New patent would extend coverage and expand potential value of MAIA’s telomere-targeting platform globally
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that the World Intellectual Property Organization (WIPO) has published MAIA’s global Patent Cooperation Treaty (PCT) application titled “Dinucleotides and Their Use in Treating Cancer.” These compounds are key next-generation telomere-targeting agents, an important extension of MAIA’s innovative cancer treatment platform.
The international patent application covers potential cancer therapies using dinucleotide compounds that target telomeres in cancer cells, and methods for using the dinucleotide compounds to treat cancers alone or before administration with checkpoint inhibitors (CPIs). The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such as THIO fragments or other THIO analogues.
The PCT system streamlines the process for obtaining patent protection globally. Under the PCT, applicants can seek patent protection in a large number of countries.
“This new IP would expand the value of our telomere-targeting compounds as first-in-class cancer treatments in regions around the world and provide patent coverage through 2043,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Previous preclinical studies of several of our second-generation telomere-targeting agents have shown highly significant anti-cancer efficacy in multiple in vivo and in vitro models. Importantly, this new coverage would further cement our robust and transformational cancer treatment franchise.”
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
https://www.ysbiopharm.comSector(s): Healthcare Industry: Biotechnology Full Time Employees: 865 Key Executives Name Title Pay Exercised Year Born Dr. Hui Shao Pres, CEO & Exec. Director N/A N/A 1969 Ms. Chunyuan Wu Chief Financial Officer
Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Reported fiscal Q2 2024 and 1H 2024. In the fiscal Q2 ended September 30, 2023, YS Biopharma reported revenues of RMB96.82 million, and RMB273.1 million for the first six months of fiscal 2024. We expected RMB121.8 million and RMB298.1 million, respectively. In the fiscal Q2, the Company reported a net loss of RMB103.7 million, or a loss of RMB1.13 per share, vs. our expected loss of RMB78.7 million, or a loss of RMB0.82 per share.
Revenues were still impacted by Covid-related issues. The Company has been working to improve raw material supply, inventory management and production output. Vaccine production returned to normal levels during the quarter, with the FQ2 expected to be the last quarter impacted by the Covid-related production delays. Management now expects third quarter YSJA vaccine revenues to be more normalized, increasing approximately 50% sequentially.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Biotechnology company Inhibrx announced today that it has entered into a definitive agreement to sell its lead therapeutic candidate, INBRX-101, to French pharmaceutical giant Sanofi in a deal valued at up to $2.2 billion.
INBRX-101 is a recombinant alpha-1 antitrypsin (AAT) therapy being developed for the treatment of alpha-1 antitrypsin deficiency (AATD), a rare genetic disorder that can cause severe lung and liver disease. Under the terms of the agreement, Sanofi will acquire Inhibrx through a merger in which Inhibrx shareholders will receive $30 per share in cash, a contingent value right (CVR) worth up to $5 per share, and one share in a new publicly traded company called Inhibrx Biosciences for every four shares of Inhibrx held.
Inhibrx Biosciences will retain all of Inhibrx’s pipeline assets and infrastructure outside of INBRX-101. This includes several early-stage therapeutic candidates such as INBRX-105 for solid tumors, INBRX-106 for hematologic malignancies, and INBRX-109 for conventional chondrosarcoma. The new company will receive $200 million in cash funding from Sanofi and begin trading publicly after the completion of the merger.
The total potential value of the upfront cash payment, CVR, and Inhibrx’s debt assumption implies an aggregate transaction value of approximately $2.2 billion. Inhibrx shareholders will also own 92% of the equity in the newly formed Inhibrx Biosciences, which will provide opportunities for future value creation.
The acquisition provides Sanofi with full rights to develop and commercialize INBRX-101 globally. The drug candidate is currently in a registrational Phase 2/3 trial evaluating its safety and efficacy in patients with AATD. Inhibrx believes INBRX-101 has multi-billion dollar peak sales potential if approved, which likely drove Sanofi’s interest in the asset.
Inhibrx’s innovative AAT therapy utilizes the company’s novel therapeutic protein engineering capabilities. INBRX-101 is designed to maintain the stability and activity of AAT, potentially enabling less frequent dosing than current AAT therapies. This next-generation approach could position INBRX-101 as a best-in-class treatment option for AATD.
