On July 24, 2023-Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) reported that the company has filed an application for partial change of approved indication of the sustained duration form of G-CSF(Granulocyte-Colony Stimulating Factor)*1 product G-Lasta [KRN125, generic name: pegfilgrastim (genetical recombination)] for the mobilization of hematopoietic stem cells into peripheral blood in autologous blood stem cell transplantation*2 (the "indication") in Japan today (Press release, Kyowa Hakko Kirin, JUL 24, 2023, View Source [SID1234633392]).

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This application is based on the results of a clinical trial conducted by Kyowa Kirin to evaluate the effect of G-Lasta on the mobilization of hematopoietic stem cells into peripheral blood in patients with multiple myeloma and malignant lymphoma.

G-Lasta is a long-acting G-CSF preparation licensed from Amgen K-A and has been marketed in Japan since 2014 for decreasing the incidence of febrile neutropenia*3 in patients receiving cancer chemotherapy. In February 2022, Kyowa Kirin received an approval for the indication of G-Lasta for the mobilization of hematopoietic stem cells into peripheral blood in allogeneic blood stem cell transplantation*4. By adding the indication of this sustained duration preparation to autologous blood stem cell transplantation, Kyowa Kirin expects to contribute to reducing burden on patients in hematopoietic stem cell transplantation therapy.

"We are very delighted with this application to add the indication to autologous blood stem cell transplantation therapy," said Yuichi Kawasaki, Executive Officer, Director of Product Strategy Department of Strategy Division at Kyowa Kirin. "

We will continue to strive to deliver this product to patients and provide new value to the blood stem cell transplantation therapy area." The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

On July 24, 2023 VBI Vaccines Inc. (NASDAQ: VBIV) (VBI or the Company), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that the underwriters of its recent underwritten public offering of common shares and accompanying common warrants to purchase common shares partially exercised their option to purchase an additional 1,536,363 common shares at a public offering price of $1.64 per common share (Press release, VBI Vaccines, JUL 24, 2023, View Source [SID1234633391]). The aggregate gross proceeds from this exercise were approximately $2.5 million, resulting in total gross proceeds of $23.5 million from the underwritten public offering and the previously completed concurrent registered direct offering, before deducting the underwriting discounts, commissions, and estimated offering expenses. The partial option exercise closed on July 21, 2023.

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Immediately following the closing of the partial option exercise, the number of outstanding common shares of the Company is 22,872,175.

Raymond James & Associates, Inc. acted as the sole book-running manager for the underwritten public offering. Newbridge Securities Corporation acted as the lead manager for the underwritten public offering. The registered direct offering was made without an underwriter or a placement agent.

VBI intends to use the net proceeds from the underwritten offering, including the partial option exercise, for the commercialization activities for PreHevbrio [Hepatitis B Vaccine (Recombinant)] in the United States, Europe, and Canada; manufacturing of PreHevbrio and clinical materials for its pipeline programs; and ongoing activities related to its development stage candidates, including VBI-1901 (glioblastoma) and VBI-2901 (coronaviruses). The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement on Form S-3 (File No. 333-267109) relating to these securities was previously filed with the Securities and Exchange Commission ("SEC") on August 26, 2022 and declared effective on September 6, 2022. A final prospectus supplement and accompanying prospectus relating to the underwritten offering were filed with the SEC and available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On July 24, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that it has opened enrollment in the UK and Germany for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer (Press release, Panbela Therapeutics, JUL 24, 2023, View Source;utm_medium=rss&utm_campaign=panbela-opens-enrollment-in-uk-and-germany-for-aspire-trial-in-pancreatic-cancer [SID1234633390]). ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Detailed information on the trial can be located at View Source

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"We’re thrilled to bring on the UK and Germany for the ASPIRE trial and to now have the full complement of Countries open and actively enrolling," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "

Next up, we are focused on having all sites open for enrollment within the next couple months, and then towards the interim data analysis in early 2024." There are approximately 95 sites planned for throughout the United States, Europe, Australia, and South Korea, in the global Aspire trial. Panbela is committed to delivering a more effective treatment for pancreatic cancer, a deadly disease with few treatment options.

On July 24, 2023 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, and Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research, reported encouraging primary and secondary endpoint results from the recently completed clinical study of VAC2 in advanced non-small cell lung cancer (NSCLC) (Press release, Lineage Cell Therapeutics, JUL 24, 2023, View Source [SID1234633389]). The Phase 1 study was a first-in-human, open label, multi-center trial designed to investigate safety, immunogenicity, and survival in patients with advanced NSCLC (defined as metastatic or locally advanced disease) when administered the allogeneic dendritic cell (DC) vaccine VAC2 (NCT03371485). VAC2 DC cells have been engineered to present hTERT, a tumor-associated antigen found almost exclusively in cancer cells, and it is postulated that VAC2 will stimulate an immunogenic anti-tumor CD4+/CD8+ T cell response toward hTERT expressed on tumor cells. All eight subjects enrolled and treated completed the full per protocol vaccination regimen, which consisted of six-consecutive weekly intradermal (ID) injections of 1 x 107 viable VAC2 cells. Overall, VAC2 was well-tolerated, there were no unexpected SAEs, and there were no dose limiting toxicities.

