On February 15, 2023 Xilis, a pioneering biotech company advancing its proprietary MicroOrganoSphere (MOS) Platform to enable functional precision medicine and high-confidence drug development for cancer patients, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration to deploy Xilis’s proprietary MicroOrganoSphere (MOS) technology in support of preclinical research to accelerate the development of novel cancer therapies (Press release, Xilis, FEB 15, 2023, View Source [SID1234627278]).

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 agreement, the two organizations aim to advance drug development and discovery projects utilizing the MOS platform, which enables translational research on patient-derived micro tumors with new capabilities and at a scale not possible with current in vivo models. If successful, this platform may offer opportunities for third-party collaborations to guide the development of new drugs and cell therapies.

"Our research suggests the MOS platform has the potential to offer new capabilities and to improve the efficiency of developing innovative drugs and cell therapies over current xenograft and organoid models, which we hope will bring medicines to patients more quickly," said Dr. Xiling Shen, CEO and co-founder of Xilis. "We look forward to working with the MD Anderson team to discover and develop the next generation of cancer treatments, and we welcome further conversations with pharmaceutical firms for tripartite drug development opportunities."

The MOS platform at MD Anderson will be run jointly by the Xilis and MD Anderson teams, and the collaboration will be led by three MD Anderson scientists: Timothy Heffernan, Ph.D., vice president of Oncology Research for MD Anderson’s Translational Research to AdvanCe Therapeutics and Innovation in ONcology (TRACTION) platform, Scott Kopetz, M.D., Ph.D., professor of Gastrointestinal Medical Oncology, and Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy.

The MOS technology provides the first reliable platform to rapidly assess how a patient’s tumor responds to a wide variety of cancer drug modalities within 14 days of obtaining harvested tumor cell samples while also sustaining the native tumor microenvironment. This is essential for determining the full spectrum of therapeutic effects, including immuno-oncology, in the clinic.

The platform also is capable of accelerating the development of disease models, enabling new opportunities to further support discovery research, translational science and drug development efforts. The collaborators intend to explore how the MOS platform could be used to establish new patient-derived models underrepresented in the field, such as rare cancers and treatment-resistant disease.

"The ability to rapidly screen many drugs ex vivo and to build an expansive catalog of disease models addressing unmet needs opens new avenues to advance impactful medicines," Heffernan said. "Our collaboration with Xilis will allow us to evaluate this exciting technology as a tool to improve the scale, speed and capabilities of our translational research efforts."

The TRACTION platform, a core component of MD Anderson’s Therapeutics Discovery division, is designed to accelerate the development of innovative cancer therapies and to identify the right treatment for the right patients. MD Anderson’s natural killer (NK) cell therapy program, led by Rezvani, is advancing novel treatments for a variety of cancers using engineered cord blood-derived NK cells.

"Developing impactful cell therapies requires an accurate determination of which cells can produce the desired effect prior to introduction in patients," Rezvani said. "In collaboration with the Xilis team, we aim to deploy the MOS platform to enable rapid screening and increase our chances of clinical success in our NK cell therapy program."

On February 15, 2023 Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, reported that members of its senior management team will participate in two panel discussions at the Wells Fargo 2023 Targeted Protein Degradation Virtual Summit, being held virtually on Tuesday, February 21, 2023 (Press release, BioTheryX, FEB 15, 2023, View Source [SID1234627277]). Details for the panel discussions are as follows:

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!

Panel Discussion: Overcoming Resistance with Targeted Protein Degradation
Speaker: Aparajita Hoskote Chourasia, M.S., Ph.D., Vice President, Biology
Date and Time: Tuesday, February 21, 2023, at 8:00 a.m. EST
Webcast link: Available here

Panel Discussion: Degradation vs. Inhibition – When does Targeted Protein Degradation Make Sense and When Does It Not?
Speaker: Leah Fung, Ph.D., Chief Scientific Officer
Date and Time: Tuesday, February 21, 2023, at 1:00 p.m. EST
Webcast link: Available here

A replay of the webcasts will be archived for up to 6 months following the event.

