On February 3, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics leveraging CRISPR-based technologies, reported the acquisition of Rewrite Therapeutics, Inc. (Rewrite), a private biotechnology company focused on advancing novel DNA writing technologies (Press release, Intellia Therapeutics, FEB 3, 2022, View Source [SID1234607765]).

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Rewrite has developed promising new tools for genome editing, including DNA writing via CRISPR/Cas9-guided polymerases. Founded by pioneering scientists Shakked Halperin, Ph.D., and Professor David Schaffer, Ph.D., of the University of California, Berkeley and backed by Civilization Ventures and Prefix Capital, Rewrite’s DNA writing technology may enable a range of precise editing strategies. These strategies include targeted corrections, insertions, deletions, and the full range of single-nucleotide changes, which could provide new ways to edit disease-causing genes and broaden the therapeutic potential for genomic medicines. Rewrite also has developed an approach that could improve the efficiency of genome editing in non-dividing cell types, a key challenge for some existing editing platforms. Rewrite’s technology could potentially be delivered using Intellia’s lipid nanoparticle (LNP) technology and adeno-associated virus (AAV) vectors.

"At Intellia, we have built the industry’s broadest and deepest genome editing platform by staying at the forefront of new techniques, while also extending the capabilities of CRISPR/Cas9 editing to make precisely targeted changes to DNA," said Intellia President and Chief Executive Officer John Leonard, M.D. "We could not be more excited to add Rewrite’s additional capabilities to our growing platform, offering us new possibilities and the potential to target diseases beyond those currently being explored in our pipeline."

Dr. Halperin, Rewrite’s President and Chief Executive Officer and the inventor of Rewrite’s gene editing platform, said:

"Since my initial discovery that CRISPR-guided polymerases could help advance genome editing capabilities, I have focused my efforts on developing a suite of genome editing tools that could one day be used to create innovative and potentially curative treatments for patients with life-threatening diseases. I am thrilled that these inventions will now be leveraged by the industry leader, Intellia, so that the full power and potential of genome editing can be harnessed to benefit patients."

As part of this transaction, Intellia will pay the Rewrite shareholders $45 million in an upfront payment and an additional $155 million in pre-specified research and regulatory approval milestones through a mix of Intellia common stock and cash. Additional financial details were not disclosed.

Goodwin Procter, Latham & Watkins and Finnegan acted as Intellia’s legal counsel. Arnold & Porter Kaye Scholer and Wilson, Sonsini, Goodrich & Rosati acted as Rewrite’s legal counsel.

On February 3, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported that it has entered into a definitive agreement to acquire Nimbus Health GmbH ("Nimbus Health") (Press release, Dr Reddy’s, FEB 3, 2022, View Source [SID1234607659]). Nimbus Health is a privately owned, licensed pharmaceutical wholesaler from Germany focusing on medical cannabis in Germany. Dr. Reddy’s will acquire Nimbus Health for an upfront payment plus performance and milestone-based earn-outs over the next four years.

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Founded in 2018, Nimbus Health is one of the pioneer companies for medical cannabis in Germany. The acquisition will allow Dr. Reddy’s to build on Nimbus Health’s strengths and introduce medical cannabis-based medicines as a promising treatment option for patients. The company will be operating under the brand Nimbus Health and as a wholly-owned subsidiary of Dr. Reddy’s.

The demand for medical cannabis has increased over the past years with the legalization of medical cannabis by the German Parliament (Bundestag) in 2017. The medical cannabis market in Germany is already valued at ~122 Mio. € with growth of ~25% in 2021 compared to 2020 and a CAGR of ~55 % since 2017, making Germany one of the largest markets in Europe. Around 150,000 German patients benefit from medical cannabis for their unmet health needs1.

The closing of the transaction is subject to customary closing conditions.

Patrick Aghanian, Head of European Generics, Dr. Reddy’s, commented: "Medical cannabis is increasingly used to address and treat high unmet medical needs, especially in pain management and CNS. Further, with numerous studies being conducted to leverage and introduce medical cannabis, we believe this is a must-be field for future healthcare delivery. Nimbus Health has established itself as a fast-growing, highly reputable, pioneering platform with an excellent network of trade partners and know-how access, where the German sick-funds fully reimburse medical cannabis. As more European countries adopt the usage of medical cannabis, the ability to leverage and access newer geographies will be key. We are very excited that with Nimbus joining Dr. Reddy’s family, together with Linus and Alessandro, we embark on a new, exciting journey of medical cannabis, which supports Dr. Reddy’s mission of meeting unmet patient needs."

"We were really excited when Dr. Reddy’s approached us and recognized Nimbus’s highly efficient importing, registering, and launching platform for various medical cannabis brands in Germany. The close alignment between the values of Dr. Reddy’s and Nimbus gave us the confidence that we can stay focused on the existing business and grow future endeavors together. We are glad to work with Dr. Reddy’s to activate synergies supporting growth in all sectors." commented Linus Maximilian Weber, Founder and Managing Director of Nimbus Health.

Dr. Alessandro Rossoni, Co-Founder and Managing Director of Nimbus Health, says: "The relationship between Dr. Reddy’s and Nimbus Health has developed very positively over the past year. It felt like a natural match to make the next steps together. We are excited that Dr. Reddy’s acknowledged the potential of Nimbus in the medical cannabis market. Dr. Reddy’s commitment sets a significant milestone for further developing medical cannabinoid-based medicines and unlocking new possibilities to benefit patients. We are very confident that being part of Dr. Reddy’s will help us strongly take our operations to the next level and further increase our impact in this quickly developing market.

