On May 28, 2020 Daiichi Sankyo, Inc. (hereafter, Daiichi Sankyo) reported that it has entered into a strategic agreement with Syneos Health (Nasdaq:SYNH) (Press release, Daiichi Sankyo, MAY 28, 2020, https://www.businesswire.com/news/home/20200528005466/en/Daiichi-Sankyo-Syneos-Health%C2%AE-Form-Strategic-Coalition [SID1234558637]). The companies are coming together to form a coalition to accomplish their shared goal of bringing promising cancer therapies to patients as safely, effectively and efficiently as possible .

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Under the agreement, Syneos Health will provide both strategic and operational solutions for three lead Daiichi Sankyo DXd antibody drug conjugates (ADC): DS-1062, U3-1402 and DS-8201 (known as ENHERTU). The coalition expands a strong, pre-existing relationship between the two companies, further leveraging Syneos Health’s insights-driven Syneos One product development model to de-risk and accelerate development.

The coalition will enable early strategic engagement of Syneos Health teams to inform critical drug development decision making from the start. Cross-functional teams from both companies will share therapeutic expertise and product development insights to shape optimal study designs and create a consistent quality clinical delivery process across a portfolio of studies. Adding to the world-class scientific and technological expertise at Daiichi Sankyo, Syneos Health brings strong clinical site-level relationships and field experts located across the globe who can engage more closely and effectively with investigator teams.

"We quickly recognized that our three flagship ADCs have transformative potential that our in-house structure and current CRO engagements could not deliver as fast as we feel obligated to for patients," said Marielle Cohard Radice, Global Head of Development Operations, Daiichi Sankyo. "The ‘one-team and patient-first’ philosophy we have built with Syneos Health will enable evaluation of our development candidates in more therapeutic settings, more swiftly and more effectively."

The combined end-to-end knowledge from the Daiichi Sankyo and Syneos Health teams will provide a robust understanding of how patients are cared for, which workflows exist, and how cutting-edge clinical investigation can best be embedded in the clinic setting. Shared insights will also enable optimized site selection and engagement to best address patient needs. By leveraging this coalition approach, Daiichi Sankyo expects deeper synergies, particularly at the clinical site level, across projects with common indications and patient populations.

"High unmet patient need and rapid scientific discovery in the oncology space are driving the need for a faster and more predictable approach to clinical development," said Paul Colvin, President, Syneos Health Clinical Solutions. "We’re pleased to collaborate with an innovative company like Daiichi Sankyo, using our unique outsourced product development model to improve clinical trial performance for their advanced oncology portfolio."

On May 28, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS), reported that the National Comprehensive Cancer Network(NCCN) updated its Clinical Practice Guidelines in Oncology for Prostate Cancer to include new recommendations for Rubraca (rucaparib) tablets (Press release, Clovis Oncology, MAY 28, 2020, View Source [SID1234558604]).i In addition to its ovarian cancer recommendations, Rubraca is now recommended in the NCCN Guidelines for the treatment of BRCA-mutant patients with mCRPC under second-line treatment and subsequent therapy as a Category 2A recommendation inclusive of the following:

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Rucaparib is a treatment option for patients with mCRPC and a pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. If the patient is not fit for chemotherapy, rucaparib can be considered even if taxane-based therapy has not been given.

"We are pleased that the NCCN has acknowledged the importance of novel targeted therapies for the treatment of advanced prostate cancer, and the need for new treatment options for patients with BRCA mutations, including Rubraca, the first PARP inhibitor approved for these patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In particular, in the current COVID-19 environment, many patients would prefer to avoid chemotherapy, which requires frequent clinical visits, in favor of an oral agent that can be delivered directly to and taken at home."

NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine.ii The NCCN prostate cancer panel’s decision to include Rubraca as a Category 2A preferred option for the treatment of patients with a BRCA mutation for second-line treatment and subsequent therapy was based on the results of the Phase 2 TRITON2 study.