The proposed transaction has been unanimously approved by the boards of directors of both companies and is expected to close in Q2 2024, subject to Inhibrx shareholder approval, regulatory clearances, and other customary closing conditions. Until then, it will be business as usual for Inhibrx as it continues developing its pipeline assets.
For Sanofi, the acquisition expands its portfolio in rare diseases while strengthening its capabilities in protein sciences and engineering. Adding INBRX-101 provides Sanofi with a promising late-stage candidate that can leverage its expertise and infrastructure in pulmonary diseases. Sanofi has been active on the deals front lately, including a recent $3.2 billion deal for Amunix Pharmaceuticals, as it refreshes its pipeline.
Meanwhile, the new Inhibrx Biosciences will emerge as an up-and-coming biotech with strong financial backing, a seasoned management team, and innovative technology platforms. The company will continue operating under the Inhibrx name and leadership. This strategic deal allows Inhibrx to unlock significant value from its lead program while retaining its other assets and resources to drive future growth.
The transaction is a win for both parties, providing Sanofi with a potential blockbuster drug and Inhibrx shareholders with an attractive return and ongoing upside through Inhibrx Biosciences. It demonstrates the broader trend of big pharma leveraging M&A to access innovative therapies from smaller biotech players. As Inhibrx’s programs advance, it will be interesting to see if Inhibrx Biosciences attracts buyout interest down the road. But for now, the company seems well-positioned to create value by advancing its earlier-stage pipeline.
– Topline Data from OLC Pivotal Trial Expected in Q2 2024 – – OLC will target the multibillion-dollar hyperphosphatemia market –
LOS ALTOS, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today issued a letter to shareholders.
Dear Shareholders:
As I sit down to write this letter, I am filled with a profound sense of gratitude and excitement, energized for the year ahead. I remain as confident as ever that the work we’re doing at Unicycive will change the treatment paradigm in kidney disease and leave a lasting impact for patients, physicians, and for you, our shareholders.
When I founded Unicycive in 2016 I knew the journey we were embarking on was ambitious—to offer hope to the millions of patients suffering from chronic kidney diseases who continue to go underserved. Thanks to your unwavering support and the steadfast commitment of our small but mighty team, I am constantly amazed at how we’re able to tackle obstacles head on, solve problems efficiently, and continue to move closer to our goal.
In this letter, I am pleased to recap for you another year of great accomplishments. We’ve made significant advancements in our clinical programs which will propel us to new heights in 2024.
Addressing a Critical Need
Today, dialysis patients experience an excessive pill burden that is among the highest across various chronic disease states including HIV/AIDS, diabetes mellitus, and congestive heart failure. Phosphate binders to treat hyperphosphatemia account for half of the problem.1
Importantly, uncontrolled hyperphosphatemia is strongly associated with increased hospitalization and mortality.2
Our lead program, Oxylanthanum Carbonate, or OLC, is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology with two key advantages. First, only three tablets are required per day (versus as many as 12) and each are meaningfully smaller in size compared to the currently approved phosphate binders. Second, the tablets are swallowed whole with water and not chewed, making it easier for patients to take.3
The novel characteristics of OLC show its potential to be a best-in-class product to treat hyperphosphatemia by reducing the pill burden volume by more than 4-fold compared to the most prescribed phosphate binder.
During 2023 we made significant progress with OLC under the FDA’s 505(b)(2) regulatory pathway which allows us to reference the already approved drug, lanthanum carbonate (Fosrenol®4) to streamline our submission package. As reported in December 2022, OLC was evaluated in a previous bioequivalence study that measured efficacy in healthy volunteers (n=80) in which OLC has found to be equivalent to the reference drug, Fosrenol.
Last year, we gained alignment with the FDA on the overall data package required (preclinical, clinical and CMC) to file a New Drug Application (NDA). The Agency agreed with our proposed clinical study design including sample size, duration of treatment, and primary endpoint of the study. Last month, we initiated the pivotal clinical trial (NCT06218290) to evaluate the tolerability of OLC in chronic kidney disease (CKD) patients on dialysis (n=60) and expect to report topline data in the second quarter of this year. This is the last major component to complete our data package to file an NDA with the FDA, which we intend to submit mid-year.
