NovalGen enters strategic partnership with HALIX B.V. to manufacture clinical trial materials

On February 22, 2021 NovalGen Ltd. ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies and HALIX B.V. ("HALIX"), a contract development and manufacturing organisation, reported a strategic partnership (Press release, UCLB, FEB 22, 2021, View Source [SID1234575421]). Within the scope of this partnership, HALIX will provide manufacturing of clinical supply of NovalGen’s therapies .

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NovalGen’s innovative platform technology has been successfully deployed at HALIX to manufacture clinical trial material for NovalGen’s first clinical program. The program, NVG-111, is a Receptor Tyrosine Kinase Like Orphan Like Receptor 1 (ROR1) targeting bispecific antibody T cell engager for the treatment of hematologic malignancies and solid tumors, is expected to enter the clinic in the first half of 2021. HALIX has supported NovalGen with the successful completion of GMP manufacture of NVG-111 from drug substance up to drug product and final release. The strategic partnership and collective expertise of both organisations has ensured an efficient technology transfer and further development of the process leading to a successful GMP manufacturing campaign.

"This collaboration with HALIX will ensure high quality, rapid and secure manufacture of clinical supplies for our current and future products. Using cutting-edge manufacturing technologies at our partner’s state-of-the-art cGMP facility, we are progressing to become a clinical stage company," said Kieran O’Donovan, SVP Chemistry and Manufacturing Controls at NovalGen."We developed a manufacturing process around the use of transient transfection to accelerate timelines and reduce costs, whilst delivering product of the highest quality. In HALIX we found the ideal partner; experience in transient transfection, modern facilities, strong leadership and a laser focus on delivery to bring NVG-111 from contract signature to vials of clinical drug in less than seven months."

"The partnership with NovalGen has been a great success," said Alex Huybens, Chief Operations Officer at HALIX. "Working closely together and utilizing the collective bispecific antibody expertise of both teams has enabled us to meet the ambitious timelines and efficiently transfer the process and deliver the product to be ready to enter the clinic. We look forward to a long and productive collaboration with NovalGen."

Enlivex Receives Notice of Allowance for Chinese Patent Application Covering Allocetra Immunotherapy

On February 22, 2021 Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for a new patent application (number 201680029277.4) covering AllocetraTM, the Company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, FEB 22, 2021, View Source [SID1234575419]). Upon issuance, the new patent will provide added intellectual property protection in China, with respect to methods, uses and pharmaceutical compositions for AllocetraTM. The company expects that this new patent will be issued in China in the coming months.

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AllocetraTM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

Cullinan Management, Inc. Announces Business Update

On February 22, 2021 Cullinan Management, Inc. (Nasdaq: CGEM) ("Cullinan"), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies, reported the following business updates (Press release, Cullinan Oncology, FEB 22, 2021, View Source [SID1234575418]):

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Portfolio Overview and Updates:

Cullinan Pearl
Based on pre-specified efficacy criteria, Cullinan recently initiated Phase 2a Dose Expansion at the 100 mg BID dosing level in the ongoing Phase 1/2a study evaluating CLN-081 in adult NSCLC patients with EGFRex20ins mutations. This expansion will enable enrollment of up to 36 patients, inclusive of 13 previously enrolled patients, at this dosing level. Cullinan is contemplating additional expansion cohorts and intends to provide updated safety and efficacy data in mid-2021.
Cullinan Florentine
In January 2021, Cullinan submitted an IND to the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial evaluating CLN-049, a bispecific antibody targeting FLT3 and CD3, in relapsed or refractory AML patients. The FDA subsequently provided feedback, including a request to consider alternative trial designs that would enable the collection of exploratory pharmacokinetic and pharmacodynamic data before dose escalation. Based on this information, Cullinan elected to withdraw the IND to determine the most efficient path forward.
Cullinan MICA
Cullinan is completing the production of GMP drug product to support an IND submission and subsequent clinical trial for its investigational product CLN-619, a monoclonal antibody designed to stimulate natural killer (NK) and T cell responses by engaging a unique target, MICA/B. Consistent with prior guidance, Cullinan intends to submit an IND in the second quarter of 2021.
SVB Leerink Global Healthcare Conference Event Details:

Chief Executive Officer, Owen Hughes, will provide a company overview and update at the 10th Annual SVB Leerink Global Healthcare Conference.

