On July 12, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to produce major improvements in treatment outcomes, and The University of Texas MD Anderson Cancer Center reported the launch of a multi-year strategic research collaboration to investigate and evaluate HMBD-002, Hummingbird’s VISTA antagonist antibody (Press release, Hummingbird Bioscience, JUL 12, 2021, View Source [SID1234584795]).

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Under the agreement, MD Anderson and Hummingbird will collaborate on the design and execution of clinical and translational research studies to better understand how HMBD-002 modulates the anti-tumor immune response, both as a monotherapy and in combination with other checkpoint inhibitors. Working with MD Anderson’s immunotherapy platform and its experts in comprehensive immunoprofiling, the teams will seek to identify biomarkers that may be used to predict clinical outcomes and adverse events.

"We are excited to be collaborating with MD Anderson to advance the clinical research of our novel immunotherapies," said Jerome Boyd-Kirkup, Ph.D., co-founder and CSO of Hummingbird Bioscience. "These studies will strengthen our understanding of VISTA and other emerging immuno-oncology targets and help us ensure that novel treatment strategies for challenging cancers get to patients as quickly as possible."

VISTA, an immune checkpoint protein, is an emerging immunotherapy target for cancer that suppresses the anti-tumor immune response. Studies indicate increased levels of VISTA are associated with the emergence of resistance to current cancer immunotherapies. HMBD-002 is designed to inhibit VISTA, removing the suppression of the immune system and allowing it to mount an anti-tumor response.

"Targeting VISTA is an exciting area of immunotherapy research with the potential to have an impact on a variety of cancer types," said Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology at MD Anderson. "This collaboration aligns our expertise in studying the anti-tumor immune response with Hummingbird’s novel therapeutic pipeline. We look forward to working with Hummingbird to advance immunotherapies that we hope will improve care for our patients."

Sharma and James Allison, Ph.D., regental chair of Immunology, are co-leaders of MD Anderson’s immunotherapy platform and will oversee the collaboration. Jordi Rodon, M.D., Ph.D., associate professor of Investigational Cancer Therapeutics and Genomic Medicine, will lead the clinical study of HMBD-002 at MD Anderson.

Disclosures

Drs. Sharma and Allison receive compensation as consultants to Hummingbird, and Dr. Sharma holds equity in the company. These financial relationships have been disclosed to MD Anderson in accordance with its COI Policy.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody advanced to clinical trials with a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

On July 12, 2021 Albany Molecular Research, Inc. (AMRI), a leading global contract research, development and manufacturing organization serving the pharmaceutical and biopharmaceutical industries, reported that it is changing its name to Curia, effective July 12, 2021 (Press release, Curia, JUL 12, 2021, View Source [SID1234644965]). The new name reinforces the company’s strategic positioning as an end-to-end global CDMO, applying its scientific expertise and extensive capabilities from research and development (R&D) through to commercial manufacturing to enable its pharmaceutical and biotechnology customers to advance important new products that improve lives. Along with the name change, the company is introducing a new brand identity including a new website: CuriaGlobal.com.

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The name Curia is derived from a Latin word for purposeful assembly and references Curia’s patient-inspired mission. The company recently celebrated three decades of growth since its founding in Albany, New York. Today, Curia offers a global suite of R&D and commercial manufacturing capabilities, with industry-leading expertise to help its customers accelerate the journey from idea to impact. Curia employs more than 3,000 people in 21 locations around the world, including more than 600 chemists, 70 biologists, 225 senior scientists and approximately 400 quality and regulatory specialists. The company’s ongoing commitment to science that scales is demonstrated by its 564 active patents and its production of more than 20 treatments included on the list of essential medicines from the World Health Organization.

"Our new name reflects the assembled deep expertise of our people, the breadth of our products, services and solutions, and our relentless determination to help customers advance from curiosity to cure," said Curia Chairman and CEO John Ratliff. "Our new brand honors our foundation in research and innovation while creating a platform for our ambitions of life-changing science so we can make ever-growing contributions to improving patients’ lives. Over the past three decades we have broadened and deepened our capabilities to become a leading provider of CDMO solutions. Today marks the beginning of the next chapter in our history."

On July 12, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the appointment of Octávio Costa, MD, as Chief Medical Officer (Press release, Monopar Therapeutics, JUL 12, 2021, View Source [SID1234584778]). In this role, Dr. Costa will oversee global clinical development and regulatory affairs, and will provide strategic direction for Monopar’s pipeline.

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Dr. Costa joins Monopar with over 30 years of experience overseeing clinical development, clinical operations, development strategy and global medical affairs. He has extensive Phase 1 through 4 clinical development expertise as well as regulatory experience. Dr. Costa’s previous roles include positions of increasing responsibility in clinical development at Merck, Celgene, Novartis and most recently as Chief Medical Officer at Rafael Pharmaceuticals. He has played an important role in the development and life-cycle management of significant products, including the blockbuster product REVLIMID (lenalidomide). Dr. Costa earned his Doctor of Medicine from The Medical College of Sorocaba, São Paulo.