If approved, OLC will target the multibillion-dollar hyperphosphatemia market and will be a new potential therapy for physicians to administer to their patients.
Strong Scientific Leadership with OLC
This year we continued to publish scientific data on OLC at national and international conferences. We presented five posters on OLC at conferences including at the National Kidney Foundation (NKF), International Society of Nephrology (ISN) and European Renal Association (ERA).
We also published two manuscripts on OLC in peer reviewed journals. The American Journal of Nephrology publication highlighted the phosphate binding capacity of OLC showing that OLC had the lowest daily phosphate binder dose volume and the lowest volume required to bind one gram of phosphate compared to five other commercially available phosphate binders.
Increasing Market Awareness
A top priority for us in 2023 was growing market awareness of OLC’s potential best-in-class product profile. We conducted live and virtual advisory board meetings with some of the country’s most influential nephrologists. Also, for the first time, Unicycive exhibited at the American Society of Nephrology Kidney Week, the world’s premier nephrology conference where we showcased the high unmet need in the management of hyperphosphatemia and the urgent need for new therapies like OLC (https://www.lesspillburden.com). We are encouraged by the overwhelmingly positive reception to the OLC story and are planning continued market-shaping activities for 2024.
Portfolio Expansion
In addition to OLC, we continue to advance our second compound UNI-494 for the treatment of acute kidney injury and chronic kidney disease. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. The asset is currently in a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete this year.
UNI-494 is protected by issued patents in the U.S. and Europe and a wide range of patent applications worldwide.
Looking Ahead
We believe 2024 will be a transformational year for Unicycive. We will report out our pivotal data for OLC next quarter and plan to complete our data package and submit an NDA mid-year. We continue to work closely with the medical community to publish data on our programs and plan for future commercialization of OLC.
As a company, all of our stakeholders are vital to our success. I would like to express my deep appreciation to the physician investigators, study participants, and especially to our dedicated Unicycive employees. The progress we have made demonstrates what’s possible when we believe in the work we are doing and come together to make a meaningful difference.
Thank you for your support,
Shalabh Gupta, MD, Chief Executive Officer of Unicycive
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
References: 1 Chiu YW, et al. Clin J Am Soc Nephrol. 2009 2 Block GA, et al. J Am Soc Nephrol. 2004 3 Dosing information: www.accessdata.fda.gov 4 Fosrenol® is a registered trademark of Shire International Licensing BV.
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of an emerging Healthcare Services platform, announced today that it will release its fiscal second quarter 2024 financial results prior to market open on Wednesday, February 7, 2024. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (February 7, 2024) at 8:30 am ET to discuss the results.
After registering, a confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call we suggest registering a day in advance or at minimum 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx or via this link.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.
With an ecosystem offering high touchpoints for consumers across insurance, medicare, pharmacy, and value-based care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, and Population Health which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
GAITHERSBURG, Md., Jan. 22, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (NASDAQ: YS) (“YS Biopharma”) along with its subsidiaries (“YS Group” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced its unaudited consolidated financial results for the first half of the fiscal year ended March 31, 2024 (the “first half of fiscal year 2024”).
Dr. David Shao, Director, President, and CEO of the Company, commented, “During the first half of fiscal year 2024, though we continued to experience the lingering impact of inventory issues from previous COVID-related disruptions at our YSJA rabies vaccine manufacturing facilities, we executed various operational enhancements to overcome past setbacks. By improving our raw material supply, refining our inventory management, and optimizing the production throughput, our vaccine production operation has returned to normal, and our inventory situation is improving. With higher production throughput and a healthier inventory level of finished products, we expect that the second quarter of our fiscal year 2024 will be the last to be impacted by the previously incurred production delays. Meanwhile, we expect YSJA rabies vaccine revenues in the third quarter, ended December 31, 2023, to increase approximately 50% sequentially from the second quarter, ended September 30, 2023. Our promising array of product candidates are advancing in the development, and we are optimistic about the potential of our PIKA rabies vaccine to provide us with an important new advantage.”
“At the same time, we are fortifying our corporate governance and streamlining our decision-making process to bolster our foundation for long-term and sustainable growth,” Dr. Shao continued. “We have taken steps to diversify our Board composition with the addition of global pharmaceutical industry leadership and US capital market expertise to our company, a move which has thus far been lauded by our shareholders. Under the stewardship of our board of directors, we will continue to innovate and capitalize on resurgent demand from the market.”
