On February 16, 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 U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review (Press release, Sesen Bio, FEB 16, 2021, View Source [SID1234575139]). In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.

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The FDA grants Priority Review for medicines that treat a serious condition and, if approved, would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of such serious condition. Priority Review designation shortens the review period goal from the standard ten months to six months from the filing acceptance of the BLA. With Priority Review, the anticipated target Prescription Drug User Fee Act (PDUFA) date for a decision on the BLA is August 18, 2021.

"We have been meeting with the FDA regularly for the past two years on the application for Vicineum," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We understand the FDA’s position and guidance very clearly and have found the review process to be collaborative and engaging. With these critical FDA decisions, we have reached an inflection point for the Company. In addition to a clear regulatory path forward, we have continued to strengthen our balance sheet in preparation for the potential launch of a product we believe represents a significant advancement over available therapies. We remain focused on the patient and our mission to save and improve lives and expect to continue to make progress around the world in the coming months."

In the next one to two months, the Company expects to submit its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and receive an update from the Company’s partner, Qilu Pharmaceutical, regarding the possible approval of the Investigational New Drug (IND) application for Vicineum in China by the Center for Drug Evaluation (CDE).

Conference Call and Webcast Information
Dr. Thomas Cannell Presided and CEO of Sesen Bio will host a conference call today at 8:00 AM ET. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 1290313. The conference call can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. A replay of the call will be available in the investor section of the Company’s website at www.sesenbio.com for 60 days.

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 February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. 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 high-risk, BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On February 16, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to developing and commercializing cures for blood cancers and serious hematologic diseases, reported the sale of $75 million of 5.875% exchangeable senior notes due in 2026 (the "notes") to certain funds managed by Highbridge Capital Management, LLC (Press release, Gamida Cell, FEB 16, 2021, View Source [SID1234575138]).

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The proceeds from this sale of notes, together with the net proceeds of Gamida Cell’s sale of $75 million of ordinary shares in December 2020, are expected to provide Gamida Cell with sufficient liquidity to fund the company’s operations into the second half of 2022. These capital infusions will be used to support manufacturing, regulatory and commercial development activities for omidubicel and to further the preclinical and clinical development of GDA-201.

"Securing this financing from a respected industry investor strengthens Gamida Cell’s financials at a pivotal time for our company. It enables us to capitalize on positive Phase 3 clinical results generated from omidubicel and to fund the key activities required to bring this therapy forward to patients," said Julian Adams, CEO of Gamida Cell. "Moreover, these additional funds help us to advance clinical development of GDA-201 by enabling us to file an IND for this product candidate."

"We are pleased to be able to provide this financing to Gamida Cell, to meaningfully advance their vision of developing cures for blood cancers and serious hematological diseases," commented Jonathan Segal, Co-Chief Investment Officer of Highbridge Capital Management. "Following our extensive due diligence, we are enthusiastic about the commercial potential for omidubicel. We are also excited about the potential for GDA-201 to be an important therapy and leader in the emerging field of NK cell therapy. We look forward to continuing to work collaboratively with Gamida Cell’s management team and board" added Jason Hempel, Co-Chief Investment Officer of Highbridge Capital Management.

The notes were sold at 100% of the principal amount thereof, are senior unsecured obligations of Gamida Cell and its wholly owned subsidiary and will accrue interest at a rate of 5.875% per year. Subject to certain limitations, the holders of the notes can elect to exchange the notes for Gamida Cell’s ordinary shares at an initial exchange rate of 56.3063 shares per $1,000 principal amount of notes (equivalent to an exchange price of $17.76 per share). The initial exchange price of the notes represents a premium of approximately 50% over the closing price of Gamida Cell’s ordinary shares on February 12, 2021 and a premium of approximately 122% over the public offering price of Gamida Cell’s shares on December 17, 2020.

Gamida Cell may redeem all or a portion of the notes for cash, at its option, at 100% of the principal amount plus accrued and unpaid interest on the notes to be redeemed if the closing price of its ordinary shares has been at least 130% of the exchange price for at least 20 trading days during any 30 consecutive trading day period.

