On September 29, 2021 Concarlo reported that US Patent 10,702,570 was issued by the United States Patent and Trademark Office (USPTO) for a metastatic breast cancer treatment (Press release, Concarlo Holdings, SEP 29, 2021, View Source [SID1234590526]). The patent, for which Concarlo is the exclusive licensee, covers IpY, a novel therapeutic peptide that addresses drug-resistant breast cancer by targeting a unique cellular pathway — p27Kip1. Concarlo has also announced that a new provisional patent application has been filed for modified versions of the therapeutic peptide that are believed to exhibit enhanced bioavailability. Concarlo is a Brooklyn-based biotechnology innovator dedicated to developing sophisticated, targeted therapies and diagnostics in the oncology space. The IpY technology is the first to address the high incidence of drug-refractory disease that develops with currently available CDK4 inhibitor (CDK4i) treatments. Such a solution has the potential to drastically increase overall survival of breast cancer patients.

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With more than 40,000 deaths due to metastatic breast cancer estimated for this year alone in the US, there is a pressing need to bring newer, more effective therapeutics to market. The recent introduction of CDK4i drugs, a class of medicines that directly targets the CDK4/6 pathway implicated in many malignancies, has had a significant impact on the way in which the disease is managed. However, such therapeutics are associated with patients transitioning to a treatment-resistant form of the condition, despite initial extended periods of remission. Backed by more than 20 years of research and development expertise, Concarlo has developed IpY and a companion diagnostic, ApY, to effectively overcome the issue of CDK4i resistance and roll out a more targeted treatment approach for optimized patient outcomes.

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"Despite the clinical efficacy of CDK4 inhibitors, we’re seeing that primary or secondary resistance to therapy is presenting a significant challenge to overall survival," commented Dr. Dominique Bridon, Chief Development Officer at Concarlo. "With the IpY technology and its unique mechanism of action, we’re effectively targeting CDK4 while simultaneously inhibiting another target — CDK2 — which has been found to be a key molecular player in the development of drug resistance. In doing so, we are the first company to successfully address the CDK4i resistance issue to provide long-term durable tumor arrest. Combined with its highly specific targeting and low toxicity profile, the positive impact of this drug on the breast cancer treatment landscape is hard to understate."

On September 29, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in patients’ lives, reported that its Board of Directors has authorized the Company to repurchase up to $25 million of the Company’s American Depositary Shares (ADS) (the Share Repurchase Program), each of which represents one ordinary share of Ascendis Pharma A/S (Press release, Ascendis Pharma, SEP 29, 2021, View Source [SID1234590523]). The program will be executed under Rules 10b-18 and 10b5-1 of the U.S. securities regulations.

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For that purpose, Ascendis Pharma A/S has appointed J.P. Morgan Securities LLC as agent to execute the program independently and without influence from Ascendis Pharma A/S. The purpose of the Share Repurchase Program is to acquire ADS needed in connection with the Company’s planned share-based incentive program. Under the agreement, J.P. Morgan Securities LLC will repurchase ADS on behalf of Ascendis Pharma A/S during the trading period starting November 1, 2021 and expected to end no later than December 31, 2021.

A maximum of 300,000 ADS in total can be bought during the trading period. The maximum number of ADS that can be repurchased on a single trading day may not exceed 10% of the average daily trading volume of Ascendis Pharma A/S ADS, in the prior full four weeks of trading. At least once every seven trading days, Ascendis Pharma A/S will issue an announcement in respect of the transactions made under the repurchase program.

The timing and total amount of ADS repurchases will depend upon market conditions and may be made from time to time in open market purchases and may be suspended or discontinued at any time. The repurchase program does not obligate the Company to acquire any particular amount of ADS. The Company expects to fund the Share Repurchase Program through its existing cash or cash equivalents.

On September 29, 2021 Healthtech company Huma and the life sciences company Bayer reported that it will use machine learning to try to improve diagnosis for certain types of lung cancer, by more precise readings of CT (Computed Tomography) scans (Press release, Bayer, SEP 29, 2021, View Source [SID1234590510]).

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The companies aim to distinguish different forms of non-small-cell lung carcinomas (NSCLCs) from CT scans. This would enable specialists to more rapidly determine which form of cancer a patient has, in order to begin more appropriate, timely treatment.

In the age of precision medicine, patients will undergo a series of tests to characterize their cancer. However, these tests can be invasive and often drive up time to results, hence treatment, and costs. In order to move beyond a "one-size-fits-all" treatment approach and ensure the right patients are being treated at the right time with the right medication, there’s an urgent need for new ways to understand each patient’s cancer. Experts have begun using machine learning to help categorise and segment patient subtypes with some diseases and Huma and Bayer are turning the technology to NSCLCs.

The research project will begin by using machine learning to spot correlations in molecular and imaging assessments such as "ground glass opacity" that can differentiate lung cancer types. The team will then create, train and test models that can accurately diagnose the different types of lung cancers.

Dan Vahdat, CEO and Founder of Huma, said: "We have shown we can use machine learning to predict an individual’s risk of depression, anxiety, cardiac events and the impact of being infected by COVID-19, and we hope this work in cancer will be a new field for us. However, as always, we will publish any significant developments in peer-reviewed journals. We know the importance of evidence-based, rigorous innovation and, by doing it the right way, we can more rapidly make meaningful, impactful changes and help people live longer, fuller lives.

