On May 2, 2018 Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, reported that it has entered into a definitive agreement under which it will acquire BeneVir Biopharm, Inc. (BeneVir), a privately-held, biopharmaceutical company specializing in the development of oncolytic immunotherapies (Press release, Janssen Pharmaceutica, MAY 2, 2018, View Source [SID1234525955]). BeneVir utilizes a proprietary T-Stealth Oncolytic Virus Platform to engineer oncolytic viruses, tailored to infect and destroy cancer cells. Johnson & Johnson Innovation LLC facilitated the transaction.

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"Oncolytic viral immunotherapy holds exciting potential in the treatment of solid tumors through the priming and augmenting of an anti-tumor immune response," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "BeneVir’s unique technology platform complements our immuno-oncology research, which is focused on bringing forward an array of novel immunotherapies and combinations that may improve treatment outcomes for patients."

BeneVir engineers oncolytic viruses through the T-Stealth platform to overcome the barrier of the body’s immune system. Janssen intends to advance pre-clinical candidates as standalone therapies and in combination with other immunotherapies for the treatment of solid tumor cancers (e.g., lung, prostate, colorectal, etc.).

"We are delighted to add the scientific caliber of the BeneVir team and their oncolytic immunotherapy platform to Janssen’s robust immuno-oncology efforts," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are committed to pursue transformational science from our own laboratories and those of others, as we continue to advance our focus on treating some of the world’s most devastating diseases."

BeneVir will maintain a research presence in Rockville, Maryland and become part of the Janssen Oncology Therapeutic Area. The team will remain focused on the optimization of next generation T-Stealth oncolytic viruses in solid tumors and the execution of pre-clinical activities.

The closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to close in the second quarter of 2018.

On May 2, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) reported results for the first quarter of 2018 (Press release, MorphoSys, MAY 2, 2018, View Source [SID1234525972]).

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"We have made a strong start to the year, with significant progress in several key programs in the first quarter of 2018. Center-stage is our most advanced proprietary drug candidate MOR208, for which we reported updated interim data from our ongoing L-MIND trial in aggressive lymphoma. The path to market under the current breakthrough therapy designation has become significantly clearer following constructive discussions with the FDA during the quarter," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Elsewhere, together with our partner Galapagos we presented promising data from the phase 1 trial of MOR106 in atopic dermatitis and recently initiated phase 2 development in that indication. We were also delighted to report that our partner Janssen has received approvals in psoriasis for Tremfya(R) in Japan, Brazil, Australia and South Korea. In Japan, Janssen also received an approval in psoriatric arthritis."

"MorphoSys is at a truly exciting stage of its corporate development. Propelled by the updated interim data from the L-MIND study and our constructive ongoing talks with the FDA, we will now start building commercial capabilities in the U.S. in order to prepare for a potential commercialization of MOR208 as our first proprietary product candidate. This is a key activity in our plan to transform MorphoSys into a fully integrated biopharmaceutical company," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "Through our recent successful Nasdaq IPO, we further raised our profile in the U.S. and strengthened our financial position. Based on our financial capabilities, we will continue to invest in the further development of MOR208, in our other proprietary drug candidates as well as in our technological capabilities."

Successful Initial Public Offering at Nasdaq

In April 2018, MorphoSys successfully closed an initial public offering at the U.S. stock exchange Nasdaq. The transaction produced total gross proceeds of USD 239.0 million from the sale of 2,075,000 new ordinary shares in the form of 8,300,000 American Depositary Shares ("ADSs") and from the exercise in full of the underwriters’ option to purchase 311,250 additional new ordinary shares in the form of 1,245,000 additional ADSs, at a price of USD 25.04 per ADS, respectively. Each ADS represents 1/4 of a MorphoSys ordinary share.

Financial Review for Q1 2018 (IFRS)

In Q1 2018 MorphoSys continued to focus on the research and development of drug candidates both for its own account as well as with its partners. Group revenues totaled EUR 2.8 million, compared to revenues of EUR 11.8 million in the first quarter of 2017. The expected decline is mainly driven by the completion of the active partnership with Novartis, which ended in accordance with the contract in November 2017. As the royalty reporting from Janssen for Q1 2018 has not yet been received, Tremfya(R) royalties booked for Q1 2018 were estimated based on Tremfya(R) sales in previous months.