On February 15, 2023 Immvira reported that following the recent publication of efficacy data on advanced melanoma, it’s intratumoral injected OV product MVR-T3011 IT has also shown positive efficacy in the treatment of advanced head and neck cancer (Press release, Immvira, FEB 15, 2023, View Source [SID1234627276]). As of January 2023, it achieved a confirmed Objective Response Rate ("ORR") of 25.0% in monotherapy treatment, which is significantly better than standard treatment (ORR: 5.8%/10.1%) and PD-1 immunotherapy (ORR: 13.3%/14.6%) for second-line and above patients.

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!

This Phase II clinical study commenced in mid-2021 in China. 19 patients with advanced head and neck squamous cell carcinoma ("HNSCC") (except nasopharyngeal carcinoma) received MVR-T3011 IT monotherapy (1*108 PFU/mL), of which 18 patients (94.7%) failed from previous platinum-based chemotherapy and PD-1 immunotherapy, 17 patients (89.5%) had distant metastases, and 6 patients (31.6%) had baseline target lesion diameters of more than 5 centimeters. Median Progression Free Survival ("PFS") was 3.9 months（95%CI: 0.89, NA). Of the 12 evaluable subjects, the confirmed ORR and Disease Control Rate ("DCR") were 25.0% (3/12) and 50.0% (6/12), respectively. Meanwhile, 72.7% (8/11) of injected target lesions and 57.1% (4/7) of non-injected target lesions were observed to have reduced lesion volume, which clinically validated the abscopal effects of MVR-T3011 IT.

As a local single-drug treatment, MVR-T3011 IT’s efficacy on second-line and above subjects after PD-1 and platinum-based chemotherapy is encouraging, with improved ORR and PFS compared to PD-1 monotherapy (see below), and it has shown advantages in subjects that have failed from chemotherapy and immunotherapy in single-agent clinical development.

Results of PD-1 monoclonal antibody as second-line therapy for relapsed and metastatic HNSCC

NO.

Phase

Sample
Size

Drug

Subjects

ORR

Median PFS
(month)

Median
OS
(month)

KEYNOTE-
040

III

247

Pembrolizumab

Second-line or salvage
therapy (failure of platinum-
based chemotherapy)

14.6 %

2.1

8.4

248

PI selected
SOCs

10.1 %

2.3

6.9

CheckMate
141

III

240

Nivolumab

Second-line or salvage
therapy (failure of platinum-
based chemotherapy)

13.3 %

2.0

7.5

121

PI selected
SOCs

5.8 %

2.3

5.1

For advanced HNSCC, patients have limited treatment options after first-line and second-line standard treatment. The efficacy of CSCO-recommended monotherapies cannot meet clinical needs with ORRs generally below 10%. MVR-T3011 IT monotherapy can achieve a significantly improved ORR of 25%, and we expect to see a significant extension of Overall Survival ("OS") with longer follow-up periods. With the fact that patients enrolled all progressed after standard chemotherapy and immunotherapy, we also observed that those patients can receive PD-1/PD-L1 treatment after disease progression from MVR-T3011 and reversed resistance to immunotherapy with significant responses, clinically validated potential breakthrough synergy in combination treatment of MVR-T3011 and immunotherapy.

About Head and Neck Cancer

Head and neck tumors refer to tumors occurring in the mouth, nose, pharynx, throat, etc. More than 90% are squamous cell carcinoma and its variants, collectively referred to as head and neck squamous cell carcinoma (HNSCC). According to the statistics of 2020 GLOBOCAN, it is estimated that the number of new cases of head and neck tumors (except nasopharyngeal carcinoma) in 2020 is about 798,577, accounting for 4.14% of all new cases of malignant tumors. The estimated number of deaths was 387,117, accounting for 3.9% of all malignant tumor deaths, ranking eighth in both the number of new cases and the number of deaths. More than 60% of HNSCCS have progressed to stage III or IV disease at presentation, while 15% to 40% of locally advanced patients will relapse or metastasize after treatment, with a 5-year survival rate of less than 50%.

About MVR-T3011

MVR-T3011, ImmVira’s proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances immune responses in the tumor microenvironment.

On February 15, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2022 fourth quarter and full year financial results on Wednesday, March 1, 2023, after the close of the U.S. financial markets (Press release, Jazz Pharmaceuticals, FEB 15, 2023, View Source [SID1234627275]). Company management will host a live audio webcast at 4:30 p.m. ET / 9:30 p.m. GMT to discuss 2022 fourth quarter and full year financial results and provide a business and financial update.

