On March 23, 2022 Medigene reported that results for fiscal year 2021 and outlook Martinsried/Munich, 23 March 2022. Medigene AG ( View Source) (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, today published its financial results and Annual Report for the 2021 fiscal year and its outlook for 2022 (Press release, MediGene, MAR 23, 2022, View Source [SID1234610751]). The full version of the Annual Report 2021 can be downloaded here: View Source/investors-media/reports-presentations/

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Business review and outlook

The Company has been repositioned with the aim of fully focusing its future development programs on T cell receptor-modified T cell immunotherapy (TCR-T immunotherapy) of solid cancer, based on scientific, clinical and commercial considerations. Medigene believes that this direction optimally leverages its unique technologies and opens the greatest commercial opportunities for the Company now and in the future. It remains Medigene’s mission to offer seriously ill cancer patients new, effective and well-tolerated therapies developed internally or through partnerships.

Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)

BioNTech recently acquired Medigene’s TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies more efficient and safer.

Under the agreement, Medigene has received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.

MDG1011 – clinically validated TCR-T therapy in blood cancers

In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity and one patient is currently still under observation, over nine months after treatment. In line with Medigene’s focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.

Unique tumor-specific antigens – the "dark matter" of our genome

Under the Company’s collaboration with the University of Montréal, Medigene gained access to 47 potential new tumor-specific antigens (TSAs) common to solid tumors of different origin, such as ovarian, breast, and lung cancer. Medigene’s high-throughput screening technology identified ten peptides that were immunogenic and able to induce specific T cell responses. To date, Medigene has isolated more than 20 TCRs of T cell clones that recognize these novel TSAs. Their further functional and safety characterization is ongoing.

Development partnerships

Medigene continues its successful collaborations with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences (Roivant/Cytovant) and initiates operations within a new partnership with BioNTech. To maximize the Company’s value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.

Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Our steadfast focus on TCR-T therapies against solid cancers, has led, most recently, to the comprehensive new partnership with BioNTech and the sound financial basis it provides for the Company.

This partnership validates Medigene’s investment in T-cell-based immunotherapy of cancer. This was clearly appreciated and valued by BioNTech in the lengthy due diligence process leading to the deal. We look forward to executing on this partnership.

Medigene is very well positioned to sustainably increase value through partnerships and our internal projects, discovering novel TCRs and developing and improving new technologies to make TCR-T therapies safer, more efficient and cost effective."

Change in the Executive Management Board

Axel Malkomes, Medigene’s Chief Financial and Business Development Officer, will leave the Company at the end of March 2022 by mutual consent at the expiry of his contract. Prof. Dolores Schendel will remain as CEO and CSO.

Dr. Gerd Zettlmeissl, Chairman of Medigene’s Supervisory Board: "Axel was a valued member of the Executive Management Board, making a significant contribution to the restructuring and improvement of Medigene’s financial outlook. We would like to thank Axel and wish him the best in his future endeavors.

We are very pleased that Dr. Birger Kohlert, Vice President Finance, Controlling, Procurement and IT at Medigene since January 2020, will act as CFO. Birger looks back on years of international experience in finance and was previously CFO at S + P Samson, Kissing, Germany, EvoBus Sweden and EvoBus Denmark. Prior to that, he had several positions in the finance department of the Daimler Group in Germany and the USA and in the audit department of KPMG in Germany. He holds a doctorate in the field of international accounting."

Financial development and guidance

In fiscal 2021, the financial forecast that was initially issued was adjusted to reflect the more favorable revenue and cost situation. Thereby, the expected range for total revenues was increased from previously EUR 7 – 9 million to EUR 10 – 11 million and the forecast for research and development expenses (R&D expenses) was reduced from EUR 14 – 20 million to EUR 11 – 12 million. The reason for this was, among other things, the efficiency measures of the previous year and active cost management, which were ultimately also reflected in the EBITDA loss, the range of which also shifted from EUR 10 – 17 million to EUR 7 – 9 million. The total revenues of EUR 10.5 million (2020: EUR 8.0 million) and EBITDA loss incurred in fiscal year 2021 of EUR -6.6 million (2020: EUR -22.2 million) were therefore within the specified forecast range, while R&D expenses of EUR 12.8 million (2020: EUR 22.3 million) were slightly higher.

The financial forecast for 2022 reflects the Company’s focus on and progress in the core business of immunotherapies and does not include potential future milestone payments from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene. In 2022, Medigene expects to achieve revenues of EUR 23 – 28 million, R&D expenses of EUR 11 – 15 million and a positive EBITDA in the amount of EUR 3 – 5 million.

