On December 23, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported the pricing of its previously announced underwritten public offering of its common stock for gross proceeds of approximately $24.5 million at a public offering price of $1.35 per share of common stock, prior to deducting underwriting discounts and commissions and estimated offering expenses (Press release, Cellectar Biosciences, DEC 23, 2020, View Source [SID1234573281]).

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The shares of common stock in the public offering were offered pursuant to a registration statement on Form S-3 (File No. 333-244362), which was declared effective by the Securities and Exchange Commission (SEC) on August 20, 2020. The public offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and the accompanying prospectus relating to the public offering will be filed by the Company with the SEC. Copies of the prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

In a separate concurrent private placement transaction led by healthcare-focused institutional investors, Cellectar offered and sold 1,518.5180 shares of Series D convertible preferred stock convertible into a number of shares of common stock equal to $13,500 divided by $1.35 (the "Conversion Price") (or 10,000 shares of common stock for each share of Series D Preferred Stock converted), at a price of $13,500 per share of Series D Preferred Stock. The gross proceeds from the private placement are expected to be approximately $20.5 million, prior to deducting placement agent fees and estimated expenses. The Series D Preferred Stock will only be convertible into common stock upon receipt of stockholder approval of the issuance of the shares of common stock as required by Nasdaq Marketplace Rule 5635(d) at a special stockholder meeting to be called for that purpose. The Series D Preferred Stock and the shares of our common stock issuable upon the exercise of the Series D Preferred Stock are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. Such preferred shares and common shares issuable upon conversion of the preferred shares have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

Oppenheimer & Co. Inc. acted as the sole book-running manager in connection with the public offering and the lead placement agent in connection with the private placement. Roth Capital Partners, Maxim Group LLC and Ladenburg Thalmann & Co. Inc. acted as co-managers in connection with the public offering and as co-placement agents in connection with the private placement.

The public offering and the private placement are expected to close on or about December 28, 2020, subject to the satisfaction or waiver of customary closing conditions.

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Cellectar being offered in the public offering or concurrent private placement, and shall not constitute an offer, solicitation or sale of any security in the public offering or concurrent private placement 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.

On December 23, 2020 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, reported that it has received a "Study May Proceed" letter from the US Food and Drug Administration (FDA) to begin a Phase Ib study evaluating CX-5461, a first-in-class G-quadruplex stabilizer, to treat solid tumors with BRCA2 or PALB2 mutations (Press release, Senhwa Biosciences, DEC 23, 2020, View Source [SID1234573240]).

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"The FDA’s approval of our Phase Ib clinical trial application for testing CX-5461 in patients with BRCA2 or PALB2 mutations is an important milestone and marks a new paradigm in the treatment of cancers with specific pathogenic mutations," stated Dr. John Soong, the Chief Medical Officer of Senhwa Biosciences.

In 2016, Canadian Cancer Trial Group (CCTG), a recipient of the Stand Up to Cancer’s Dream Team Grant selected CX-5461 to study in their Phase I trial. In the CCTG Trial, CX-5461 demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers that were resistant to platinum and other chemotherapeutics. This new Phase Ib trial will occur in both the US and Canada, and study endpoints include a re-confirmation of the efficacy signal. This trial is currently under review with Health Canada.

CX-5461 was recently named as a PCF (Prostate Cancer Foundation)-Pfizer Global Challenge Award recipient. Specifically, it will be used together with Pfizer’s PARP inhibitor (PARPi), Talazoparib, to evaluate the combined therapeutic potential in treating prostate cancer. For American men, prostate cancer is the second-leading cause of cancer death. Due to a DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality; however, PARPi resistance is commonly seen in clinical use. More than 40% of BRCA1/2-deficient patients fail to respond to PARPi.

"CX-5461 has proven human efficacy across certain tumor types by accelerating dsDNA breaks. We believe CX-5461 has great potential as a therapeutic for patients who have developed resistance to PAPRi or other chemotherapies. Addressing treatment for resistant tumors continues to be an unmet medical need in cancer treatment," said Dr. Tai-Sen Soong, CEO of Senhwa Biosciences.

