On January 19, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,reported that it is partnering with The Royal Marsden NHS Foundation Trust on Part C of its "Tracking mutations in cell free DNA to predict Relapse in eArly Colorectal Cancer" (TRACC) study, which will evaluate the use of circulating tumor DNA (ctDNA) to guide chemotherapy treatment decisions after curative-intent surgery in patients with early-stage colorectal cancer (CRC) (Press release, Guardant Health, JAN 19, 2023, View Source [SID1234626385]). The trial is intended to determine whether patients can be spared unnecessary chemotherapy and the associated side effects if they test negative for ctDNA using the Guardant Reveal blood test following surgery.

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Currently, many patients with high-risk stage II and stage III CRC are routinely offered chemotherapy after surgery to help reduce the risk of relapse from microscopic minimal residual disease (MRD). However, approximately 50-80% of these patients are cured with surgery alone, and many may be over-treated because doctors have not been able to clearly advise patients on whether they are likely to benefit from the treatment.1,2,3 Chemotherapy can cause debilitating and sometimes life-long side-effects, such as damage to the nerves in the hands and feet, life-threatening infections and blood clots.

The study will use the Guardant Reveal blood test to detect MRD by measuring the DNA shed from tumor cells into the bloodstream. Global studies have shown that a negative ctDNA result after surgery is associated with a significantly lower likelihood of the cancer returning.4 The TRACC Part C trial aims to evaluate the use of ctDNA results from the Guardant Reveal test to guide chemotherapy treatment decisions in a multi-center, prospective, randomized study over the next four years.

"Patients with high-risk colorectal cancer are often over-treated and can suffer long-term neurotoxicity from chemotherapy," said Professor David Cunningham, director of clinical research at The Royal Marsden NHS Foundation Trust, chief investigator for the TRACC Part C study. "This study will generate evidence and insights to help us understand when we can avoid unnecessary chemotherapy for our patients who have no disease detected following surgery. This information can help us tailor treatment decisions to benefit patients and potentially realize significant cost savings for the healthcare system."

"With the Guardant Reveal test, a simple blood draw can be used to identify colorectal cancer patients who have residual disease and are most likely to benefit from adjuvant therapy," said Helmy Eltoukhy, Guardant Health co-CEO. "We’re pleased to partner with The Royal Marsden in the TRACC Part C study to enable the investigators to more accurately predict when cancer is unlikely to return, help guide chemotherapy treatment decisions and provide patients with a better quality of life."

TRACC Part C began opening sites in August 2022 and will involve approximately 40 sites across the United Kingdom with a planned recruitment of 1,621 patients over four years. The Royal Marsden NHS Foundation Trust announced that the first patient was enrolled in TRACC Part C in September 2022. The trial is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute of Health Research (NIHR) partnership.

On January 19, 2023 Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 75,730 shares of Geron common stock as inducements to a newly hired employee in connection with commencement of employment with the Company (Press release, Geron, JAN 19, 2023, View Source [SID1234626384]).

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The stock options were granted on January 18, 2023 at an exercise price of $3.12 per share, which is equal to the closing price of Geron common stock on the date of grant. A stock option representing an aggregate of 70,000 shares has a 10-year term and vests over four years, with 12.5% of the shares underlying the option vesting on the six-month anniversary of commencement of employment for the employee and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 5,730 shares have a 10-year term and vest in full upon achievement of certain regulatory milestones, subject to continued employment with Geron through the applicable vesting dates. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

On January 19, 2023 Galapagos presented its investors presentation (Presentation, Galapagos, JAN 19, 2023, View Source [SID1234626383]).

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On January 19, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that in the lawsuit Exelixis, Inc. (Exelixis) v. MSN Laboratories Private Limited et al. (MSN), Action No. 19-2017 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to the cabozantinib compound patent (U.S. 7,579,473) (Press release, Exelixis, JAN 19, 2023, View Source [SID1234626382]). The District Court’s decision follows an earlier Stipulation and Order of October 1, 2021, that MSN’s proposed generic cabozantinib product (Abbreviated New Drug Application [ANDA] No. 213878) infringes the ’473 patent.

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Additionally, the District Court ruled that MSN’s proposed ANDA product does not infringe Exelixis’ N-2 polymorph patent (U.S. 8,877,776), which expires on October 8, 2030. The District Court’s decision does not address the validity of the ’776 patent, which was not contested by MSN.

"We are pleased the court upheld the validity of Exelixis’ cabozantinib compound patent," said Jeffrey Hessekiel, J.D., Executive Vice President, General Counsel and Secretary, Exelixis. "While we are disappointed with the court’s decision concerning infringement of the ’776 patent, we remain confident in the strength of the cabozantinib patent estate. We will continue to vigorously defend our intellectual property, safeguarding the scientific innovation that drives Exelixis’ ability to continue to discover, develop and ultimately bring new medicines to patients with difficult-to-treat cancers."

As a result of the ruling, Exelixis intends to request that the District Court order that the effective date of any potential U.S. regulatory approval of MSN’s generic product, subject to any appeals or challenges, would be no earlier than August 14, 2026, which is the expiration date of Exelixis’ ‘473 patent.

This ruling does not impact Exelixis’ separate and ongoing suit against MSN, Exelixis, Inc. vs. MSN Laboratories Private Limited et al., Civil Action No. 22-00228 (Consolidated) (MSN II), concerning four different Orange Book-listed patents related to cabozantinib, including U.S. Patents No. 11,091,439 (crystalline salt forms); 11,091,440 (pharmaceutical compositions); 11,098,015 (methods of treatment); and 11,298,349 (pharmaceutical composition). MSN has already stipulated to infringement of the ’439, ’440, and ’015 patents, which expire on January 15, 2030. The remaining ’349 patent expires on February 10, 2032. Trial in MSN II is scheduled to begin in October 2023 in the U.S. District Court for the District of Delaware.

On January 19, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported that the U.S. Food and Drug Administration ("FDA") has granted fast track designation for the Company’s personalized cancer therapy, EVX-01, in combination with KEYTRUDA (Press release, Evaxion Biotech, JAN 19, 2023, View Source [SID1234626381]).

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In December 2023, Evaxion received FDA approval to proceed with its Phase 2b clinical trial, where EVX-01 is given in combination with KEYTRUDA to patients with metastatic melanoma. On January 17, 2023, Evaxion furthermore received fast track designation for the vaccine candidate. The fast track is designed to expedite the FDA’s review of innovative, new drugs that demonstrate the potential to address an unmet medical need.

"We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine. This is first and foremost to the benefit of the patients. And it is a great validation of our AI platform, PIONEER, and our drug development candidate," says Per Norlén, CEO at Evaxion.

EVX-01 is a peptide-based cancer immunotherapy and is Evaxion’s most advanced clinical asset. Under the program, a unique drug is generated for each patient based on gene analysis of their tumors and on matching with their immune system. This process is made possible by the Company’s proprietary AI platform, PIONEER.

The ongoing Phase 2b study is conducted at clinical sites across the United States, Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA. The trial was initiated in Australia with the enrollment of the first patient in September 2022.
Read about EVX-01 Ph2b on clinicaltrials.gov: NCT05309421