On July 12, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported the appointments of Katherine L. Ruffner, M.D., as chief medical officer (CMO) and James E. Levine as chief financial officer (CFO) (Press release, Cardiff Oncology, JUL 12, 2021, View Source [SID1234584783]).

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Dr. Ruffner has over 25 years of clinical care, oncology biotechnology, and pharmaceutical drug development experience. Mr. Levine has extensive corporate and investment banking experience in the biotechnology industry, including corporate finance, capital markets and business development. In their newly created roles at Cardiff Oncology, Dr. Ruffner will be responsible for overseeing the strategy and execution of clinical programs, as well as the identification and evaluation of pipeline expansion opportunities. In his role as CFO, Mr. Levine will guide Cardiff Oncology’s financial strategy and lead its business development efforts, which will focus on maintaining an optimal financial benefit-risk balance across each of the Company’s programs. Mr. Levine will also serve as the Company’s principal financial and accounting officer.

"With these appointments we have continued to execute on our goal of strengthening our executive team through the addition of highly talented individuals with complementary skill sets," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "They come at a time of significant company opportunity and growth, as our lead program in KRAS-mutated metastatic colorectal cancer is poised for important clinical milestones and we have a meaningful and exciting platform of new clinical indications on the horizon. Katherine’s extensive experience in oncology clinical care and drug development, including advancing novel cancer treatments towards regulatory approval, makes her an ideal fit to lead onvansertib’s development as we work to advance our clinical programs. Her talents, along with Jamie’s track record of financing clinical-stage biotech companies, leading business development pre-clinical and clinical collaborations, and commercial partnerships, will be instrumental to our continued evolution as a company and our commitment to increasing shareholder value. We are thrilled to welcome Katherine and Jamie to our team."

"Onvansertib in combination with other anti-cancer therapeutics has the potential to address unmet patient needs in a number of critically important cancer indications that are currently underserved by available standard-of-care therapies," said Dr. Ruffner. "I am excited to be joining the Cardiff Oncology team to advance these important potential new treatment option in an environment that combines a rare blend of the nimbleness of a clinical-stage biotech company with the resources, expertise and rigor of a much more mature company."

Mr. Levine added, "This is a pivotal time to be joining Cardiff Oncology. With a strong financial foundation, a base of healthcare-focused institutional investors and promising clinical data, the Company is well positioned for upcoming clinical and pre-clinical catalysts. I look forward to working with my new colleagues as we strive to generate shareholder value and, most importantly, address the medical needs of patients with cancer through onvansertib’s continued clinical development."

Appointee Bios
Dr. Ruffner is a US-trained hematologist/oncologist and brings extensive experience in oncology clinical development and clinical care, from early clinical phase through post-commercialization, both at major pharma companies and focused biotech companies.
Most recently, Dr. Ruffner served as vice president, clinical development for ALX Oncology, where she led strategy and execution of their initial clinical asset across a number of different malignancies, both solid tumor and hematologic, and achieved rapid clinical growth from a single trial open in two countries to a program with six global trials across five different cancer indications. Prior to joining ALX, she was a consulting global clinical lead for Lumoxiti at Acerta/Astra Zeneca, and from April 2008 to February 2019, held multiple clinical development positions within the oncology field, most recently as vice president, clinical development for CTI Biopharma, where she oversaw design of Phase 3 confirmatory protocol for pacritinib in myelofibrosis. Previously, Dr. Ruffner served as senior director, clinical development/medical affairs for Seattle Genetics, and before that, as clinical lead for the immuno-oncology agent pidilizumab in hematologic malignancies at Medivation. Earlier in her career, Dr. Ruffner worked in oncology clinical development at Pfizer, Biogen, and Amgen in addition to providing clinical care of patients undergoing treatment for hematologic malignancies.
Dr. Ruffner earned a BS in Biology from Duke University and an MD from the University of Tennessee. She went on to complete her internal medicine residency at the University of Michigan and her oncology fellowship at the University of Washington/Fred Hutchinson Cancer Research Center. Prior to joining industry, she was an Assistant Professor at Vanderbilt University from 2002-2007 on the Hematopoietic Stem Cell faculty.
Mr. Levine joins Cardiff Oncology with extensive corporate and investment banking experience with both private and public biotechnology and pharmaceutical companies. Prior to joining Cardiff Oncology, Mr. Levine served as CFO of Cidara Therapeutics, where he led the financial aspects of important pre-clinical and clinical collaborations with Janssen Pharmaceuticals (part of Johnson & Johnson) and Mundipharma with a combined value of over $1.3 billion. Previously, Mr. Levine was the president and chief executive officer of Sapphire Energy Inc., a private industrial biotechnology company that was sold to two private investor groups. He also previously served in the same roles at Verenium Corp., where he negotiated six product commercialization partnerships and asset sales, before selling the company to BASF. He also previously was a managing director in the investment banking division of Goldman Sachs & Co., serving in its healthcare and energy groups.
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Mr. Levine earned an MBA in finance from the Wharton School of the University of Pennsylvania and a BA in economics from Brandeis University.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
In connection with Dr. Ruffner and Mr. Levine joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock option awards to purchase 200,000 and 390,000, shares of Cardiff Oncology common stock, respectively, outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock options were granted as inducements material to Dr. Ruffner and Mr. Levine becoming employees of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The options were granted to Dr. Ruffner and Mr. Levine as of July 12, 2021, and have an exercise price of $6.55 per share, which is equal to the closing price of Cardiff Oncology’s common stock on the day immediately preceding the grant date. The options vest over four years, with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36 months, subject to Dr. Ruffner’s and Mr. Levine ‘s continued employment with Cardiff Oncology on such vesting dates.

