On October 18, 2021 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported that Bristol Myers Squibb has licensed a fifth TriNKET Immunotherapy drug candidate, bringing the total drug candidates licensed by Bristol Myers Squibb to six including Dragonfly’s novel IL-12 cytokine DF6002/BMS-986415 (Press release, Dragonfly Therapeutics, OCT 18, 2021, View Source [SID1234596017]). Since their original 2017 collaboration focusing on hematology malignancies, the companies have agreed to two additional collaborations which include oncology and neuroinflammation targets.

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Dragonfly also announced that the first patients have been dosed in Phase 1 clinical trials of both the CC-96191 and CC-92328 investigational immunotherapies, which are licensed to Bristol Myers Squibb. Following Dragonfly’s wholly-owned HER2-targeted NK cell engager therapy, DF1001, these are the second and third TriNKET drug candidates in the clinic, along with DF6002/BMS-986415 novel IL12-Fc fusion protein.

"We believe this recent opt-in decision by Bristol Myers Squibb further validates our drug discovery platform," said Bill Haney, Dragonfly’s CEO. "We are also delighted that Bristol Myers Squibb has brought our partnered targeted NK cell engager therapies to their first patients. The ongoing clinical trials of four Dragonfly-developed drugs, including our first cytokine, underscores the breadth of Dragonfly’s portfolio of innovative therapeutics, and the pace with which our team is bringing important new treatment options to patients with cancer and autoimmune disease."

The Phase 1 clinical trial for the CC-96191 TriNKET is a first-in-human study which will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of relapsed or refractory acute myeloid leukemia (R/R AML). Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04789655).

The Phase 1 clinical trial for the CC-92328 TriNKET is a first-in-human study which will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04975399).

On October 18, 2021 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported the completion of patient enrollment in the IMerge Phase 3 clinical trial to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS) (Press release, Geron, OCT 18, 2021, View Source [SID1234591453]). Based upon current planning assumptions, Geron expects top-line results for IMerge Phase 3 to be available at the beginning of January 2023.

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"Completing patient enrollment in IMerge Phase 3 brings us one step closer to delivering imetelstat as a potential treatment alternative for patients with lower risk MDS who are relapsed or refractory to ESAs. Achieving durable transfusion independence remains a significant medical need for these patients," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "I would like to thank all of the patients and their families, the investigators, clinical site staff, as well as our employees for supporting the achievement of this important milestone."

Patients from the IMerge Phase 2 clinical trial achieved durable transfusion independence with imetelstat treatment, including transfusion-free periods greater than one year, irrespective of the disease subgroup, such as ringed sideroblast positive or ringed sideroblast negative. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia and the debilitating impact of serial blood transfusions. In addition, depletion of cytogenetic abnormalities and reductions in key driver mutations associated with lower risk MDS were observed, and these results were also correlated with transfusion independence. Based on the IMerge Phase 2 data, taken together, the durability, molecular and cytogenetic data provide strong evidence for disease-modifying activity of imetelstat, which has the potential to differentiate it from other currently approved and investigational treatments in lower risk MDS today.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

For further information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.

About Myelodysplastic Syndromes

Myelodysplastic syndromes are a group of diverse blood disorders that develop because bone marrow cells do not mature into healthy blood cells. There are approximately 60,000 people living with the disease in the United States. Approximately 70% of MDS patients are categorized in the lower risk groups at diagnosis, according to the International Prognostic Scoring System that assigns relative risk of progression to acute myelogenous leukemia and overall survival by taking into account the presence of a number of disease factors, such as cytopenias and cytogenetics. The predominant clinical problem in lower risk MDS is chronic anemia, and many patients become dependent on red blood cell transfusions which leads to iron overload, heart and kidney complications, decreases in quality of life and shorter overall survival.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in myeloid hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk myelofibrosis whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.

