On May 6, 2021 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Adaptimmune, MAY 6, 2021, View Source [SID1234579397]).

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"We will present initial data at ASCO (Free ASCO Whitepaper) from our SPEARHEAD-1 trial that will support BLA submission in 2022. We have seen good enrollment in the SURPASS and ADP-A2AFP trials and will present data later this year," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "We continue to deliver against our ambitions laid out in our 2-2-5-2 strategic plan to bring products forward for clinical development and launch. At ASGCT (Free ASGCT Whitepaper) next week, we will present preclinical data from our first HiT product targeting mesothelin. Results indicate that this HiT works as well or better than similar cell therapy constructs targeting the same antigen in in vitro killing assays as well as an animal model."

Upcoming confirmed data updates

Data from the Company’s HiT mesothelin program, being co-developed with Astellas, to be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), in a poster presentation that will be available on the conference’s website May 11 at 8:00 a.m. EDT

Important progress towards achievement of preclinical pipeline milestones laid out in the Company’s strategic five-year "2-2-5-2" product development plan presented at Investor Day in November 2020
Preclinical data validate that human T-cells expressing a TCR that targets mesothelin independent of peptide-HLA recognition, can kill human tumor cells
Presentation will include animal model data that demonstrate superiority of the Company’s HiT targeting mesothelin over a comparator T-cell therapy construct targeting the same antigen in an in vivo tumor xenograft study
This product was nominated by Astellas as the first candidate under the agreement to co-develop and co-commercialize iPSc (stem-cell) derived allogeneic CAR-T and TCR T-cell therapies

Oral presentation of initial data from the SPEARHEAD-1 trial with afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) for people with synovial sarcoma and MRCLS at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 4th during the Sarcoma Session starting at 1:30 p.m. EDT (abstract # 11504)

At time of data cut-off for the abstract1, 32 patients had received afami-cel. Twenty-five patients were evaluable for preliminary efficacy and 7 patients had insufficient follow-up
On May 19, 2021 at 5:00 p.m. EDT, abstracts will be released on ASCO (Free ASCO Whitepaper)’s Meeting Library and the Company plans to issue a press release2
The Phase 2 SPEARHEAD-1 trial was initiated after promising results from the Phase 1 trial showed durable responses with afami-cel in synovial sarcoma with confirmed responses in 44% of patients, disease control rate of 94%, and median duration of response of 28 weeks presented at CTOS 2020
The Company will submit an abstract with a further update for consideration at CTOS 2021
Planned data updates 3

SURPASS Phase 1 trial with ADP-A2M4CD8 (next-generation product targeting MAGE-A4) at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September
ADP-A2AFP Phase 1 trial for people with liver cancer at the International Liver Cancer Association (ILCA) in September
Radiation sub-study of the ADP-A2M4 Phase 1 trial at American Society for Radiation Oncology (ASTRO) in October
Afami-cel translational data update at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November
Other Corporate News

Astellas has nominated the second target as part of the co-development and co-commercialization agreement signed with Adaptimmune in January 2020
Financial Results for the first quarter ended March 31, 2021

Cash / liquidity position: As of March 31, 2021, Adaptimmune had cash and cash equivalents of $32.4 million and Total Liquidity4 of $317.9 million.
Revenue: Revenue for the first quarter ended March 31, 2021 was $0.4 million, compared to $0.8 million for the same period in 2020.
Research and development (R&D) expenses: R&D expenses for the first quarter ended March 31, 2021 were $24.5 million compared to $21.3 million for the same period in 2020. R&D expenses increased in the quarter ended March 31, 2021 due to an increase in the number of employees engaged in research and development, and increases in costs related to the development of a companion diagnostic assay and our Phase 2 clinical trial associated with ADP-A2M4CD8. These increases were offset by an increase in reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the first quarter ended March 31, 2021 were $13.8 million compared to $9.3 million for the same period in 2020 due to an increase in share-based compensation expense and an increase in employee related costs.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the first quarter ended March 31, 2021 was $37.8 million ($(0.04 per ordinary share), compared to $28.2 million ($(0.04) per ordinary share) for the same period in 2020.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations into early 2023, as further detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, to be filed with the Securities and Exchange Commission following this earnings release.

Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 9:00 a.m. EDT (2:00 p.m. BST) today, May 6, 2021. A live webcast of the conference call and replay can be accessed at https://bit.ly/2Ry9DdR. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (9271335).

On May 6, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported it will host a conference call on Wednesday May 12, at 8:00 a.m. Eastern time to discuss its financial and operating results for the first quarter of 2021, in addition to providing a business update (Press release, VolitionRX, MAY 6, 2021, View Source [SID1234579414]).

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Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the first quarter of 2021, and milestones for 2021 and beyond.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 26, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13719633.