Cash and cash equivalents amounted to EUR 22.4 million at the end of 2021 (31 December 2020: EUR 30.0 million). Including the upfront payment of EUR 26 million received under the new partnership with BioNTech signed in February 2022, Medigene is financed into Q4 2024 based on current planning.

Conference call

The Management Board will hold a conference call in English today at 3 pm CET (10 am ET). Please register beforehand and latest 2 hours prior to the event through this link in order to get your personal access information (phone number, passcode + individual PIN):

On March 23, 2022 Virtuoso Therapeutics, Inc., a private oncology-focused company developing novel bispecific antibody and antibody drug conjugate (ADC) therapies, reported that it will present two posters highlighting the preclinical data from leading bispecific antibody programs at the American Associate for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting (Press release, Virtuoso Therapeutics, MAR 23, 2022, View Source [SID1234610768]).

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The details of the Company’s presentations at the AACR (Free AACR Whitepaper) are as follows:

Poster Presentation #5385:

Title: Multiple modes of action of the CD38 x ICAM-1 bispecific antibody
Session Category: Experimental and Molecular Therapeutics
Session Title: Mechanisms of Drug Action
Presenting Author: Xiaocheng Chen, Ph.D. VP of Antibody Therapeutics
Date/Time: Friday, April 8, 2022, 12:00 – 1:00 p.m. Central
Location: E-Poster Website

Poster Presentation #3430:

Title: CD47 x ICAM-1 bispecific antibody represents a novel approach for treating ICAM-1 overexpressing tumors
Session Category: Clinical Research Excluding Trials
Session Title: Combination Immunotherapies / Therapeutic Antibodies
Presenting Author: Xinhua Wang, Ph.D. Director of Antibody Engineering
Date/Time: Tuesday, April 12, 2022, 1:30 – 5:00 p.m. Central
Location: E-Poster Website

Virtuoso bispecific antibodies confer greater tumor selectivity than monoclonal antibodies. This greater selectivity allows enhanced efficacy with strong effector functions, and improved safety profile. Posters will be available at www.virtuosotherapuetics.com after the meeting.

On March 23, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported the pricing of a global offering of ordinary shares represented by American Depository Shares ("ADSs") in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom (Press release, argenx, MAR 23, 2022, View Source,%E2%82%AC273.10%20per%20ordinary%20share. [SID1234610915]). The Company anticipates total gross proceeds of approximately $700 million (approximately €637 million) from the sale of 1,551,044 ADSs at a price of $300.00 per ADS and the sale of 782,290 ordinary shares at a price of €273.10 per ordinary share. Each of the ADSs offered in the offering represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are currently expected to close simultaneously on March 28, 2022, subject to customary closing conditions.

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In addition, argenx has granted the underwriters of the offering a 30-day option to purchase up to 350,000 ordinary shares (which may be represented by ADSs) on the same terms and conditions.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX" and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX".

J.P. Morgan, Morgan Stanley, Cowen and SVB Leerink are acting as joint bookrunning managers for the offering. Wells Fargo Securities, Kempen & Co, H.C. Wainwright & Co., Raymond James and Wedbush PacGrow are acting as co-managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities was filed with the SEC on March 22, 2022. The final prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; or from SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected].

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On March 23, 2022 Manhattan BioSolutions, Inc, an emerging biotechnology company developing a new class of targeted immunotherapies for the treatment of advanced and metastatic cancers, reported that it has been awarded a grant from the University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UB CAT program) (Press release, Manhattan BioSolutions, MAR 23, 2022, View Source [SID1234610713]). The UB CAT grant will enable early-stage preclinical characterization of novel monoclonal antibody-based therapies targeting immunomodulatory receptors highly expressed in hematological malignancies. This collaborative research will be conducted in partnership with the laboratory of Dr Dhaval Shah, Associate Professor at the Department of Pharmaceutical Sciences, University at Buffalo, whose cutting-edge research in protein therapeutics and pharmacokinetic-pharmacodynamic modeling has significantly impacted drug development field around the globe.

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The new monoclonal antibody (mAb) being developed by Manhattan BioSolutions binds to a highly conserved lymphocyte surface receptor that senses the presence of various components from fungi, viruses, and bacteria. This protein functions to regulate T-cell activation and plays an important role in the development and progression of hematological cancers. The proposed project focuses on experimental validation of the new mAb, enabling generation of safe and highly efficacious antibody-drug conjugates directed against selected tumor antigen.

