CMAB Biopharma Congratulates QureBio on FDA Clearance of IND Application for Claudin18.2/PD-L1 Bispecific Antibody

On March 2, 2021 CMAB Biopharma (Suzhou) Inc’s ("CMAB") partner QureBio Ltd ("QureBio") reported its innovative drug Q-1802 received United States Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application (Press release, CMAB Biopharma, MAR 2, 2021, View Source [SID1234575875]). This application is the first clinical research in the U.S. by QureBio.

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Q-1802 is the lead candidate in QureBio’s pipeline and is the first bispecific antibody against PD-L1 and Claudin18.2 to be studied in a U.S. clinical trial. As part of the collaboration, CMAB provided integrated CDMO services for the Q-1802 program, utilizing its antibody production platform. Services included CMC development activities and successful production of drug substance and drug product batches in only 9 months.

"We are very glad to collaborate with CMAB. During the Q-1802 program, the two groups worked together and completed the CMC development and production of clinical samples efficiently and rapidly." said Dr. Xiangdong Qu, Founder and CEO of QureBio. "The first-class technology and GMP level, as well as thoughtful services of CMAB team impressed us a lot during our collaboration. We are looking forward to continuing work with CMAB, and we are also striving to bring better innovative dual anti-drugs to patients as soon as possible."

Dr. Yongzhong Wang, CEO of CMAB said, "We appreciate the trust of Dr.Qu and QureBio, and congratulation them on having Q-1802 become the world’s first bispecific antibody against PD-L1 and Claudin18.2 approved for a clinical trial in the US. There are unique development challenges when dealing with a bispecific antibody and we are very proud of our team who utilized our antibody platform in order to achieve, industry-leading speed to get a US IND approved successfully. It is also a testament to the excellent cooperation between CMAB and QureBio. CMAB will continue to accelerate the process of Q-1802 from QureBio, and look forward to reaching the next milestone early."

TLC to Present at Upcoming Virtual Investor Conferences

On March 2, 2021 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, reported that the Company’s management team will be presenting at the following virtual investor conferences (Press release, Taiwan Liposome Company, MAR 2, 2021, View Source [SID1234575954]):

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HC Wainwright & Co Global Life Sciences Conference (March 9-10, 2021)
Presentation: on-demand starting 7am ET, Tuesday, March 9, 2021

Oppenheimer 31st Annual Healthcare Conference (March 16-17, 2021)
Presentation: 8am ET, Wednesday, March 17, 2021

The management team will also be participating in one-on-one meetings during the conference. The corporate presentation will be available on the TLC website at www.tlcbio.com in the Investors section, under News & Events.

FDA Approves Investigational New Drug (IND) for Neuroendocrine Tumors from Molecular Targeting Technologies, Inc.

On March 2, 2021 Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, reported the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) (Press release, Molecular Targeting Technologies, MAR 2, 2021, View Source [SID1234575970]). It enables a Phase I clinical study of the Safety and Dosimetry of its lead product, EBTATE (177Lu-DOTA-EB-TATE), in patients with neuroendocrine tumors (NET).

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EBTATE is used in Precision Medicine for Targeted Radionuclide Therapy. The key feature of this technology is the appendage of Evans blue (EB) to the targeting radiopharmaceutical. EB binds reversibly to serum albumin to enhance the radiotherapeutic time window with longer circulation half-life and increase tumor uptake/retention to improve therapeutic outcome.

Dr. Chris Pak, President & CEO of MTTI commented: "The clearance of our IND is an important milestone for MTTI. Having solidified our clinical trial preparedness and manufacturing readiness, we are well-positioned to advance EBTATE. The upcoming trial is an open-label, dose-escalation study planned for patients with neuroendocrine tumors (NET)."

