lion TCR reported abstracts presentation at the European Association for the Study of the Liver (EASL) Digital Liver Cancer Summit 2021 on 05-06 February 2021 for the use of its lead T-cell product, LioCyx-M for the treatment of unresectable Hepatitis B virus (HBV)- related hepatocellular carcinoma (HCC) in a Phase 1 study (NCT03899415), with an oral abstract (O07) selected for Highlights in the Best of Liver Cancer Summit (Press release, Lion TCR, FEB 8, 2021, View Source [SID1234574729]).

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We have previously presented clinical data for this study at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, highlighting the use of LioCyx-M as a promising TCR-T immunotherapy for primary HCC. Here, we present an updated clinical data (poster abstract P065), with supporting biomarker analysis data (oral abstract O07).

The median overall survival was 33.57 months with a follow-up period of 47.9 months and an objective response rate of 16.7%. LioCyx-M infusions were well tolerated with no cytokine release syndrome (CRS), neurotoxicity or other systemic immune-related adverse events observed. Two patients had a self-limiting and localized liver inflammation upon infusion of 1x10E05 cells/kg per bodyweight that fully resolved despite the advanced pathological liver condition of the patient.

A total of 3 patients had elevations of serum chemokines and/or activation of the T cell compartment upon receiving the treatment, indicative of treatment induced immunological alterations. These alterations were followed with subsequent tumour destruction (partial response as per modified RECIST) in one patient with a durable tumour response lasting approximately 30 months, or a stable disease in the other 2, implicating the LioCyx-M treatment induced immunological alterations with anti-tumour response.

Overall, the clinical and biomarker data highlight the good safety profile and efficacy of LioCyx-M. Further exploration of efficacy of LioCyx-M treatment for advanced HBV-HCC is warranted in a Phase 2 study. Lion TCR is actively applying for global multi-center Phase II clinical trials, including the US FDA, Singapore HSA and China NMPA.

Details of oral presentation:

Abstract Title Immunological alterations induced by HBV-TCR T cell immunotherapy associates with treatment response of primary HBV related-HCC
Presenter Name Dr Tan Anthony Tanoto
Abstract Number O07 (Click here for oral presentation slides)

Details of poster presentation:

Abstract Title Phase 1 study of autologous hepatitis B virus (HBV)-specific T cell receptor (TCR) T-cells, LioCyx-M in unresectable HBV-related hepatocellular carcinoma (HCC)
Presenter Name Prof Fu-Sheng Wang
Abstract Number P065 (Click here for poster)

The full abstracts are attached in this release and will be published in The Digital Liver Cancer Summit 2021 abstract book on 22 January at 10:00 CET.

Abstract O07 has been chosen to be highlighted in the Best of Liver Cancer Summit.

On February 8, 2021 Dana-Farber Cancer Institute and Deerfield Management Company, a healthcare investment management firm focused on advancing healthcare through investment, information and philanthropy, reported that have formed a major translational research partnership to accelerate the development of therapeutics and diagnostics for cancer (Press release, Dana-Farber Cancer Institute, FEB 8, 2021, View Source [SID1234574745]). Deerfield has committed up to $130 million over the next 10 years to advance research at Dana-Farber and translate scientific discoveries with potential applications for patients.

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Riverway Discoveries represents the first time Deerfield has created a second such partnership with one of its academic collaborators. In the first agreement, announced in 2018, Deerfield committed $80 million to create the Center for Protein Degradation at Dana-Farber.

"Translational funding in biomedical research, when the promise of success is not obvious or guaranteed, can often be the engine that ensures innovative research moves forward, paving the way for important discoveries and new and better therapies," said Laurie H. Glimcher, MD, president and CEO, Dana-Farber Cancer Institute. "I am hopeful that this investment by Deerfield at Dana-Farber now will eventually help improve the lives of people with cancer everywhere."

"Supporting the innovation engines at institutions with world class science, investigators and leadership through financial, operational and translational expertise focused on projects with the potential to change lives can ultimately lead to the financial success of the institutions. This may be the most powerful way we can help support the healthcare ecosystem," stated James Flynn, Deerfield managing partner. "Dana Farber is the perfect example of an institution with all the fundamentals where a flywheel of innovation can be supported with translational funding. We are pleased to be an innovation partner with now two separate collaborations focused on the most exciting and life saving translational projects."

Getting new therapeutics to patients is a driver in Dana-Farber’s research and drug discovery work. Building on Dana-Farber’s history and strong foundation of scientific leadership, innovation and drug development, this partnership with Deerfield and Riverway Discoveries will support the preclinical development, spurring commercialization to help advance the most promising research expeditiously. Advancing the drug pipeline forward more swiftly, enables new treatments to be developed more quickly, delivering on the ultimate goal of improving patient care and saving lives.

"We are thrilled to collaborate again with Deerfield, as our previous partnership in protein degradation is enabling us to advance an exciting portfolio of discoveries. This new partnership will give scientists across Dana-Farber a new pathway to incubate cutting-edge science that will advance cancer care," said Lesley Solomon, Senior Vice President and Chief Innovation Officer at Dana-Farber. "Many promising innovations outgrow the laboratory as they require greater resources than an academic setting can typically provide. Dana-Farber’s partnership with Deerfield will catalyze important innovation growth."