On February 3, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)- based DNA manufacturing and nucleic acid-based technologies, reported that it will report fiscal 2022 first quarter financial results after market close on Thursday, February 10, 2022 (Press release, Applied DNA Sciences, FEB 3, 2022, View Source [SID1234607678]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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Conference Call and Webcast Information – Live

Date: Thursday, February 10, 2022, at 4:30 p.m. Eastern Time
Dial in: 844-887-9402; 412-317-6798 (international)
Hosts: Dr. James A. Hayward, chairman, president, and CEO; Beth Jantzen, chief financial officer
Webcast: View Source

Conference Call and Webcast Information – Replay

A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

Dial in: 877-344-7529; 412-317-0088 (international); Access Code: 2723913
Webcast: View Source
Availability: Telephonic replay: until Thursday, February 17, 2022; webcast replay: 1 year

On February 3, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that Snehal Patel, CEO of Greenwich LifeSciences, will present in-person at 2:30 pm ET on February 14, 2022 at the 2022 BIO CEO & Investor Conference and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference (Press release, Greenwich LifeSciences, FEB 3, 2022, View Source [SID1234607693]).

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BIO CEO & Investor Conference

The 2022 BIO CEO & Investor Conference will be held from February 14-17, 2022. For more than 20 years, the BIO CEO & Investor Conference has fueled biotech industry networking with premier investor and banking communities, focused on established and emerging publicly traded and select private biotech companies. In addition, there will be four days of in-person and virtual meetings with institutional investors, industry analysts, and senior business development executives seeking potential investments and deal partners. For more information please visit: View Source

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On February 3, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported a collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma (CM) cases (Press release, Castle Biosciences, FEB 3, 2022, View Source [SID1234607713]).

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CM cases in the SEER registries that were diagnosed between 2013-2018 were linked with DecisionDx-Melanoma results and additional clinicopathologic information from patients tested between 2013-2018. The Company expects to continue collaborating with the NCI to link the SEER registries’ CM cases diagnosed post-2018 with DecisionDx-Melanoma test results. The initial linked dataset is expected to be broadly available to interested researchers through the standard data request process for SEER Specialized Datasets in 2022.

Data analysis from the first subset of patients was shared in a poster presentation at the 2022 Winter Clinical Dermatology Conference, held Jan. 14-19 in Koloa, Hawaii.

"We are excited to collaborate with the NCI to link DecisionDx-Melanoma test results with the SEER registries’ data," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Castle is committed to providing clinically actionable tests to improve patient outcomes. Analysis from the first subset of patients (65 years or older at time of diagnosis and diagnosed in 2016 or later) provides real-world evidence of the capability of our test to do just that. Specifically, when controlling for demographic and clinicopathological variables, patients tested with DecisionDx-Melanoma had better overall survival rates over 2.5 years than patients not tested."

The poster, titled "31-gene expression profile testing survival benefit in a population-based analysis of cutaneous melanoma patients ≥65 years of age," highlighted the first analysis of Castle’s DecisionDx-Melanoma testing data in the NCI’s SEER Program registry. The poster can be viewed here.

Study methods and findings:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. Among other outputs of the test, DecisionDx-Melanoma classifies a patient’s tumor as lowest risk of recurrence/metastasis (Class 1A), increased risk of recurrence/metastasis (Class 1B/2A) or highest risk of recurrence/metastasis (Class 2B).
All incident CM cases diagnosed between 2013-2018 in the NCI’s SEER Program registry were included in the study. The SEER registries linked CM cases in the registry to DecisionDx-Melanoma testing data provided by Castle Biosciences.
While all CM diagnoses between 2013-2018 were included in the linkage, this analysis was limited to a subset of 2,048 patients with Stage I-III melanoma who were ≥65 years or older at the time of diagnosis and were diagnosed between 2016-2018 to account for access to adjuvant therapy.
Patients tested with DecisionDx-Melanoma were successfully matched to those not tested with DecisionDx-Melanoma based on clinical, pathological and demographic data.
After matching, patients tested with DecisionDx-Melanoma had better overall survival rates than patients who had not been tested, demonstrating a direct effect of DecisionDx-Melanoma testing on patient survival (hazard ratio=0.66 compared to untested patients, p=0.002).
The results also confirmed DecisionDx-Melanoma’s ability to stratify patient risk in an unselected, prospectively tested population of CM patients into low (Class 1A) and high-risk (Class 2B) mortality groups.
Patients who received a DecisionDx-Melanoma high-risk result had a ten-fold increase in death rate compared to patients who received a low-risk result (12.3% death rate for a Class 2B result compared to 1.5% for a Class 1A result), demonstrating the independent prognostic value of the test.
In sum, the study data provide direct evidence that CM patients tested with DecisionDx-Melanoma have better survival rates than untested patients, suggesting that the test can aid in risk-aligned treatment plans for improved patient outcomes and survival rates.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Sept. 30, 2021, DecisionDx-Melanoma has been ordered 84,195 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About the SEER Program

The Surveillance, Epidemiology and End Results (SEER) Program (View Source) is an authoritative source for cancer statistics in the United States. The SEER Program provides information on cancer statistics in an effort to reduce the cancer burden among the U.S. population and is supported by the Surveillance Research Program (SRP) in the NCI’s Division of Cancer Control and Population Sciences (DCCPS). The SEER Program registries collect data on cancer cases diagnosed in their catchment area from various locations and sources throughout the United States. Data collection began in 1973 with a limited number of registries and continues to expand to include even more areas and demographics today covering 48% of US population. The SEER Program registries link to data provided by a variety of federal and commercial partners to support the research community in conducting cancer surveillance and epidemiological research. The data are available to qualified researchers.