Ms. Brenda Wu, CFO of the Company, added, “For the first half of fiscal year 2024, our revenues were RMB273.1 million, mainly due to COVID-related disruptions affecting raw material supply chains, manufacturing operations, and production output at our YSJA rabies vaccine production facilities. Our gross profit for the period was RMB220.9 million, and we expanded our gross profit margin by 4.3 percentage points to 80.9%. Our cash and cash equivalents totaled RMB259.9 million at the end of the period. Looking ahead, we will continue to strategically enhance our business and capitalize on growth opportunities as we strive to deliver long-term value for our shareholders.”
Business Updates
YSJA™ Rabies Vaccine
YS Biopharma’s marketed vaccine product, YSJA™ rabies vaccine, was the first aluminum-free lyophilized rabies vaccine launched in China. Since the Company commenced production at its current GMP-compliant facilities in February 2020, and, since it commenced the product’s commercialization in late 2020, market intake of the Company’s YSJA rabies vaccine has been consistent and strong. As of September 30, 2023, YS Biopharma had sold more than 23.5 million doses of YSJA™ rabies vaccines to approximately 1,718 Chinese Center(s) for Disease Control and Prevention (“CDC”) customers, which represents over 59.6% of CDC customers in China since October 2020.
Clinical Pipeline
YS Biopharma continues to advance its portfolio of innovative product candidates under various clinical development stages, including PIKA rabies vaccine, PIKA recombinant COVID-19 vaccine, PIKA YS-ON-001, and PIKA YS-HBV-002.
PIKA Rabies Vaccine
On October 31, 2023, the Company announced that it had completed the enrollment of subjects in its Phase III clinical trial of the PIKA rabies vaccine. The trial includes a total of 4,500 participants from Pakistan and the Philippines, and will assess the safety, immunogenicity, and lot-to-lot consistency of the PIKA rabies vaccine. Interim results are expected in the first half of 2024.
PIKA Recombinant COVID-19 Vaccine
In March 2023, the Company reported positive interim safety and immunogenicity data for the PIKA recombinant COVID-19 vaccine from Phase II of the Phase II/III clinical studies which were completed in the Philippines and the UAE. The safety and efficacy of the Company’s PIKA adjuvant technology was validated in the Phase II/III trial, which involved roughly 6,000 participants. The Company anticipates that the results from the Phase III clinical trials will be released during the first half of 2024.
The Company will continue to monitor the evolving global situation surrounding COVID-19, and will utilize appropriate commercialization strategies for the PIKA recombinant COVID-19 vaccine accordingly.
PIKA YS-ON-001
PIKA YS-ON-001 is designed as an immunological therapeutical agent against cancers. The Company has completed the Phase I clinical trial of PIKA YS-ON-001 in China.
PIKA YS-HBV-002
On September 15, 2023, the Company announced that the United States Patent and Trademark Office had issued it a patent covering its PIKA YS-HBV-002, an immunotherapeutic vaccine designed to treat patients suffering from chronic hepatitis B virus (HBV) infection.
The Company expects to complete an Investigational New Drug (IND) application and commence the clinical development of PIKA YS-HBV-002 as a novel immunotherapy for the treatment of chronic HBV infection in 2024.
First Half of Fiscal Year 2024Financial Results
Total Revenues
Total revenues were RMB273.1 million (US$38.0 million) in the first half of fiscal year 2024, compared to RMB399.5 million in the same period of fiscal year 2023, representing a decrease of 31.6%. This was primarily due to COVID-related disruptions affecting the Company’s manufacturing operations and production, which reduced batch approvals and doses available for sale; offset by the increases in product price by approximately RMB3.0 per dose.
Gross Profit
Gross profit was RMB220.9 million (US$30.8 million), representing an 80.9% gross margin, compared to RMB305.8 million, or a 76.5% gross margin, in the same period of fiscal year 2023.
Selling and Marketing Expenses
Selling and marketing expenses in the first half of fiscal year 2024 were RMB157.7 million (US$22.0 million), compared to RMB150.2 million in the same period of fiscal year 2023. This increase was primarily attributable to an increase in promotional and marketing services fees as the Company continued to promote its YSJA rabies vaccine.