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.

On July 11, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported data from two abstracts featuring its Bladder EpiCheck test at the 36th Annual European Association of Urology (EAU) Virtual Congress (Press release, Nucleix, JUL 11, 2021, View Source [SID1234584771]).

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The first abstract titled, "Real world evidence of alternating cystoscopy/cytology with Bladder EpiCheck in NMIBC surveillance," shows the results of a pilot performed at Radboud University Medical Center evaluating the feasibility and clinical outcomes of alternating between cystoscopy/cytology and Bladder EpiCheck in non-muscle invasive bladder cancer (NMIBC) surveillance. To alleviate the burden of invasive and costly standard surveillance methods on patients, urine collection was performed at home and shipped to a central lab to perform the Bladder EpiCheck test. In the pilot analysis, patients with follow-up showed Bladder EpiCheck achieved 100% sensitivity for high-grade disease, with specificity of 88%, thereby avoiding 76% of unnecessary cystoscopies. Authors concluded this modified surveillance schedule was both safe and cost-effective due to Bladder EpiCheck’s high sensitivity for high-grade disease and high specificity.

"This is the first published evidence for using an alternating schedule of a urine marker, such as Bladder EpiCheck, and cystoscopy or cytology. Due to Bladder EpiCheck’s high sensitivity for high-grade disease and high specificity, and a well-planned infrastructure, all high-grade tumors, including muscle invasive tumors, were detected while avoiding 76% of unnecessary cystoscopies," said Fred Witjes, M.D., Professor of Medical Sciences at Radboud University Medical Center. "As a result of the pilot, Radboud University hospital has implemented this monitoring schedule as a routine for all NMIBC patients."

The second abstract titled, "DNA methylation urine biomarkers test (EpiCheck assay) in the diagnosis of upper tract urothelial carcinoma: results from a single-center prospective study," evaluated the performance of Bladder EpiCheck in the detection of upper urinary tract urothelial carcinoma (UTUC) among 80 consecutive patients undergoing ureteroscopy for the diagnosis, treatment or follow-up of UTUC. The study found that Bladder EpiCheck achieved a high-grade sensitivity of 95.8%; a high-grade negative predictive value of 97.2%; and a specificity of 80.6% in urine collected from the ureter-bladder junction, compared to 80.0%, 90.0% and 91.7% for cytology, respectively.

"It is very challenging to stage a UTUC with a biopsy, as we know that up to 30% of UTUC are understaged with this technique. This can be detrimental to the patient as high-grade UTUC, if missed, can progress to metastases very quickly. Alternatively, if a patient with a low-grade tumor is mistaken for high-grade, or high-grade disease can’t be ruled-out, they might undergo unnecessary procedures such as removal of the ureter and kidney of that side," said Dr. Alberto Breda, head of the oncological urology unit and the kidney transplant team in Fundació Puigvert, Barcelona, Spain. "The results of this study show that Bladder EpiCheck can be a useful tool in the UTUC setting and could play a crucial role in the diagnosis and follow-up of the disease, particularly in ruling-out high-grade disease."

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-risk cancer is present1. Bladder EpiCheck is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.

On July 11, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the first patient has been dosed in a Phase 1 study of IBI323, an anti-LAG-3/PD-L1 bispecific antibody (Press release, Innovent Biologics, JUL 11, 2021, View Source [SID1234584772]).

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The objective of this open-label, multi-center Phase 1 dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI323 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.