"We are excited to welcome Octávio, especially as our lead program enters late-stage clinical studies," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "Octávio’s track record of navigating all stages of clinical development will aid Monopar in executing our growing clinical development pipeline."

"I am thrilled to be joining this accomplished management team, as Monopar’s Chief Medical Officer," said Dr. Costa. "My industry knowledge and expertise in moving cancer therapies through all stages of clinical testing is well suited to help accelerate Monopar’s pipeline of innovative mid- and late-stage clinical programs and early drug development candidates."

On July 12, 2021 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported that it is proposing to offer and sell, subject to market conditions, $175 million of shares of its common stock in an underwritten public offering (Press release, Celldex Therapeutics, JUL 12, 2021, View Source [SID1234584815]). Celldex expects to grant the underwriters a 30-day option to purchase up to an additional $26.25 million of shares of common stock offered in the public offering. All of the shares of common stock are being offered by the Company. Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates and for general corporate purposes. The final terms of the offering will depend on market and other conditions at the time of pricing, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies, SVB Leerink, Guggenheim Securities and Cantor are acting as the joint book-running managers for the proposed offering.

The securities described above will be offered pursuant to a shelf registration statement on Form S-3 (No. 333-249917), which was previously filed with the Securities and Exchange Commission ("SEC") and deemed effective on November 6, 2020. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source, copies of which may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by e-mail at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

This offering will be made only by means of a prospectus. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 11, 2021 Alpha Tau reported that proprietary Alpha DaRT is designed to deliver uniquely potent alpha radiation to destroy solid tumors with localized precision, sparing surrounding healthy tissue, thereby maintaining cancer patients’ quality of life (Press release, Alpha Tau Medical, JUL 11, 2021, View Source [SID1234584768]). Alpha DaRT has recently received FDA’s Breakthrough Device Designation for the indication of Squamous Cell Carcinoma of the skin and oral cavity without curative standard of care, and preclinical studies support evaluation across various cancer indications (skin, pancreas, breast and GBM, among others).

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– The transaction represents an implied pro forma equity value of approximately $1 billion and is expected to provide up to $367 million in gross proceeds, including up to $275 million of cash held in the trust account of Healthcare Capital Corp. (Nasdaq: HCCC) and a $92 million PIPE.

– The $92 million fully-committed PIPE is anchored by a combination of Healthcare-focused financial and strategic investors including Yozma Investment Co. (part of Yozma Group Korea), Grand Decade Developments (an affiliate of China Grand Pharmaceutical and Healthcare Holdings), as well as other leading technology investors including OurCrowd, Regah Ventures and the co-founders of Apax Partners, Alan Patricof and Sir Ronald Cohen. Medison Group, an early supporter of Alpha Tau and global pharma company that provides access to highly innovative therapies to patients in international markets, is also an investor in the PIPE.

– After giving effect to the transaction (and assuming no redemptions by public shareholders), Alpha Tau is expected to have approximately $362 million of cash on the balance sheet.

– Net proceeds are to be used for further expansion of Alpha Tau’s clinical strategy including the pursuit of FDA marketing authorization, a broad array of R&D activities, expanding manufacturing capacity and preparing for commercialization, and are expected to provide cash runway at least into 2024.

– All Alpha Tau shareholders will retain 100% of their equity holdings in the public company.

– Alpha Tau will continue to be led by its current management team, and upon closing, it is expected that HCC Chairman Dr. David M. Milch will be appointed to the Alpha Tau Board of Directors.

– The proposed business combination is expected to be completed by the end of 2021, upon which Alpha Tau is expected to be listed on Nasdaq.

JERUSALEM and WILMINGTON, Del., July 8, 2021 /PRNewswire/ — Alpha Tau Medical Limited ("Alpha Tau"), the developer of the pioneering alpha-radiation cancer therapy Alpha DaRT, and Healthcare Capital Corp. ("HCC") (Nasdaq: HCCC), a special purpose acquisition company, reported they have entered into a definitive business combination agreement (the "Business Combination"). Upon closing of the Business Combination, Alpha Tau is expected to be listed on the Nasdaq.

Alpha Tau’s proprietary Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) enables highly potent and conformal alpha-irradiation of solid tumors through the intra-tumoral insertion of radium-224 impregnated sources mainly affecting the tumor, sparing the healthy tissue around it. In the company’s first-in-human clinical trial for Squamous Cell Carcinoma ("SCC") tumors of the skin & oral cavity exhibited 100% overall response rate and approximately 78% complete response rate. In June 2021, Alpha Tau received FDA Breakthrough Device Designation for the use of Alpha DaRT in the treatment of SCC of the skin and oral cavity without curative standard of care.

Alpha Tau has developed a robust clinical trial strategy with leading global centers, including its flagship US multi-center feasibility study currently ongoing, led at Memorial Sloan Kettering Cancer Center in New York, which recently enrolled its first patient.

