Duality Biologics and Harbour BioMed reached a strategic collaboration agreement

On January 19, 2022 Duality Biologics reported a strategic cooperation agreement with Harbour BioMed (Press release, DualityBio, JAN 19, 2022, View Source [SID1234649926]). According to the agreement, Harbour BioMed will grant the self-developed preferred monoclonal antibody for specific tumor targets to Duality Biologics for the exclusive development of ADC medicines in the world. Based on the DITAC (Duality Immune Toxin Antibody Conjugate) technology platform with its independent intellectual property rights, Duality Biologics will rapidly develop the world’s first-in-class ADC medicines to benefit patients all over the world. And Harbour BioMed will receive the down payment, milestone payments and sales-based royalties paid by Duality Biologics.

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Harbour BioMed and Duality Biologics always maintain a strategic win-win cooperative relationship. After signing the agreement, both parties will continue to uphold the common goal of rapid research and development of high-quality ADC: Duality Biologics will be responsible for the preclinical research, clinical development, clinical registration, production and commercialization of the ADC candidate molecule; Harbour BioMed will continue to pay close attention to the relevant follow-up research of this molecule and provide necessary support.

"Previously, fully human antibodies developed from Harbour Mice have been used in multiple company’s ADCs development projects, demonstrating the advantages of our fully human antibodies in ADC development. With Duality Biologics’ strong R&D advantages in ADC development, this strategic collaboration will further strengthen our overall strategy in the field of ADC, maximize the value of Harbour Mice, develop more high-quality and differentiated new ADC drugs to meet global patients’ needs." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

"I’m very pleased to achieve strategic collaboration with Harbour BioMed, and we are both very excited and confident about this new target of ADC drug. The combination of our proprietary ADC platform in next-generation and tumor-specific antibody will optimize the value of our DITAC platform, a leading 3rd generation toxin ADC platform with significantly improved therapeutic window, and rapidly enrich our pipeline to generate original innovative products. The signing of this agreement is the beginning of our platform-based strategic win-win cooperation. In the future, Duality Biologics hopes to maintain the close cooperation with Harbour BioMed and continue to propel more product development, jointly bringing better therapeutics to patients." said Dr. John Zhu, founder and CEO of Duality Biologics.

Entry into a Material Definitive Agreement

On January 14, 2022, Sorrento Therapeutics, Inc. (the "Company") entered into an Agreement and Plan of Merger (the "Merger Agreement") with Virex Health, Inc., a Delaware corporation ("Virex"), VH Merger Sub I, Inc., a Delaware corporation and wholly owned subsidiary of the Company ("Merger Sub"), VH Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company ("Merger LLC"), and Fortis Advisors LLC, as representative of the equityholders of Virex (the "Stockholders’ Representative") (Filing, 8-K, Sorrento Therapeutics, JAN 19, 2022, View Source [SID1234605584]). Pursuant to the terms of the Merger Agreement, Merger Sub will merge with and into Virex (the "Initial Merger"), with Virex continuing as the surviving corporation in such merger, and subsequent to the Initial Merger, Virex will merge with and into Merger LLC, with Merger LLC surviving as a wholly owned subsidiary of the Company (the "Subsequent Merger" and together with the Initial Merger, the "Merger"). At the effective time of the Subsequent Merger, the name of Merger LLC as the surviving company in the Subsequent Merger will change to Virex Health, LLC.

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As consideration for the Merger, upon completion of the Initial Merger, the equityholders of Virex (the "Virex Equityholders") will be entitled to receive the following amounts (to be paid in cash and stock as further described below): (i) $12,000,000, subject to certain adjustments pursuant to the terms of the Merger Agreement for indebtedness, transaction expenses and cash (the "Closing Consideration") and (ii) subject to achievement of certain regulatory milestones, up to $10,000,000 in additional consideration (the "Milestone Payment" and together with the Closing Consideration, the "Merger Consideration").

Pursuant to the Merger Agreement, the Merger Consideration shall be paid as follows: (i) 59% in cash; and (ii) 41% in shares of common stock of the Company, par value $0.0001 per share ("Common Stock"). At any time shares of Common Stock are issued in respect of the Merger Consideration (the "Shares"), the number of shares to be issued will be based on a price per share equal to the volume weighted average closing price per share of the Common Stock, as reported on The Nasdaq Stock Market LLC for the eleven consecutive trading days ending on the date that is three trading days prior to the applicable issuance date. The aggregate number of shares of Common Stock issuable pursuant to the Merger Agreement as Merger Consideration shall not exceed 19.99% of the total number of shares of Common Stock issued and outstanding immediately prior to the effective time of the Merger. In the event the Company determines in its reasonable discretion that a Virex Equityholder is not an "accredited investor" as defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended (the "Securities Act"), the Company shall pay the portion of the Merger Consideration payable to such Virex Equityholder in the form of cash only and shall be entitled to proportionately decrease the amount of cash, and increase the number of shares of Common Stock, payable to the "accredited investors" so as to maintain the 59% cash and 41% stock allocation referenced above. Ten percent of the Closing Consideration will be deposited into an escrow account (in the form of cash and stock) as partial security for the indemnification obligations of the Virex Equityholders under the Merger Agreement and $150,000 will be set aside for expenses that may be incurred by the Stockholders’ Representative.

The closing of the Merger is subject to customary conditions, including the accuracy of the representations and warranties contained in the Merger Agreement (subject to certain materiality qualifiers) and compliance with covenants and agreements in the Merger Agreement in all material respects.

