On January 31, 2022 Elusys Therapeutics, Inc. (Elusys) reported that it has finalized a contract with the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) for the continued supply of ANTHIM (obiltoxaximab), an anthrax antitoxin, for use against a potential anthrax attack (Press release, NightHawk Biosciences, JAN 31, 2022, View Source [SID1234612541]).

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"Elusys is pleased to continue its successful track record of supplying a critical medicine to treat the deadly effects of anthrax exposure," said Elizabeth Posillico, president and chief executive officer of Elusys. "ANTHIM is a key therapeutic in the U.S. government’s preparedness strategy to protect the U.S. population against natural and man-made biothreats."

The contract for the procurement of ANTHIM consists of a base period of performance, valued at $50 million, which has been fulfilled. The contract includes options valued up to $31 million. If all options are exercised, the total contract value will be $80,864,000 with completion of the contract expected by the first half of 2023. Contract 75A50121C00073 is funded by HHS ASPR.

As previously announced, Elusys has executed a definitive merger agreement with Heat Biologics, Inc. (NASDAQ: HTBX), pursuant to which Elusys will merge into a wholly owned subsidiary of Heat. The acquisition is expected to close during the first quarter of 2022 and is subject to customary closing conditions.

About ANTHIM
ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.

WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.

ADVERSE REACTIONS
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.

USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.

On January 31, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious disease, reported that it will issue financial results for its third quarter fiscal year 2022, ended December 31, 2021, at 4:15 p.m. EST on Monday, February 14, 2022 (Press release, Aethlon Medical, JAN 31, 2022, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-third-quarter-financial-results-and-host-conference-call-on-february-14-2022-301471097.html [SID1234607531]).

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Management will host a conference call on Monday, February 14, 2022 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 14, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 2728183.

On January 31, 2022 Aravive, Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that the Company has dosed the first patient in the Phase 2 portion of the Phase 1b/2 study of batiraxcept for the treatment of clear cell renal cell carcinoma (ccRCC) (Press release, Aravive, JAN 31, 2022, View Source [SID1234607516]).

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"Safety and preliminary activity data from the Phase 1b study of batiraxcept in combination with cabozantinib in patients with 2L+ ccRCC gives us confidence to initiate the Phase 2 portion of the trial and expand the study to additional cohorts," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "I’m grateful to our team for their diligence and dedication to expedite the ccRCC program. The data reported to date shows clinically relevant benefit of adding batiraxcept to the current standard of care in ccRCC without adding to the toxicity profile. We will continue to update the ongoing Phase 1b portion of the study as data mature and anticipate providing clinical activity and safety updates of the P2 portion of the study throughout 2022."

The Phase 2 portion of the Phase 1b/2 clinical trial of batiraxcept in ccRCC is an open-label study in which 55 patients are anticipated to enroll across three parts. Part A is expected to enroll approximately 25 patients and will investigate batiraxcept 15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients. Part B is expected to enroll approximately 20 patients and evaluate batiraxcept 15 mg/kg in combination with standard of care nivolumab and cabozantinib in first-line ccRCC patients. Part C is expected to evaluate batiraxcept 15 mg/kg monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies. The primary endpoint of each part of the Phase 2 portion of the trial is objective response rate ("ORR") and key secondary endpoints include duration of response ("DOR"), progression free survival ("PFS"), and overall survival ("OS"). Additional information on the trials: NCT04300140.

About Batiraxcept (AVB-500)
Batiraxcept is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, batiraxcept selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. Batiraxcept is currently being evaluated in multiple clinical trials and has been granted Fast Track designation by the U.S. Food and Drug Administration and orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer.

On January 31, 2022 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, reported the promotion of current CMO, Marcel Rozencweig, M.D., to President and the appointment of Scott Z. Fields, M.D., as the new chief medical officer, effective tomorrow, Feb. 1, 2022 (Press release, NeoTX, JAN 31, 2022, View Source [SID1234607532]). Dr. Fields brings more than 30 years of experience in clinical drug development and has been previously the Senior Vice President and Pharmaceutical Development Head, Oncology at Bayer Pharmaceuticals.