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!

Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.

A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

On February 15, 2023 10x Genomics, Inc. (Nasdaq: TXG) reported financial results for the fourth quarter and full year ended December 31, 2022 and provided outlook for 2023 (Press release, 10x Genomics, FEB 15, 2023, View Source [SID1234627274]).

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!

Recent Highlights

Revenue was $156.2 million for the fourth quarter and $516.4 million for the full year of 2022, representing 9% and 5% increases over the corresponding periods of 2021.
Increased cumulative instruments sold to more than 4,600 as of the end of 2022, driven by continued adoption of Chromium X Series instruments and strong demand for Visium CytAssist.
Began shipping the Xenium platform for in situ analysis, delivering key performance advantages in data quality, workflow and throughput through highly differentiated chemistry, hardware and software.
Unveiled new data and showcased key advances and future development directions for all three platforms at the 2023 Advances in Genome Biology and Technology General Meeting.
"The clear highlight of 2022 was the velocity of our innovation engine as our team delivered catalytic launches across all three platforms," said Serge Saxonov, Co-founder and CEO of 10x Genomics. "We finished the year with momentum and in a strong position to capture the massive opportunities ahead."

Fourth Quarter 2022 Financial Results

Revenue was $156.2 million for the three months ended December 31, 2022, a 9% increase from $143.5 million for the three months ended December 31, 2021. This increase was primarily the result of higher consumables revenue in the Americas and EMEA regions partially offset by a decline in China, and overall higher volume of instruments sold including the sales of our newly introduced Xenium instruments, partially offset by unfavorable foreign currency exchange fluctuations.

Gross margin was 76% for the fourth quarter of 2022, as compared to 81% for the corresponding prior year period. The decrease in gross margin was primarily due to change in product mix with newly introduced products.

Operating expenses were $142.5 million for the fourth quarter of 2022, a 8% increase from $131.8 million for the corresponding prior year period. The increase in operating expenses was primarily driven by higher personnel expenses, including stock-based compensation and restructuring costs, increased costs for facilities and information technology to support operational expansion and higher legal expenses, partially offset by lower costs for laboratory materials and supplies and a decrease in marketing expenses.

Operating loss was $23.1 million for the fourth quarter of 2022, as compared to an operating loss of $15.8 million for the corresponding prior year period. Operating loss also includes $41.0 million of stock-based compensation for the fourth quarter of 2022, as compared to $26.9 million for the fourth quarter of 2021.

Net loss was $17.2 million for the fourth quarter of 2022, as compared to a net loss of $18.4 million for the corresponding prior year period.

Full Year 2022 Financial Results

Revenue was $516.4 million for the year ended December 31, 2022, a 5% increase from $490.5 million for 2021.

Gross margin was 77% for full year 2022, as compared to 85% for 2021. The decrease in gross margin was primarily due to higher accrued royalties including a one-time reversal of $14.7 million of previously accrued royalties in 2021, change in product mix with newly introduced products and increased manufacturing and logistics costs.

Operating expenses were $564.0 million for full year 2022, as compared to $468.7 million for 2021, an increase of 20%. The increase in operating expenses was primarily due to higher personnel expenses, including stock-based compensation and restructuring costs, increased expenses related to laboratory materials and supplies to support our research and development efforts and increased facilities and information technology costs to support operational expansion, partially offset by lower legal expenses, consulting and professional services and marketing expenses.

Operating loss was $167.9 million for full year 2022, as compared to an operating loss of $52.3 million for 2021. This includes $136.8 million of stock-based compensation for full year 2022, as compared to $96.0 million for full year 2021.

Net loss was $166.0 million for full year 2022, as compared to a net loss of $58.2 million for 2021.

Cash and cash equivalents and marketable securities were $430.0 million as of December 31, 2022.

2023 Financial Guidance

10x Genomics expects full year 2023 revenue to be in the range of $580 million to $600 million, representing 12% to 16% growth over full year 2022 revenue.

Webcast and Conference Call Information

10x Genomics will host a conference call to discuss the fourth quarter and full year 2022 financial results, business developments and outlook after market close on Wednesday, February 15, 2023 at 1:30 PM Pacific Time / 4:30 PM Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 45 days after the event.