Starting later this month, Dana-Farber researchers may submit proposals on projects for consideration by a Riverway Discoveries joint steering committee whose membership comprises equal scientific leadership representing Dana-Farber and Deerfield. Through Riverway Discoveries, Deerfield will provide funding and operational support for accepted projects.

On February 8, 2021 Enzychem Lifesciences (KOSDAQ: 183490), a biopharmaceutical company developing innovative medicines to improve the lives of patients with cancer and inflammatory diseases, reported it will present new study data regarding its lead drug candidate, EC-18 in combination with immune checkpoint inhibitor (ICI) therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, held virtually, April 10-15 and May 17-21 (Press release, Enzychem Lifesciences, FEB 8, 2021, View Source [SID1234574763]).

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ICI is approved and used in the treatment of various cancers. However, some carcinomas are refractory to ICI and the treatment effect diminishes through drug resistance. Adenosine-induced tumor progression and drug resistance are major obstacles to ICI therapy. Effective removal of adenosine surrounding the tumor can improve the ICI effect and suppress tumor progression.

"We are excited to present our in vitro cell analysis results at AACR (Free AACR Whitepaper), that support EC-18’s unique mechanism of action and synergistic therapeutic effect in combination with immune checkpoint inhibitors," said Ki Young Sohn, CEO & Chairman, Enzychem Lifesciences. "Based on these results, EC-18 has an anti-tumor effect by quickly eliminating eAdo extracellular adenosine (eAdo), which is a key factor for successful ICI therapy. PLAG, the active pharmaceutical ingredient of EC-18, may help cancer cells absorb and remove eAdo, thereby, effectively inhibiting tumor growth and changing the tumor microenvironment. PLAG may enhance the therapeutic effect of ICI in the treatment of LLC-1 lung carcinoma cells."

Details of the virtual poster presentation are below:
Abstract Title: Suppressive effect of PLAG on tumor progression and its synergistic therapeutic effect with ICI therapy through adenosine clearance.
Date: Saturday, April 10, 2021
Abstract Number: 1447
Session: Targeting the Tumor Microenvironment in Drug Development

The virtual abstract is available in the program section of the virtual AACR (Free AACR Whitepaper) annual meeting website: View Source

On February 7, 2021 The Board of Directors in Medivir AB (publ) ("Medivir" or the "Company") reported that has decided to summon an extraordinary general meeting on 11 March 2021 to propose a directed issue (the "Directed Issue") to the Company’s existing specialist investor LINC AB ("LINC"), controlled by the Company’s board member Bengt Julander (Press release, Medivir, FEB 7, 2021, View Source [SID1234574711]).

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In the rights issue, from which the preliminary results was announced on 5 February 2021 (the "Rights Issue"), Bengt Julander (through LINC) among others entered into subscription and guarantee commitments. The Rights Issue was substantially oversubscribed and no guarantee commitments needed to be utilized. Through an over-allotment option related to the Rights Issue (the "Over-allotment Option") the specialist investor Healthinvest Partners AB was added to the Company’s shareholder base. As a result of the strong interest in the Rights Issue and in order to further strengthen the Company’s institutional shareholder base, the Board of Directors has decided to summon an extraordinary general meeting on 11 March 2021 to propose a directed issue of approximately SEK 28 million to Bengt Julander (through LINC).

Since the Directed Issue is directed to a company controlled by board member Bengt Julander, part of the Company’s category of related parties referenced in the Swedish Companies Act (sw. ABL) chapter 16 (2005:551), the Directed Issue requires approval by the Company’s shareholders representing at least nine tenths of the votes casted as well as the shares represented at the extraordinary general meeting on 11 March 2021, for which a notice will be published separately. Bengt Julander did not participate in the decision regarding the Directed Issue by the Board of Directors.

The extraordinary general meeting will decide on the proposal to issue a total of 3,600,000 new series B shares, directed to Bengt Julander (through LINC), at a subscription price of SEK 7.73 per share, corresponding to the closing price as of 5 February 2021. The reason for deviating from the shareholders’ preferential rights in the Directed Issue is to strengthen the Company’ institutional shareholder base and the proceeds will be used to accelerate the Company’s existing business plan, mainly focusing on the development of MIV-818.

Through the Directed Issue, the number of shares in Medivir will increase from 52,135,651 series B shares, including the shares issued in connection with the Rights Issue and the Over-allotment Option, to 55,735,651 series B shares, corresponding to a dilutive effect of approximately 6.5 per cent of the total number of outstanding shares and votes in the Company. Following the completion of the Directed Issue, LINC will hold shares in the Company corresponding to approximately 10 per cent of the total number of outstanding shares in the Company.

Advisors
ABG Sundal Collier is the financial advisor and Vinge is the legal advisor to Medivir in connection with the transaction.