Event: 10th Annual SVB Leerink Global Healthcare Conference
Location: Virtual
Date: Friday, February 26, 2021
Time: 4:20 PM ET/1:20PM PT
Members of the Cullinan management team will also host investor meetings during the SVB Leerink Global Healthcare Conference.

A webcast of the SVB Leerink presentation will be available in the Investors section of the Cullinan website at View Source

About CLN-081
CLN-081 is an orally available, irreversible EGFR inhibitor that is designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertion mutations, with relative sparing of cells expressing wild type EGFR. CLN-081 is currently in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFRex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy. CLN-081 is being developed in Cullinan Pearl, a Cullinan subsidiary.

About CLN-049
CLN-049 is a humanized bispecific antibody targeting FLT3 on target leukemic cells and CD3 on T cells, triggering cancer cell lysis via T cell cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens such as CD33 and CD123. CLN-049 is being developed in Cullinan Florentine, a Cullinan subsidiary.

About CLN-619
CLN-619 is MICA/B-targeted, humanized IgG1 monoclonal antibody that Cullinan intends to develop in patients with advanced solid tumors. MICA/B are stress-induced ligands that innate and adaptive immune cell populations recognize via the NKG2D receptor. To evade potential cytotoxic destruction by NK cells and T cells, tumors shed MICA/B from the cell surface. CLN-619 is designed to promote an antitumor response through multiple mechanisms of action, including shielding the proteolytic cleavage sites of MICA/B on cancer cells. CLN-619 is being developed in Cullinan MICA, a Cullinan subsidiary.

New Horizon Stages $263 Million HK IPO for Cancer Screening Tests

On February 22, 2021 New Horizon Health reported that $263 million IPO last week on the Hong Kong Exchange to support its early cancer screening tests (Press release, New Horizons Diagnostics, FEB 22, 2021, View Source [SID1234575417]). The stock tripled in trading, giving the company a market cap of $4.3 billion. New Horizon markets two stool based tests in China: ColoClear, a multi-target, FIT-DNA test aimed at people at risk for colorectal cancer, and Pupu Tube, a self-administered FIT test intended to screen a larger population. The company also has two late-stage product candidates for gastric and cervical cancer screening.

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Bristol Myers Squibb and Celgene Issue Notices of Redemption and Partial Redemption of Certain of Their Senior Notes at “Make Whole” Prices

On February 22, 2021 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol Myers Squibb") reported a notice of redemption to The Bank of New York Mellon (successor to The Chase Manhattan Bank (National Association)), as trustee, to redeem (i) all of Bristol Myers Squibb’s 4.000% Notes due 2023 (CUSIP/ISIN Nos (Press release, Bristol-Myers Squibb, FEB 22, 2021, View Source [SID1234575416]). 110122DA3/110122BL1/U11009AL8), originally issued on November 22, 2019, that remain outstanding after the early settlement of the previously announced tender offers (the "BMS 4.000% Notes") and (ii) $42,250,000 principal amount of $932,101,000 principal amount of Bristol Myers Squibb’s outstanding 3.250% Notes due 2023 (CUSIP/ISIN Nos. 110122BK3/U11009AK0/110122CZ9), originally issued on November 22, 2019 (the "BMS 3.250% Notes" and, together with the BMS 4.000% Notes, the "BMS Notes") at the applicable "make whole" redemption prices (the "BMS Redemption Prices") to be calculated as set forth in the indenture, as supplemented, pursuant to which the BMS Notes were issued, plus accrued and unpaid interest to, but excluding, the redemption date of March 24, 2021 with respect to the BMS 4.000% Notes (the "4.000% Redemption Date") and the redemption date of March 9, 2021 with respect to the BMS 3.250% Notes (the "3.250% Redemption Date"; the 4.000% Redemption Date with the 3.250% Redemption Date, the "Redemption Dates"), as applicable.

