On January 6, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and announced strategic objectives and expected milestones for 2023 (Press release, Mersana Therapeutics, JAN 6, 2023, View Source [SID1234625972]).

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!

"Following a year of tremendous accomplishment in 2022, we are now approaching top-line data from our first registrational trial of UpRi, which we believe will provide an opportunity to further demonstrate Mersana’s increasing role as an ADC leader," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "The data we expect to report from our UPLIFT clinical trial in mid-2023 will represent the most significant milestone to date in our effort to establish UpRi as a foundational medicine for patients with ovarian cancer. Assuming positive data, we plan to target the submission of a BLA around the end of 2023 and prepare for a potential U.S. commercial launch in 2024. We will also continue to advance our UP-NEXT and UPGRADE-A trials of UpRi in earlier lines of treatment."

"Beyond UpRi, our efforts to expand the reach of all three of our fully-scaled ADC platforms, each supported by substantial data, will remain a central theme in 2023," continued Ms. Protopapas. "We will work aggressively to progress our two next-generation ADCs, XMT-1660 and XMT-2056, in Phase 1 trials and establish proof-of concept. Additionally, exploring new collaborations will remain a core component of our strategy as we seek to build upon Mersana’s recent business development successes."

Strategic Objective: Establish UpRi as a Foundational Medicine in Ovarian Cancer

2022 Accomplishments

Completed enrollment in UPLIFT, the company’s single-arm registrational trial of UpRi in platinum-resistant ovarian cancer
Initiated Phase 3 UP-NEXT clinical trial of UpRi as a maintenance monotherapy in recurrent platinum-sensitive ovarian cancer
Neared completion of dose escalation in Phase 1 UPGRADE-A trial of UpRi in combination with carboplatin in platinum-sensitive ovarian cancer
Announced that the European Commission has designated UpRi as an orphan medicinal product for the treatment of ovarian cancer

Expected Milestones

Report top-line data from UPLIFT in mid-2023
Assuming positive data, submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) around the end of 2023
Prepare for potential U.S. accelerated approval and commercial launch in 2024
Significantly advance enrollment of UP-NEXT in 2023
Initiate dose expansion portion of UPGRADE-A in the first quarter of 2023 and report interim data from UPGRADE-A in the second half of 2023

Strategic Objective: Advance Clinical-Stage Pipeline

2022 Accomplishments

XMT-1660: Initiated multicenter Phase 1 clinical trial in patients with previously treated breast, endometrial and ovarian cancers
XMT-1660: Announced Fast Track designation for the treatment of adult patients with advanced or metastatic triple-negative breast cancer
XMT-2056: Announced FDA orphan drug designation for the treatment of gastric cancer

Expected Milestones

XMT-1660: Complete dose escalation portion of Phase 1 clinical trial in 2023
XMT-2056: Initiate Phase 1 clinical trial in the first quarter of 2023
Strategic Objective: Position Mersana as the ADC Partner-of-Choice

2022 Accomplishments

Entered into the following agreements that collectively provided Mersana with $170 million in upfront payments and an opportunity for more than $3 billion in milestones, plus royalties:
An Immunosynthen research collaboration and license agreement with Merck KGaA, Darmstadt, Germany ​for two targets, which includes a $30 million upfront payment to Mersana and the potential for up to $800 million in total potential milestones, plus tiered royalties up to the low double-digits on net sales
A collaboration, option and license agreement with GlaxoSmithKline plc (GSK) for the co-development and commercialization of XMT-2056, which provided Mersana with a $100 million upfront option purchase fee and the potential to receive up to $1.36 billion in the form of an additional option exercise fee and milestone payments, plus an option for Mersana to retain a U.S. profit share and tiered royalties on net sales outside of the United States or to receive tiered royalties up to the mid-twenties on global net sales
A Dolasynthen research collaboration and license agreement with Janssen Biotech, Inc. for three targets, which provided Mersana with a $40 million upfront payment and the potential to receive over $1 billion in total potential milestones, plus tiered royalties up to the low double-digits on net sales

Expected Milestones

Pursue impactful new collaborations
Execute against existing collaboration agreements

Financial Update

Mersana estimates that its cash, cash equivalents and marketable securities as of December 31, 2022 were approximately $280 million. This figure is preliminary and unaudited. The company expects to report its audited cash, cash equivalents and marketable securities, as well as other information necessary for a complete understanding of its financial position, in its Annual Report on Form 10-K for the year ended December 31, 2022. The company expects that its available funds, together with the $30 million upfront payment due from Merck KGaA, Darmstadt, Germany ​under the collaboration and license agreement referenced above, will be sufficient to support its operating plan commitments into the second half of 2024.

On January 6, 2023 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported its participation in the 41st Annual JP Morgan Healthcare Conference, taking place January 9-12, 2023 (Press release, Lexicon Pharmaceuticals, JAN 6, 2023, View Source [SID1234625971]).

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!

Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation which will be available on-demand beginning at 3:00 pm ET/12:00 pm PST on Thursday, January 12, 2023.

A simultaneous webcast of the presentation will be available in the "Events" section of the Lexicon website at www.lexpharma.com/events, and a recording of the webcast will be available for two weeks following the original on-demand date.