General and Administrative Expenses
General and administrative expenses in the first half of fiscal year 2024 were RMB67.6 million (US$9.4 million), compared to RMB49.6 million in the same period of fiscal 2023. This change was primarily attributable to increases in 1) professional service fees, due to the Company’s status as a publicly-listed entity, 2) management salaries, and 3) provision for trade receivables and inventories.
Research and Development Expenses
Research and development expenses were RMB178.9 million (US$24.9 million) in the first half of fiscal year 2024, compared to RMB123.9 million in the same period of fiscal 2023. The increase was primarily driven by an increase in testing and clinical trial fees associated with the Company’s COVID-19 vaccine, PIKA rabies vaccine, and hepatitis B vaccines.
Net Loss
Net loss for the first half of fiscal year 2024 was RMB174.5 million (US$24.3 million), compared with RMB11.1 million in the same period of 2023.
Balance Sheet
As of September 30, 2023, the Company had cash and cash equivalents of RMB259.9 million (US$36.2 million), compared with RMB370.4 million as of March 31, 2023.
About YS Group
YS Group is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. YS Biopharma operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.ysbiopharm.com.
Exchange Rate Information
This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from RMB to U.S. dollars are made at a rate of RMB7.1798 to US$1.00, the exchange rate set forth in the central parity rate release of the People’s Bank of China on September 30, 2023.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of the Company, the development progress of all product candidates, the progress and results of all clinical trials, the Company’s ability to source and retain talent, and the cash position of the Company following the closing of the Business Combination. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma’s management and are not predictions of actual performance.
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from those expressed or implied by these forward-looking statements. Although YS Biopharma believes that it has a reasonable basis for each forward-looking statement contained in this press release, YS Biopharma cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. In addition, there are risks and uncertainties described in the final prospectus relating to the Business Combination, and other documents filed by YS Biopharma from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, the ability to recognize the anticipated benefits of the Business Combination, costs related to the transaction, the impact of the global COVID-19 pandemic, the risk that the transaction disrupts current plans and operations as a result of the consummation of the transaction, the outcome of any potential litigation, government or regulatory proceedings, the sales performance of the marketed vaccine product and the clinical trial development results of the product candidates of YS Biopharma, and other risks and uncertainties, including those included under the heading “Risk Factors” in the post-effective amendment No. 1 to Form F-1 filed with the SEC on August 8, 2023 which became effective on August 10, 2023, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Publication Shows Inflammasome Activity In Triple Negative Breast Cancer. A new study has been published in a peer-reviewed journal, Acta Neuropathologica Communications, showing the role of inflammasomes in the growth of brain metastases in triple-negative breast cancer (TNBC). The study found the components that form inflammasomes were upregulated and activated, starting the pathway for metastatic TNBC tumor cells to proliferate. We see this as an important potential indication for ZyVersa IC 100, a drug that blocks inflammasomes.
ZyVersa Is Developing IC 100 As An Inflammasome Inhibitor. Inflammasomes are protein complexes that assemble from three component proteins. Upon activation by pathogens or cell damage, inflammasomes form and provide signals for inflammation. Inflammasomes also form aggregates that stimulate cytokine release and maintain the inflammation process.
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Lead candidate THIO maintains unprecedented disease control rates in Phase 2 non-small cell lung cancer (NSCLC) clinical trial
Multiple clinical milestones ahead for THIO-101 Phase 2 trial
Company enters 2024 with robust clinical pipeline in multiple hard-to-treat cancer indications
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, announced new interim data for its ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC) and outlined key clinical milestones for 2024.
In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The observed disease control was well sustained compared to previous scans.
“We are entering 2024 with strong momentum and great excitement about our programs and pipeline,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “To date, preliminary Phase 2 data on THIO in NSCLC has demonstrated unprecedented rates of disease control and response — measures that vastly outperform the standard of care.”
“In addition to NSCLC, our pipeline of immuno-oncology therapies includes THIO orphan drug designations for multiple hard-to-treat cancers, and our research includes THIO-like second-generation telomere-targeting agents. The main objective for the second-generation program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity,” Dr. Vitoc continued.