MannKind Corporation Prices Upsized $200.0 Million Convertible Senior Notes Offering

On March 2, 2021 MannKind Corporation (Nasdaq: MNKD) reported the pricing of $200.0 million aggregate principal amount of 2.50% Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Mannkind, MAR 2, 2021, View Source [SID1234575901]). MannKind also granted the initial purchasers of the notes an option to purchase, within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $30.0 million aggregate principal amount of notes. The sale of the notes is expected to close on March 4, 2021, subject to customary closing conditions.

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The notes will be general unsecured obligations of MannKind and will accrue interest at a rate of 2.50% per annum, payable semiannually in arrears on March 1 and September 1 of each year, beginning on September 1, 2021. The notes will mature on March 1, 2026, unless earlier converted, redeemed or repurchased.

Before December 1, 2025, holders will have the right to convert their notes only upon the occurrence of certain events. From and after December 1, 2025, until the close of business on the business day immediately preceding the maturity date, holders will have the right to convert all or any portion of their notes at their election. Upon conversion, MannKind will pay or deliver, as the case may be, cash, shares of MannKind’s common stock or a combination of cash and shares of MannKind’s common stock, at its election. The initial conversion rate is 191.8281 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $5.21 per share of common stock. The initial conversion price represents a premium of approximately 30% over the last reported sale of $4.01 per share of MannKind’s common stock on March 1, 2021. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events.

MannKind may not redeem the notes prior to March 6, 2024. MannKind may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after March 6, 2024 and prior to the 36th scheduled trading day immediately preceding the maturity date, if the last reported sale price of MannKind’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which MannKind provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If a "fundamental change" (as defined in the indenture for the notes) occurs, then, subject to limited exceptions, holders may require MannKind to repurchase their notes for cash. The repurchase price would be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

MannKind estimates that the net proceeds from the offering will be approximately $193.8 million (or approximately $222.9 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses. MannKind intends to use the net proceeds from this offering for working capital and other general corporate purposes, including a Phase 3 clinical trial of Afrezza in pediatric subjects and further development of product candidates in MannKind’s pipeline. MannKind may also use a portion of the proceeds from this offering to pay down a portion of existing debt or for acquisitions or strategic investments in complementary businesses or technologies, although MannKind does not currently have any plans for any such debt repayment, acquisitions or investments.

The notes and any shares of MannKind’s common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

New Cardinal Health cancer research study published in JAMA

On March 2, 2021 Cardinal Health Specialty Solutions reported that it is making important strides in cancer research using real-world evidence (RWE) (Press release, Cardinal Health, MAR 2, 2021, View Source [SID1234575923]). Research developed by Cardinal Health, published today in the Journal of the American Medical Association, suggests that RWE may be able to be applied more broadly in cancer research and regulatory filings, and could lead to accelerated clinical trials in cancer research . Real-world evidence is generated during routine clinical practice and outside the context of randomized controlled trials.

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"The potential to use RWE to complement and supplement traditional data from randomized controlled trials is exciting because it could significantly accelerate the speed at which clinical trials are conducted, and as a result, innovative medicines could be approved and reach patients faster," said Bruce Feinberg, DO, Chief Medical Officer at Cardinal Health Specialty Solutions and lead author of the study.

Although randomized controlled trials remain the standard for assessing the safety and efficacy of new cancer therapies, there is increasing recognition that this research method is costly, time consuming and does not accurately represent the general population. These factors – combined with the growth of targeted therapies and the rapidly expanding field of drug development – have researchers and policy makers like the Federal Drug Administration (FDA) exploring how real-world evidence can be used to accelerate the drug development process.

The Cardinal Health study included 956 patients who were receiving first-line treatment for thyroid cancer, breast cancer or melanoma between 2014 and 2017. The research used a novel, real-world application of the Response Evaluation Criteria in Solid Tumors (RECIST) methodology to assess how the patients’ tumors responded to the therapy.

"The study findings show that applying RECIST methodology to real-world data may allow for accurate comparisons between real-world data and RCT data in solid tumors. We believe these findings may open the door for broader use of RWE across many areas of cancer research," said Ajeet Gajra, MD, Sr. Medical Director at Cardinal Health and one of the co-authors of the study.