About Prostate Cancer

The American Cancer Society estimates that nearly 192,000 men in the United States will be diagnosed with prostate cancer in 2020iii, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 450,000 men in Europe were diagnosed with prostate cancer in 2018.iv Castration-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castration-resistant prostate cancer, or mCRPC, is an incurable disease, usually associated with poor prognosis. Approximately 43,000 men in the U.S. are expected to be diagnosed with mCRPC in 2020.v According to the American Cancer Society, the five-year survival rate for mCRPC is approximately 30 percent.vi Approximately 12 percent of patients with mCRPC harbor a deleterious germline and/or somatic mutation in the genes BRCA1 and BRCA2. These molecular markers may be used to select patients for treatment with a PARP inhibitor.vii

Rubraca U.S. FDA Approved Indication

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Click here for full Prescribing Information for Rubraca.

You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

About Accessing Rubraca

Rubraca is available in the United States through specialty pharmacies and distributors. Clovis is committed to ensuring Rubraca access for patients and offers eligible patients financial and reimbursement support through Rubraca Connections. More information about Rubraca Connections is available at RubracaConnections.com or by calling 1-844-779-7707 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

On May 28, 2020 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases reported its financial results for the first quarter ended March 31, 2020 and provided an update on clinical activities (Press release, NewLink Genetics, MAY 28, 2020, View Source [SID1234558622]).

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"This has been an exciting and busy time for Lumos Pharma," commented Rick Hawkins, Chairman, CEO and President. "With the recent close of our merger, the Company continues to execute its strategy to develop its oral therapeutic candidate, LUM-201, for pediatric growth hormone deficiency. Furthermore, we are now engaging in activities that we hope will lead to the expansion of our pipeline through the licensure of other rare disease assets. While we acknowledge that the worldwide coronavirus pandemic will adversely impact the conduct of our Phase 2b clinical trial, with our strong balance sheet and expected non-dilutive funds from the monetization of our priority review voucher, we believe Lumos Pharma is well positioned to execute on our clinical and business development plans."

Clinical Update and COVID-19 Impact
Phase 2b trial of LUM-201 in Pediatric Growth Hormone Deficiency (PGHD) – Lumos Pharma continues to prioritize the clinical development of LUM-201, its orally administered therapeutic candidate for a subset of children with PGHD. The Company is proceeding with the necessary steps to initiate this trial, from site preparation through readying the clinical drug supply. The coronavirus pandemic, however, has caused pervasive interruptions to clinical trials industrywide. Facing similar near-term impediments, the Company now expects to initiate its Phase 2b clinical trial in PGHD prior to the end of 2020 with the possibility of further delays should the pandemic persist.
Pipeline Expansion – The Company is also actively pursuing other business development opportunities to expand its rare disease portfolio. With an experienced team in place, we believe we are well-positioned to be successful in our pursuit of opportunities to expand our pipeline and build shareholder value.

Corporate Update
Completion of Merger – On March 18, 2020, the merger of privately held Lumos Pharma, Inc. with publicly listed NewLink Genetics Corporation was completed, and a 1-for-9 reverse stock split was effected, upon an overwhelmingly favorable vote by the stockholders of NewLink Genetics. In conjunction with the transaction, NewLink Genetics assumed the name Lumos Pharma, Inc. and on March 19, 2020 began trading on the Nasdaq under the symbol "LUMO."

New Board of Directors Formed – Upon the completion of the merger, the new Board of Directors of Lumos Pharma, Inc. was formed. Members include Rick Hawkins, CEO; Emmett T. Cunningham, Jr., M.D., Ph.D., Senior Managing Director, Blackstone Life Sciences group; Kevin Lalande, Co-founder and Managing Director, Santé Ventures; Lota S. Zoth, Chairman, Zymeworks and former CFO, MedImmune; Thomas A. Raffin, M.D., co-founder and partner, Telegraph Hill Partners and Professor Emeritus, Stanford School of Medicine; and Chad Johnson, General Counsel, Stine Seed Company. Subsequently, the Board named Rick Hawkins Chairman along with President and CEO and