“Multiple milestones are on target for 2024 as enrollment continues in THIO-101, including long-term efficacy as a major clinical inflection point.”
Key 2023 Achievements
Positive Preliminary Efficacy Data: Key findings from THIO-101 included:
100% preliminary disease control rate (DCR) in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
DCR across all dose levels met pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.
Third orphan drug designation (ODD) granted to THIO: MAIA’s portfolio of immuno-oncology therapies with ODDs now includes a third hard-to-treat cancer, glioblastoma, the most aggressive and most common type of brain cancer with only limited treatment options.
U.S. FDA Investigational New Drug (IND) Clearance: The FDA cleared U.S.-based evaluation for THIO as part of THIO-101. The trial drew a strong pace of enrollment in 2023 compared with previous NSCLC trials by other drug developers.
Dose Selection: A 180mg/cycle dose of THIO was selected for THIO-101 based on stronger efficacy compared to other doses. The selected dose showed unprecedented disease control and overall response rates for a NSCLC clinical trial.
Next Generation Telomere Targeting Agents: MAIA’s second-generation telomere-targeting program is engaged in research and development for new prodrugs derived from lipid-modified THIO molecules. Capable of acting through similar mechanisms of activity as THIO, the higher potency of these compounds at lower dose levels will be investigated further in 2024.
THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Up to 40% of women with triple negative breast cancer (TNBC) experience metastasis to their brain, which affects physical function, independence, personality, quality of life, and significantly increases mortality rates.
Published data demonstrate that inflammasome activation increases proliferation of TNBC cells in the brain, which was prevented by inhibition of NLRP3 inflammasomes in both mouse and human models.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.
WESTON, Fla., Jan. 17, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Acta Neuropathologica Communications, demonstrating that inflammasome activation enhances cancer metastasis to the brain in women with TNBC.
In the paper titled, “Inflammasome activation in peritumoral astrocytes is a key player in breast cancer brain metastasis development,” the authors evaluated in vivo and in vitro brain metastasis models, as well as human cultures of astrocytes and TNBC cells. Key findings are as follows:
Activation of the NLRP3 inflammasome results in excretion of IL-1β in the tumor environment, enhancing proliferation of metastatic cells in the brain.
Expression of IL-1β correlates with the size of metastatic lesions, being absent in tumor-free brain areas and more intense in the vicinity of large tumors in comparison to smaller ones.
Inhibition of NLRP3 activation prevented proliferation of TNBC cells in both mouse and human models.
The authors stated, “We are the first to show that peritumoral reactive astrocytes promote the proliferation of TNBC cells in the brain through NLRP3 inflammasome-dependent secretion of IL-1β. Brain metastases are among the most aggressive and the least curable malignant tumors; therefore, we need novel therapies targeting mechanisms that contribute to the proliferation of metastatic cells in the brain.” They concluded, “We suggest that inflammasome inhibition might become a therapeutic option in this currently incurable disease.”
“The research published in Acta Neuropathologica Communications linking inflammasome activation in patients with triple-negative breast cancer to brain metastasis supports a growing body of evidence about the role of dysregulated inflammasome pathways in a broad range of devastating diseases,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “We are excited about the potential to transform the treatment of a multitude of inflammatory diseases with drugs like Inflammasome ASC Inhibitor IC 100. IC 100 uniquely inhibits inflammasome ASC and ASC specks to block initiation and perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate and IR Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
MALVERN, Pa., Jan. 16, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Bob Smith, former Senior Vice President, Global Gene Therapy Business at Pfizer, has joined the Company’s Business Advisory Board (BAB). The BAB was established in June 2023 to assist in driving public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; creating awareness of the Company’s differentiated capabilities; and promoting access to the Company’s therapies around the world.
“Bob has the experience Ocugen needs to pursue business development activities with companies that have the size and scale to bring our gene therapies through to commercialization,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “He is a consummate healthcare professional who truly understands the need to drive the pipeline so that we can ultimately get our first-in-class gene therapies to patients with blindness diseases.”
For nearly eight years, Mr. Smith led Pfizer’s global gene therapy business, including the strategic and operational development and implementation of Pfizer’s end-to-end, enterprise-wide efforts to be an industry leader in gene therapy. He is an accomplished biopharmaceutical executive with over thirty-five years’ experience in a variety of alliance management, business development, commercial, corporate strategy, mergers and acquisitions, and research and development executive leadership roles.
