On February 28, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2019 (Press release, Mersana Therapeutics, FEB 28, 2020, View Source [SID1234554967]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to present updated data from our ongoing dose escalation study in heavily pre-treated and biomarker unselected patients at the upcoming SGO 2020 Annual Meeting on Women’s Cancer. We plan to demonstrate that, at doses up to 43 mg/m2, XMT-1536 is well tolerated without the severe neutropenia, neuropathy or ocular toxicities typically observed with other ADC platforms," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Additionally, we continue to execute on our proof-of-concept expansion cohorts in ovarian and non-small cell lung cancer for XMT-1536 and are on track for additional data disclosures throughout the year. These data readouts will be important milestones as we chart a fast-to-market path to registration in ovarian cancer."

Recent Highlights and Updates

Clinical Programs

·XMT-1536 dose escalation abstract accepted for late-breaker oral presentation at upcoming Society of Gynecologic Oncology (SGO) 2020 Annual Meeting on Women’s Cancer. Updated data from the Phase 1 dose escalation study, including the 30, 36 and 43 mg/m2 once-every-four-week dose cohorts, will be presented at the upcoming SGO Annual Meeting on March 30, 2020. The presentation will include safety, tolerability, clinical activity and initial correlation with the NaPi2b biomarker. The Company initiated the evaluation of a 52 mg/m2 once-every-four-week dose escalation cohort in heavily pre-treated and biomarker unselected patients in early 2020 and the study remains ongoing.

·The expansion portion of the XMT-1536 Phase 1 study continues to enroll both ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma patients in the 43 mg/m2 dose cohort. Mersana remains on track to enroll approximately 45 patients each in the ovarian cancer and NSCLC adenocarcinoma patient cohorts. The Company expects to present interim data from the expansion study in the second quarter of 2020 and to be able to report more mature data in the second half of 2020.

·Mersana is on track to initiate a Phase 1 study for its second clinical candidate, XMT-1592, a Dolasynthen ADC targeting NaPi2b, in the first half of 2020. XMT-1592 was created with the Dolasynthen platform, retaining the Company’s proprietary NaPi2b antibody and auristatin DolaLock payload with controlled bystander effect plus the added benefits of site-specific conjugation, precise drug-to-antibody ratio, and even greater hydrophilicity for further enhanced drug-like properties and tumor exposure. In preclinical studies, Dolasynthen has shown four times greater efficacy in a patient-derived lung tumor model in comparison to Dolaflexin, a platform that has already shown success when targeted to NaPi2b. The Phase 1 study will seek to clinically validate the differentiation of XMT-1592 by using the Company’s NaPi2b experience to rapidly and efficiently progress this candidate through dose escalation.

Discovery & Platform Progress

·Initiating Investigational New Drug (IND)-enabling studies for B7-H4, a first-in-class ADC target. B7-H4 is expressed on both tumor cells and tumor-associated macrophages (TAMs). A B7-H4 ADC delivering a DolaLock payload has been shown in preclinical studies to exert a direct cytotoxic effect via uptake by tumor cells and also has the potential to deliver additional payload release in the tumor environment through binding and catabolism in B7-H4-expressing TAMs. It has been shown in preclinical studies that the DolaLock payload can activate dendritic cells and induce immunogenic cell death, with the potential to provide a secondary immune-based anti-tumor effect in addition to the primary cytotoxic effect. The Company expects to disclose its development candidate and supporting data in the second half of 2020.

·Disclosure of the first Immunosynthen development candidate in the second half of 2020. The Company has developed a novel STING agonist ADC platform and has generated preclinical data across multiple targets and models showing complete regression of tumors in vivo with a single, well-tolerated dose, consistent with increased cytokine expression and immune cell infiltration within the tumor. Mersana expects to select its first STING agonist ADC development candidate in the second half of 2020. The Company also expects to present additional preclinical data at scientific meetings throughout 2020.

Upcoming First Quarter 2020 Events

·Mersana will give a corporate presentation at the Cowen & Co. Annual Health Care Conference on Monday, March 2, 2020, at 4:10 pm E.T. in Boston, MA.

·The Company will present XMT-1536 Phase 1 dose escalation data in the Late Breaking Abstract Session at the Society of Gynecologic Oncology (SGO) 2020 Annual Meeting on Women’s Cancer in Toronto, Canada on Monday, March 30, 2020, during the 2:30 pm E.T. session. Management will host a conference call after the close of the U.S. financial markets on March 30, 2020.

·Mersana will present preclinical data from its work on XMT-1592, a Dolasynthen ADC targeting NaPi2b, and its STING Agonist ADC development candidates, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 24 – April 29, 2020, in San Diego, CA.

