On January 13, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Investigational New Drug (IND) application submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) by the Company’s partner in China, Qilu Pharmaceutical, was accepted for review. (Press release, Sesen Bio, JAN 13, 2021, View Source [SID1234573970]) If the IND is approved, Qilu will be authorized to conduct the proposed clinical trial to assess the efficacy and safety of VicineumTM in patients with non-muscle invasive bladder cancer (NMIBC) in Greater China. The Company’s lead program, Vicineum, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial in the United States (US) for the treatment of high-risk, bacillus Calmette-Guérin (BCG)-unresponsive NMIBC. In December 2020, the Company completed the Biologics License Application (BLA) submission for Vicineum to the FDA.

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"The IND submission and acceptance for review by the NMPA for Vicineum in China is a significant milestone for Sesen Bio and our mission of saving and improving the lives of patients with cancer around the world. This accomplishment further highlights the productive collaboration we have with our partner Qilu Pharmaceutical" said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Vicineum is a highly differentiated and potentially best-in-class therapeutic for the treatment of NMIBC. Given the positive Phase 3 trial results achieved in the US and the highly experienced clinical oncology team at Qilu Pharmaceutical, we are optimistic on the prospects for a successful trial. We look forward to continuing to work with Qilu Pharmaceutical and the NMPA to develop and commercialize Vicineum in China."

The proposed open-label, single-arm, multi-center bridging trial will evaluate the efficacy and safety of Vicineum in approximately 53 patients with carcinoma in situ (CIS) with or without papillary disease, high-grade Ta papillary disease or T1 papillary disease of any grade. Patients will be required to have failed previous treatment with BCG for inclusion in the trial. The primary endpoints are the complete response rate (for CIS patients) and the recurrence-free rate (for papillary patients) at 6 months, with the complete response rate and the recurrence-free rate at 3 months, safety and tolerability as the secondary endpoints.

Upon approval of the IND application by the NMPA, expected in the first half of 2021, Sesen Bio is entitled to receive a $3M milestone payment from Qilu Pharmaceutical, the first of $23M in potential milestone payments. China represents a large potential market for Vicineum, with peak year sales estimated at $155-418M. Furthermore, due to more limited use of BCG in China compared to the US, there is a major opportunity to transform the treatment paradigm of NMIBC in China and save and improve the lives of patients with cancer.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In December 2020, Sesen Bio completed the BLA submission for Vicineum to the FDA. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On January 13, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that patient recruitment has commenced in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM) (Press release, Kintara Therapeutics, JAN 13, 2021, View Source [SID1234573969]). The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a revolutionary, patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM.

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Key GBM AGILE Highlights for VAL-083

Only therapeutic agent currently being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT; newly-diagnosed unmethylated MGMT; and recurrent
May accelerate VAL-083’s time to pivotal trial completion and potential regulatory submission by up to 18 months
Cost-effective opportunity to advance VAL-083 due to the GBM AGILE study’s expense sharing protocol
Anticipating rapid enrollment, targeting 150-200 patients with 34 active and recruiting U.S. sites with plans to increase to 40 sites during Q1, 2021, including Canada and other international locations to follow
"The entire Kintara team is grateful and excited to participate in GCAR’s groundbreaking GBM AGILE study as it offers an extraordinary opportunity to facilitate the advancement of VAL-083’s clinical development in a premier GBM study," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "This is truly an important milestone for Kintara as we believe the study will generate important insights into the breadth of VAL-083’s potential to address this deadliest form of brain cancer in all patient subtypes, while potentially bringing the program to the doorstep of commercialization."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

Kintara’s VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

On January 13, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma (Press release, Harpoon Therapeutics, JAN 13, 2021, View Source [SID1234573968]). HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform.

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"Orphan Drug Designation for multiple myeloma represents a significant milestone in the development of HPN217 and recognizes its potential to address a significant unmet medical need for the patients suffering from this condition," said Jerry McMahon, Ph.D., President and Chief Executive of Harpoon Therapeutics. "I am pleased with the clinical progress we are making with this program and we are planning to present interim data from the ongoing Phase 1/2 dose escalation trial later this year."

The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

About the Phase 1/2 Trial for HPN217

In April 2020, Harpoon announced dosing of the first patient with HPN217 (BCMA TriTAC) in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM). HPN217 is covered by a global development and option agreement with AbbVie Inc. (NYSE: ABBV). Dose escalation for HPN217 in the Phase 1/2 clinical trial is progressing rapidly. HPN217 has been well tolerated, and no DLTs had been observed as of the most recent December 1, 2020 data cutoff date. A presentation of interim data is anticipated in 2021, with initiation of a dose expansion cohort in the second half of 2021.