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"We are thrilled that Marcel will be the President to lead NeoTX in its next chapter of growth and success. He has been a key part of NeoTX growth since its inception and, in his new role as President, will help to accelerate growth and expand strategic industry partnerships," said Asher Nathan, Ph.D., chief executive officer of NeoTX.

"I am very pleased and looking forward to leading, as President, in NeoTX’s advancement," said Dr. Rozencweig. "Additionally, as a founding member of NeoTX, it gives me great pleasure to welcome Dr. Fields to our leadership team."

"We, at NeoTX, are delighted that Scott is bringing his strong industry and operational leadership, which will prove valuable for our clinical development and registration strategies. His broad experience in oncology drug development, with over a dozen drug approvals, is an excellent fit with our vision," said Asher Nathan, Ph.D., chief executive officer of NeoTX.

"I’m thrilled to join NeoTX at this time of important growth and evolution of the company," said Dr. Fields. "Together with our experienced leadership team, I look forward to helping the company accelerate the development of our pipeline and bring innovative new medicines to patients."

As Global Head of Development for Oncology at Bayer Pharmaceuticals, Dr. Fields was responsible for early and late-stage development including several novel oncology medicines across the platforms for targeted therapies/precision medicine, antibody drug/alpha radiation conjugates and novel Immuno-Oncology agents. His group was responsible for the development and global registration of Darolutamide – a next generation androgen receptor inhibitor for prostate cancer and with partner Loxo, for Larotrectinb – a tissue agnostic NTRK inhibitor. He was also responsible for the Oncology Operations, Project Management, Regulatory, Biomarkers, Biostatistics and Medical Writing groups. Prior to his position at Bayer, Dr. Fields held senior positions at Vertex Pharmaceuticals, SmithKline Beecham, Amgen, Eisai, and Arno Therapeutics and helped bring over a dozen drugs to market. He also practiced oncology/hematology and transplant medicine in academic settings. Dr. Fields received his medical degree from SUNY Downstate Medical Center in New York, followed by training in internal medicine, hematology and oncology at Columbia University Medical Center.

On January 31, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, reported preliminary unaudited year-end financial results for the twelve months ended December 31, 2021 (Press release, IceCure Medical, JAN 31, 2022, View Source [SID1234607533]).

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Revenues increased to $4.1 million in 2021 compared to $3.9 million in 2020, primarily driven by sales through distribution agreements in Europe and sales of the Company’s ProSense system and probes in the United States.

As of December 31, 2021, the Company’s cash and cash equivalents totaled $25.6 million compared to $3.5 million for the period ending December 31, 2020, as a result of the two equity raises in 2021 totaling $32 million.

"2021 was pivotal for IceCure, beginning with a private placement of $15 million early in the year, listing of our shares on the Nasdaq, followed by an additional $17 million offering at a greater enterprise value. We have expanded the global distribution network for ProSense and increased our sales in the United States and Europe. Furthermore, our U.S. ICE3 trial demonstrated supportive data for our cryoablation technology in combating early-stage breast cancer which we reported at various academic meetings," stated Mr. Eyal Shamir, the Chief Executive Officer of IceCure.

"Notably, we remain focused on expansion on all fronts from both a commercial and product development standpoint, and we have also made important progress on the development of our next-generation cryoablation, single-probe, and multi-probe systems with a European patent-pending for our cryogenic pump which will potentially expand clinical applications with cryoablation for bigger tumors or multiple tumors simultaneously."

"In 2022, we intend to further advance our regulatory and commercial strategies in the United States, China, and Japan. We also plan to engage with new strategic commercial partners. One of our major focuses will be additional regulatory approvals in major countries for our business, namely, the United States and China. In the United States, we’ve already filed a pre-submission package with the Food and Drug Administration (the "FDA") for early-stage breast cancer and high risk to surgery and suggested a De Novo classification based on our ongoing ICE3 clinical trial. We hope that our Breakthrough Device Designation with the FDA will secure priority review," Mr. Shamir concluded.

IceCure plans to report full 2021 audited financial results upon filing its annual report on Form 20-F with the U.S. Securities and Exchange Commission.

The above information reflects preliminary estimates with respect to certain results of IceCure Medical for the full year ended December 31, 2021, based on currently available information. Because the audit for 2021 is not yet complete, IceCure’s final results may vary from the preliminary estimates.