In the Proprietary Development segment, MorphoSys focuses on research into, and clinical development of, its own drug candidates in the fields of cancer and inflammation. In Q1 2018, this segment recorded revenues of EUR 0.2 million (Q1 2017: EUR 0.2 million).

In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new antibodies for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. In Q1 2018, revenues in this segment reached EUR 2.6 million (Q1 2017: EUR 11.6 million).

Total operating expenses reached EUR 21.9 million in the first quarter of 2018 (Q1 2017: EUR 26.9 million). Proprietary development expenses and technology development expenses declined by 18% to EUR 15.5 million (Q1 2017: EUR 19.0 million). The year-on-year decline in the proprietary development expenses is mainly due to decreased development costs for MOR202 in connection with the licensing agreement with I-Mab from November 2017.

Earnings before interest and taxes (EBIT) in Q1 2018 amounted to EUR -19.0 million (Q1 2017: EUR -14.9 million). As expected, the operational loss reflects ongoing activities in the clinical development of the Company’s proprietary drug candidates as well as the expected revenue decrease. The Proprietary Development segment reported an EBIT of EUR -15.9 million (Q1 2017: EUR -18.9 million). EBIT in the Partnered Discovery segment was EUR 0.6 million (Q1 2017: EUR 7.3 million). In Q1 2018, the consolidated net result amounted to EUR -19.5 million (Q1 2017: EUR -15.0 million). The earnings per share for Q1 2018 reached EUR -0.67 (Q1 2017: EUR -0.52).

At the end of Q1 2018, the Company had a cash position of EUR 285.8 million compared to EUR 312.2 million on December 31, 2017. On the balance sheet, this cash position is reported under the following items: cash and cash equivalents; financial assets at fair value through profit or loss; and current other financial assets at amortized cost. The cash position does not include gross proceeds of USD 239.0 million from the capital increase with the successful Nasdaq listing in April 2018.

The number of shares issued totaled 29,420,785 at the end of Q1 2018 (year-end 2017: 29,420,785). The number of shares does not include shares issued in connection with the Nasdaq listing.

Financial Guidance and Operational Outlook for 2018

For the financial year 2018, MorphoSys continues to expect Group revenues in the range of EUR 20 to 25 million. Expenses for proprietary development and technology development are confirmed to be in a corridor of EUR 95 to 105 million. The Company confirmed its guidance for earnings before interest and taxes (EBIT) of EUR -110 to -120 million. This guidance does not include any additional revenue from potential new collaborations and/or licensing partnerships nor effects from potential in-licensing or co-development deals for new development candidates.

In the Proprietary Development segment, MorphoSys expects the following events and activities taking place in 2018:

– MOR208

– L-MIND: Continue analysis of maturing data of all 81 patients enrolled in the trial

– B-MIND: Continue the pivotal phase 3 study evaluating MOR208 plus bendamustine versus rituximab plus bendamustine in r/r DLBCL

– COSMOS: Continue the phase 2 trial of MOR208 plus idelalisib or venetoclax in CLL/SLL and present data at an appropriate medical conference

– Commercial activities: Begin setup of commercial capabilities for MOR208 in the U.S., in preparation for an anticipated launch in 2020

– MOR202

– Multiple myeloma: Complete current phase 1/2a dose-escalation trial of MOR202 in multiple myeloma and present study data at an appropriate medical conference; evaluate further partnering opportunities with the goal of securing future development of MOR202 in multiple myeloma

– NSCLC: Preparation of planned exploratory phase 1/2 clinical trial

– MOR106: Continue patient recruitment to phase 2 IGUANA study recently started together with partner Galapagos in patients with atopic dermatitis

– MOR107: Following the completion of a phase 1 clinical study in healthy volunteers in 2017 and initial preclinical anti-tumor data, continue preclinical investigations of MOR107 with a focus on oncology indications to inform a decision regarding potential further clinical testing

