On November 15, 2022 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that the first patient has been dosed in a Phase I/II clinical trial designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors (Press release, Enlivex Therapeutics, NOV 15, 2022, View Source [SID1234624086]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, stated "Our team is continuing to focus on execution of our strategic and operating plan across our various clinical development verticals, with an ongoing sepsis Phase II clinical trial and two ongoing oncology Phase I/II clinical trials. We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to observing safety and potential indication of effect in patients, who we expect to enroll in our open-label oncology trials during 2023.

ABOUT THE PHASE I/II TRIAL

The Phase I/II trial is a multicenter, open-label, dose escalation trial that is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. Stage 1 of the trial will examine escalating doses of Allocetra monotherapy administered intravenously (IV) or intraperitoneally (IP) once a week for three consecutive weeks. Stage 2 will evaluate escalating doses of Allocetra administered IV or IP and combined with anti-PD1 therapy. Patients in Stage 2 will receive three injections of Allocetra concomitantly with the studied anti-PD1 agent. The primary objective of the study is to evaluate safety and tolerability throughout the treatment period and through one week after the last administration of Allocetra. Key secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. Changes in immune cell/cytokine profiling in peritoneal fluid will also be assessed as an exploratory endpoint. The study population encompasses adult patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for, or have declined additional standard-of-care systemic therapy.

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On November 14, 2022, at the request of the FDA, Clovis Oncology, Inc. (the "Company") met by teleconference with the FDA to discuss the overall survival (OS) data from the Company’s ARIEL3 clinical trial (Filing, Clovis Oncology, NOV 14, 2022, View Source [SID1234624529]). The ARIEL3 dataset formed the basis for the approval of Rubraca in the US in April 2018 and in Europe in January 2019 respectively, as second-line maintenance treatment in adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The Company submitted final OS data, including in exploratory subgroups, from the ARIEL3 study to the FDA in September 2022. The FDA requested that the Company voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment to tBRCA patients only. The FDA further indicated to the Company that if an agreement could not be reached on the revised indication, the FDA would convene an ODAC meeting to review this matter. The Company is currently evaluating FDA’s request.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CASI Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 14, 2022 Lupeng Pharmaceutical Ltd. ("Lupeng Pharmaceutical") reported that successfully completed the second phase of the Pre-B round of financing totaling US$35 million (Press release, Guangzhou Lupeng Pharmaceutical, NOV 14, 2022, View Source [SID1234624136]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The second phase of the Pre-B round of financing was led by world-renowned investment institutions Kaitai Capital and Temasek, followed by other strategic investors such as Lilly Asia Ventures (LAV), Fengchuan Capital, and Qingchi Capital.

The funds raised in this round of financing will be used for the clinical research of the industry-leading product LP-168, the highly selective Bcl-2 inhibitor LP-108, and LP-118.

Dr. Tan Fenlai and Dr. Chen Yi, co-founders of the company, said: "Under the influence of the current market environment and the macro environment, investors are more pursuing certainty and stability. In our core projects LP-168 and LP-108 We are about to enter the stage of critical registration clinical research for listing, and we are honored to receive further financial support from well-known investment institutions and recognition in terms of technical level and value potential. This financing is another milestone for Lupeng Pharmaceuticals. An important milestone, after this financing, the company will focus its resources on the clinical registration research of core projects, accelerate the research process of core products, and bring good medicines to cancer patients around the world as soon as possible."

Mr. Li Xianxian, partner of Kaitai Capital, said: "Congratulations to Lupeng for completing the new round of financing. As the company’s seed round investor, Kaitai Capital has witnessed the rapid and high-quality development of Lupeng Pharmaceuticals. During this process, the Lupeng team Demonstrating excellent innovation and execution capabilities, Kaitai has also participated in the company’s subsequent rounds of financing for many times. The completion of this financing symbolizes that the company has entered a new stage closer to industrialization and capitalization. We Continue to participate in this round of financing, hope to continue to support Lupeng’s new drug development business, and wish Lupeng greater achievements in the new stage!"

On November 14, 2022 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, reported the pricing of its initial public offering of 7,550,000 shares of common stock at a public offering price of $12.50 per share (Press release, Acrivon Therapeutics, NOV 14, 2022, View Source [SID1234624135]). In addition, Acrivon has granted the underwriters a 30-day option to purchase up to an additional 1,132,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. In addition to the shares sold in the initial public offering, Acrivon announced a concurrent sale of 400,000 shares of common stock at the public offering price per share in a private placement to Chione Limited, an existing stockholder of Acrivon. The sale of the shares of common stock in the private placement will not be registered under the Securities Act of 1933, as amended. The gross proceeds to Acrivon from the initial public offering and the concurrent private placement, without giving effect to the underwriters’ option to purchase additional shares and before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $99.4 million. All of the shares of common stock are being offered by Acrivon.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Acrivon’s shares are expected to begin trading on the Nasdaq Global Market on November 15, 2022 under the ticker symbol "ACRV." The offering is expected to close on November 17, 2022, subject to customary closing conditions.

Jefferies, Cowen and Piper Sandler are acting as joint lead book-running managers for the offering.

A registration statement relating to the shares being sold in this offering has been filed with the U.S. Securities and Exchange Commission and was declared effective on November 9, 2022. The offering of the shares is being made only by means of a prospectus forming part of the effective registration statement relating to these shares. Copies of the final prospectus, when available, may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, email: [email protected], telephone: 1-833-297-2926; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected].

The concurrent private placement is also scheduled to close on November 17, 2022, subject to the satisfaction of customary closing conditions. The closing of Acrivon’s initial public offering is not conditioned upon the closing of the concurrent private placement, but the closing of the concurrent private placement is conditioned upon the closing of the initial public offering.

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