On June 16, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark (Press release, Hoffmann-La Roche, JUN 16, 2022, View Source [SID1234616241]). This new solution enables a patient to privately collect her sample for HPV screening while at a healthcare facility, following instructions provided by a healthcare worker. The clinically-validated vaginal sample is analysed with the Roche cobas HPV test on a Roche molecular instrument.
Screening for human papillomavirus (HPV) can help identify women who are at risk of developing cervical cancer, so that the disease can be found and treated early before it has a chance to develop. There are many drivers that contribute to women not participating in cervical cancer screening programs, including limited access to testing, past experiences, embarrassment, and cultural influences. Roche’s self-sampling solution helps reduce these barriers by offering women an alternative to more invasive clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions.

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"The elimination of cervical cancer is within reach. Reducing barriers to HPV screening by enabling women to self-collect their own specimen for HPV testing is a critical tool in the fight against cervical cancer," said Thomas Schinecker, CEO Roche Diagnostics.

In low- and middle-income countries, women are often diagnosed with cervical cancer at a more advanced stage, where the opportunity for cure is low. By broadening access through removing barriers and enabling screening in additional healthcare environments, Roche highlights its commitment to achieving the World Health Organisation’s global strategy to eliminate cervical cancer and reduce the overall mortality rate.3

About the cobas HPV test

The cobas HPV test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including HPV primary screening, co-testing (or adjunctive screen) with cytology, and for triage of women with abnormal cytology, to assess the risk for cervical precancer and cancer. Test performance for this new sampling method demonstrates that selfcollected vaginal specimens tested using a molecular technology are fully adequate, and provide
results that are comparable to clinician-collected cervical samples.

Cervical cancer screening using the cobas HPV test is clinically validated in large, FDA registrational trials for use on cobas Systems, and the assay individually identifies the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers4 – and reporting the 12 other high-risk HPV types as a combined result, all in
one test and from one patient sample. More information about the cobas HPV tests is available at diagnostics.roche.com/cervicalcancer or cervicalcancer-screening.com.

The fully automated cobas 6800/8800 Systems offer the fastest time to results, providing up to 96 results in about three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. Learn more now: View Source

On On June 16, 2022, Morphic Holding, Inc. (the "Company") reported that received notice from AbbVie Biotechnology Ltd ("AbbVie") that AbbVie has elected to terminate the Collaboration and Option Agreement (the "Collaboration Agreement") between AbbVie and Morphic Therapeutic, Inc., a wholly owned subsidiary of the Company ("Morphic"), dated October 16, 2018 (Filing, 8-K, Morphic Therapeutic, JUN 16, 2022, View Source [SID1234616130]). AbbVie exercised its right to terminate the Collaboration Agreement for convenience. The termination will be effective as of December 13, 2022, or such earlier date as agreed by the parties.

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Under the terms of the Collaboration Agreement, Morphic granted AbbVie exclusive license options on certain product candidates directed at multiple targets. The termination follows AbbVie’s delivery of notice to the Company that it did not intend to advance any of the selective oral αvβ6-specific integrin inhibitors, which AbbVie had previously licensed pursuant to the terms of the Collaboration Agreement, due to a suspected on-target/ αvβ6-mediated safety signal observed in pre-clinical testing. Effective upon the termination of the Collaboration Agreement, all rights and licenses granted thereunder shall immediately terminate.

On June 16, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the closing of its upsized underwritten public offering of 17,899,698 shares of its common stock, and to certain investors in lieu thereof, pre-funded warrants to purchase 3,030,302 shares of its common stock at an exercise price of $0.01 per share (Press release, Cogent Biosciences, JUN 16, 2022, View Source [SID1234616061]). The shares of common stock sold include 2,730,000 shares pursuant to the option to purchase additional shares granted by Cogent to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $8.25 and the public offering price of each pre-funded warrant was $8.24. The aggregate gross proceeds to Cogent from this offering were approximately $172.6 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

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The net proceeds from the offering will be used for development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, as well as for working capital and general corporate purposes.

Jefferies, Piper Sandler & Co. and Guggenheim Securities, LLC acted as joint book-running managers for the offering. LifeSci Capital also acted as lead manager for the offering.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-264773) filed with the Securities and Exchange Commission (SEC), which became effective on May 24, 2022. A copy of the final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and may be obtained from the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; or Guggenheim Securities, LLC: Attention: Equity Syndicate Department, 330 Madison, New York, New York 10017, by telephone at 212-518-9544, or by email at [email protected].

This press release does 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 laws of that state or jurisdiction.

On June 16, 2022 Nammi Therapeutics, Inc. (Nammi), a Los Angeles based immunotherapy company, reported that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of Pancreatic Cancer (Press release, Nammi Therapeutics, JUN 16, 2022, View Source [SID1234616055]). Nammi has previously received ODD for QXL138AM for treatment of multiple myeloma.

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QXL138AM is a Masked Immunocytokine (MIC) that targets a masked interferon alpha (IFNα) to the CD138 protein on the surface of the tumor cells. Once bound to the tumor cell, proteases on the tumor cell surface cleave the mask off the IFNα allowing it to bind its receptor. Activation of the IFNAR complex induces direct killing of Pancreatic tumor cells as well as activating innate and adaptive anti-tumor immunity.

Pancreatic Cancer is a relatively rare form of cancer, with the American Cancer Society estimating over 62,210 new cases and 49,830 deaths from Pancreatic Cancer this year. Surgical removal is the only potentially curative treatment known and 80% of patients present with advanced disease that do not benefit from surgery. IFNα based therapeutics have demonstrated anti-tumor activity in clinical studies but are infrequently used due to significant toxicities. QXL138AM directly addresses this toxicity issue by targeting the IFNα to the tumor cells with an anti-CD138 antibody and by masking the IFNα activity until it gets to the tumor.

About QXL138AM
QXL138AM is a first in class MIC comprised of a CD138-targeted antibody fused with Interferon alpha (IFNα) that is masked with a tumor-selectively releasable peptide. CD138 is expressed in multiple myeloma as well as many different solid tumor indications including pancreatic, breast, colon, hepatic, ovarian, urothelial, and head and neck cancers. Nammi Therapeutics is expecting to file an Investigational New Drug (IND) application with the FDA to allow initiation of clinical studies this year.

On June 16, 2022 Global Cord Blood Corporation (NYSE: CO) ("GCBC" or the "Company"), China’s leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, reported that Cellenkos, Inc. ("CLNK") recently announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib (Press release, Global Cord Blood, JUN 16, 2022, View Source [SID1234616053]). Details related to this news can be found via the following Cellenkos news announcement:

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Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0804 as Add on Therapy to Ruxolitinib for the Treatment of Myelofibrosis (prnewswire.com)

Ms. Ting Zheng, Chief Executive Officer and Chairperson of GCBC commented, "The Global Cord Blood team is encouraged by the above news announced by CLNK which highlights a potentially transformative treatment for myelofibrosis patients. We congratulate CLNK team on this development."