On July 12, 2021 48Hour Discovery Inc and RayzeBio reported the companies have entered a strategic research collaboration to discover and develop novel peptide-based radiopharmaceuticals for the treatment of cancer (Press release, 48Hour Discovery, JUL 12, 2021, View Source [SID1234586901]).

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 excited to work with a cutting edge biotechnology company like RayzeBio" said Ratmir Derda, CEO of 48Hour Discovery "For this collaboration project, 48Hour Discovery will identify potent ligands for a series of targets selected by RayzeBio. This project will help us further validate the potential of our billion-scale molecular libraries and cloud-based discovery pipeline. We are looking forward to accelerating the preclinical programs of RayzeBio and providing peptide drug candidates that will advance the radiopharmaceutical field."

"48Hour Discovery has a promising proprietary platform for novel peptide discovery," said Ken Song, M.D., CEO of RayzeBio. "We are intrigued by the potential to quickly discover novel binders."

Under the terms of the agreement, 48HD will receive undisclosed payments. RayzeBio has exclusive rights to develop and commercialize peptides discovered under the collaboration, and an option to further expand the collaboration to include additional targets.

On July 12, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that clinicians at University of California (UC) Davis Comprehensive Cancer Center initiated dosing of the first patient in a clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve acute myeloid leukemia (AML). Brian A. Jonas, MD, PhD, FACP, UC Davis Division of Hematology/Oncology, is the clinical trial’s principal investigator (Press release, GlycoMimetics, JUL 12, 2021, View Source [SID1234584780]).

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!

According to Eric Feldman, MD, GlycoMimetics’ Chief Medical Officer, "While the field has seen strong uptake on venetoclax paired with a hypomethylating agent (HMA) in the frontline unfit AML setting, the depth and durability of responses, particularly in patients with adverse risk biology, has been somewhat less than optimal. In this setting, there remains a significant unmet need, and we know that environment-mediated drug resistance (EMDR), driven by E-selectin, contributes to HMA/venetoclax resistance. If the study shows that E-selectin antagonism with uproleselan improves minimal residual disease (MRD) negative response rates, this would be an important step forward that underscores the foundational opportunities for uproleselan across the broad spectrum of patients treated for AML."

The UC Davis Comprehensive Cancer Center study is an investigator-sponsored trial (IST) for which GlycoMimetics is providing uproleselan. Designed to evaluate the safety and efficacy of the triple combination, the study is non-randomized, open label and multi-center. The goal of the two-part trial is first to determine a recommended Phase 2 dose, and then to explore efficacy in a dose expansion cohort. Up to 31 patients will be enrolled, and a preliminary/interim readout is expected in 2022.

At the 2020 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), a preclinical study of uproleselan in combination with venetoclax and the HMA azacitidine demonstrated the triple combination’s potential in overcoming some of the limitations related to depth and durability of response with venetoclax/HMA alone. An oral presentation highlighted how antagonizing E-selectin with uproleselan can overcome microenvironment-mediated resistance to venetoclax/HMA therapy. In the study, the addition of uproleselan both prolonged survival of the murine model, and also promoted normal hematopeoic stem cell pro-survival signaling.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. FDA and the Chinese Health authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.

On July 12, 2021 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported that it has commenced an underwritten initial public offering of up to 7,000,000 shares of its common stock (Press release, Imago BioSciences, JUL 12, 2021, View Source [SID1234584797]). All of the shares to be sold in the offering will be offered by Imago. In addition, Imago expects to grant the underwriters for the offering a 30-day option to purchase up to an additional 1,050,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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!

Imago currently expects to use the net proceeds from this offering to fund the clinical development of bomedemstat for essential thrombocythemia through the completion of both the ongoing Phase 2 clinical trial and the planned Phase 3 clinical trial, clinical development of bomedemstat for myelofibrosis through the completion of both the ongoing and planned Phase 2 clinical trials, cGMP process development for bomedemstat, development of bomedemstat for additional indications, and for the development of additional pipeline candidates, internal research, and any remaining amounts for working capital and general corporate purposes.

Jefferies, Cowen, Stifel and Guggenheim Securities are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the 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 of these securities under the securities laws of any such state or jurisdiction.

In addition to the shares being sold in the initial public offering, Imago has agreed to sell an additional $20 million of its common stock in a concurrent private placement at the public offering price per share to Pfizer Inc. The sale of these shares of common stock will not be registered under the Securities Act of 1933, as amended, and will be subject to a 180-day lock-up agreement. The concurrent private placement is also scheduled to close concurrent with the initial public offering, subject to satisfaction of customary closing conditions. The closing of Imago’s initial public offering is not conditioned upon the closing of the concurrent private placement, but the closing of the concurrent private placement is conditioned upon the closing of the initial public offering.