On January 13, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported the research collaboration with Astellas Pharma Inc. (TSE:4503) ("Astellas") to develop novel targeted radiotherapies using its Antibody Warhead Enabling (AWE) technology platform. (Press release, Actinium Pharmaceuticals, JAN 13, 2021, View Source [SID1234573967]) Under this agreement, Actinium will utilize its AWE Platform technology to develop and characterize selected Astellas targeting agents labeled with the potent alpha-emitting radioisotope Actinium-225 (Ac-225). This collaboration is a component of Astellas’ internal initiative to develop theranostics as part of its Rx+ business (For more information, please visit View Source).

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"We are excited to execute on this research collaboration with Astellas, a global leader at the forefront of healthcare innovation," stated Dr. Dale Ludwig, Chief Scientific and Technology Officer of Actinium. "Targeted radiotherapy has a highly differentiated mechanism of action with the potential to address multiple disease indications and therefore has been an area of significant exploration and investment of late. Through our AWE technology platform, we are able to bring our significant know-how in working with Actinium-225, as well as our robust clinical experience with targeted radiotherapies and supply chain to bear in this collaboration. With our enhanced laboratory capabilities and the expertise of our R&D team, we are well positioned to execute on this collaboration with Astellas as well as our own R&D strategy, to complement our Iomab-B and Actimab-A clinical programs."

The intellectual property encompassing Actinium’s AWE technology platform covers its gold standard linker technology, methods of ARC manufacture in addition to methods of use for ARCs in multiple diseases, including indication, dose and scheduling, radionuclide warhead, and therapeutic combinations. Actinium’s AWE technology patent portfolio includes 30 patent families comprised of over 135 issued or pending global patent applications, of which 10 are issued and 24 pending in the United States.

Sandesh Seth, Chairman and Chief Executive Officer of Actinium, added, "Through our development efforts, Actinium has established itself as a leader in the field of Actinium-225 based targeted radiotherapies. We have amassed the most experience treating patients with Actinium-225 via our CD33 program’s several Actimab-A trials and have gained important insights in developing targeted radiotherapies through the execution of the Actimab-A and also SIERRA Phase 3 pivotal trial for our lead asset, Iomab-B. This expertise and experience with radiopharmaceuticals has been invaluable to us and we believe will also be to Astellas in this collaboration. As Iomab-B and Actimab-A advance in the clinic with multiple clinical milestones upcoming from each of our trials, we look forward to executing this collaboration and furthering the field of targeted radiotherapy with Astellas."

About Our Antibody Warhead Enabling Platform Technology

The Antibody Warhead Enabling (AWE) Program has at its centerpiece the AWE Platform Technology. The Company’s proprietary AWE Platform Technology is supported by intellectual property and know-how that enables the creation of Actinium-225 (Ac-225) Radio-Conjugates (ARCs) wherein a biomolecular targeting agent is stably labeled with the powerful Ac-225 payload to enhance targeted cell killing. The AWE Platform is protected by intellectual property covering the use of the "gold standard" chelator DOTA, and any conceivable derivative thereof. Additionally, Actinium holds intellectual property protection covering methods of chelation or labeling of the targeting agent with Ac-225, including newer next-generation methodologies for chelation of Ac-225.

The AWE Program is structured to provide the opportunity for partners or collaborators to derive maximum value from a collaboration by leveraging Actinium’s extensive technical know-how, access to its ARC drug development infrastructure and to its underlying AWE Platform Technology. The AWE Program provides a partner or collaborator with access to Actinium’s knowledge bank and infrastructure allowing collaborators to benefit from accelerated development timelines for its ARCs.

To learn more about the AWE Technology Platform or the AWE Program please contact our Business Development team at [email protected].

On January 13, 2021 Affimed N.V. ("Affimed" or the "Company") (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the pricing of its previously announced public offering of 16,666,667 of its common shares at a public offering price of $6.00 per common share (Press release, Affimed, JAN 13, 2021, View Source,of%20its%20common%20shares%20at [SID1234573966]). In addition, Affimed has granted the underwriters a 30-day over-allotment option to purchase up to 2,500,000 common shares at the public offering price less underwriting discounts. After deducting the underwriting discounts, the net proceeds of the public offering are expected to be approximately $94 million. The offering is expected to close on or about January 15, 2021, subject to customary closing conditions.

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Jefferies LLC, SVB Leerink LLC and Credit Suisse Securities (USA) LLC are acting as joint book-running managers and Laidlaw & Company (UK) Ltd. is acting as co-manager. A shelf registration statement relating to these securities filed with the Securities and Exchange Commission (the "SEC") was declared effective by the SEC on December 30, 2020. The offering will be made only by means of a prospectus and prospectus supplement. A preliminary prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available at the SEC’s website located at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. Copies of the preliminary prospectus supplement and accompanying prospectus related to the offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388 or by email at [email protected], SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132, or by email at [email protected], or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected].

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