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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

On January 19, 2023 Eli Lilly and Company (NYSE: LLY) will reported its fourth-quarter 2022 financial results on Thursday, Feb. 2, 2023 (Press release, Eli Lilly, JAN 19, 2023, View Source [SID1234626380]). Lilly will also conduct a conference call that day with the investment community and media to further detail the company’s financial performance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call will begin at 10 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.