On May 16, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported the pricing of its underwritten public offering of 11,764,706 shares of its common stock at a price to the public of $4.25 per share (Press release, Coherus Biosciences, MAY 16, 2023, View Source [SID1234631771]). All of the shares of the common stock to be sold in the offering will be offered by Coherus. In addition, Coherus has granted the underwriters a 30-day option to purchase up to an additional 1,764,705 shares of its common stock at the public offering price, less underwriting discounts and commissions.

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!

Coherus intends to use substantially all of the net proceeds from this offering for general corporate purposes, including the cost of manufacturing clinical and commercial supplies of product candidates and products. Coherus may also use a portion of the net proceeds from this offering, together with existing cash, cash equivalents and marketable securities, to in-license, acquire or invest in complementary businesses, technologies, products or assets. If there are any remaining net proceeds from this offering, Coherus intends to use them for working capital and other general corporate purposes.

The offering is expected to close on or about May 18, 2023, subject to satisfaction of customary closing conditions.

J.P. Morgan and Citigroup are acting as co-lead book-running managers for the offering. Mizuho is acting as lead manager for the offering.

A shelf registration statement (including a base prospectus) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 17, 2022. This offering is being made solely by means of a prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and are available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (866) 803-9204, email: [email protected] or Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 (Tel: 800-831-9146).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 16, 2023 Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, presented data for its CD45 Shielded Cell & Immunotherapy Pair (SCIP) program at the American Society of Gene and Cell Therapy’s Annual Meeting in Los Angeles (Press release, Cimeio Therapeutics, MAY 16, 2023, View Source [SID1234631770]). The findings build upon prior successful studies using CD117 and CD123 variants and collectively provide further proof of concept for Cimeio’s platform, which offers a novel and promising therapeutic approach to improve the outcomes for patients with benign and malignant hematological diseases in need of a hematopoietic stem cell (HSC) transplant.

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!

The new study demonstrates that a genetically engineered variant of the cell surface receptor CD45 is fully functional and, importantly, evades a paired immunotherapy directed against the wild-type molecule.

CD45 is a pan-hematopoietic marker critical for the function of immune cells. While eradication of CD45+ cells could represent a universal approach to reset the hematopoietic system for hematologic malignancies or severe autoimmune diseases, the current application of CD45-targeted cell-depleting therapies is limited by potentially severe toxicities due to the near ubiquitous expression of the target on hematopoietic cells. In contrast, the molecular shielding of CD45 will allow a patient to develop a healthy, protected and fully functional hematopoietic system, ensuring the paired immunotherapy targets just the diseased host cells.

A poster titled, "Molecular Shielding of the Pan-Hematopoietic Marker CD45 May Enable a Targeted Universal Approach for Replacement of the Hematopoietic System," was authored by Lukas T. Jeker, M.D., Ph.D., co-founder of Cimeio and Professor of Experimental Transplantation Immunology & Nephrology at the Department of Biomedicine, University of Basel and at the Basel University Hospital, Switzerland.

Key takeaways from the poster are as follows:

Engineered HSCs were generated expressing a stable variant of CD45 and demonstrated no binding to the paired immunotherapy
A novel, humanized, potent CD45-targeting antibody-drug conjugate (ADC) was developed that killed CD45 cancer cells in vitro while sparing edited cells from depletion
In vivo experiments showed efficient engraftment and differentiation of the engineered CD45 variant HSCs, as well as shielding and strong enrichment in combination with the CD45 immunotherapy
"Cimeio’s platform continues to show potential as a safe and efficient method to enable HSC transplants for patients suffering from a variety of severe diseases," said Dr. Jeker. "I look forward to the continued progress of the CD45 program, as well as the additional programs in the company’s deep pipeline of medicines."

On May 16, 2023 Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, reported that George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, will present at the upcoming 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), which is being held at the Los Angeles Convention Center on May 16-20, 2023 (Press release, Catalent, MAY 16, 2023, https://www.catalent.com/catalent-news/catalent-to-present-on-integrated-uptempo-gene-therapy-development-platform/ [SID1234631769]).

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!

Dr. Buchman’s presentation, on Friday, May 19, at 4:30 p.m. PDT, is entitled "One-stop Integrated Viral Vector Platform for Speed to Clinic," and will focus on a consolidated and standardized platform to help fast-track AAV vectors to the clinic with a scalable CGMP-ready process. The complete UpTempo℠ AAV platform, which was re-launched in its expanded form in March 2023, provides increased consistency and efficiency, reducing the time to manufacture clinical-quality drug product to just nine months, while delivering a process that will readily advance to late-stage CGMP manufacture.

