On April 20, 2022 Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed "NightHawk Biosciences"), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported it has completed the acquisition of Elusys Therapeutics, Inc. a commercial-stage biodefense company and developer of ANTHIM (obiltoxaximab), a treatment for inhalation anthrax. ANTHIM is approved for use in the U.S. and Canada, and under the brand name Obiltoxaximab SFL in Europe and the United Kingdom (Press release, NightHawk Biosciences, APR 20, 2022, View Source [SID1234612571]).

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Nighthawk acquired all outstanding shares of Elusys, which will continue to operate as a wholly-owned subsidiary of NightHawk. No stock or warrants were issued in connection with the acquisition, and Elusys had no outstanding term debt.

The strategic acquisition of Elusys significantly expands the Company’s role in the biodefense space, complementing NightHawk’s RapidVax platform, which is designed to target emerging biological threats. Pursuant to this acquisition, NightHawk also announced it plans to migrate manufacturing of ANTHIM to its planned 500,000 square foot Scorpion biomanufacturing facility in Manhattan, Kansas, which is being constructed to support development of commercial-scale biologics and large molecules.

To date, Elusys has been awarded over $350 million in research and development grants, contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) and the U. S. Strategic National Stockpile (SNS). Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM to the SNS – the government’s repository of critical medical supplies for biodefense preparedness.

Jeff Wolf, CEO of NightHawk, commented, "We are excited to announce the closing of this transformative acquisition, which provides us with a solid foothold in the biodefense space. Elusys has an established a successful track record collaborating with U.S. government agencies including BARDA, NIH, SNS and DOD. We plan to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax, our "plug and play" platform designed for rapid development and delivery of new vaccines. In addition, we look forward to leveraging our new Kansas facility, which will enable us to manufacture these therapies internally and therefore benefit from significant operating synergies, as well as enhanced oversight, quality control, and speed to market. We are also exploring opportunities to expand ANTHIM distribution abroad. This transaction is perfectly aligned with our overall vision to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently."

David Lasseter, former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and a member of NightHawk’s Biothreat Advisory Board, commented, "This transaction is extremely timely, given the global uncertainty and unprecedented threats from foreign nations and rogue actors. Anthrax is one of the most significant biological warfare threats facing our country, with real potential for mass casualties. ANTHIM represents a key medical countermeasure for the treatment of inhalation Anthrax."

A special committee of Heat’s Board of Directors negotiated and approved the transaction and Cassel Salpeter & Co. provided a fairness opinion in connection with the transaction. Blank Rome LLP acted as legal counsel to Heat. Elusys was advised by RBC Capital Markets, LLC. Additional details on the transaction are outlined in Company’s Form 8-K, which will be filed with the Securities and Exchange Commission and will be available on the Company’s website.

About ANTHIM

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.

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.

Indications and Usage

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.

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.
To see the complete prescribing information for ANTHIM, click here.

On April 20, 2022 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the upcoming presentations by members of its management team at several industry and scientific conferences during April and May 2022 (Press release, ImmuneTune, APR 20, 2022, View Source [SID1234612539]).

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"I am glad to announce that we have been selected to present at the Neoantigen Summit and the Cancer Immunotherapy meeting," said Sijme Zeilemaker, CEO of Immunetune. "As our lead program NeoVAC has recently completed GLP toxicity studies, we are looking forward to present our preclinical package and connect with other leaders in this exciting industry of immunotherapies for the treatment of cancer."

Upcoming conferences:

Innovation for Health, April 21, Amsterdam, the Netherlands

CEO Sijme Zeilemaker will be participating.
Neoantigen Summit Europe, April 26 – 28, Amsterdam, the Netherlands

CEO Sijme Zeilemaker will take part in the Industry Leader’s Fireside Chat on April 27th, 10:40 – 11:00 AM, on the great challenges and opportunities in cancer vaccine development.
CSO Jeroen van Bergen will be presenting on April 27th, 12:00 – 12:30 PM, on ‘Optimizing Vaccine Manufacturing for Targeting Neoantigens’ in the Clinical Translation & Manufacturing track.
Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting, May 10-12, Mainz, Germany

CSO Jeroen van Bergen will be giving a poster presentation on May 10th between 3:30 – 6:00 PM.
CSO Jeroen van Bergen will be giving an oral presentation in the short-talk session presenting on on May 12th between 9:00 – 10:30 AM.
The selected abstract for both sessions is titled "Personalized synthetic polyepitope DNA cancer vaccines including a novel pyroptotic adjuvant synergize with checkpoint inhibitor therapy to generate effective anti-tumor T cell immunity". Abstracts will be available online prior to the start of the conference.
Knowledge for Growth, May 19, Ghent, Belgium

CEO Sijme Zeilemaker will be participating.