About CX-5461

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by CX-5461 through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, CX-5461 is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On December 23, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported that their Phase 1b/2 clinical trial, an Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (ClinicalTrials.gov Identifier: NCT04305795) has enrolled and treated its first patient in the United States, at The University of Texas MD Anderson Cancer Center, Houston, Texas (Press release, Rakuten Medical, DEC 23, 2020, View Source [SID1234573239]). Approximately 74 patients are planned for this trial in Head and Neck Squamous Cell Carcinoma (HNSCC) and Cutaneous Squamous Cell Carcinoma (CuSCC).

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The trial will enroll three cohorts of patients within distinct populations – all with locally advanced, recurrent and/or metastatic HNSCC or locally advanced or metastatic CuSCC. Primary endpoints of this study include safety, tolerability, and tumor response of the ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy.

"This trial is part of our commitment to develop ASP-1929 as part of our proprietary Illuminox platform for advancing treatment in HNSCC, as well as expanding into CuSCC," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "Based on the approval of ASP-1929 by the MHLW in Japan, we are hopeful in this latest expansion into CuSCC as part of our lifecycle management strategy."

On December 23, 2020 AbbVie (NYSE: ABBV) reported that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), based on the final analysis of the Phase 3 iNNOVATE study (Press release, AbbVie, DEC 23, 2020, View Source [SID1234573237]). First approved in 2013, IMBRUVICA is currently available to patients with several types of blood cancer, as well as chronic graft-versus-host disease. It was approved as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018 based on the iNNOVATE primary analysis.

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"We’re encouraged by this latest recognition from the FDA as it underscores our commitment to supporting those impacted by Waldenström’s macroglobulinemia, a rare and incurable form of non-Hodgkin’s lymphoma," said Danelle James, M.D., M.A.S., IMBRUVICA Global Development Lead, Pharmacyclics LLC, an AbbVie company. "IMBRUVICA is the only FDA-approved treatment for these patients and now includes more than five years of safety and efficacy data to help provide better understanding of how to treat this rare blood cancer."

As of today, IMBRUVICA is the only Bruton’s tyrosine kinase (BTK) inhibitor approved to treat WM. WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may also be affected. In the U.S., there are approximately 2,800 new cases of WM each year.1 The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends IMBRUVICA, with or without rituximab, as the only Category 1 Preferred regimen for patients with previously untreated or previously treated WM.2

"The long-term results from the Phase 3 iNNOVATE study provide clinicians even more evidence that patients with WM can benefit from treatment with an ibrutinib-based regimen and maintain prolonged progression-free survival," said Dr. Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator.

The IMBRUVICA Prescribing Information now includes final analysis data, with an overall follow-up of 63 months, from the Phase 3 iNNOVATE clinical trial. With additional follow-up since the primary analysis, the combination of IMBRUVICA plus rituximab continued to demonstrate prolonged progression-free survival (PFS) in WM patients compared to rituximab monotherapy. Patients treated in the IMBRUVICA arm experienced a 75 percent reduction in risk of disease progression or death compared to rituximab monotherapy (hazard ratio [HR] 0.25; 95% confidence interval [CI]: 0.15-0.42; p<0.0001). Results from the final analysis of the study were recently featured as an oral presentation at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Abstract #336).

In the iNNOVATE study primary analysis, the most common side effects (≥20%) in patients treated with IMBRUVICA plus rituximab were bruising, muscle pain, bleeding problems, diarrhea, rash, joint pain, nausea and high blood pressure.