"We want to start by providing more personalised care for people with non-small cell lung cancer. In the future, our vision is to include other cancers and even other therapeutic areas such as rare diseases. We want to broaden our existing smartphone platform to combine imaging, digital phenotyping, and genomics with the real-world, real-time data from patients that we already collect. We want to take therapies from bench to bedside to breakfast table."

Robert LaCaze, Head of Oncology, Pharmaceuticals Division of Bayer, added: "Rather than treating all lung cancer patients with standardized regimens, precision medicine can allow physicians to prescribe medicines tailored to the tumor’s specific oncogenic driver. Our collaboration leverages Huma’s proven expertise in Machine Learning and Bayer’s vast capabilities in Oncology and Medical Imaging to help accelerate the identification of those patients with certain types of non-small cell lung cancer who can most benefit from these tailored treatments."

Leaps by Bayer, the impact investment arm of Bayer, has been a Series B (2019) and Series C (2021) investor into Huma. Huma and Bayer plan to begin work on this project immediately.

On September 29, 2021 BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported that it has entered into stock purchase agreements with a group of institutional investors in connection with a private placement of its common stock (Press release, BioAtla, SEP 29, 2021, View Source [SID1234590495]). The Company will issue 2.7 million shares of common stock for a purchase price of $28 per share. The transaction is expected to result in gross proceeds to the Company of $75.0 million, before deducting placement agent fees and other offering expenses. The Company plans to use the net proceeds from the private placement primarily to advance clinical development, medical affairs and commercial preparation, and for general corporate purposes.

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Investors in the offering included Great Point Partners, Deerfield Management Company, Cormorant Asset Management, Soleus Capital, Sphera Healthcare, Ikarian Capital, LLC, HBM Healthcare Investments, Monashee Investment Management, LLC, funds managed by Hudson Bay Capital Management, and Pappas Capital.

The closing of the private placement is subject to certain conditions and is expected to occur on or about Thursday, September 30, 2021.

J.P. Morgan acted as lead placement agent and Jefferies acted as co-placement agent for the private placement.

The common stock being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the common stock, nor shall there be any sale of the common stock in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the common stock under the resale registration statement will only be by means of a prospectus.

On September 29, 2021 Castle Creek Biosciences, Inc., a clinical-stage cell and gene therapy company focused on developing and commercializing disease-modifying therapies for patients suffering from rare diseases for which there is a lack of available treatment options, reported a research collaboration with Mayo Clinic to advance discovery and pre-clinical development of investigational gene therapy candidates for the treatment of osteogenesis imperfecta (OI) and classical Ehlers-Danlos syndrome (EDS), which are rare genetic connective tissue disorders that currently have no treatments approved by the U.S. Food & Drug Administration (FDA) (Press release, Mayo Clinic, SEP 29, 2021, View Source [SID1234590494]). The research will be led by principal investigator David R. Deyle, M.D., a board-certified medical geneticist with the department of medical genetics at Mayo Clinic and a leader in the field of connective tissue disorders.

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"We are honored to be working with Dr. Deyle and his highly regarded research team at Mayo Clinic to identify and evaluate gene therapy candidates that hold promise for treating debilitating, rare connective tissue disorders with high unmet medical needs," said Matthew Gantz, president and chief executive officer of Castle Creek Biosciences. "We expect this initiative will be the first of multiple Castle Creek strategic collaborations with leading medical research institutions that have the potential to expand our innovative gene therapy discoveries for rare diseases and offer hope to underserved patient communities impacted by these devastating conditions."

Osteogenesis imperfecta, also known as brittle bone disease, is caused by genetic mutations that affect the synthesis of Type I collagen and can lead to fragile bones, scoliosis, short stature, dental disorders, and laxity of skin ligaments. OI is estimated to affect one in 6,600 people in the U.S. and may be diagnosed at any age. Classical EDS results from genetic mutations affecting synthesis of Type V collagen and is associated with skin hyperextensibility and fragility, hypotonia, joint instability, chronic pain, and fragile blood vessels. Vascular and pulmonary complications have also been reported. EDS is estimated to affect one in 20,000 people in the U.S.

"Castle Creek is leveraging its proven expertise and experience in rare diseases and late-stage clinical development of cell and gene therapies to establish strategic collaborations with world-class research organizations for studying early-stage novel treatments to address critical, unmet medical challenges of patients suffering from rare genetic conditions," said Jeff Aronin, founder and chairman of Castle Creek Biosciences, and founder, chairman and chief executive officer of Paragon Biosciences, LLC. "We commend Matthew and his leadership team for their strategic insight and guidance that have long-term potential to fuel discovery and advancement of innovative gene therapy candidates and enhance the depth of Castle Creek’s pipeline."

For this research collaboration, Castle Creek will contribute its proficiency in rare diseases and gene therapy development and has licensed intellectual property related to OI and classical EDS from Mayo Clinic. Following completion of the discovery through pre-clinical development phases at Mayo Clinic, Castle Creek anticipates moving into clinical development of selected gene therapy candidates at its in-house, commercial-scale current good manufacturing practices (cGMP) manufacturing facility located in Exton, Pa.