On October 18, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that October 19, 2021 has been set as the record date for the dividend of shares of common stock of 2seventy to be distributed to bluebird stockholders in order to effect the separation of bluebird bio and 2seventy bio, Inc. into two independent, publicly traded companies (Press release, bluebird bio, OCT 18, 2021, View Source [SID1234591469]).

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Each bluebird bio stockholder of record as of the close of business on October 19, 2021 will receive, on the distribution date, one share of 2seventy common stock for every three shares of bluebird common stock held. The share dividend is expected to be distributed to bluebird stockholders on or about November 4, 2021. Following the separation, bluebird stockholders will also receive cash in lieu of any fractional shares of 2seventy common stock that those holders would have received after application of the 3:1 distribution ratio. No action is required by bluebird stockholders in order to receive the shares of 2seventy common stock in the dividend distribution.

Additionally, on October 18, 2021 the Securities and Exchange Commission declared 2seventy’s Registration Statement on Form 10 (the "Form 10") effective. This Form 10 contains further information regarding bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company, including the conditions to completion of the separation.

"When-issued" trading for 2seventy common stock and "ex-distribution" trading for bluebird common stock is expected to commence on October 18, 2021 under the stock ticker symbols "TSVTV" and "BLUEV", respectively. A description of these expected trading markets is included in the Form 10. After the separation, 2seventy common stock is expected to trade on the Nasdaq Global Select Market under the stock ticker symbol "TSVT" and bluebird will continue to trade on Nasdaq Global Select Market under the stock ticker symbol "BLUE."

On October 18, 2021 Evopoint Biosciences reported XNW7201 approved by Beijing Cancer Hospital, the unit of the team leader, for the Phase IIa clinical trial on October 18, 2021 (Press release, Evopoint Biosciences, OCT 18, 2021, View Source [SID1234656283]).

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Variation of Wnt signaling pathway is common in gastrointestinal tumors (e.g., gastric cancer, colorectal cancer, esophageal cancer, pancreatic cancer, etc.). Inhibition of Porcupine protein can block the abnormally activated Wnt signaling pathway. Moreover, it has been confirmed that the use of Wnt inhibitor is expected to enhance the effect of tumor immunotherapy. In this regard, Evopoint will continue to make every effort to promote the Phase IIa clinical trial of XNW7201 and strive to accelerate product launch for the benefit of numerous sufferers.

On October 18, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States (Press release, Lipocine, OCT 18, 2021, View Source [SID1234591454]). TLANDO is an oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

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As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. Upon the expiration of the exclusivity period granted to Clarus Therapeutics, Inc., with respect to its drug, JATENZO, under the Hatch-Waxman Act, which expires on March 27, 2022, TLANDO will be eligible for final approval. The FDA has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes a two-month FDA review goal period.

Under the terms of the agreement, Lipocine will receive an immediate upfront cash payment of $11.0 million and, subject to certain conditions, an additional $5.0 million licensing payment in January 2025 and another $5.0 million licensing payment in January 2026. Lipocine will also be entitled to receive sales-based commercial milestone payments totaling up to $160.0 million based on TLANDO net sales and, if Antares Pharma exercises its option, TLANDO XR sales, in addition to tiered royalty payments at rates ranging from the mid-teens to up to 20% on net sales of TLANDO. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S.

In addition, Lipocine has granted Antares Pharma an option to license, on or before March 31, 2022, TLANDO XR, a next-generation, potential once-daily oral product candidate for TRT, in the U.S. TLANDO XR met primary and secondary regulatory end points for TRT in an earlier Phase 2 clinical study. Upon exercise of the TLANDO XR option, Lipocine is entitled to receive an additional $4.0 million in license fees, clinical and regulatory milestone payments of up to an aggregate of $35.0 million, and tiered royalties on net sales at rates ranging from the mid-teens to up to 20%. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR.

"We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. Dr. Patel further stated, "Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma’s capabilities, given its established marketing experience and demonstrated success in the TRT space. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet needs."