On May 6, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2021, and recent corporate highlights (Press release, Checkpoint Therapeutics, MAY 6, 2021, View Source [SID1234579436]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "During the first quarter of 2021, we continued to advance the development of our two lead drug candidates while also enhancing our cash position. Enrollment in our registration-enabling study for cosibelimab in metastatic cutaneous squamous cell carcinoma ("mCSCC") is nearly complete and the study remains on track to report top-line results by year-end. With a successful study, we anticipate submitting our first application for marketing approval for cosibelimab next year."

Mr. Oliviero continued, "Additionally, our collaboration partner in Asia for olafertinib (CK-101), Neupharma Inc., continues to enroll patients as planned into a Phase 3, registration-enabling study in first-line, EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer ("NSCLC"). We intend to meet with the FDA to discuss the ongoing Phase 3 study design and its potential use to support a New Drug Application submission in the United States."

Recent Corporate Highlights:

In March 2021, Checkpoint announced the formation of a Scientific Advisory Board comprised of industry thought leaders. Members include Wayne A. Marasco, M.D., Ph.D., Roy S. Herbst, M.D., Ph.D., F. Stephen Hodi, Jr., M.D., Bruce E. Johnson, M.D., David Miller, M.D., Ph.D., and Emily Ruiz, M.D., M.P.H.
During the first quarter of 2021, Checkpoint raised $23.9 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement at an average price of $3.50.
Financial Results:

Cash Position: As of March 31, 2021, Checkpoint’s cash and cash equivalents totaled $60.0 million, compared to $40.8 million at December 31, 2020, an increase of $19.2 million.
R&D Expenses: Research and development expenses for the first quarter of 2021 were $4.2 million, compared to $2.6 million for the first quarter of 2020, an increase of $1.6 million. Research and development expenses for the first quarter of 2021 included $0.2 million of non-cash stock expenses, compared to $0.1 million in the first quarter of 2020.
G&A Expenses: General and administrative expenses for the first quarter of 2021 were $2.4 million, compared to $1.7 million for the first quarter of 2020, an increase of $0.7 million. General and administrative expenses for the first quarter of 2021 included $1.2 million of non-cash stock expenses, compared to $0.5 million for the first quarter of 2020.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2021 was $6.5 million, or $0.09 per share, compared to a net loss of $3.3 million, or $0.06 per share, in the first quarter of 2020. Net loss for the first quarter of 2021 included $1.4 million of non-cash stock expenses, compared to $0.6 million for the first quarter of 2020.

On May 6, 2021 Hope Medicine reported the completion of a Series B financing US$56 million (Press release, Hope Medicine, MAY 6, 2021, View Source [SID1234632778]). This round of financing was jointly led by Qiming Venture Partners and Grand Flight Investment. HighLight Capital (HLC) co-invested with Sinovation Ventures. The Series A investor，Trust Bridge Partners，continued to subscribe. HaoYue Capital acted as the exclusive financial advisor for this round of financing.

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HopeMed is a global science-driven innovative biopharmaceutical company with R&D bases and offices in Nanjing, Shanghai, and Beijing, China. The company was founded by Professor Rui-Ping Xiao, the dean of the College of Future Technology of Peking University, and an associate editor of New England Journal of Medicine. HopeMed has always followed the founding philosophy of In China, For Global, and has built an international multi-disciplinary team dedicated to global unmet medical needs with first-in-class medicines.

HopeMed focuses on the three major disease areas of women’s health, endocrine, and cardiovascular diseases, and aims at the unmet medical needs, through an independent R&D as well as license-in models, to further establish and enrich our research and development pipelines.

Previously, HopeMed has signed a world-wide exclusive license agreement with Bayer AG on the development and commercialization of a human antibody (HMI-115) targeting the prolactin (PRL) receptor for the treatment of male and female pattern hair loss, endometriosis and other chronic diseases with dysregulated PRL signaling. Under the terms of the license agreement, Hope Medicine will develop and globally commercialize the novel PRL receptor antibody based on intellectual property from Bayer. At present, HMI-115 has completed phase I clinical trials in the European Union, with positive safety results. The global multi-center phase II clinical trials for androgenic alopecia and endometriosis will soon be launched.

‘We have built a world-class professional team and strong global intellectual property rights to develop the best pharmaceuticals for the global market. China’s innovative pharmaceutical research and development have now entered an exciting new era of ‘dare to do, can do, and must do’. The diseases in women health, endocrinology, and cardiovascular fields are our primary battlefields. We will not forget our original purpose and strive for first-in-class medicines with disruptive innovation to benefit patients worldwide. Here we would like to express our sincere thanks to our new and old investors for their precious recognition and trust in HopeMed. This round of financing will provide strong support for the company’s upcoming MRCT international phase II clinical studies and commercial product development.’ Said Rui-Ping Xiao, Founder, and CEO of HopeMed.