Exhibit 99.1

appointed its seventh member, Joseph S. McCracken, DVM, MS, currently a director on the boards of Savara, Inc. and Kindred Biosciences.
Executive Team Strengthened – Just after the close of Q1, John McKew, PhD, was promoted to the position of Chief Operating Officer and Chief Scientific Officer. Dr. McKew has twenty-seven years of public and private sector experience developing novel therapeutics where he successfully advanced therapies through preclinical and into clinical development. In addition, on May 6, 2020, Aaron Schuchart joined Lumos Pharma as its Chief Business Officer where he will support the Company’s strategy of expanding its pipeline through the addition of other assets. Aaron Schuchart has over twenty years of experience in key leadership roles for both large multinationals and small biotech companies, including Amgen, Novartis Diagnostics/Grifols, and Coherus Biosciences.
Financial Results for the Three-Month Period Ended March 31, 2020 and Updated Cash Guidance
The Coronavirus Aid, Relief, and Economic Security (CARES) Act: To respond to the devastating effect the coronavirus pandemic has had on businesses worldwide, on March 27, 2020, Congress passed The CARES Act to provide rapid financial assistance to American workers, families, and businesses. As a result, the Company’s Q1 2020 financial results include a tax benefit of $4.5 million resulting from changes in the treatment of tax net operating losses under the provisions of The CARES Act and the refund the Company anticipates receiving.
Cash Position: Lumos Pharma ended the quarter on March 31, 2020, with cash and cash equivalents totaling $85.8 million compared to $5.0 million December 31, 2019 and pro forma December 31, 2019 cash of $95.5 million. The Company expects its cash on hand is sufficient to fund current operations through the Phase 2b LUM-201 trial read-out.
R&D Expenses: Research and development expenses for the three months ended March 31, 2020 were $1.9 million, an increase of $450,000 from $1.5 million for the same period in 2019. The increase is primarily due to additional expenses incurred as a result of the Merger including the write-off of the acquired NewLink in-process research and development of $426,000, increase of $84,000 in personnel-related and stock compensation expense, and an increase of $68,000 in equipment and supplies expense, offset by a decrease in research and development consulting of $128,000.
G&A Expenses: General and administrative expenses for the three months ended March 31, 2020 were $3.3 million, an increase of $2.6 million from $683,000 for the same period in 2019. The increase was due primarily to increases of $1.6 million in legal and professional fees incurred mainly related to the Merger, $663,000 in personnel-related expense, $295,000 due to increased operating expenses for rent, supplies, and depreciation and $91,000 due to insurance.
Net Income (Loss): The net income for the three months ended March 31, 2020 was $340,000 compared to a net loss of $2.1 million for the same period in 2019.
Lumos Pharma ended Q1 2020 with 8,292,803 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question and answer session following management’s prepared remarks.
Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at www.lumos-pharma.com in the "Investors & Media" section under "Events and Presentations" or through this link: View Source To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 9129999. The replay will be available for two weeks from the date of the call.

On May 28, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) for treating all stages of cancer, reported a clinical collaboration with Merck (known as MSD outside the U.S. and Canada) to evaluate the safety and efficacy of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with BgRT in multiple late-stage cancers, including non-small cell lung cancer (NSCLC), in two randomized controlled clinical trials (Press release, RefleXion Medical, MAY 28, 2020, View Source [SID1234558638]).

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"It is exciting to see these companies from different fields collaborating to investigate immuno-radiotherapy approaches for patients with metastatic cancer," said Jason Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center and associate professor of medicine at the University of Pittsburgh School of Medicine. "Several published clinical and translational studies laid the foundation for combining immunotherapy and radiotherapy, but despite their promise, available conventional radiotherapy techniques are limited in their general ability to reach more than 1-2 tumors.

"We hypothesize that BgRT may improve treatment efficacy and expand the immunologic impact of therapy by overcoming this limitation and treating more tumors," continued Dr. Luke. "This expanded treatment potential allows the field to pose new questions such as: What outcomes can combination therapy achieve when BgRT treats 5, 10 or even more sites of disease?"