A group of Healthcare-focused financial and strategic investors have committed to participate in the transaction through a fully committed ordinary share PIPE of approximately $92 million at $10.00 per share. Investors in the PIPE include Yozma Investment Co. (part of Yozma Group Korea) and Grand Decade Developments (an affiliate of China Grand Pharmaceutical and Healthcare Holdings) as well as other leading technology investors including OurCrowd, Regah Ventures and the co-founders of Apax Partners, Alan Patricof and Sir Ronald Cohen. Medison Group, an early supporter of Alpha Tau and global pharma company that provides access to highly innovative therapies to patients in international markets, is also an investor in the PIPE.

"Following the recent enrollment of the first patient in our flagship US feasibility study and receipt of FDA Breakthrough Device Designation, this transaction represents another significant milestone on Alpha Tau’s journey to transform the treatment of solid tumors through the precision delivery of alpha radiation. We are grateful to the outstanding team at HCC, whose cadre of experienced and well-regarded professionals have provided superb execution and continued support for Alpha Tau, and we are excited for Dr. David M. Milch to join as our newest member of the Board of Directors upon the closing of the business combination. We thank our investors, both new joiners as well as those who have supported us for years, who continue to demonstrate their faith in the company and its leadership," said Uzi Sofer, CEO and Chairman of Alpha Tau.

"The completion of this transaction will allow the company to realize its vision and implement the clinical development plans and construction of our manufacturing plants around the world, in order to bring hope to millions of patients around the world."

"This transaction ensures that we are well capitalized to accelerate our ambitious plans across multiple fronts," said Raphi Levy, CFO of Alpha Tau. "We look forward to delivering continued clinical momentum and hope for patients as we evolve into a public company."

"We are excited about Alpha Tau’s unique therapy, which has generated a response observed across a wide array of solid tumors in pre-clinical studies, with minimal side effects, positioning it to potentially become a vital weapon in the battle against cancer," said Dr. David M. Milch. "After evaluating many opportunities in the healthcare industry, we believe that Alpha Tau stands out as the best choice for a business combination due to its proprietary technology, rapid clinical and product development and easy to administer treatment solution for the great number of cancer patients worldwide."

"It was a pleasure to work with the team at HCC as their due diligence advisor following my departure as Commissioner of the FDA in January 2021," said Dr. Stephen M. Hahn. "My background as a medical and radiation oncologist helped me immediately appreciate the potential of Alpha Tau’s therapy in providing a solution for a potentially significant number of patients, including those with untreatable or difficult to treat tumors, whether alone or in combination with other therapies such as immunotherapies. I would expect the product to be well received by the clinical community because of the potential applications, modest side effect profile, and demonstrated potency of the Alpha DaRT"

Proceeds of the business combination and the PIPE will be primarily used to:

advance ongoing, and launch, new clinical trials;

continue existing, and initiate additional, clinical and research collaborations;

develop and expand global manufacturing capacity;

develop KOL centers of excellence; and

prepare for commercialization efforts.

Key Transaction Terms

The Business Combination values Alpha Tau at an implied pre-money equity value of $600 million, and is expected to add approximately $337 million of cash to its balance sheet upon closing, inclusive of $275 million in HCC’s trust (assuming no redemptions by public shareholders) and $92 million in PIPE proceeds, net of transaction expenses.

All existing Alpha Tau shareholders will retain 100% of their current equity holdings and are expected to hold approximately 59% of the pro forma company immediately following the closing. Following the closing of the business combination, Alpha Tau is expected to be listed on the Nasdaq.

The Business Combination was unanimously approved by each of Alpha Tau’s and HCC’s Boards of Directors, and HCC Chairman Dr. David M. Milch is expected to join the Board of Directors after closing. The transaction is expected to be completed by the end of 2021, and is subject to obtaining necessary regulatory approvals, the fulfillment of customary closing conditions, as well as the approval of both Alpha Tau’s and HCC’s shareholders.

Additional information about the proposed business combination, including a copy of the definitive agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by HCC with the Securities and Exchange Commission and available at www.sec.gov.

Advisors

Citigroup is acting as financial advisor to Alpha Tau. Citigroup, Piper Sandler, and Cantor Fitzgerald are acting as joint placement agents on the PIPE. Cantor Fitzgerald is acting as a capital markets advisor to HCC. Value Base M&A Ltd. is also acting as financial advisor on the transaction.

Latham & Watkins LLP and Meitar | Law Offices are acting as legal advisors to Alpha Tau. Ellenoff Grossman & Schole LLP and FBC & Co. are acting as legal advisors to HCC. Winston & Strawn LLP is acting as legal advisor to the placement agents.

Management Presentation

A link to a presentation by management of Alpha Tau and HCC discussing the business and the proposed transaction can be found at www.netroadshow.com/nrs/home/#!/?show=d422ce03

The investor presentation is being filed by Alpha Tau and HCC with the Securities and Exchange Commission ("SEC") and will be available on the SEC’s website at www.sec.gov.