On April 19, 2022 Panolos Biosciences reported the results of anti-cancer research of its main pipeline, PB101, at the AACR (Free AACR Whitepaper) Annual Meeting 2022 held from the 8th (local time) to the 13th (Press release, Panolos Bioscience, APR 19, 2022, View Source [SID1234633689]).

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PB101 is an anti-cancer drug developed by Panolos and being jointly researched by Professor Hong-Jae Jeon and Chan Kim’s team at the Department of Hematology and Oncology at CHA Bundang Hospital. It has a mechanism to inhibit the growth of cancer cells by targeting all types of vascular endothelial growth factors (VEGF-A, VEGF-B, Placental Growth Factor) that are excessively produced around cancer cells.

According to the non-clinical results presented by Panolos at this AACR (Free AACR Whitepaper), PB101 not only inhibits tumor growth by blocking intratumoral angiogenesis, but also increases tumor-hostile immune cells by influencing the immune environment in the tumor microenvironment. appear. In addition, the excellent antitumor effect and survival rate were confirmed through an experiment of combination administration of PB101 with an immuno-anticancer drug, and unlike the single administration experiment group, 27.2% of subjects in the combination administration experiment group showed a complete remission effect.

In an experiment to confirm growth and lung metastasis through repetitive tumor engraftment on subjects who showed complete remission, it was confirmed that, unlike the control group, cancer did not grow. This is due to the formation of memory immune cells that remember the tumor cell line during the combination treatment process. It is estimated that it did.

Based on the results presented at this AACR (Free AACR Whitepaper), Panolos hopes that PB101’s inhibitory effect on angiogenesis in tumors and its immune-activating effect can create a synergistic effect when used in combination with existing immuno-cancer drugs, providing new treatment options to patients. is looking forward to PB101 aims to apply for a phase 1 clinical trial approval (IND) within this year.

On April 19, 2022 The University of Texas MD Anderson Cancer Center reported that it was awarded more than $10 million in grants to support collaborative research teams working to advance novel interception and treatment strategies that will improve outcomes for several cancer types with the greatest unmet need, including pancreatic cancer, ovarian cancer and glioblastoma (GBM) (Press release, Break Through Cancer, APR 19, 2022, View Source,need%2C%20including%20pancreatic%20cancer%2C%20ovarian [SID1234613224]).

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Funded by Break Through Cancer, this work is part of $50 million in grants being made to teams across five cancer research centers: MD Anderson, Dana-Farber Cancer Institute, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Memorial Sloan Kettering Cancer Center, and Koch Institute for Integrative Cancer Research at MIT.

This new model for collaboration enables researchers to boldly tackle some of the biggest challenges in cancer. Break Through Cancer’s innovative approach will help overcome conventional barriers to multi-institution teamwork by using streamlined processes and systems for more effective data collaborations.

Giulio Draetta, M.D., Ph.D., MD Anderson’s chief scientific officer, and David Jaffray, Ph.D., MD Anderson’s chief technology and digital officer, serve as members of the Break Through Cancer Board of Directors.

"Collaborative team science is the cornerstone of our work at MD Anderson, with the goal of advancing breakthroughs that can improve patients’ lives. We also know that, to make real progress, our research cannot stand alone," Draetta said. "Break Through Cancer’s unique approach unites some of the greatest minds in cancer research to better understand disease mechanisms underlying currently intractable cancers. Through this work, we hope to drive real impact and innovation."

All projects funded by Break Through Cancer will use a model that allows researchers and physicians from each institution to work collaboratively in real time. Additionally, new technology and systems will make data collaborations frictionless. Reducing the day-to-day barriers to cross-institutional collaboration, such as contract negotiations, data access, intellectual property management and authorship rights, will pave the way for faster discoveries.

Together with Jaffray, Caroline Chung, M.D., MD Anderson’s chief data officer, has worked closely with Break Through Cancer to coordinate our approach to data. In partnership with Break Through Cancer’s growing multi-institutional data science team, Chung has shaped the interface between data governance and data science to enable seamless collaborations across institutions and domains — basic science, clinical research and data science — to make transformative advances in cancer.