– MOR103/GSK3196165: For this HuCAL antibody out-licensed to GSK, the publication of data from a phase 2b study in rheumatoid arthritis and a phase 2a study in hand osteoarthritis, both conducted by GSK, is expected

In its Partnered Discovery segment, MorphoSys expects the following events in 2018:

– Tremfya(R) (guselkumab): Janssen is currently investigating guselkumab in phase 3 trials in psoriasis and in psoriatic arthritis and plans to develop the product in Crohn’s disease. Several phase 3 trials in psoriasis are scheduled for primary completion in 2018, including a head-to-head trial comparing Tremfya(R) to secukinumab in plaque psoriasis

– Gantenerumab: MorphoSys’s partner Roche is expected to initiate two new pivotal phase 3 trials (GRADUATE-1 and GRADUATE-2) in 2018 in Alzheimer’s disease

– Clinical data and potential regulatory milestones from a number of other partnered programs could be published during the year

MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, and/or acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

On May 2, 2018 Novavax, Inc. (Nasdaq:NVAX) reported it will report its first quarter 2018 financial and operating results following the close of U.S. financial markets on Wednesday, May 9, 2018 (Press release, Novavax, MAY 2, 2018, http://ir.novavax.com/news-releases/news-release-details/novavax-host-conference-call-discuss-first-quarter-financial-1 [SID1234525990]).

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Conference call details are as follows:

Date: May 9, 2018
Time: 4:30 p.m. U.S. Eastern Time (ET)
Dial-in number: (877) 212-6076 (Domestic) or (707) 287-9331 (International)
Passcode: 3687883
Webcast: www.novavax.com, "Investors"/ "Events"

Conference call and webcast replay:

Dates: Starting at 7:30 p.m. ET, May 9, 2018 until
7:30 p.m. ET May 16, 2018
Dial-in number: (855) 859-2056 (Domestic) or (404) 537-3406 (International)
Passcode: 3687883
Webcast: www.novavax.com, "Investors"/ "Events", until August 9, 2017

On May 2, 2018 EpicentRx, a San Diego biotechnology company developing a next-generation immunotherapy platform of viruses that infect and kill cancer cells for the treatment of several tumor types, reported that it has developed the first ever series of oncolytic viruses tailored to tumors of individual patients (Press release, EpicentRx, MAY 2, 2018, View Source [SID1234528889]). The first patient, treated at the University of Cincinnati (UC) in Cincinnati, Ohio, by John Morris, MD, professor at the UC College of Medicine and director of the area’s only Phase I/Experimental Therapeutics Program, has been enrolled to receive a personalized virus that has been "armed" with peptide fragments or neoantigens from his specific tumors.

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Neoantigens are ideal targets for the immune system because they are selectively expressed on tumors not on normal cells. Viruses naturally target and kill cancer cells and these personalized viruses, which are derived from viruses that cause the common cold, have been engineered to improve on that ability since they use the machinery of the cancer cell to produce thousands of copies of themselves and the neoantigens that they are carrying. Hence, these viruses are administered with the goal of training the immune system to seek out and destroy the cancer cells that display these neoantigens.

This trial "provides proof-of-principle that personalized viral vaccines tailored and targeted to patient tumors can be made quickly and on demand," said Dr. Tony R. Reid, Chief Scientific Officer of EpicentRx and Associate Professor of Oncology at UCSD in California.

Dr. Corey A. Carter, CEO of EpicentRx, added that while current treatment paradigm in oncology relies on off the shelf, one size fits all therapies, "we know that every patient and patient’s tumor is different. To target an individual tumor in individual patients is nothing short of a revolution."

Drs. Carter and Reid felt that further development of personalized viral vaccines is warranted in combination with other immunotherapy weapons such as checkpoint inhibitors, which also trigger immune responses against cancer neoantigens, albeit non-specifically. "The reality is that other immunotherapies, such as checkpoint inhibitor drugs, only benefit 20-25% of patients in selected tumor types. There’s nothing for the other 75-80% of patients that don’t benefit. We can and must do better. These viruses are potentially a way to increase response rates so that the other 75-80% of patients start to benefit," said Dr. Carter.

