On November 16, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported that patients in a Phase 1 study of iopofosine I-131 ("iopofosine") in children and adolescents with relapsed and refractory high grade gliomas (HGGs) and soft tissue sarcomas, exhibited positive changes in various tumor parameters (Press release, Cellectar Biosciences, NOV 16, 2021, View Source [SID1234595695]). The Phase 1 study is an international, open-label, dose escalation, safety study of iopofosine in children and adolescents with relapsed or refractory cancers, specifically HGGs, high risk neuroblastoma and select soft tissue sarcomas.

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The independent data monitoring committee (DMC) had previously determined that doses up to 60 mCi/m2 were safe and tolerable and to initiate the 75 mCi/m2 dosing cohort. The DMC advised, based upon the initial data, to enrich the 60 mCi/m2 dose level for patients over the age of 10 with HGG and Ewing sarcoma. The initial response and tumor uptake were confirmed by further therapeutic responses, evidenced by changes in tumor parameters. This includes patients with relapsed HGGs experiencing over 5 months of progression free survival (PFS).

"Initial responses to iopofosine I-131 in relapsed pediatric brain tumors are most encouraging. Current treatment paradigms typically result in only 2-3 months1 of PFS and while there is no comparator in this study, iopofosine data to date have demonstrated nearly double the PFS versus historical data," said Laurence Reilly interim chief medical officer of Cellectar. "Based upon these data we will continue to enroll patients with high grade gliomas and soft tissue sarcomas, and we look forward to engaging with the FDA in order to outline a potential registrational pathway."

Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes including diffuse intrinsic pontine gliomas, glioblastomas, astrocytomas and ependymomas. Children with these tumors have a poor prognosis and 5-year survival of less than 30%.

About iopofosine (also known as CLR 131)

Iopofosine is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

On November 16, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that new data from two clinical trials evaluating the company’s lead asset NT-I7 (efineptakin alfa), a novel T cell amplifier, in three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting (Press release, NeoImmuneTech, NOV 16, 2021, View Source [SID1234595711]). The data come from two cohorts of the Phase 2a portion of a Phase 1b/2a clinical trial evaluating NT-I7 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with relapsed/refractory advanced solid tumors, as well as a Phase 1 investigator-initiated trial evaluating NT-I7 following adjuvant chemotherapy (temozolomide [TMZ]) and radiation in patients with high-grade gliomas (HGG).

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The combination data of NT-I7 and pembrolizumab were presented in two posters, titled "Initial Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced MSS-Colorectal Cancer" and "Preliminary Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced Pancreatic Cancer," by lead authors Richard D. Kim, M.D., Moffitt Cancer Center, and Aung Naing, M.D., The University of Texas MD Anderson Cancer Center, respectively.

The data shows that the combination of NT-I7 and pembrolizumab was well tolerated and showed early anti-tumor activity in patients with checkpoint inhibitor (CPI)-naive relapsed/refractory (r/r) pancreatic and microsatellite-stable colorectal cancers (MSS-CRC), two immune-cold tumor types. The interim analysis of the phase 2 met the primary endpoint of overall response rate (ORR) in these cohorts. The median follow-up of the efficacy data was ~5.8 months in the MSS-CRC Cohort and ~4.6 months in the Pancreatic Cancer Cohort. Three immune partial responses (iPR) by iRECIST were observed, including one partial response (PR) by RECIST 1.1 in 17 evaluable MSS-CRC patients, as well as one iPR/PR observed in 17 evaluable pancreatic cancer patients. The pancreatic cancer responder was confirmed to have a microsatellite-stable tumor. Responses were first observed at weeks 12, 18, and 24 post-first dose. Increase of T cell infiltration in the tumor microenvironment were observed in the responders, a key indicator that the tumor microenvironment is shifting from immune-cold to immune-hot. Importantly, an even greater magnitude of increase in stem-cell memory CD8+ T cells (Tscm) was observed in the blood.

The data for NT-I7 following chemoradiation were presented in a poster titled "NT-I7, a long-acting interleukin-7, promotes expansion of CD8 T cells and NK cells and immune activation in patients with newly diagnosed high-grade gliomas after chemoradiation," by lead author Jian Campian, M.D., Ph.D., Mayo Clinic.

The data shows that NT-I7 is well tolerated following chemoradiation therapy in HGG patients. Notable ALC increases were observed, with more prominent increases in patients dosed at the 540µg/kg or higher levels of NT-I7. Marked increase of Tscm was also observed, in this case in absence of a checkpoint inhibitor. Durable progression-free survival (PFS) was noted in MGMTp unmethylated HGG patients, a sub-group who often have a poorer prognosis. Six out of eight patients treated at the therapeutic dose of 720µg/kg or higher are continuing on in the study.

"We are excited to share that the combination of NT-I7 and pembrolizumab was found to be well tolerated and showed early signs of clinical activity in patients with difficult-to-treat cancers, like relapsed/refractory pancreatic and microsatellite-stable colorectal cancer," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech. "Immune-cold tumors such as MSS-CRC and pancreatic cancer have shown very limited clinical activity with current standard of care therapies. We are also encouraged by the preliminary clinical efficacy results in NT-I7 following chemoradiation. These clinical data support our continued efforts in these and other tumor types, and we look forward to future analyses of the data as we move forward."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About NT-I7
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced 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). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On November 16, 2021 Purple Biotech Presented the Corporate Presentation (Presentation, Purple Biotech, NOV 16, 2021, View Source [SID1234595696])

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On November 16, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ reported that its presentation time at the Jefferies London Healthcare Conference has been changed (Press release, Humanigen, NOV 16, 2021, View Source [SID1234595712]).

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Jefferies London Healthcare Conference

Timothy Morris, COO and CFO, will now make a corporate presentation at 9:20am EST on November 17, 2021. A livestream will be accessible via the link below and a webcast link to a recording of the event will be posted to the "Events and Presentations" section of Humanigen’s investor relations website after the event.

Webcast: View Source
The webcast will be available for 90 days under the Investor Relations section of the company’s website at www.ir.humanigen.com

On November 16, 2021 Apellis Pharmaceuticals, Inc., (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, reported the pricing of its underwritten public offering of 8,750,000 shares of its common stock at a public offering price of $40.00 per share, for total gross proceeds of $350 million, before deducting underwriting discounts and commissions and expenses payable by Apellis (Press release, Apellis Pharmaceuticals, NOV 16, 2021, View Source [SID1234595729]). All of the shares in the offering are being sold by Apellis. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 1,312,500 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on November 18, 2021, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Robert W. Baird & Co. Incorporated, Oppenheimer & Co. Inc. and Raymond James & Associates, Inc. are acting as lead managers for the offering.

The shares are being offered by Apellis pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on January 7, 2020. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or Evercore Group L.L.C., Attention: ECM General Counsel, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected].

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 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.