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"The unmet medical need in refractory NSCLC is significant and results from recent clinical trials support the investigation of cancer vaccines as a promising approach to treating this disease. The antigen-loaded VAC2 product candidate appeared to be well tolerated in all treated patients and the adverse events which we did observe were modest and expected from a therapy designed to generate a robust and durable immune response to tumor antigens. The immunogenicity data reported to date are also encouraging and supportive of the clinical observations we noted in the patients," stated Professor Gary Middleton MB, BS, MD, FRCP, Professor of Medical Oncology, Institute of Immunology and Immunotherapy, The University of Birmingham, UK.

Brian Culley, Chief Executive Officer of Lineage, added: "The conclusion of this partnered study represents an important milestone for Lineage’s allogeneic cell therapy pipeline. We have completed clinical studies using three separate cell types in dramatically different diseases; geographic atrophy secondary to dry-form age-related macular degeneration, spinal cord injury, and most recently, NSCLC. The overall safety and efficacy data from these studies affirm our belief in the potential for allogeneic cell therapy to address some of the most serious medical needs, which unfortunately remain unaddressed by conventional approaches. Our goal is to determine how best to advance and expand not only the VAC platform as a delivery vehicle for tumor-associated and neoantigen vaccine delivery to resistant tumors, but also our overall approach to differentiated cell transplants as an emerging branch of medicine."

"Lung cancer is the third most common cancer in the UK and unfortunately, only 10% of patients survive their disease for 10 years or more, so we desperately need better treatment options. We are excited to see these initial VAC2 clinical data from a first-in-human application in what is the most common form of lung cancer and are hopeful that we can continue our collaborative work with Lineage on the next phase of development for this promising treatment approach," added Nigel Blackburn, PhD, Cancer Research UK’s Director of Drug Development.

On May 7th, 2020, Lineage completed an early exercise of its option to acquire data from Cancer Research UK and assumed responsibility for further development of the VAC2 product candidate as well as future development opportunities derived from the VAC platform, while Cancer Research UK’s Centre for Drug Development completed the clinical study in NSCLC. Lineage is currently reviewing these data, as well as several tertiary and exploratory endpoint assessments, and will determine next steps to evaluate VAC2 following these analyses. Lineage, Cancer Research UK, and the participating investigators intend to present these data at future medical and scientific conferences and submit publications to relevant journals for peer review.

On July 24, 2023 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity"), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported that it has terminated its previously announced merger agreement providing for the merger with MEI Pharma, Inc. ("MEI") (Press release, Infinity Pharmaceuticals, JUL 24, 2023, View Source [SID1234633388]).

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At a special meeting of MEI stockholders on July 23, 2023, MEI did not obtain MEI stockholder approval for the merger with Infinity, nor could MEI obtain approval for an adjournment of the special meeting. In the process of attempting to obtain approval for the merger, which the MEI board supported based on the value creation potential of the combined companies with eganelisib as the lead asset, MEI was forced to contend with an unsolicited public proposal to acquire MEI by certain activist stockholders who launched a public campaign to buy MEI at a significant discount to its cash on hand.

Infinity has continued to prepare for the initiation of a planned global Phase 2 clinical trial evaluating eganelisib in head and neck squamous cell carcinoma, and, following FDA feedback, the final protocol has been submitted to the FDA. Based on the strength of the eganelisib data generated across several tumor types to date, Infinity’s board of directors continues to believe in the value of eganelisib and will explore strategic alternatives intended to realize this potential value. Infinity’s board believes that eganelisib offers a near-term value creation opportunity and would be attractive to potential acquirers and intends to engage one or more strategic advisors to assist in the process. In an effort to conserve resources and preserve value for stockholders during this process, the company’s board and management team expect to undertake a series of cost saving measures.

Infinity provided a conditional notice of termination to MEI indicating that Infinity was terminating the merger agreement if MEI did not obtain stockholder approval of the issuance of MEI common stock in connection with the merger. As a result of the termination of the merger agreement, we believe Infinity is entitled to reimbursement of certain expenses and fees of $1,000,000 from MEI in accordance with the terms of the merger agreement. Infinity has the potential to receive an additional $4,000,000 termination fee from MEI under certain circumstances outlined in the joint proxy statement/prospectus relating to the merger.