About iNNOVATE
iNNOVATE (PCYC-1127) is a Pharmacyclics-sponsored, randomized, placebo-controlled, double-blind, Phase 3 study, which enrolled 150 patients with relapsed/refractory and treatment-naïve Waldenström’s macroglobulinemia. All patients received intravenous rituximab 375 mg/m2 once weekly for four consecutive weeks, followed by a second four-weekly rituximab course following a three-month interval. Patients were randomized to receive either ibrutinib 420 mg or placebo once daily continuously until criteria for treatment discontinuation were met. The primary endpoint was progression-free survival; secondary endpoints included overall response rate; hematological improvement measured by hemoglobin; time-to-next treatment; overall survival; and number of participants with adverse events as a measure of safety and tolerability within each treatment arm.

About IMBRUVICA
IMBRUVICA is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company, and Janssen Biotech, Inc. (Janssen). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.3,4 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.5

Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; WM; previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.6

IMBRUVICA is now approved in 101 countries and has been used to treat more than 200,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

As of early 2019, the National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and is a Category 1 treatment for treatment-naïve patients without deletion 17p. In January 2020, the NCCN Guidelines were updated to recommend IMBRUVICA, with or without rituximab, as a preferred regimen for the treatment of relapsed/refractory MCL, regardless of response duration to prior chemoimmunotherapy. In September 2020, the NCCN guidelines for WM were updated and now recommends IMBRUVICA, with or without rituximab, as the only Category 1 Preferred regimen for patients with previously untreated or previously treated WM.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. For more information, visit www.IMBRUVICA.com.

*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Side Effect Information

Before taking IMBRUVICA, tell your healthcare provider about all of your medical conditions, including if you:

have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA for any planned medical, surgical, or dental procedure.
have bleeding problems.
have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
have an infection.
have liver problems.
are pregnant or plan to become pregnant. IMBRUVICA can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA.
Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA and for 1 month after the last dose.
Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA and for 1 month after the last dose.
are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects.

How should I take IMBRUVICA?

Take IMBRUVICA exactly as your healthcare provider tells you to take it.
Take IMBRUVICA 1 time a day.
Swallow IMBRUVICA capsules or tablets whole with a glass of water.
Do not open, break or chew IMBRUVICA capsules.
Do not cut, crush or chew IMBRUVICA tablets.
Take IMBRUVICA at about the same time each day.
If you miss a dose of IMBRUVICA take it as soon as you remember on the same day. Take your next dose of IMBRUVICA at your regular time on the next day. Do not take extra doses of IMBRUVICA to make up for a missed dose.
If you take too much IMBRUVICA call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking IMBRUVICA?

You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA. These products may increase the amount of IMBRUVICA in your blood.
What are the possible side effects of IMBRUVICA?

IMBRUVICA may cause serious side effects, including:

Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
Infections can happen during treatment with IMBRUVICA. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA.
Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter), heart failure, and death have happened in people treated with IMBRUVICA, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles, or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA dose.
High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
Second primary cancers. New cancers have happened during treatment with IMBRUVICA, including cancers of the skin or other organs.
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
The most common side effects of IMBRUVICA in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

diarrhea
tiredness
muscle and bone pain
rash
bruising
The most common side effects of IMBRUVICA in adults with cGVHD include:

tiredness
bruising
diarrhea
mouth sores (stomatitis)
muscle spasms
nausea
pneumonia
Diarrhea is a common side effect in people who take IMBRUVICA. Drink plenty of fluids during treatment with IMBRUVICA to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA for a condition for which it was not prescribed. Do not give IMBRUVICA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA that is written for health professionals.

On December 23, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported its participation in the following conferences in January (Press release, I-Mab Biopharma, DEC 23, 2020, View Source [SID1234573236]). Details of the conferences and management presentation are as follows:

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H.C. Wainwright BioConnect 2021 Conference (Virtual)
Presentation: Monday, January 11, 2021 at 6:00 a.m. EST
Presenters: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

Webcast link: View Source The webcast will also be available under "Event Calendar" on IMAB’s IR website at View Source

Citi Greater China Healthcare Corporate Day 2021 (Virtual)
Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

One-on-one and small group meetings: January 14-15, 2021

For more information, please contact your Citi representative.

UBS Greater China Conference 2021 (Virtual)
Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

One-on-one and small group meetings: January 18-22, 2021