On December 22, 2022 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling and advanced medicinal chemistry technology, reported that the pricing of a public offering of an aggregate of 1,290,322 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 warrants to purchase up to 1,290,322 shares of common stock and Series A-2 warrants to purchase 1,290,322 shares of common stock, at a combined public offering price of $7.75 per share (or pre-funded warrant) and accompanying warrants (Press release, HTG Molecular Diagnostics, DEC 23, 2022, View Source [SID1234625572]). The Series A-1 warrants will have an exercise price of $7.50 per share, will be exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-2 warrants will have an exercise price of $7.50 per share, will be exercisable immediately upon issuance and will expire twenty-four months from the date of issuance. The closing of the offering is expected to occur on or about December 23, 2022, subject to the satisfaction of customary closing conditions.

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!

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

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $10.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include research and development expenses, clinical trial expenses, capital expenditures and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-268681), which was declared effective by the Securities and Exchange Commission (the "SEC") on December 21, 2022. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

On December 23, 2022 Equillium, Inc. (Nasdaq: EQ) and Metacrine, Inc. reported the mutual termination of their previously announced definitive merger agreement (Press release, Equillium, DEC 23, 2022, View Source [SID1234625571]).

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!

"Equillium first set out to acquire Metacrine in an all-stock transaction in early 2022, with the intent of adding cash runway in a very difficult financing market," said Bruce Steel, chief executive officer of Equillium. "However, our recent strategic partnership with Ono Pharmaceutical is expected to extend our cash runway into 2025, and possibly further with potential option exercise and milestone payments. We therefore find ourselves in a strong financial position, and with our pipeline of wholly-owned multi-cytokine inhibitors in the clinic we are excited about the opportunity to unlock value in our programs during 2023 and beyond."

Additional information regarding the termination of the definitive merger agreement is set forth in a Current Report on Form 8-K filed by Equillium with the Securities and Exchange Commission today and is available at www.sec.gov and on Equillium’s website under the heading "Investors."

On December 23, 2022 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications,reported that it will hold a webcast on December 29, 2022 at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) to discuss the performance of leronlimab in its clinical trials and the recent charges against its former CEO Nader Pourhassan, who was previously terminated on January 24, 2022, and has had no affiliation with the Company since that time (Press release, CytoDyn, DEC 23, 2022, View Source [SID1234625570]).

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!

Webcast Access Information

Date: Thursday, December 29, 2022
Time: 8:00 a.m. Pacific Time / 11:00 a.m. Eastern Time
Access: View Source
The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until January 29, 2023.

About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.

On December 23, 2022 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapiesfor cancer and autoimmune disease, reported the results of a positive follow-up Type C meeting with the US Food and Drug Administration (FDA) regarding late-stage clinical development plans for its first-in-class soluble LAG-3 protein, eftilagimod alpha ("efti"), in conjunction with standard-of-care chemotherapy for the treatment of metastatic breast cancer (MBC) (Press release, Immutep, DEC 23, 2022, View Source [SID1234625567]). The Company and the FDA have agreed to an integrated Phase II/III trial design that will help inform a Biologics License Application (BLA).

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!

Based on the encouraging efficacy, favourable safety, and learnings from the randomised AIPAC Phase IIb trial, which administered efti and chemotherapy on different days and ceased chemotherapy at six months, patients will receive efti and paclitaxel on the same day and treatment will continue until disease progression. The patient population has also been expanded to include triple-negative breast cancer (TNBC), an aggressive form of breast cancer with limited treatment options.

Immutep CEO, Marc Voigt, commented: "As recently announced, our late-stage clinical development efforts for efti are now focused on frontline NSCLC in combination with anti-PD-1 therapy, given the large market opportunity and need for more durable and tolerable options. With this said, progress reported to date with the FDA and EMA provides Immutep and its potential partners flexibility for late-stage clinical development of efti plus standard-of-care chemotherapy to address the high unmet need for metastatic breast cancer patients, while maintaining their quality of life as was shown in the AIPAC trial."

Immutep CSO & CMO, Dr. Frédéric Triebel, stated: "We are excited about efti’s promise to stimulate the immune system and improve standard-of-care chemotherapy by activating dendritic cells to present antigens from chemo-induced cancer cell death to cytotoxic T cells. Our engagement with regulatory agencies to establish the optimal design of a registrational trial has steadily progressed during the year and we are pleased with the FDA’s positive feedback during this follow up meeting. The chosen trial design provides us with a very risk-balanced approach before potentially embarking on the Phase 3 part of this study."

