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 MaxCyte, Inc., (LSE: MXCT) (LSE: MXCN), a leading provider of platform technologies for cell engineering, reported the public filing of a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed dual listing of its shares of common stock on the Nasdaq Global Market ("Nasdaq") under the symbol "MXCT (Press release, MaxCyte, JUL 12, 2021, View Source [SID1234584773])." As part of the proposed Nasdaq dual listing, MaxCyte is planning a public offering of shares of its common stock in the United States (the "Offering"). Upon completion of the Offering, MaxCyte’s common stock will continue to be admitted to trading on the AIM market of the London Stock Exchange under the symbols "MXCT" and "MXCN."

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All shares to be sold in the Offering will be offered by MaxCyte. The number of shares to be offered and the price range for the proposed Offering have not yet been determined. The Offering is expected to commence after the SEC completes its review process, subject to market and other conditions. Stockholders and potential investors should note that there is no guarantee as to whether or when the potential Offering will proceed.

Cowen, Stifel and William Blair are acting as joint book-running managers for the Offering and as representatives of the underwriters for the proposed Offering. BTIG and Stephens Inc. will also act as co-managers of the Offering.

The proposed Offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Offering may be obtained from the offices of Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1 (415) 364-2720 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 1-800-621-0687 or by email at [email protected].

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy these securities 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 these securities, 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 law of any such state or jurisdiction.

On July 12, 2021 Akeso, Inc. reported that, CD47 monoclonal antibody (AK117), a second-generation novel drug for immuno-oncology therapy independently developed by the Company, has completed phase I dose escalation trial in Australia (Press release, Akeso Biopharma, JUL 12, 2021, View Source [SID1234584790]). AK117 resulted in no dose-limiting toxicity (DLT) and no anemia of clinical significance in subjects in all dose escalation cohorts (with 0.3 mg/kg to 45 mg/kg administered once-weekly (QW)), and was well tolerated by subjects in all cohorts. Low-dose priming was not required.

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Akeso has obtained approval from the National Medical Products Administration (NMPA) of China to initiate phase Ib/II clinical trial of AK117 in combination with azacitidine for the treatment of acute myeloid leukemia (AML). AK117, a second-generation CD47 monoclonal antibody, has a significantly improved safety profile compared to the first-generation CD47 monoclonal antibody, and AK117 in combination with azacitidine is expected to perform better than similar drugs in the treatment of AML. Previous studies of AK117 in myelodysplastic syndromes (MDS) have shown its advantages of safety and the majority of MDS patients had hematologic improvement while receiving AK117 treatment. To date, clinical trials of AK117 in both solid tumors and hematologic tumors have been initiated and began patient dosing.

AML is a group of highly heterogeneous diseases with clonal proliferation abnormalities of hematopoietic stem cells and is the most common type of adult acute leukemia. CD47 is highly expressed on the surface of several tumor cells, including solid tumors and hematologic tumors, and is associated with poor prognosis. CD47 blockade stimulates phagocytosis of tumor cells by macrophages and promotes adaptive immune response. Preclinical data showed that CD47 monoclonal antibody in combination with azacitidine can further induce endogenous expression of calreticulin on the cell surface, thereby further enhancing the phagocytosis of tumors by macrophages. At the same time, there are clinical data showing that CD47 monoclonal antibody in combination with azacitidine is significantly more effective than azacitidine alone in treating AML subjects who are not suitable for chemotherapy at first treatment, and is safe and well tolerated.

Information about AK117 (CD47 Monoclonal Antibody)

AK117 is a novel humanized IgG4 mAb independently developed by the Company. It can bind with CD47 expressed on tumor cells to prevent the interaction between CD47 and its receptor, SIRPα, expressed on macrophages so as to enhance phagocytosis to inhibit the growth of tumor cells. Previously published data demonstrated exceptional safety profile. AK117 resulted in no DLT and no anemia of clinical significance in subjects in all doseescalation cohort (the highest dose cohort was 45 mg/kg QW), and was well tolerated by subjects in all cohorts. The CD47 receptor occupancy rate (RO) of the peripheral blood T cells has reached and maintained at 100% in the 3 mg/kg cohort.

On July 12, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported the closing of its underwritten public offering of 5,333,333 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commissions, including the exercise in full by the underwriters of their option to purchase up to an additional 695,652 shares of common stock in the offering (Press release, Ideaya Biosciences, JUL 12, 2021, View Source [SID1234584791]). The net proceeds from the offering were approximately $86.1 million, after deducting the underwriting discount and commissions and estimated offering expenses payable by IDEAYA. All shares in the offering were offered by IDEAYA.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under IDEAYA’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities acted as joint book-running managers for the offering.

The public offering was made by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission, or the SEC. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by request from: J.P. Morgan, by mail at 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]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 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.

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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."