On December 10, 2020 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported achievement of fifty percent enrollment in the IMerge Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes (MDS) (Press release, Geron, DEC 10, 2020, View Source [SID1234572607]). Data from the IMerge Phase 2 were recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and support the ongoing Phase 3.

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"Reaching fifty percent enrollment is a key milestone towards the completion of this registration-enabling Phase 3 clinical trial, and we appreciate all of the support from our investigators and the patients who are participating in this study," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "We believe that the IMerge Phase 3 will confirm the meaningful and durable transfusion independence and the disease-modifying activity of imetelstat observed from the Phase 2, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS."

The IMerge Phase 3 is a double-blind, randomized, placebo-controlled clinical trial with registration intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk MDS, or 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 a consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI of at least 24 weeks, or 24-week RBC-TI rate, 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, and duration of transfusion independence.

The Company continues to expect full enrollment in the IMerge Phase 3 in the second quarter of 2021. As long as enrollment is completed by the end of the first half of 2021, Geron maintains its projection of top-line results from IMerge to be available in the second half of 2022.

To learn more about IMerge and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov.

About Myelodysplastic Syndromes (MDS)

Myelodysplastic syndromes is a group of blood disorders in which the proliferation of malignant progenitor cells produces multiple malignant cell clones in the bone marrow resulting in disordered and ineffective blood production. There are approximately 60,000 people in the United States living with the disease and approximately 16,000 reported new cases of MDS in the United States every year. The majority of patients, approximately 70%, fall into the lower risk groups at diagnosis, according to the International Prognostic Scoring System that takes into account the presence of a number of disease factors, such as cytopenias and cytogenetics, to assign relative risk of progression to acute myeloid leukemia (AML) and overall survival.

Chronic anemia is the predominant clinical problem in patients who have lower risk MDS. Due to low hemoglobin, many of these patients become dependent on red blood cell transfusions which can lead to iron overload, higher risk of development AML and poorer overall survival. Currently, no drug therapy has been shown prospectively to alter or delay disease progression.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data strongly suggest that imetelstat has disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Current clinical studies of imetelstat include IMerge, an ongoing Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMpactMF, an upcoming Phase 3 clinical trial in refractory myelofibrosis (MF). 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 MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

On December 10, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported dosing of the first patient in the ENVASARC registration trial (Press release, Tracon Pharmaceuticals, DEC 10, 2020, View Source [SID1234572606]).

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"We are pleased to initiate dosing in the ENVASARC registration trial of envafolimab in sarcoma," said Sant Chawla, M.D., Director of the Sarcoma Oncology Center, Santa Monica. "Immunotherapy has radically changed the treatment paradigm for a number of cancers, and we believe envafolimab has the potential to do the same for sarcoma patients who have few treatment options."

"Dosing the first patient in the ENVASARC registration trial within one year of executing the license to envafolimab fulfills our 2020 expectations for what has been a productive year of clinical development and regulatory interactions for our lead product candidate," said Charles Theuer, M.D., Ph.D., President and Chief Executive Officer of TRACON. "We look forward to the availability of interim top-line data from this important study, which we expect in mid-2021."

About ENVASARC (NCT 04480502)

Key elements of the ENVASARC registration trial include:

Multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States.
Eligible patients will have undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) and received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
Open-label format with blinded independent central review of efficacy endpoint data.
About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently being studied in the ENVASARC Phase 2 registration trial in the U.S. sponsored by TRACON, as well as in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer in November 2020. In the Phase 2 registration trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

On December 10, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported a planned reverse stock split of its shares of common stock at a ratio of 1-for-7 (Press release, Heat Biologics, DEC 10, 2020, View Source [SID1234572605]). The reverse stock split will take effect as of 12:01 a.m. ET, December 11, 2020. Shares of Heat common stock will trade on a post-split basis on the Nasdaq Capital Market under the existing trading symbol, "HTBX," at the market open on December 11, 2020.

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Jeff Wolf, CEO of Heat, commented, "Our sole purpose in conducting this reverse-split was to address market concerns related to the Nasdaq minimum bid price requirement. Importantly, we remain in compliance with Nasdaq requirements and have important upcoming milestones related to our programs that we expect to announce soon, which we believe will further validate our strategy. It’s also important to note that we have a solid balance sheet with over $113 million of cash as of December 9, 2020."

During the Company’s special shareholder meeting held February 27, 2020, shareholders approved the Company’s reverse stock split, and granted the board of directors the authority to implement and determine the exact split ratio, which was set by the board at 1-for-7. Following the reverse stock split, the new CUSIP number will be 42237K 409, with the par value per share of common stock remaining at $0.0002. A proportionate adjustment will be made to the per-share exercise prices and number of shares issuable under all outstanding stock options and warrants.

The reverse stock split is intended to increase the market price per share of the Company’s common stock to help ensure a share price high enough to satisfy the $1.00 minimum bid price requirement by Nasdaq and to potentially increase the visibility of our company among a larger pool of institutional investors.

When the reverse stock split becomes effective, every seven shares of the Company’s issued and outstanding common stock will be combined into one share of common stock. Effecting the reverse stock split will reduce the number of issued and outstanding common stock from approximately 159.8 million shares to approximately 22.8 million. The reverse stock split will also subsequently adjust outstanding options issued under Heat’s equity incentive plan and outstanding warrants to purchase common stock.