Dr Borys Shor, Chief Executive Officer, Manhattan BioSolutions, commented, "This new program will expand Manhattan BioSolutions’ current discovery pipeline focused on the unique biologic therapies at the intersection of innate, adaptive immunity and cancer. Our industry expertise in antibody- and antibody-drug conjugate development complements world-class research conducted by Dr Shah’ laboratory and thus strengthen our commitment to discover innovative medicines for patients in need."

Dr Dhaval Shah added, "The primary benefit of this collaboration is the strong synergy between our teams based on the unique expertise in antibody discovery, translational pharmacology and pharmacokinetic modeling of novel biologics. Together, we will be in a strong position to fully validate the selected antibodies in preclinical experiments."

On March 23, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Dr. Roy D. Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July (Press release, Merck & Co, MAR 23, 2022, View Source [SID1234610752]). Dr. Baynes will be succeeded by Dr. Eliav Barr, effective April 1, 2022. Dr. Baynes will continue to report to Dr. Dean Y. Li, president, Merck Research Laboratories, until his retirement.

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"Roy is one of the world’s pre-eminent oncologists and clinical development experts, and his masterful spearheading of the development of KEYTRUDA leaves an indelible mark on Merck, on oncology and on the lives of patients and their families. As textbooks are updated to reflect the era of immuno-oncology, Roy’s contributions cannot be overstated, and will persist far beyond his eight years with Merck," said Dr. Li. "I know there are many who join me in thanking Roy for his efforts and wishing him well in his next chapter."

Dr. Baynes joined Merck in 2013. Under his leadership, Merck has become a leading oncology company and achieved more than 140 medicine and vaccine approvals globally across numerous therapeutic areas. This includes the development of KEYTRUDA (pembrolizumab), WELIREG (belzutifan), VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine), ZEPATIER (elbasvir and grazoprevir), LAGEVRIO (molnupiravir), ZERBAXA (ceftolozane and tazobactam), RECARBRIO (relebactam), PREVYMIS (letermovir), BRIDION (sugammadex) among others and, in collaboration with AstraZeneca, Eisai and Bayer, the development of Lynparza (olaparib), Lenvima (lenvatinib) and VERQUVO (vericiguat), respectively. He also led the expansion of Merck’s research and development in China and Japan.

"It has been a privilege to have led the global clinical development organization during my tenure at Merck," said Dr. Baynes. "I am immensely proud of the team’s accomplishments and the difference we are making in the lives of patients worldwide. I look forward to continuing to work with Eliav in the coming months to ensure a smooth transition."

Dr. Baynes will be succeeded by Dr. Eliav Barr, senior vice president, Global Clinical Development. During his more than two decades at Merck, Dr. Barr has held positions of increasing responsibility including leadership roles in oncology and infectious diseases clinical development. Dr. Barr oversaw the company’s Vaccines/Infectious Disease area during a period of high productivity, including the development of novel therapies for chronic hepatitis C and HIV-1 infections. Most recently he led MRL’s Global Medical Affairs organization from 2018 to January 2022, significantly expanding Merck’s scientific engagement and implementation efforts in oncology, vaccines and more. In his new role Dr. Barr will lead all late-stage clinical development for Merck’s expansive human health portfolio and pipeline and will report to Dr. Li.

"Eliav’s career at Merck has been marked by roles spanning infectious diseases, oncology and vaccines involving the development of several first-of-their-kind medicines and vaccines that have since been used by millions of people around the world. Most notably, he led the development of Merck’s human papillomavirus (HPV) vaccines, which have become key tools in the global effort to reduce the burden of certain cancers and diseases caused by HPV," said Dr. Li. "Eliav’s expertise in global clinical development combined with his unwavering commitment to patients and Merck’s purpose to save and improve lives make him well qualified to be the next Chief Medical Officer for Merck and the ideal leader for our industry-leading global clinical development team."

Dr. Barr is a cardiologist by training. He received his undergraduate degree from Penn State University and his medical degree from Sidney Kimmel Medical College, Thomas Jefferson University. He completed his Internal Medicine residency and Cardiology Fellowship at Johns Hopkins University, and subsequently pursued post-doctoral training at the University of Michigan. Prior to joining Merck in 1995, he held a faculty position at the University of Chicago. In 2019, he was a proud recipient of a Penn State Alumni Fellow Award for his dedication to the development of medicines and vaccines that treat and prevent infectious diseases.

"I am honored to assume the role as head of Merck’s industry-leading clinical development organization," said Dr. Barr. "I am grateful to Roy for his mentorship and excited by the opportunity to build on Merck’s proud legacy of delivering breakthrough medicines and vaccines for the patients we serve."