2019 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2019, were $99.8 million, compared to $70.1 million as of December 31, 2018. In addition, the Company has the option to draw additional funds of up to $15.0 million through the existing debt financing agreement with Silicon Valley Bank. The Company expects that its current cash, cash equivalents and marketable securities will enable it to fund its operating plan through important milestones, including the XMT-1536 Phase 1 clinical study and the planned dose escalation study for XMT-1592.

Fourth Quarter 2019

·Collaboration revenue for the fourth quarter 2019 was immaterial, compared to $1.2 million for the same period in 2018. The decrease in collaboration revenue was primarily as a result of a decrease in services performed in support of partners’ programs.

·Research and development expenses for the fourth quarter 2019 were approximately $12.4 million, compared to $19.8 million for the same period in 2018. The decrease was primarily due to decreased manufacturing costs for XMT-1536 and XMT-1522, offset by increased costs for XMT-1536 clinical and regulatory expenses, XMT-1592 preclinical studies and discovery efforts, and advancement of companion diagnostics development efforts for the NaPi2b biomarker.

·General and administrative expenses for the fourth quarter 2019 remained flat at $4.2 million, compared to the same period in 2018.

·Net loss for the fourth quarter 2019 was $16.2 million, or $0.34 per share, compared to a net loss of $22.4 million, or $0.97 per share, for the same period in 2018. Weighted average common shares outstanding for the quarters ended December 31, 2019 and December 31, 2018, were 47,886,144 and 23,184,459 respectively.

Full Year 2019

·Collaboration revenue for the full year 2019 was approximately $42.1 million, compared to $10.6 million for the full year 2018. The increase was primarily as a result of the termination of the Takeda agreements and the recognition of the remaining deferred revenue of $40.0 million. Additionally, revenue of $2.1 million was recognized in connection with the Merck KGaA Agreements in the year ended December 31, 2019.

·Research and development expenses for the full year 2019 were approximately $55.0 million, compared to $59.9 million for the full year 2018. The decrease was primarily due to decreased manufacturing costs for XMT-1536 and XMT-1522, offset by increased costs for XMT-1592 preclinical studies and discovery efforts, XMT-1536 clinical and regulatory expenses, further platform development including Immunosynthen, advancement of companion diagnostics development efforts for the NaPi2b biomarker and a milestone paid on the initiation of the expansion cohort.

·General and administrative expenses for the full year 2019 were approximately $17.3 million, compared to $16.3 million for the full year 2018, driven primarily by increased stock-based compensation expense.

·Net loss for the full year 2019 was $28.2 million, or $0.65 per share, compared to a net loss of $64.3 million, or $2.79 per share, for the full year 2018. Weighted average common shares outstanding for the periods ended December 31, 2019 and December 31, 2018, were 43,492,113 and 23,032,250, respectively.

Conference Call Details

Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the fourth quarter and year-end of 2019 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 4849085. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On February 28, 2020 Cancer Research UK and its European partners, Fondazione AIRC and Asociación Española Contra el Cáncer (AECC), reported that it will invest £27.4 million into seven new international projects to accelerate lifesaving cancer research, announced today (Friday) (Press release, Cancer Research UK, FEB 28, 2020, View Source [SID1234554923]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"If current trends continue, the world will see a 60% increase in cancer cases over the next two decades. Cancer is a global problem and no one country can tackle it alone." – Dr Iain Foulkes, Cancer Research UK
The Cancer Research UK Accelerator Awards programme, which provides five years of funding for international projects, reflects a longstanding link between the UK and Europe, working together to drive progress for people affected by cancer.

The successful teams will develop new research tools, resources and infrastructure to improve scientists’ understanding of cancer, including rare and hard-to-treat cancers, helping to find better ways to treat them. Projects include investigating how to best combine radiotherapy with the latest immunotherapies, and refocussing research efforts on mesothelioma, an asbestos related cancer, cases of which continue to rise globally.*

Dr Iain Foulkes, executive director of research and innovation at Cancer Research UK, said: "If current trends continue, the world will see a 60% increase in cancer cases over the next two decades. Cancer is a global problem and no one country can tackle it alone.

"Now the UK has left the European Union, the need to retain collaborative cancer research between the EU and the UK has never been greater. This partnership will also strengthen UK cancer research by the sharing of expertise, new technologies and research talent."

Professor Paul French, a physicist based at Imperial College London, will lead one of the projects to improve the way we develop and test anti-cancer drugs in the lab.

Traditionally, drug discovery research has used thin ‘2D’ layers of cells that can be easily controlled and imaged on conventional microscopes. However, such simplified disease models don’t adequately represent the complex 3D cancer environment within the body.