The Merger Agreement contains customary representations, warranties and covenants of the Company and Virex. Subject to certain customary limitations, following the closing of the Merger, the Virex Equityholders shall indemnify the Company and its officers, directors, employees and agents against certain losses related to, among other things, breaches of Virex’s representations and warranties, certain specified liabilities and the failure to perform covenants or obligations under the Merger Agreement.

Pursuant to the terms of the Merger Agreement (and subject to the limitations set forth therein), the Company has agreed to prepare and file one or more registration statements with the Securities and Exchange Commission (the "SEC") following the closing of the Merger, for the purpose of registering for resale the shares of Common Stock issued as Merger Consideration. Under the Merger Agreement, the Company is required to file such registration statement with the SEC within 30 days of the issuance of such shares of Common Stock.

The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement, which is filed herewith as Exhibit 2.1.

The representations, warranties and covenants contained in the Merger Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Merger Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Merger Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Merger Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.

Item 3.02. Unregistered Sale of Securities.

The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference into this Item 3.02 in its entirety. The Shares will be issued to accredited Virex Equityholders in a transaction exempt from registration under the Securities Act, in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder. Each Virex Equityholder that receives any shares of Common Stock as Merger Consideration will represent that such equityholder is an "accredited investor," as defined in Regulation D, and will acquire such shares of Common Stock for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof.

Except for the registration rights contemplated by the Merger Agreement, the Shares will not be registered under the Securities Act and such Shares may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws. Neither this Current Report on Form 8-K nor the exhibits attached hereto is an offer to sell or the solicitation of an offer to buy shares of Common Stock or any other securities of the Company.

Pierian and Biodesix Partner to Advance Lung Cancer Diagnostics

On January 19, 2022 Pierian, the global leader in clinical genomics knowledge, reported that it has partnered with Biodesix to provide its interpretation technology platform for use with the Biodesix newly launched GeneStrat NGS genomic test, a blood-based tumor profiling test to detect actionable mutations in patients with non-small cell lung cancer (NSCLC) (Press release, PierianDx, JAN 19, 2022, View Source [SID1234611225]). Biodesix (Nasdaq: BDSX) will use the Pierian platform to provide clear, up-to-date clinical interpretations for mutations detected by the GeneStrat NGS test as part of patient test results used by physicians to help inform a personalized treatment strategy and facilitate monitoring in lung cancer.

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The GeneStrat NGS test is a key part o f the IQLung testing strategy, designed to measure tumor-specific mutations and patient immune profiles with results in an unprecedented 72 hours so that physicians can assess overall prognosis and personalize treatment plans. The IQLung strategy uses genomic profiling to detect actionable mutations in lung cancer, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

The GeneStrat NGS test data will be analyzed and interpreted using the most current therapy approvals and oncology guideline recommendations and delivered in a physician-ready report. The technology is backed by a comprehensive clinical knowledgebase and adaptive learning algorithms that take disparate inputs and translate them into concise interpretations with supporting evidence. As a result, characteristics of patient variants, even though rare or novel, are leveraged to present the most optimal treatment possibilities.

"We are helping to meet an unmet need in the continuum of care for lung cancer," said Scott Hutton, CEO of Biodesix. "Partnering with Pierian not only helps to deliver rapid results to physicians, but it also gives them information that can be easily interpreted and actioned, supporting them in providing precision care for their patients."

"We are thrilled to provide our interpretation technology to support the outstanding testing solution from Biodesix to treat patients with lung cancer," states Mark McDonough, CEO of Pierian. "We are committed to democratizing clinical genomics globally and this partnership with Biodesix supports our vision to broaden access to genomic testing and provide precision care to patients everywhere."

Alligator Bioscience Announces Commencement of a Sponsored Research Agreement with the University of Pennsylvania Led by Dr. Gregory Beatty

On January 19, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the initiation of a sponsored research collaboration to study biomarker data from Alligator´s OPTIMIZE-1 study with the University of Pennsylvania’s (UPENN) Pancreatic Cancer Research Center (Press release, Alligator Bioscience, JAN 19, 2022, View Source [SID1234605565]).

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Gregory Beatty, MD, PhD, assistant professor of Medicine in the Division of Hematology/Oncology, UPENN, will serve as the faculty investigator for the sponsored Research agreements. Data analysis by Dr. Beatty and his team will be conducted at the Beatty Laboratory at UPENN.

The priority of Dr. Beatty’s study will be to apply their analytical capabilities on data collected on patients receiving mFOLFIRINOX in combination with mitazalimab, Alligator’s agonistic CD40 antibody. The UPENN study is a part of Alligator’s OPTIMIZE-1 clinical trial, an open-label, multi-center phase 1B/I I trial assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFOLFIRINOX) in patients with metastatic pancreatic cancer. Enrollment of OPTIMIZE-1 is planned for up to 67 patients.

"The addition of the UPENN study, conducted by a researcher of Dr. Beatty’s caliber, to Alligator’s on-going OPTIMIZE-1 trail is very exciting. The resulting data will provide additional and valuable insight into the clinical development opportunities for mitazalimab in a patient population with high unmet medical needs," said Alligator’s CEO, Søren Bregenholt. "We are also thrilled to welcome Dr. Beatty as a scientific advisor to Alligator."

Qualigen Therapeutics Secures Worldwide Rights to G4-Selective Transcription Inhibitors from UCL to Develop as Cancer Therapeutics

On January 19, 2022 Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, has reported the exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program, which was developed by Professor Stephen Neidle and his team from the UCL School of Pharmacy (Press release, UCLB, JAN 19, 2022, View Source [SID1234605585]). The license agreement was carried out by UCL Business.

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Qualigen intends to develop the lead compound, now called QN-302, as a treatment for pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers. QN-302 was also supported by the UCL Technology Fund, and in the earlier years, in part by Cancer Research UK funding.