"No two cancer cells are exactly alike, making it difficult to target cancer cells with drugs that inhibit one receptor or even one pathway since the cancer cells may and often do vary with respect to genetic changes and survival mechanisms," says Dr. Morris. "This personalized viral vaccine has the ability to contain express many different neoantigens from the tumor, targeting multiple genetic mutations in tumor cells, which could potentially prevent the cancer cells from sidestepping the immune system. We are excited to be part of this trial, which could prove beneficial for many patients."

"When you infect a cancer cell with a virus, it is like waving a big red flag at a bull, which stimulates the immune system to ‘go after’ the cancer. But like a matador cancer often has the ability to maneuver away from the threatening attack. In our experiments we have found that when the virus is personalized to the tumor with multiple neoantigens, the tumor is unable to escape the immune system’s charge and is ‘gored’," said Dr. Reid. "Effectively what we are doing with these viruses is to use the immune system’s natural ability to attack many target antigens, which is what happens every time we get an infection."

Oncolytic viruses have been tested in thousands of patients in the clinic and generally appear to only cause flu-like symptoms for about a week, according to Dr. Reid.

The viruses were manufactured in house according to Good Manufacturing Practice (GMP) regulations and samples of patient tumors and normal DNA from blood underwent whole-exome sequencing to reveal mutations present only in the tumor.

According to Dr. Carter, "Future personalized viral vaccine trials will be done under a separate Investigational New Drug application to the FDA, so many more patients with advanced disease may be enrolled to test the efficacy of the viruses both alone and with checkpoint blockade and other immunotherapeutics. Personalized viruses have the potential to be applied to any cancer with enough neoantigens for vaccination."

Tumor-targeting viruses can rally the immune system against cancers, boosting the efficacy of immunotherapy drugs and opening the door to promising combination treatments for aggressive and difficult-to-treat cancers. Many viruses naturally target and kill cancer cells, and experimental oncolytic viruses are often engineered to improve that ability.

On May 2, 2018 OnKure, Inc., the epigenetics–focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials, reported it has completed a $7M Series A financing (Press release, OnKure, MAY 2, 2018, View Source [SID1234535520]). Delian Capital led the investment round with participation from existing and new investors including OnKure management. The investment will help the company aggressively accelerate its research and development activities.

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Delian Capital invests in early stage biopharmaceutical startups that redefine or create large new markets, with notable investments such as Chance Pharma, MicuRx and Bioceutiq. The Series A financing builds on an exceptional year for OnKure, which made significant progress towards advancing its first clinical candidate, OKI-179, towards Phase 1.

OnKure’s platform transforms naturally occurring, biologically active lead compounds into commercial drugs that address a variety of diseases with an emphasis on oncology. At the heart of OnKure’s solution to Class 1 histone deacetylase inhibition is a molecule (OKI-179) that parallels the potency and selectivity of Romidepsin (Istodax), the most potent Class 1 biased histone deacetylase inhibitor currently approved by the FDA. While Romidepsin is administered by continuous infusion, OKI-179 was designed as an orally active drug and has demonstrated a superior safety profile in preclinical studies. As an orally administered therapy, it is also more suitable for combination dosing with a variety of targeted anti-cancer agents.

"We are delighted that Delian Capital chose to lead our Series A round and I look forward to working with Mr. Guobao Zhao, Vice President of Delian Capital’s Healthcare Division and OnKure’s newest addition to the board," said Tony Piscopio, co-founder, President & CEO of OnKure. "OnKure will use these funds to accelerate the clinical development of OKI-179 and expand its pipeline through in-licensing first–in–class or best–in–class compounds that synergize with OKI-179."

Mr. Guobao Zhao, Vice President of Delian Capital, commented, "Delian invests in pharmaceutical companies with a deep understanding of disease mechanisms and extensive clinical expertise." Mr. Zhao added, "OnKure has a very experienced management team, and thus we look forward to supporting the parallel development of OKI-179 in the United States and China, as this novel HDAC inhibitor has the potential to offer an attractive option for addressing cancer’s growing unmet medical needs."