Professor French said: "The complexity of cancer is beyond our current understanding and existing therapies. By developing technology to investigate more sophisticated 3D cancer models, which allow us to explore how drugs work on tumour cells interacting with their local environment, we could find new ways to overcome challenges like drug resistance."

Professor Kevin Blyth, a clinician scientist based at the University of Glasgow, will lead another of the projects, focussed on finding better treatments for mesothelioma, a hard-to-treat asbestos related cancer that most commonly starts in the layers of tissue that cover each lung.

Professor Blyth said: "It’s been difficult to build a network of scientists, with enough cases of the disease to build a thorough understanding of how to best treat mesothelioma. And this has left people with the disease very few treatment options.

"In the future it’s likely that the global incidence of mesothelioma will continue to increase, as there are many countries that still don’t regulate the use of asbestos. So, it’s important to build a research community now and improve our understanding to help those affected by this cancer."

The Accelerator Awards bring together world-class researchers who would not previously have been able to work together, without the unique structure of this grant scheme. Each collaboration aims to deepen the research community’s understanding of cancer and bring people with cancer closer to new treatments, making use of the expertise and diverse technologies of different partner organisations.

Ignacio Muñoz Pidal, president of the AECC, said: "The AECC believes international collaboration is essential to accelerate cancer research. The Accelerator Awards allow European researchers to not only receive five years of funding, but also enables them access to an international collaborative platform where they can share knowledge and data."

Professor Federico Caligaris Cappio, scientific director of Fondazione AIRC, said: "Rare tumours are individually of little interest to drug developers and are difficult to study because patients are few. For this reason, the knowledge we have of many of these cancers is fairly basic.

"For research to be as effective as possible, it is necessary to bring together expertise from several countries. This is one of the strengths of the Accelerator Awards that sees Fondazione AIRC, Cancer Research UK and AECC come together. Supporting research projects that are aimed at accelerating skills and seeking new and more effective therapeutic solutions."

The next round of the Accelerator Awards will open on 2 March for international research groups.

On February 27, 2020 PokeAcell, a newly founded immunotherapy company, has secured exclusive licensing rights to a proprietary technology, for personalized T cell therapy (Press release, PokeAcell, FEB 27, 2020, View Source [SID1234596101]). The new technology can activate and grow cancer-specific T cells present in patient’s own blood and the cells can then be given back to the patient as fully personalized treatment. The T cell therapy hold the potential of curative treatment in Metastatic Melanoma and Merkel Cell carcinoma – two of the most severe skin cancers today and with potential in several other indications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are founding PokeAcell with the mission to provide curative treatment to solid tumor patients with no available treatment today. We are pleased to sign this exclusive licensing agreement with DTU on the ImmPACT activation technology and further strengthen the development of personalized T cell therapy," says Anne Reker Cordt, CEO and co-founder PokeAcell

PokeAcell is a spin out of DTU Health Technologies based on the distinct expertise of Prof. Sine R. Hadrup, PhD., who will receive the prestigious Elite Research Prize from the Ministry of Higher Education and Science at a ceremony later today.

Prof. Sine R. Hadrup – inventor and co-founder of PokeAcell, says: "T cells are the natural soldiers of the immune system and hold immense potential in the treatment of cancer. The ImmPACT technology create a personalized cell product with very beneficial properties and is now one step closer to helping patients in need of better treatment".

PokeAcell is founded by an experienced team of science and business leaders and have established a strong advisory Board, which includes profiles such as John Haurum, biotech executive and board member and Inge Marie Svane, Prof, MD Herlev CCIT.

"In patients with metastatic cancers it can be very difficult for the immune system to overcome the influence of the cancer. T cell therapy has shown good results in clinical trials and PokeAcell’s T cell technology has a very interesting potential for extending T cell therapy to more patients with Metastatic Melanoma. I look forward to the results of the first clinical evaluation," says Inge Marie Svane, Prof, MD Herlev CCIT.

PokeAcells is a Copenhagen based privately owned immunotherapy company. PokeAcell’s personalized T cell product is in pre-clinical evaluation and is in preparation for an investigator lead phase I in Metastatic Melanoma at Herlev CCIT.

On February 27, 2020, Deka Biosciences reported that an upcoming episode of Advancements with Ted Danson, scheduled to broadcast 2Q/2020, will explore innovative treatment solutions for maladies, such as Inflammatory Bowel Disease (IBD), specifically Crohn’s Disease (Crohn’s), and Oncology (Press release, Deka Biosciences, FEB 27, 2020, View Source [SID1234580080]). Check local listings for more info.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This segment will focus on a novel platform developed by Deka Biosciences, Inc. (Deka Biosciences), that will enable the delivery of next generation cytokine or combination of cytokines to a specific tissue of interest. Viewers will learn how this cutting-edge technology, termed Diakines, has led to the development of two potential therapeutic molecules involving an affinity modified Interleukin 10 cytokine.