Dr. Buchman works in Catalent’s Cell & Gene Therapy business, which provides research services and process development and enables the translation of programs into clinical trials and commercial CGMP manufacturing. He has worked more than 30 years in the biotech industry, including at Life Technologies (now Thermo Fisher Scientific), Celera Genomics, and GeneLogic. Dr. Buchman obtained his bachelor’s degree in biochemistry from Albright College, Reading, Pennsylvania, and his doctorate in biochemistry from the University of Maryland.

Catalent will also be exhibiting at the conference, in booth 229. To find out more information about this event, visit https://www.catalent.com/events/asgct-annual-meeting-2023/ and to find out more about Catalent’s UpTempo AAV platform, visit Catalent.com/UpTempo.

On May 16, 2023 Sony Corporation (President and CEO: Kimio Maki, "Sony") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that they have entered into a collaborative research agreement to discover a novel Antibody-Drug Conjugate (ADC)*1 platform in oncology based on Sony’s unique polymeric material, "KIRAVIATM*2 Backbone*3 (Press release, Astellas, MAY 16, 2023, View Source [SID1234631768]). ADC is expected to selectively deliver anti-cancer drugs to target cells, thereby increasing efficacy and reducing side effects caused by anti-cancer drugs attacking normal cells. The technology to create linkers which conjugates antibodies and drugs, is considered to be a key to development of a better-performing ADC. This collaborative research leverages the flexibility in design and resulting properties such as high capacity and solubility of KIRAVIA Backbone as a linker of ADC, to effectively deliver anti-cancer drugs to targeted cells in a stable manner, aiming to further enhance therapeutic efficacy by achieving high Drug-to-Antibody Ratio (DAR) etc.

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!

The two companies jointly began exploratory research of new linker technology aimed at creating a new ADC platform in July 2022, and the expected profile was obtained in feasibility studies using human cancer cells. Under this agreement, Sony and Astellas will jointly develop and optimize a new ADC platform using the KIRAVIA Backbone as a linker. In addition, Astellas will conduct non-clinical trials of development candidates. Furthermore, in order to build a drug discovery platform not limited to ADC, the two companies have agreed to continue discussions on expanding research partnerships to create new value by combining Sony’s cutting-edge technology with Astellas’ renowned pharmaceutical capabilities.

"Sony’s life science business has accumulated substantial knowledge in the field of cell analysis," said Katsunori Ogawa, Head of Life Science & Technology Business Unit at Sony Corporation. "Through this collaboration, Sony is striving to contribute to the medical and drug discovery fields and provide further social value by leveraging Sony’s technological capabilities in the development of anti-cancer drugs therapy, which are expected to grow."

"We are pleased to enter into a joint research agreement with Sony," said Yoshitsugu Shitaka, Ph.D., Chief Scientific Officer (CScO), Astellas Pharma Inc. "Astellas is working to create innovative drugs from a multifaceted perspective called the Focus Area approach*4, which identifies combinations of biology, therapeutic modality or technology and diseases with high unmet medical needs. The partnership will further strengthen our ability to utilize suitable modalities. It is our expectation that the collaboration will lead to the continuous creation of innovative drugs for patients around the world."

On May 16, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a registrational Phase 3 trial design for batiraxcept in clear cell renal cell carcinoma (ccRCC) at an End-of-Phase 2 (EOP2) meeting (Press release, Aravive, MAY 16, 2023, View Source [SID1234631767]).

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 very pleased to be advancing batiraxcept into Phase 3 development in ccRCC, having successfully completed our EOP2 meeting with the FDA," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We believe our trial design and planned endpoint analyses are consistent with the FDA’s guidance, and we look forward to initiating our registrational Phase 3 trial in the second half of 2023. Topline results are expected in 2025 and, if successful, will support a supplemental biologics license application (sBLA) submission in ccRCC."

The randomized, double-blind, registrational Phase 3 trial is designed to evaluate efficacy and tolerability of batiraxcept at a dose of 15 mg/kg in combination with cabozantinib compared to cabozantinib alone. The trial is expected to enroll approximately 300 patients with histologically confirmed advanced or metastatic ccRCC who have progressed after one or two prior lines of systemic therapy, which include immuno-oncology (IO)-based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies (either in combination or sequentially). Patients who were previously treated with cabozantinib are excluded from the trial. This ccRCC population was chosen based upon results from our Phase 1/2 trial which demonstrated a benefit in both median PFS and ORR with the addition of batiraxcept to cabozantinib in patients who had failed prior IO and VEGF-TKI treatments. The global trial is planned to be conducted at approximately 100 sites in the U.S. and around the world. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, duration of response, and objective response rates. Batiraxcept was granted Fast Track Designation by the FDA for ccRCC in November 2022.