This clinical collaboration reflects interest by researchers, clinicians and industry in exploring external beam radiotherapy to potentially expand the application of immunotherapy and improve outcomes for patients with advanced-stage cancer. Worldwide, over 1,000 clinical trials registered with the National Institutes of Health seek to determine the effect of combining immunotherapy and radiotherapy. Currently, very few of these trials reflect collaboration between radiotherapy and pharmaceutical companies.1

The aim of the clinical collaboration between RefleXion and Merck is to establish whether treating multiple tumors with BgRT, a novel external beam radiotherapy treatment modality in development, is safe and amplifies KEYTRUDA’s therapeutic effect. The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that restrict radiotherapy delivery to one or two sites of disease, and instead allow it to reach multiple sites during the same treatment session, even those sites that move due to breathing or digestion.

"We believe BgRT will one day treat all visible tumor sites, which could lead to better patient outcomes, particularly when used with immunotherapy," said Todd Powell, CEO and president of RefleXion. "The collaboration with Merck will allow us to explore this combined effect in randomized controlled clinical trials that, if successful, may lead to significant changes in the way physicians approach cancer care for patients with late-stage disease."

RefleXion recently announced the close of a $100M equity financing round, the sale of their first commercial system and FDA clearance for the X1 machine for conventional radiotherapy applications. The X1 is the only platform that includes high quality computed tomography (CT) imaging to reduce motion artifacts during patient setup and x-ray treatment delivery, resulting in accurate targeting of the radiation dose to a patient’s tumor.

About Combining Immunotherapy and External Beam Radiotherapy

External Beam Radiotherapy (EBRT) by itself treats a discrete target to provide local tumor control; however, clinical evidence suggests that EBRT potentially converts the locally radiated tumor into an in situ vaccine that contributes to systemic control of the cancer.2 The exploration of EBRT with immunotherapy began in earnest after a rapid succession of advances led to a corresponding acceleration of clinical trials and FDA approvals of different drugs for various cancer indications. Ongoing clinical trials for this combined approach are aimed at confirming safety and demonstrating clinical efficacy, determining the appropriate dosing and sequencing of each treatment, and developing biomarkers to identify the patients most likely to benefit.3

On May 28, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that warrants to purchase approximately 5.4 million shares of common stock issued in connection with capital raises in May 2018 and November 2019 with two institutional investors have been exercised at a price of $0.46 per share, resulting in cash proceeds of approximately $2.5 million to the Company (Press release, Genprex, MAY 28, 2020, View Source [SID1234558605]). The warrants were exercised on or about May 22, 2020, the first day they became exercisable under the terms of their respective agreements.

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The exercised warrants include all warrants that have been issued to investors in the Company’s public financings to date and represent approximately 70% of the Company’s overall outstanding warrants. Warrants remaining after the exercise carry a weighted average exercise price of approximately $3.93. Genprex believes that the elimination of the majority of its outstanding warrants is a significant milestone for the Company in that it provides a dramatically simplified capital structure.

In 2020, Genprex has raised gross proceeds of $25.5 million in two registered direct offerings, both priced at the market, with no warrants issued. The additional capital from these recent warrant excercises brings the equity capital raised during 2020 for advancing the Company’s research and development programs and other corporate initiatives, which could include strategic transactions, to roughly $28 million.

With the Company’s significantly strengthened balance sheet (the warrant exercise proceeds added to the more than $23 million in cash on the Company’s balance sheet as of March 31, 2020), Genprex believes it is in a strong position to pursue its planned clinical trial of its lead gene therapy drug candidate, Oncoprex immunogene therapy, combined with targeted therapy Tagrisso (marketed by AstraZeneca) in non-small cell lung cancer (NSCLC) patients whose tumors progressed on Tagrisso, for which the Company was granted United States FDA Fast Track Designation in January 2020; and a planned clinical trial of Oncoprex combined with Keytruda (marketed by Merck) for late stage NSCLC.