"New models and infrastructure are essential to enable the seamless collaboration required for an effort of this significance," Jaffray said. "Our work will allow researchers across the country to collaborate as if they are standing shoulder to shoulder, transforming the team science process so we can accelerate meaningful progress."

Projects have been funded based on their unique cohort of researchers and potentially transformational science. The projects and faculty researchers include:

Intercepting Ovarian Cancer – Barrett Lawson, M.D., Karen Lu, M.D., Larissa Meyer, M.D., and Linghua Wang, M.D., Ph.D.
Targeting Minimal Residual Disease in Ovarian Cancer – Tyler Hillman, M.D., Ph.D., Amir Jazaeri, M.D., Karen Lu, M.D., Linghua Wang, M.D., Ph.D. and Shannon Westin, M.D.
Conquering KRAS in Pancreatic Cancer (in partnership with the Lustgarten Foundation) – Ronald DePinho, M.D., Timothy Heffernan, Ph.D., Raghu Kalluri, M.D., Ph.D., Anirban Maitra, M.B.B.S., Shubham Pant, M.D., and Linghua Wang, M.D., Ph.D.
Revolutionizing GBM Drug Development Through Serial Biopsies – Kadir Akdemir, Ph.D., Sangeeta Goswami, M.D., Ph.D., Jian Hu, Ph.D., Jason Huse, M.D., Ph.D., Wen Jiang, M.D., Ph.D., Betty Kim, M.D., Ph.D., Frederick Lang, M.D., Vinay Puduvalli, M.D., Padmanee Sharma, M.D., Ph.D., Shiao-Pei Weathers, M.D., and Ying Yuan, Ph.D.
"We are honored to be part of this united effort that aligns so well with our mission to end cancer," said Peter WT Pisters, M.D., president of MD Anderson. "This tremendous support from Break Through Cancer will stimulate compelling projects being led by many of the top minds across the country, and we look forward to seeing impactful results."

On April 19, 2022 The University of Camerino (UniCam) reported that has extended its strategic business partnership with CureLab Oncology Inc., a clinical-stage biotech company, to develop anti-cancer immunotherapy for humans, and has signed a similar agreement with CureLab Veterinary Inc. to reapply this medicine for treatment of companion animals (Press release, CureLab Oncology, APR 19, 2022, View Source [SID1234612855]).

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In 2012, the university signed a strategic partnership agreement with CureLab Oncology for researching the DNA plasmid coding p62/SQSTM1 gene (p62) that resulted in patents being granted in more than 20 countries. Subsequently, initial p62 plasmid clinical trials have shown great promise in treating the deadliest forms of ovarian and breast cancer. Given this success, CureLab Oncology and UniCam have agreed to extend their partnership./p>

As a first result of the prolonged partnership agreement, scientists from UniCam and CureLab just published a paper in the journal General and Comparative Endocrinology, one of the top scientific journals focused on animal science and zoology. The choice of a journal was based on a concomitant agreement that UniCam signed with CureLab Veterinary, which licensed the p62 IP for application in cats, dogs, and horses. Earlier, this scientific team successfully treated 10 out of 11 dogs with breast cancer.

"UniCam has a well-established School of Biosciences and Veterinary Medicine," said Prof. Guido Favia, director of the school. "This new partnership with CureLab Veterinary, based on both scientific and clinical strength, brings attractive development opportunities for the entire school."

"We are very pleased to continue our partnership with CureLab Oncology," said Prof. Maria Giovanna Sabbieti of the School of Biosciences and Veterinary Medicine at UniCam. "The new clinical data released by CureLab Oncology paves the road to even more new discoveries in our laboratory, while at the same time, our lab data helps CureLab target new applications for its p62 product."

"Our partnership with CureLab Veterinary opens up new opportunities for the research on bone and inflammatory-based diseases of domestic and farm animals," said Dr. Dimitrios Agas of the School of Biosciences and Veterinary Medicine at UniCam.

"CureLab Veterinary is very pleased to be working with the University of Camerino to explore translational studies in the areas of osteoarthritis, cancer, aging and age-associated diseases to improve and extend the lives of our four-legged family members," said Robert Devlin, DVM, MBA, of CureLab Veterinary.