IBI323 is a recombinant LAG-3/PD-L1 bispecific antibody. Preclinical studies showed that IBI323 effectively blocks both the PD-1/PD-L1 and LAG-3 pathways and can generate more effective and durable activation of T lymphocyte activation than the combination of anti-PD-L1 monoclonal antibody and anti-LAG monoclonal antibody. Besides, through the bridging effect of bispecific antibody, tumor cells expressing PD-L1 can be drawn closer to T lymphocyte expressing LAG-3, thus forming stable TCR: MHC immune synapses and enhancing T lymphocyte activation. Therefore, IBI323 shows advantages compared with two drugs combination according to the mechanism. Recently, an article about IBI323’s bispecific antibody enhances tumor-specific immunity was published on Oncolmmunology.

Professor Caicun Zhou, Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University Medical School, stated: "Although immune checkpoint inhibitors have shown promising results in the treatment of a wide range of tumors, there still remains many new challenges. Many patients inevitably develop drugs resistance and the efficacy of immune checkpoint inhibitors needs to be further enhanced. Therefore, it is of great value to develop the next generation of bispecific antibodies. LAG-3 is one of the most promising targets among cancer immunotherapy, combining innovative techniques for bispecific monoclonal antibody, we look forward to the results of IBI323 clinical trials. "

Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, stated: "The LAG-3/PD-L1 bispecific antibody can specifically target both LAG-3 and PD-L1, block both the PD-1/PD-L1 and LAG-3 pathways, synergically enhance the activity of T lymphocyte and close the distance between tumor cells with high PD-L1 expression and T cells expressing LAG-3. The preclinical results have shown that compared with two monoclonal antibodies, IBI323 can further enhance the immune activation with improved convenience of administration. Therefore, the development of LAG-3/PD-L1 bispecific antibody will provide patients with a novel, comprehensive, effective and cost-saving treatment regimen. We hope that IBI323 will benefit more patients. "

About IBI323 (anti-LAG-3/PD-L1 bispecific antibody)

IBI323 is a recombinant LAG-3/PD-L1 bispecific antibody developed by Innovent Biologic. The IND of IBI323 has been approved by NMPA and we are actively conducting the clinical trial in China. We also plan to prepare an IND application with the U.S. Food and Drug Administration (FDA).

About the Phase 1 Study of IBI323 (CIBI323A101)

Conducted by Innovent in China, the CIBI323A101 trial is a Phase 1 open-label, multi-center study of the safety, tolerability and primary efficacy of IBI323 in patients with advanced solid tumors (ClinicalTrials.gov, NCT04916119).

On July 9, 2021 Fertin Pharma reported $813 million deal for oral drug delivery Marlboro maker Philip Morris International is doubling down on its pharma ambitions with plans to snap up inhalation-specialist-turned-CDMO Vectura (Press release, Fertin Pharma, JUL 9, 2021, View Source [SID1234584769]).

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Philip Morris has aligned with Vectura’s board to acquire the company for £852 million ($1.2 billion) in cash. The arrangement puts Vectura shareholders in line to receive 150 pence per share, marking a 46% premium on the company’s 103-pence closing price on May 25, Philip Morris said in a release.

Adding a recent dividend payment into the mix, Vectura said the deal is valued at around £1.045 billion (about $1.45 billion). The sale is expected to close in the second half of the year.

The move follows Philip Morris’ February rollout of its "Beyond Nicotine" strategy, under which the tobacco giant aims to move beyond cigarette sales and into fields such as respiratory drug delivery and "selfcare wellness."

Philip Morris is banking on "Beyond Nicotine" to deliver at least $1 billion in net revenues by 2025, CEO Jacek Olczak said in a statement.

RELATED: Verona sells Chinese rights to inhaled drug for $40M upfront

But Philip Morris isn’t Vectura’s only suitor. The company in late May said it had accepted a buyout offer from prominent healthcare investment firm The Carlyle Group. In light of Philip Morris’ "superior proposal" per Vectura share, Vectura’s directors plan to recommend that shareholders accept the Philip Morris bid, the company said in its release.

Philip Morris’ 150 pence-per-share offer marks a roughly 10% increase over Carlyle’s ex-dividend offer of 136 pence, a Vectura spokesperson said over email.

For its part, Carlyle says it’s "considering its options" and will make another announcement down the line, potentially signaling an upcoming bidding war.

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Vectura has 13 inhaled products on the market and generated £191 million (about $245 million) in 2020 sales, Philip Morris said. Vectura has also reinvented itself as a CDMO in recent years, bringing on Catalent veteran Will Downie as CEO in late 2019. Under the proposed deal, the companies aim to forge a pipeline of both prescription and over-the-counter products, Philip Morris said.

The Vectura purchase marks Philip Morris’ second pharma acquisition of the month. On July 1, oral drug delivery specialist Fertin Pharma said it had accepted a 5.1 billion Danish krone ($813 million) buyout bid from Philip Morris, which will see the tobacco giant gain access to manufacturing and R&D sites in Denmark, Canada and India, where Fertin employs around 860.