Moelis & Company served as a transaction advisor to Gamida Cell.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the US Food and Drug Administration. In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.12 Based on the recently completed Phase 3 clinical study, in which omidubicel achieved statistically significant and clinical meaningful results in the prespecified primary and secondary endpoints, Gamida Cell plans to submit the full Biologics License Application (BLA) to the FDA in the second half of 2021. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is currently in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.3 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy has not been established by the FDA or any other health authority.

On February 16, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported the first patient has been dosed in a Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy (Press release, NeoImmuneTech, FEB 16, 2021, View Source [SID1234575137]). The purpose of this study is to evaluate preliminary anti-tumor activity of NT-I7 and nivolumab, compared with nivolumab alone, in patients with previously treated advanced or metastatic gastric, gastro-esophageal junction (GEJ), or esophageal adenocarcinoma, and to establish safety and tolerability of the combination in these patients.

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"We are thrilled to have dosed the first patient in this trial and to be evaluating a potential new treatment option for these cancers, especially given the current limited treatment options these patients have," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "NT-I7’s ability to amplify T cells and excellent safety profile in cancer patients makes it an ideal candidate for a combination therapy with checkpoint inhibitors like nivolumab. It is our hope that this study will pave the way for a potential new treatment in a patient population where it is greatly needed."

The results of this Phase 2, randomized, proof-of-principle study will be used to further clinical development of this combination in selected clinical settings and tumor types.

More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04594811

Opdivo is a registered trademark of Bristol Myers Squibb.

About NT-I7
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On February 16, 2021 AmMax Bio, Inc. ("AmMax"), a private clinical-stage biopharmaceutical company focused on developing first-in-class or best-in-class treatments with its proprietary dual anti-inflammatory/anti-fibrotic therapeutic platform targeting the colony-stimulating factor 1 receptor (CSF1R), reported that Larry Hsu, Ph.D., Chief Executive Officer and the management team will participate in one-on-one meetings with investors at the 41st Annual Cowen Health Care Conference on Wednesday, March 3, 2021 (Press release, AmMax Bio, FEB 16, 2021, View Source [SID1234575136]).

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AmMax was founded in March 2020 to develop therapies under an exclusive worldwide license from Amgen, Inc. that leverage the diverse and critical roles played by the CSF1 signaling pathway for macrophage regulation in multiple organ systems. Based on a potent monoclonal antibody named AMB-05X, the company is using this proprietary platform to build a portfolio of therapies that address diseases with significant unmet medical needs and substantial commercial potential. AmMax’s robust drug development pipeline includes Phase 2 clinical programs for tenosynovial giant cell tumor (TGCT) and idiopathic pulmonary fibrosis (IPF), in addition to earlier stage programs for polycystic kidney diseases and certain ocular disorders.

About AMB-05X

A potent monoclonal anti-CSF1R antibody, AMB-05X is a therapeutic platform targeting macrophage-driven diseases with significant unmet medical needs and substantial commercial potential. The CSF1R, via its binding to two regulatory cytokines, CSF1 and IL-34, is critically involved in the regulation of macrophages and related cells in multiple biological processes across multiple organ systems, making it an attractive target with broad therapeutic applications. Overactivation of the CSF1/IL-34 – CSF1R axis substantially contributes to the inflammation and fibrosis inherent in many diseases. Thus, the potent inhibition of CSF1R activity by AMB-05X represents a novel and powerful means of therapeutic intervention via its dual action.

On February 16, 2021 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome, reported Duncan Peyton, Chief Executive Officer of 4D pharma, will participate in Cantor Fitzgerald’s virtual panel, titled "Microbiome Players with Guided Readouts in 2021," on Thursday, February 18, 2021 at 15:00 GMT (10:00 ET) (Press release, 4d Pharma, FEB 16, 2021, View Source [SID1234575135]).

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A webcast of the panel will be available via the "Events" section of the 4D pharma website at www.4dpharmaplc.com.