The show will also explore how Deka Biosciences is using Diakines to harness the spectrum of therapeutically useful and clinically validated IL10 and other cytokine specific biologies. Spectators will see how these Diakines can maximize patient benefits through improved PK/PD function combined with a MOA directed patient selection strategy.

"The biopharma industry has known for a while that cytokines play an integral role in immunology and disease management, and that delivery of cytokine therapeutics into diseased tissues will dramatically enhance therapeutic benefit," said Dr. John Mumm, co-founder & CEO of Deka Biosciences. He continued to say, "Deka Biosciences has harnessed the wealth of clinical knowledge around cytokines and IL-10 in particular, to develop a novel delivery platform to enrich cytokine variants in effected tissues, coupled with methods to determine how to select the patients with the greatest likelihood of response to ensure that the right patients get the right medicines."

In addition, the show will also inform about Deka Biosciences’ Precision Medicine strategy, which enables Deka to identify the right patients to treat with these new medicines.

"Deka’s platform has the potential to enable discoveries of next generation therapies," said Richard Lubin, senior producer for DMG Productions and the Advancements series. "We are eager to explore how Deka is set to influence future treatment options for IBD, Crohn’s."

On February 27, 2020 In honor of Rare Disease Day on February 29th, Incyte (NASDAQ:INCY) is reported the launch of Rare Reflections: MPNs Unmasked, a disease awareness initiative focused on raising awareness of and educating about myeloproliferative neoplasms (MPNs), a group of rare, chronic blood cancers (Press release, Incyte, FEB 27, 2020, View Source [SID1234555965]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of ongoing efforts to raise awareness of MPNs, Incyte has partnered with J.G. Jones, a renowned comic book artist who was diagnosed with an MPN over a decade ago, to capture the experiences of those impacted by MPNs. Rare Reflections features a series of portraits by Jones who uses graphic art to tell the powerful and personal stories of real patients with MPNs and those impacted by MPNs.

The illustrations can be viewed at www.VoicesofMPN.com/RareReflections, along with more information about Jones’ disease journey and the stories of others living with MPNs.

"Art has the amazing ability to capture the emotions of its subjects beyond the surface, and I am honored to partner with Incyte on Rare Reflections to raise awareness of MPNs by doing the work I love," said Jones. "I know first-hand how living with an MPN can affect many aspects of a person’s life – physically and emotionally – and I hope, through increased awareness and education, to empower others living with an MPN to take control of their journey."

"Rare Disease Day offers a time for patients, caregivers, advocates and healthcare providers to join together to shine a light on the estimated 200,000 individuals in the United States living with an MPN," said Hervé Hoppenot, Chief Executive Officer, Incyte. "Incyte is pleased to partner with a respected illustrator such as J.G. Jones to bring to life the real stories of those living with an MPN and to highlight the unique experiences of people across the MPN community."

In honor of Rare Disease Day, Incyte is also supporting several efforts intended to raise awareness of MPNs and help patients with MPNs find tools and resources to help address the daily challenges they may face:

Ask an MPN Expert Facebook Live: Tune into Voices of MPN’s "Ask an MPN Expert" Facebook Live, where Incyte Oncology Clinical Nurse Educators (OCNEs) will provide educational information about MPNs and answer your MPN-related questions. The Facebook Live Chat will begin tonight, February 27, at 7:00 p.m. ET. Join the conversation here.
Nominate your MPN Hero: Honor the individual or organization in your life who has contributed to the MPN community by going above and beyond to make a real difference. In honor of Rare Disease Day, the nomination period for the 2020 MPN Heroes program opens tomorrow, February 28, and nominations are being accepted through September 12, 2020. To learn more about the program or to submit a nomination, visit www.MPNHeroes.com.
Stay connected and informed about all of the MPN awareness activities by "Liking" the "Voices of MPN" Facebook page, following "Voices of MPN" on Pinterest and following "Voices of MPN" on Twitter.

About Myeloproliferative Neoplasms

Myeloproliferative neoplasms (MPNs) are a closely related group of blood cancers in which the bone marrow functions abnormally. The bone marrow is where the body’s blood cells are made. MPNs are progressive blood cancers that can strike anyone at any age, but they are more common in older adults. Estimates of the prevalence of MPNs vary, but analysis of claims data suggests there may be as many as 200,000 people in the U.S. living with MF, PV or ET.1