The offering of these securities is being made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by phone at 877-821-7388; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected].

Imago has applied to list its common stock on The Nasdaq Global Select Market under the symbol "IMGO."

On July 12, 2021 Biogen Inc. (Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX: 09969) reported that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS) (Press release, Biogen, JUL 12, 2021, View Source [SID1234584816]). Orelabrutinib is a covalent BTKi with high selectivity and the ability to cross the blood-brain barrier, and is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS.

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!

Orelabrutinib inhibits BTK, which is a key enzyme that is part of the signaling cascade of immune cells including B cells and myeloid cells. With the ability to cross the blood brain barrier, orelabrutinib has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system (CNS), and may provide a clinically meaningful benefit on progression in all forms of MS. By addressing the progressive biology of the disease, orelabrutinib may offer people living with MS an additional treatment option and the possibility to slow disease progression.

"Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTKi programs," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "For over 30 years, Biogen has led in MS research and today has a leading portfolio of MS products. We are focused on developing next-generation approaches that we hope will improve outcomes for those living with progressive and relapsing forms of MS."

"Biogen is a recognized leader in neuroscience and we believe this transaction will help advance the development of orelabrutinib in MS," said Jasmine Cui, Ph.D., Co-Founder, Chairwoman and Chief Executive Officer at InnoCare. "We are excited about the potential of orelabrutinib for the treatment of patients with all forms of MS given the potential efficacy and safety profile, plus a promising level of blood-brain barrier penetration. BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS."

Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). InnoCare will receive a $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

About Orelabrutinib
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and in development for the potential treatment of autoimmune diseases.

In the field of multiple sclerosis, orelabrutinib is a BTKi with high selectivity and ability to cross the blood-brain barrier and could achieve high-target occupancy in the central nervous system. It is currently being investigated in a global Phase 2 study in RRMS patients.

In the field of oncology, InnoCare received approval for orelabrutinib from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL).

About Bruton’s Tyrosine Kinase Inhibitors
Bruton’s tyrosine kinase (BTK) is a tyrosine kinase that is encoded by the BTK gene in humans. BTK plays a crucial role in B-cell receptor signaling cascade in B cells leading to B cell proliferation, survival, differentiation and cytokine production. BTK also plays a key function in myeloid cell signaling. Central nervous system (CNS) penetrant BTK small molecule inhibitors work by inhibiting B cells and myeloid cells in the periphery and in the CNS. Among myeloid cells expressing BTK, microglia, which reside in the CNS, have been shown to express high level of BTK in multiple sclerosis.

On July 12, 2021 Albany Molecular Research, Inc. (AMRI), a leading global contract research, development and manufacturing organization serving the pharmaceutical and biopharmaceutical industries, reported that it is changing its name to Curia, effective July 12, 2021 (Press release, Curia, JUL 12, 2021, View Source [SID1234644965]). The new name reinforces the company’s strategic positioning as an end-to-end global CDMO, applying its scientific expertise and extensive capabilities from research and development (R&D) through to commercial manufacturing to enable its pharmaceutical and biotechnology customers to advance important new products that improve lives. Along with the name change, the company is introducing a new brand identity including a new website: CuriaGlobal.com.

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 name Curia is derived from a Latin word for purposeful assembly and references Curia’s patient-inspired mission. The company recently celebrated three decades of growth since its founding in Albany, New York. Today, Curia offers a global suite of R&D and commercial manufacturing capabilities, with industry-leading expertise to help its customers accelerate the journey from idea to impact. Curia employs more than 3,000 people in 21 locations around the world, including more than 600 chemists, 70 biologists, 225 senior scientists and approximately 400 quality and regulatory specialists. The company’s ongoing commitment to science that scales is demonstrated by its 564 active patents and its production of more than 20 treatments included on the list of essential medicines from the World Health Organization.

"Our new name reflects the assembled deep expertise of our people, the breadth of our products, services and solutions, and our relentless determination to help customers advance from curiosity to cure," said Curia Chairman and CEO John Ratliff. "Our new brand honors our foundation in research and innovation while creating a platform for our ambitions of life-changing science so we can make ever-growing contributions to improving patients’ lives. Over the past three decades we have broadened and deepened our capabilities to become a leading provider of CDMO solutions. Today marks the beginning of the next chapter in our history."