On January 6, 2023 Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us") reported that NXC-201 treatment continues to demonstrate 100% complete responses in a total of 6 relapsed/refractory AL amyloidosis patients (Press release, Immix Biopharma, JAN 6, 2023, View Source [SID1234625967]). Clinical data published December 2022 in Clinical Cancer Research (View Source) demonstrated 100% complete response rate; 100% organ response rate; NXC-201 Duration of Response Not Yet Reached at a median follow-up of 5.2 months (range: 2.5-9.5 months), resulting in a mean 65% reduction (2,656pg/mL) in NT-proBNP from baseline; no grade 4 Cytokine Release Syndrome (CRS); no ICANS neurotoxicity was observed; a 2-stage improvement in NYHA stage was observed. Low-grade CRS duration of median 2 days (range:1-4 days) with median onset on day 2 (range: 1-3 days) points to NXC-201 potentially becoming the first and only out-patient CAR-T to treat AL Amyloidosis and other BCMA-positive malignancies.

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!

"As we enroll additional patients, we continue to be encouraged by the consistent 100% complete response rate for AL amyloidosis patients treated with NXC-201 to-date," said Gabriel Morris, President, Nexcella, Inc. "We are heartened to provide hope for patients with this devastating disease in our ongoing efforts to bring NXC-201 to market."

Immix Biopharma Subsidiary Nexcella, Inc Announces Additional Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in Relapsed/Refractory AL Amyloidosis Patients, Duration of Response Not Yet Reached

4 patients with relapsed or refractory AL amyloidosis treated with NXC-201 were included in the December 2022 Clinical Cancer Research publication. 4 of 4 patients (100%) experienced a complete response and 4 of 4 patients (100%) experienced an organ response after treatment with NXC-201. 4 of 4 patients (100%) had cardiac involvement at the time of their baseline echocardiogram reading as defined by NT-proBNP levels (>100 pg/ml) (range: 119 – 7,500. Mean 3,100. Median 2,391). Treatment with NXC-201 resulted in a mean 65% (mean 2,656 pg/mL) reduction in mean NT-proBNP from baseline. Additionally, a 2-stage improvement in NYHA stage was observed after treatment with NXC-201.

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory plasma cell dyscrasias, including multiple myeloma and AL amyloidosis.

The primary objective of the Phase 1b portion of the study, is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 with endpoints of overall survival, progression-free survival and response rates.

About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by plasma cells cause buildup in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage, and high mortality rates.

AL amyloidosis affects roughly 30,000 – 40,000 patients in total throughout the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases of AL amyloidosis annually in the U.S. The annual global incidence of AL Amyloidosis is ~15,000 patients.

On January 6, 2023, Keros Therapeutics, Inc. (the "Company") entered into a first amendment (the "Lease Amendment") to that certain indenture of lease, dated September 7, 2021 (as amended, the "Lease") with Revolution Labs Owner, LLC, a Delaware limited liability company (the "Landlord"), with respect to the Company’s office and laboratory space consisting of approximately 35,662 square feet located at 1050 Waltham Street, Lexington, Massachusetts (the "Premises") (Filing, 8-K, Keros Therapeutics, JAN 6, 2023, View Source [SID1234625970]).

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!

Under the terms of the Lease Amendment, the Company has agreed to the phased delivery of the Premises to the Company by the Landlord as follows: (i) the Landlord will deliver approximately 31,991 square feet of the Premises (the "Phase A Premises") on or before January 4, 2023 (the "Phase A Premises Commencement Date"), and (ii) the Landlord will deliver the additional approximately 3,671 rentable square feet of vivarium space (the "Phase B Premises") when the Landlord substantially completes work on the Phase B Premises, currently estimated to occur on or before May 1, 2023 (the "Phase B Premises Commencement Date").

Per the Lease Amendment, the term of the Lease will now commence on the Phase A Premises Commencement Date. The Lease has a term of eight years, measured from the Phase A Premises Commencement Date.

The Company’s obligation for the payment of base rent for the Phase A Premises begins on the date which is earlier to occur of (i) eight months following the Phase B Premises Commencement Date or (ii) 11 months following the Phase A Premises Commencement Date (such earlier date, the "Phase A Rent Commencement Date"). The Company’s obligation for the payment of base rent for the Phase B Premises begins on the date which is eight months following the Phase B Premises Commencement Date (the "Phase B Rent Commencement Date"). Base rent will initially be fixed at $202,084.66 per month, which will increase by approximately 3% per annum. From and after the Phase A Rent Commencement Date and until the occurrence of the Phase B Rent Commencement Date, the Company will be obligated to pay base rent at the per square foot rent for the Phase A Premises only. Upon the Phase B Rent Commencement Date, the Company will be obligated to pay the base rent for the entirety of the Premises. The Company will be obligated to pay the Landlord for certain costs, taxes and operating expenses as specified in the Lease.

The description of the Lease Amendment contained in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Lease Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending March 31, 2023.

On January 6, 2023 Immunome presented its corporate presentation (Press release, Immunome, JAN 6, 2023, View Source [SID1234625968]).

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!