“I am impressed with the science behind Ocugen’s modifier gene therapy programs and look forward to introducing this novel approach to potential business partners,” said Mr. Smith. “Having previously worked with members of the Ocugen leadership team at Wyeth and Pfizer, I welcome the opportunity to join the BAB and support their short- and long-term goals for the company.”
Mr. Smith joins Connie Collingsworth, Senator Pat Toomey, Ambassador Joseph W. Westphal, Ph.D., and Dennis Carey, Ph.D. on the BAB. These advisors will work alongside the Executive Leadership Team to strengthen Ocugen’s network across a variety of stakeholders.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Merck has announced a definitive agreement to acquire clinical-stage biotech Harpoon Therapeutics for $23 per share in an all-cash deal valued at approximately $680 million. The acquisition provides Merck with Harpoon’s promising pipeline of novel T-cell engager immunotherapies that harness the body’s immune system to treat cancer.
Harpoon’s lead asset is HPN328, an investigational T-cell engager targeting delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and other neuroendocrine tumors expressing DLL3. HPN328 directs a patient’s T-cells to kill tumor cells displaying DLL3. In October 2022, Harpoon reported positive interim data from the ongoing Phase 1/2 trial showing encouraging tolerability and early signs of efficacy for HPN328.
The acquisition expands Merck’s burgeoning oncology portfolio, adding a new modality to its toolkit. “This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon. We look forward to further evaluating HPN328 in innovative combinations with other pipeline candidates,” stated Dr. Dean Y. Li, President of Merck Research Laboratories.
Harpoon’s TriTAC and ProTriTAC Platforms
Beyond HPN328, Merck also gains Harpoon’s proprietary TriTAC and ProTriTAC platforms for developing novel T-cell engagers. TriTACs (tri-specific T-cell activating constructs) are engineered protein therapies designed to recruit a patient’s immune cells to attack tumor cells. The ProTriTAC platform applies a prodrug concept to remain inactive until reaching the tumor site.
Harpoon has an extensive pipeline of TriTAC candidates against various cancer targets, including:
HPN217: Targets B-cell maturation antigen (BCMA) for relapsed/refractory multiple myeloma, currently in Phase 1.
HPN424: Targets delta-like ligand 4 (DLL4) for solid tumors.
Other preclinical TriTACs targeting tumor antigens like NaPi2b, FLT3, and DLL3.
The platforms offer modular designs to quickly generate and test new immunotherapies directed to disease-specific targets. Merck can leverage these platforms to strengthen its immunotherapy pipeline in cancer and possibly other disease areas.
Merck Building an Oncology Powerhouse
Cancer immunotherapies represent the next wave of innovation in oncology drug development. The Harpoon acquisition aligns with Merck’s strategy to establish leadership in immuno-oncology.
Merck already markets the blockbuster PD-1 checkpoint inhibitor Keytruda, approved for 30 different cancer indications. Keytruda generated $17.2 billion in sales in 2021. Now with Harpoon, Merck adds T-cell engagers to its arsenal. These therapies provide another way to leverage the immune system against hard-to-treat tumors like SCLC.
Merck is also developing numerous other novel agents across various modalities:
Cancer vaccines targeting specific tumor mutations (Personalized Cancer Vaccine, V590, V591)
Bispecific fusion proteins targeting both PD-1 and LAG-3
First-in-class inhibitors (MK-6482, KL-A)
Combined with its extensive capabilities in discovery research and clinical development, Merck is positioning itself as an oncology powerhouse able to take on cancers from all angles.
The Harpoon acquisition provides another building block in this strategy. In Harpoon’s pipeline and platforms, Merck gains cutting-edge T-cell engager capabilities to complement internal immuno-oncology programs. Merck can advance Harpoon’s therapies into new combination regimens and indications to maximize their potential.
Deal Details
Under the terms of the agreement, Merck will acquire Harpoon through a subsidiary, purchasing all outstanding Harpoon shares for $23 each in cash. This represents a premium of 118% over Harpoon’s previous closing share price.
The deal has been approved by Harpoon’s Board of Directors and is expected to close in the first half of 2024, pending shareholder approval and regulatory clearances. It will be accounted for as an asset acquisition by Merck.
