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.

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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 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported that it is proposing to offer and sell, subject to market conditions, $175 million of shares of its common stock in an underwritten public offering (Press release, Celldex Therapeutics, JUL 12, 2021, View Source [SID1234584815]). Celldex expects to grant the underwriters a 30-day option to purchase up to an additional $26.25 million of shares of common stock offered in the public offering. All of the shares of common stock are being offered by the Company. Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates and for general corporate purposes. The final terms of the offering will depend on market and other conditions at the time of pricing, 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.

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Jefferies, SVB Leerink, Guggenheim Securities and Cantor are acting as the joint book-running managers for the proposed offering.

The securities described above will be offered pursuant to a shelf registration statement on Form S-3 (No. 333-249917), which was previously filed with the Securities and Exchange Commission ("SEC") and deemed effective on November 6, 2020. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source, copies of which may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by e-mail at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

This offering will be made only by means of a prospectus. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 12, 2021 Inotiv, Inc. (NASDAQ:NOTV) (the "Company", "We", "Our" or "Inotiv"), a leading contract research organization specializing in nonclinical and analytical drug discovery and development services, reported that the Company has acquired key genetic toxicology assets from MilliporeSigma’s BioReliance portfolio, including standard operating procedures, stock cultures, historic control data and client list (Press release, MilliporeSigma, JUL 12, 2021, View Source [SID1234584808]). While Inotiv did not disclose the specific financial terms, the transaction consists of a sales-based royalty agreement and does not require upfront funding from the Company.

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Robert Leasure, Jr., President and CEO of Inotiv, commented, "This transaction with MilliporeSigma adds genetic toxicology to our suite of internal capabilities. We now have assembled in-house all of the critical nonclinical services necessary to support our clients’ goals of advancing to human clinical trials."

MilliporeSigma is discontinuing their Genetic Toxicology operations. The agreement with Inotiv is designed to ensure continuity of services for existing clients. Inotiv also plans to offer employment to certain MilliporeSigma employees who otherwise may have been displaced.

To facilitate entry into the genetic toxicology business, Inotiv also announced that Gopala Krishna, PhD, MBA, has joined Inotiv as Senior Vice President, Genetic Toxicology, to lead the Company’s genetic toxicology service offering. Dr. Krishna is a Diplomate, American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, and has over three decades of pharmaceutical industry experience as a drug discovery and development nonclinical leader at large and small Pharma companies, such as Pfizer, Abbott Labs, MGI Pharma, Enzon, and Supernus. He has also served as Professor (Adjunct) at the University of Michigan teaching Pharmacology & Toxicology in the School of Public Health, Ann Arbor, MI. Most recently he served as Principal Consultant – Nonclinical at PAREXEL International. Currently, he is the President of National Capital Area Chapter (NCAC) of Society of Toxicology (SOT) and has been a contributing senior member of the Environmental Mutagenesis and Genomics (Genetic Toxicology) Society (EMGS) for over 35 years.

"Evaluation of the potential for novel therapeutics to interact with and alter DNA is a key element of the safety assessment of those drug candidates," said John E. Sagartz, Chief Strategy Officer of Inotiv. "Inotiv historically has relied on other vendors to provide these key assessments. I’m excited to announce the addition of the BioReliance assets and Dr. Krishna, and we look forward to developing the genetic toxicology business. We believe this is another significant milestone for Inotiv and our clients."

Dr. Krishna commented, "I am delighted to join Inotiv with the task of expanding the service offering to include genotoxicity capabilities and look forward to leveraging the assets of the BioReliance portfolio to assist our clients in the development of safe novel therapeutics."

In support of this new offering, Inotiv expects to lease space near the current MilliporeSigma’s facilities in Rockville, Maryland.

On July 12, 2021 ProfoundBio reported the closing of a $55+ million Series A financing round led by Lilly Asia Venture and co-led by LYFE Capital, with participation from Sequoia Capital China and Oriza (Press release, ProfoundBio, JUL 12, 2021, View Source [SID1234584798]). All investors from the Series Pre-A financing, K2VC, Gaorong Capital, and Chang’an Capital, also participated in this round of financing.

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ProfoundBio will use the proceeds to accelerate development and implementation of novel technology platforms for ADCs and IO therapeutics and to advance a portfolio of differentiated therapeutics into clinical development.

"We made significant progress with our lead programs and novel technology platforms since the completion of Series Pre-A financing. The additional funding will allow us to further strengthen and expand our integrated R&D capability, grow and broaden our innovative product pipeline, and prepare for multiple IND submissions in 2022 and beyond," said Baiteng Zhao, PhD, co-founder, CEO, and Chair of the Board of ProfoundBio. "We are really excited about the enthusiastic participation of the new investors and the continued support from our shareholders. I am confident that by working together, we can bring more innovative targeted therapeutics to patients with cancer sooner."

"We believe emerging modalities, such as ADCs, will bring hope to patients with solid tumor to address the significant unmet medical needs," said Dr. Fei Chen, Managing Partner of LAV. "ProfoundBio’s founding team are industry veterans with rich experience, deep knowhow and a FDA drug approval track record established during their tenure at the global leader of ADC drug development. It is a great pleasure to partner with ProfoundBio at this critical moment, and we are committed to support the company to realize the potential of ADC and create new targeted drugs for patients around the world."

According to LYFE Capital, "The antibody-drug conjugate modality has demonstrated great potential in oncology treatment. The ProfoundBio team has extensive R&D and clinical translation experience in ADC drug development. The company quickly established a strong R&D and translational platform and built up a differentiated ADC drug pipeline. We believe that the ProfoundBio team will leverage their rich experiences and efficient R&D platform to develop more differentiated ADC drug pipeline to address large unmet clinical needs in oncology."

"Congratulations to ProfoundBio on completing Series A funding!" said Lynn Yang, Partner of Sequoia Capital China. "Healthcare has been a key sector of investment since Sequoia Capital China’s establishment. We are impressed by ProfoundBio’s long-term commitment to ADC development, where the company has gained extensive experience and achieved remarkable progress. We hope ProfoundBio will continue creating value for society by helping more patients in their recovery."

"Antibody-drug conjugate (ADC) has become another important sector after monoclonal antibodies," said Yunfei Chen, Investment Director of Oriza. "ProfoundBio’s management team comes from SeaGen, a global leader in the ADC industry, which makes them well experienced in ADC development. ProfoundBio focuses on clinical unmet needs instead of overcrowded targets and mainly develops ADC drugs with innovative targets. We expect ProfoundBio to become a leading ADC enterprise. Oriza is pleased to help ProfoundBio grow rapidly and benefit more patients as soon as possible with greater success."

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.

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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."