Subject to regulatory and ethic committee feedback, the Phase II portion of the MBC trial is expected to begin during the first quarter of 2023. In addition to the biologically active 30mg dosing for efti, the Company and FDA have agreed to test 90mg efti dosing in combination with paclitaxel driven predominantly by the excellent safety profile of the AIPAC Phase IIb trial, along with the FDA’s Project Optimus initiative in oncology. The trial design has a safety lead in of 6 to 12 patients, given the higher 90mg dosing of efti, followed by 58 patients for the randomised Phase II portion of the trial. Depending on Phase II results and resources, the Phase III portion will follow and be directed to MBC patients most likely to benefit from treatment, taking into consideration the strong overall survival results in pre-specified and post-hoc subgroups from the AIPAC trial.

The Phase II portion of the MBC trial and the initiation of the registrational trial in 1st line NSCLC are included in the budget of the Company and have no impact on its expected cash runway to the end of the 1st half of calendar year 2024.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator for the treatment of cancer, capitalising on LAG-3’s unique characteristics to stimulate both innate and adaptive immunity. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

On December 23, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Nippon Shinyaku Co., Ltd. (TOKYO: 4516) reported that Chugai obtained regulatory approval today from the Ministry of Health, Labour and Welfare (MHLW) for an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma) (Press release, Chugai, DEC 23, 2022, View Source [SID1234625551]).

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!

"We are very pleased that this line extension enables us to offer the combination treatment as a new treatment option for patients with chronic lymphocytic leukemia (CLL)," said Chugai’s President and CEO, Dr. Osamu Okuda. "CLL has a long disease course. We will continue to provide information on efficacy and safety of Gazyva for the benefit of patients with CLL ."

"We are very pleased that Gazyva has become a new option for the treatment of chronic lymphocytic leukemia (CLL), and to be able to meet medical needs," said Nippon Shinyaku’s President, Toru Nakai. "We hope for Gazyva to become a contribution for treating patients with CLL, and will continue to promote information provision activities for the proper use of Gazyva."

The approval is based on data including the phase III ELEVATE-TN study, conducted by AstraZeneca, which evaluated the efficacy and safety of Gazyva and acalabrutinib (Bruton’s tyrosine kinase (BTK) inhibitor, product name Calquence) in patients with untreated CLL. The study showed that the combination of Gazyva and acalabrutinib significantly improved progression free survival compared to the combination of Gazyva and chlorambucil (hazard ratio: 0.10, 95% confidence interval: 0.06-0.17, p value < 0.0001). Major adverse reactions were neutropenia, headache, diarrhea, contusion, fatigue, nausea, thrombocytopenia, rash, arthralgia, petechiae, dizziness and anemia.

About ELEVATE-TN study
ELEVATE-TN (ACE-CL-007, NCT02475681) study is a randomized, multicenter, open-label Phase III trial evaluating the safety and efficacy of acalabrutinib in combination with obinutuzumab or acalabrutinib alone versus chlorambucil (unapproved) in combination with obinutuzumab in previously untreated patients with CLL. In the study, 535 patients are randomized 1:1:1 to following groups: chlorambucil plus obinutuzumab, acalabrutinib plus obinutuzumab, and acalabrutinib monotherapy.

The primary endpoint is IRC-assessed progression-free survival (PFS) with acalabrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab. The secondary endpoint is IRC-assessed PFS with acalabrutinib monotherapy versus chlorambucil plus obinutuzumab. Other secondary endpoints are overall response rate, time to next treatment, safety and overall survival etc.1)

Approval Information *Newly added description

Indications:
CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma)

Dosage and administrations:
When used in combination with acalabrutinib, the usual adult dose of obinutuzumab (genetical recombination) is 100 mg infused intravenously on Day 1 of Cycle 1 concomitant with acalabrutinib, 900 mg on Day 2, and 1000 mg on Days 8 and 15, and then 1000 mg on Day 1 of Cycle 2 and subsequent cycles. One cycle is 28 days, and administration is repeated for up to 6 cycles.

Precautions concerning dosage and administrations (Excerpt version):
Start administration of GAZYVA after administering acalabrutinib for 28 days.

About Gazyva (obinutuzumab)
Gazyva is a glycoengineered type II anti-CD20 monoclonal antibody designed to bind to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva is designed to attack and destroy targeted B cells both directly and together with the body’s immune system. Chugai and Nippon Shinyaku jointly develop and market the product in Japan.

About chronic lymphocytic leukemia (CLL)
In CLL, blood stem cells in the bone marrow become excessive abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets.2) This could result in anemia, infection, and bleeding. Small lymphocytic lymphoma is the same type of cancer as CLL. When lymphocytes are not located in the peripheral blood or bone marrow, the disease is called small lymphocytic lymphoma.3) CLL/ small lymphocytic lymphoma is a rare type of lymphoma accounting for less than one case in 100,000 population annually in Japan.4) B-cell receptor signaling through BTK is one of the essential growth pathways for CLL.