Harpoon shareholders will vote on the acquisition at a future shareholder meeting. The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act will also need to expire.
Advisors on the deal include Evercore Group for Merck and Centerview Partners for Harpoon.
With promising new immunotherapies and platforms adding to its robust oncology pipeline, Merck strengthens its leadership in the high-growth cancer drug market. The Harpoon acquisition provides Merck with new T-cell engager capabilities to help develop life-changing medicines for patients with cancer worldwide.
Strengthening GeoVax’s Team Advancing Gedeptin® Clinical Program
Atlanta, GA, January 8, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the appointment of J. Marc Pipas, M.D., to serve as the Company’s Executive Medical Director, Oncology.
Kelly McKee, M.D., MPH, GeoVax Chief Medical Officer, commented, “Dr. Pipas’ addition to our team represents an important step forward in the strengthening of GeoVax’s organizational and operational resources to support advancement of our principal oncology asset, Gedeptin®, through clinical development and regulatory approval. He is also well-positioned to guide the clinical development of GeoVax’s broader immune-oncology portfolio. We are excited to leverage the wealth of knowledge, expertise, and insights he will provide relative to the clinical developments in support of our oncology programs.”
“I am pleased to be joining the GeoVax team,” said Dr. Pipas. “Oncologic research and development is my passion and I look forward to engaging with our clinical researchers, regulatory authorities, and the medical community at large, to advance GeoVax’s mission.”
Dr. Pipas has extensive clinical, research, and leadership expertise in oncology, built on a long and successful academic career at Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, an NCI Comprehensive Cancer Center. During his academic career, Dr Pipas led the GI Clinical Oncology Group for >10 years, served as Hematology/Oncology Fellowship Director, was Medical Director for the Office of Clinical Research in the Cancer Center, and served for more than a decade as a member of Human Subject Protection and Data Monitoring Boards. Following his academic career, he held positions of increasing responsibility in the biopharma industry, guiding the development of several novel oncology therapeutics through early- and late-stage clinical trials.
Dr. Pipas received his Doctor of Medicine degree from SUNY-HSC at Syracuse in 1989 and completed a residency in Internal Medicine at the Medical University of South Carolina in Charleston. Following this, he completed a fellowship in Hematology/Oncology at Dartmouth-Hitchcock Medical Center in New Hampshire and was then invited to become a faculty member at Dartmouth Medical School where he achieved the rank of Full Professor. He has 40 scientific papers and more than 60 abstracts to his credit and has numerous nominations and awards for teaching and humanism in medicine. Dr Pipas brings a deep understanding of oncologic therapeutics and clinical trial management, as well as a network of research contacts and leadership skills honed by many years of experience.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
GAITHERSBURG, Md., Jan. 8, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (NASDAQ: YS) (“YS Biopharma” or the “Company“), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that the Company’s Board of Directors (the “Board“) has approved Ms. Rui Yu as the new Chairperson of its Audit Committee, as a member of its Compensation Committee, and as a member of the Nominating and Corporate Governance Committee on January 7, 2024 (Beijing Time), with immediate effect. Ms. Yu currently serves as a partner at Oceanpine Capital, a position she has held since 2021. Prior to that, she served as a managing director at China Renaissance Group and vice president and head of China healthcare research at Gerson Lehman Group. Ms. Yu received her Bachelor of Science degree from Guangdong Pharmaceutical University, her Master of Science degree from the University of Missouri School of Medicine, and her MBA from the University of Chicago Booth School of Business with concentrations in finance, accounting and entrepreneurship.
Accordingly, the membership of each Board Committee will be as follows:
Audit Committee
Rui Yu (Chairperson), Viren Mehta, and Shaojing Tong
Compensation Committee
Viren Mehta (Chairperson), Ajit Shetty, Shaojing Tong, and Rui Yu
Nominating and Corporate Governance Committee
Ajit Shetty (Chairperson), Viren Mehta, Rui Yu, and Yi Zhang
About YS Biopharma
YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit investor.ysbiopharm.com.
Investor Relations Contact Robin Yang Partner, ICR, LLC Tel: +1 (212) 537-4035 Email: YSBiopharma.IR@icrinc.com
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