No fractional shares will be issued in connection with the reverse stock split. Shareholders of record will receive a cash payment in lieu of fractional shares to which they would otherwise be entitled. Shareholders with shares held in certificate form will receive a Letter of Transmittal with instructions from Heat’s transfer and exchange agent, Continental Stock Transfer & Trust Company. Shareholders that hold shares in book-entry form or in brokerage accounts are not required to take any action, and will see the impact of the reverse stock split reflected in their accounts. Additionally, beneficial holders may contact their bank, broker, custodian or other nominee with questions regarding processing procedures for the reverse stock split. Additional information is available in the Form 8-K filed today with the U.S. Securities and Exchange Commission, and in the definitive proxy statement filed on January 24, 2020.

On December 10, 2020 Boehringer Ingelheim reported the signing of a binding agreement for acquiring all shares of NBE-Therapeutics, a private, clinical-stage Swiss biotechnology company focused on antibody-drug conjugates and advancing targeted cancer therapies derived from its immune stimulatory iADC platform (Press release, Boehringer Ingelheim, DEC 10, 2020, View Source [SID1234572604]). NBE-Therapeutics’ lead compound NBE-002 is currently in phase I clinical studies for triple negative breast cancer and other solid tumors. Importantly, Boehringer Ingelheim gains access to an innovative and unique platform that it will use to build a leading ADC portfolio and develop potential combinations with other assets from its cancer immunology portfolio.

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"NBE-Therapeutics’ iADC platform adds exceptional tumor targeting capabilities to our oncology portfolio. Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients," said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "This acquisition is a further example of Boehringer Ingelheim’s long-term strategy to enhance our position as an innovator of novel cancer therapies for patients in need. We welcome NBE-Therapeutics’ richly talented team to Boehringer Ingelheim and we look forward to collaborating with them on this important work."

The total transaction value is 1.18 billion euros and also includes contingent clinical and regulatory milestones.

"I am extremely proud of the NBE-Therapeutics’ team and delighted that our world class ADC expertise is being recognized by Boehringer Ingelheim. This transaction is a validation of our platform and its potential for the next generation cancer therapies," said Bertrand Damour, Chief Executive Officer of NBE-Therapeutics. "We look forward to progressing NBE-002, our lead program and best-in-class anti ROR1 ADC, and to continuing the fight against cancer alongside Boehringer Ingelheim with its strong clinical development capabilities."

Boehringer Ingelheim’s cancer cell directed research is focused on the development of targeted therapies for the treatment of difficult-to-treat solid tumors. Inducing tumor cell death is a key component, and ADC based approaches have emerged as a powerful targeted therapy with potential for induction of immunogenic cell death at reduced systemic exposure and toxicity.

The NBE-Therapeutics’ acquisition will significantly strengthen Boehringer Ingelheim’s strategic focus on targeted cancer cell-directed therapies and complements existing capabilities in antigen discovery as well as antibody and T-cell engager technologies. By combining its world-class, in-house research and development with that of highly innovative biotechnology companies, Boehringer Ingelheim is developing innovative therapies and accelerating the delivery of the next generation of cancer treatments. This builds on recent strategic acquisitions and collaborations, including the acquisition of ViraTherapeutics and AMAL Therapeutics, which are also contributing assets.

NBE-Therapeutics is headquartered in Basel, Switzerland, where it was founded with financial backing from a syndicate of both corporate and institutional investors, including the Boehringer Ingelheim Venture Fund, and PPF Group, as their largest shareholders, and Denmark’s Novo Holdings. NBE-Therapeutics’ technology platform and derived assets are protected by a broad portfolio of patents and licenses.

The consummation of the transaction is subject to customary closing conditions and is expected during the course of Q1 2021.

About the ADC Platform
Antibody-drug conjugates (ADC’s) are a class of drugs that consist of an antibody that specifically binds to a target on tumor cells. The antibody is also linked to a cytotoxic drug to kill these cells. If the drug was given systemically, it would cause an unacceptable level of toxicity. However, due to the ability to now localize the drug to the tumor microenvironment using an antibody, the safety profile of the drug becomes acceptable.

NBE-Therapeutics’ proprietary technology platform creates highly potent immune stimulatory antibody-drug conjugates with an anthracycline payload, directly targeting tumor cells and inducing a long-lasting immunological anti-tumor effect. Its technology also incorporates a proprietary enzymatic conjugation step allowing for the site-specific conjugation of small molecule drugs to monoclonal antibodies overcoming liabilities related to limited serum stability and heterogeneous linkage.

About NBE-002
NBE-Therapeutics’ lead candidate, NBE-002, is an anti-ROR1 ADC. ROR1 is a receptor tyrosine kinase expressed in various hematologic and solid malignancies, including triple negative breast cancers and lung adenocarcinoma. The compound is currently in phase I clinical studies.

On December 10, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that it has entered into a securities purchase agreement with several institutional and accredited investors providing for the purchase and sale of 2,448,980 shares of the Company’s common stock at a purchase price of $2.45 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Xenetic Biosciences, DEC 10, 2020, View Source [SID1234572584]). The offering is expected to result in gross proceeds to Xenetic of approximately $6.0 million before deducting placement agent fees and other offering expenses payable by Xenetic.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Company intends to use the net proceeds of this offering for general corporate purposes, working capital, and for the advancement of the XCART platform, the Company’s differentiated, proprietary approach to personalized CAR T therapy in development for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas.

The registered direct offering is expected to close on or about December 14, 2020, subject to the satisfaction of customary closing conditions.

The shares described above are being offered by Xenetic pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227572) previously filed with the U.S. Securities and Exchange Commission ("SEC") on September 27, 2018 and declared effective by the SEC on October 12, 2018. Such shares may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Alternatively, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (646) 975-6996.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.