Amy Tang, a venture partner with Qiming Venture Partners, said, "China’s innovative drug R&D sector is maturing. As a science-driven innovative drug R&D company, Hope Medicine has formed solid cooperations with world-class scientific research and development platform, such as IMM. The company develops first-in-class drugs to target unmet clinical needs and push forward with this goal. We are honored to cooperate with the visionary company, which is also effective at execution. Qiming hopes to explore the huge R&D potential of Hope Medicine and help their pipeline to go to market as soon as possible, to benefit the patients."

Mr. Jun Yang, Managing Partner of Grand Flight Investment said that they are very optimistic about the development of China’s biomedical industry and are convinced that China’s domestic grown innovative pharmaceutical companies can achieve more First-in-Class innovations. The HopeMed team led by Professor Xiao has a global vision and experience and is committed to the research and development of First-in-Class innovative medicines based on a deep understanding of translational medicine. HopeMed’s HMI-115 antibody has shown very significant effects in the natural NHP model, and human clinical trials have also shown positive safety results. Grand Flight is very optimistic about its follow-up clinical advancement and the expansion of more indications. HopeMed’s innovative pipelines in other disease fields also enrich the company’s future product layout.

‘After ten years of accumulation, the research and development of innovative pharmaceuticals in China has entered the spring of rapid development. We are very excited about the development of China’s medical and healthcare industry in recent years and its long-term prospects, and we are willing to accompany the growth of truly original pharmaceutical companies. HopeMed is a First-in-Class pharmaceutical research and development practice based in China and aiming at the world. Trust Bridge Partners is honored to be the founding investor and partner of HopeMed. This investment is in line with our vision to develop and provide international standard medical products for the Chinese and global markets.’ Said Mr. Feng Ge, the Managing Partner of Trust Bridge Partners.

Mr. Richard Yang, Partner of Sinovation Ventures commented that HopeMed is founded on the remarkable achievements in advanced translational medicine accumulating years of domain know-how led by Professor Xiao. The company develops competitive pipelines in multiple therapeutic areas with the world’s leading research and experiment platforms. Sinovation Ventures is honored to work with Professor Xiao’s team, and is highly confident that HopeMed will create great commercial value and social impact.

Mr. Liu Hao, Founder and CEO of HaoYue Capital, said that ‘we are honored to assist HopeMed in completing this round of financing. HopeMed has a world-class R&D team, including basic research, clinical translation, and CMC manufacturing. HopeMed always focuses on unmet clinical needs and refuses to follow others. HaoYue Capital is also committed to serving the best R&D team and the most innovative biopharmaceutical company in the world. We believe that HopeMed can provide patients with products with true clinical value.’

On May 6, 2021 Sanofi reported that it has entered into a three-year research collaboration with Stanford University School of Medicine. Together, the two organizations and their scientists will work to advance the understanding of immunology and inflammation through open scientific exchange (Press release, Sanofi, MAY 6, 2021, View Source [SID1234579260]). Additionally, Sanofi will provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas including autoimmune diseases and inflammatory conditions.

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"We look forward to working with some of the most innovative scientists in the human immunology community. Together we will explore groundbreaking concepts and obtain deeper insights into underlying inflammatory disease mechanisms," said Frank Nestle, Global Head of Research and Chief Scientific Officer, Sanofi. "Sanofi’s collaboration with Stanford University aims to transform how autoimmune disorders and inflammatory conditions are understood and treated. It will help accelerate our ambitious immunoscience programs as we advance a rich pipeline of first- and best-in-class medicines across key therapeutic areas to address unmet patient needs."

Sanofi and Stanford Medicine will create a Joint Steering Committee to fund up to three programs a year. Sanofi will host an annual research forum for researchers from both organizations to further exchange ideas, share knowledge and perspectives on relevant scientific matters, and discuss collaborative research projects.

"Stanford Medicine is dedicated to advancing knowledge and discovery with the goal of improving our ability to predict, prevent and cure disease with the most precise approaches," said Lloyd Minor, MD, Dean of the Stanford School of Medicine. "The opportunity for long-term collaboration with our colleagues at Sanofi will allow us to explore together new frontiers in autoimmune diseases and inflammatory conditions."

The collaboration will begin with three "deep-dive" research projects:

Exploring cytokine crosstalk in type 2 inflammation, specifically examining the impact of Sanofi’s investigational molecules on excessive type 2 inflammation.
Decoding molecular drivers of effector and suppressor T cells in autoimmunity, to better understand the specific antigens that may cause type 1 diabetes.
Defining the mechanisms of immune-related adverse events with immune checkpoint inhibitor therapy – with a focus on pneumonitis and inflammatory arthritis – to explore the role of genomics and pathogenic cell identification.

EDITOR’S NOTE: This new initiative is the latest chapter in Sanofi’s long history of collaboration that includes the Sanofi Innovation Awards (iAwards), a multi-institutional academic partnership program designed to accelerate and innovative, early-stage, disease-relevant research towards the clinic. The iAwards represent one of the largest academic–industry collaborations run by a biopharma company, and have generated early research that has led to important scientific advancements in the field, including contributions to Sanofi’s own pipeline.