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On February 22, 2021, Bristol Myers Squibb’s wholly-owned subsidiary Celgene Corporation ("Celgene") also issued a notice of redemption to The Bank of New York Mellon Trust Company, N.A., as trustee, (together, with The Bank of New York Mellon, the "Trustees"), to redeem (i) all of Celgene’s 4.000% Notes due 2023 (CUSIP No. 151020AJ3), originally issued on August 6, 2013, that remain outstanding after the early settlement of the previously announced tender offers (the "Celgene 4.000% Notes") and (ii) all of Celgene’s 3.250% Notes due 2023 (CUSIP No. 151020BA1), originally issued on February 20, 2018 (the "Celgene 3.250% Notes" and, together with the Celgene 4.000% Notes, the "Celgene Notes"; the BMS Notes with the Celgene Notes, the "Notes") at the applicable "make whole" redemption prices (the "Celgene Redemption Prices" and, together with the BMS Redemption Prices, the "Redemption Prices") to be calculated as set forth in the indentures pursuant to which the Celgene Notes were issued, plus accrued and unpaid interest to, but excluding, the 4.000% Redemption Date with respect to the Celgene 4.000% Notes and the 3.250% Redemption Date with respect to the Celgene 3.250 % Notes.

Payment of the applicable Redemption Prices will be made on or after the applicable Redemption Dates only upon presentation and surrender of the Notes to the Trustees, and the Trustees will determine which portions of the Notes will be redeemed. On the applicable Redemption Date, the applicable Redemption Prices will become due and payable on the relevant Notes and, unless Bristol Myers Squibb or Celgene, as the case may be, defaults in the payment of such Redemption Prices, interest on such Notes will cease to accrue on and after the applicable Redemption Date. Bristol Myers Squibb and Celgene will use cash on hand to finance the redemption of the Notes at the Redemption Prices. Following the early settlement of the previously announced tender offers and the settlement of the "make whole" redemptions described above, Bristol Myers Squibb will have purchased approximately $4.0 billion in aggregate purchase price for its debt securities as previously disclosed.

This announcement is neither an offer to sell nor a solicitation to buy any security and shall not constitute an offer, solicitation, or sale in any jurisdiction in which an offer, solicitation, or sale would be unlawful. The details concerning the terms and conditions of the redemptions are fully described in the notices of redemption distributed to registered holders of the Notes. Beneficial holders with any questions about the redemptions should contact their respective brokerage firm or financial institution. This announcement does not form part of the notices of redemption or otherwise constitute a notice of redemption with respect to either the BMS Notes or the Celgene Notes and is qualified in its entirety by reference to the notices of redemption issued by Bristol Myers Squibb and Celgene concerning the Notes.

This communication is not being made by, and has not been approved by, an authorized person for the purposes of Section 21 of the Financial Services and Markets Act 2000, as amended (the "FSMA)". Accordingly, this communication is not being distributed to, and must not be passed on to, persons within the United Kingdom save in circumstances where section 21(1) of the FSMA does not apply.

In particular, this communication is only addressed to and directed at: (A) in any Member State of the European Economic Area, qualified investors in that Member State within the meaning of the Prospectus Regulation and (B) (i) persons that are outside the United Kingdom or (ii) persons in the United Kingdom falling within the definition of investment professionals (as defined in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Financial Promotion Order")) or within Article 43 of the Financial Promotion Order, or to other persons to whom it may otherwise lawfully be communicated under the Financial Promotion Order.