On August 3, 2022 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, reported its Half-Year Report 2022 with an overview on its business performance and financial results (Press release, MediGene, AUG 3, 2022, View Source [SID1234617402]). The full version of the report can be downloaded here: View Source

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Business review Q2 2022 and outlook

MDG1011 – Clinically validated T cell receptor-modified T cell (TCR-T) therapy in blood cancers

In June 2021, the last patient was enrolled in the third dose cohort of the Phase I part of the Phase I/II trial of MDG1011 in blood cancer patients and Medigene successfully reported on safety, tolerability and feasibility in December 2021. In February 2022, the first positive efficacy and immune monitoring data were published. The last trial visit of a patient whose myelodysplastic syndrome did not progress to secondary acute myeloid leukemia took place in June 2022, final data are currently being analyzed and will be published upon completion.

Development partnerships

At the end of June 2022, the research term for the partnership with 2seventy bio, Inc. was successfully concluded in accordance with the contract and Medigene remains eligible for potential milestone payments and royalties on future products based on Medigene’s technology. Roivant Sciences divested its holding in Cytovant Sciences in July 2022, which subsequently became Hongsheng Sciences HK Limited (Hongsheng Sciences). Due to financing constraints, Hongsheng Sciences has temporarily suspended its development activities within the Medigene partnership, but Medigene has meanwhile already started the extensive work under the new partnership with BioNTech SE (BioNTech) signed in February 2022.

Discovery of novel T cell receptors (TCRs) against undisclosed target molecules in solid tumors

Using Medigene’s proprietary TCR screening and discovery platform, the Company continuously evaluates novel target molecules in the solid tumor arena including tumor-specific molecules of the cancer-testis-antigen family, "dark matter" antigens stemming from non-coding regions of the DNA, and as yet undisclosed targets. If these targets fulfil Medigene’s target safety criteria during screening, candidates are selected for further TCR development, as part of the Company’s ongoing process to expand its pipeline.

Changes in the Executive Management Board

Dr. Selwyn Ho joined Medigene as Chief Executive Officer (CEO) on 25 July 2022. As a consequence, Prof. Dolores Schendel stepped down as CEO at the end of 24 July 2022 and now fully focuses on her responsibilities as Chief Scientific Officer (CSO) and Head of Research and Development at Medigene.

Prof. Dolores Schendel, CSO at Medigene: "The first half of 2022 was a period of significant transition at Medigene. Importantly, we completed two central projects that have involved intense efforts over the last few years. The Phase I part of our MDG1011 TCR-T trial in blood cancer was concluded with the end-of-trial visit of the last patient at 12 months. The experience we gained here regarding high fidelity manufacturing, drug product characterization, and implementation of immune monitoring strategies for patient assessment now enables straightforward transition to development activities for TCR-Ts in solid cancer.

Secondly, the TCR discovery phase of the 2seventy bio alliance concluded at the end of June, enabling Medigene to rapidly transition to our new multi-faceted alliance with BioNTech that extends beyond projects in TCR discovery to include innovation tools designed and developed at Medigene for next generation TCR-T immunotherapies.

We are also delighted to welcome Dr. Selwyn Ho as CEO of Medigene, which means I return to focusing full time on my role as CSO and Head of Research and Development. Selwyn has the ideal experience to take over and lead Medigene at this exciting time, enabling Medigene to optimally position itself for clinical development of TCR-T immunotherapies for solid cancer in the near future."

Dr. Selwyn Ho, CEO at Medigene: "Medigene is one of the pioneers in the TCR-T space, and the strength and potential of its validated and integrated discovery platform is what attracted me to join. From TCR screening and discovery of novel targets, with the ability to further enhance the activity of our selected TCR with product optimization tools, and finally to a validated manufacturing and clinical biomarker monitoring platform, Medigene has the capabilities to develop potentially highly differentiated TCR-based therapies for solid tumors with high unmet need.

We remain focused on our partnering activities as well as advancing our pipeline of wholly owned TCRs and optimization tools for solid tumors into the clinic as soon as possible. I look forward to be able to announce and discuss our updated plans in further detail by the end of this year."

Financial development and financial forecast

The Company’s revenues increased to €25.3 m in the first half of 2022 (6M 2020: €4.3 m) mainly resulting from the new partnership with BioNTech, research and development (R&D) expenses decreased by 42% to €3.7 m (6M 2021: €6.3 m) and the EBITDA improved to €15.4 m (6M 2021: €-4.5 m) due to the partnership with BioNTech.

Management confirms the financial forecast and still expects revenues of €23-28 m, R&D expenses of €11-15 m and EBITDA of €3-5 m in 2022, without the COVID-19 pandemic or Ukraine crisis having a material impact on these expectations. These estimates do not include potential future milestone payments from existing or future partnerships or transactions, as the occurrence of such events or their timing and scope depends to a large extent on external parties and therefore cannot be reliably forecast by Medigene.

As of 30 June 2022, cash and cash equivalents and time deposits amounted to €39.4 m (31 December 2021: €22.4 m). Based on its current planning, the Company has sufficient financial resources to fund business operations into the fourth quarter of 2024.

Investor and analyst conference call

Date: Wednesday, 3 August 2022, 3:00 pm CEST (9:00 am EDT)
Registration: View Source;linkSecurityString=9253bcaa2
Speakers*: Prof. Dr. Dolores Schendel, CSO and Head of Research and Development
Dr. Birger Kohlert, CFO
*Please note: Since both the report and the presentation mainly refer to the first six months of 2022, Prof. Dr. Dolores Schendel will lead the presentation.

Please register beforehand and latest 2 hours prior to the event through the registration link provided above to receive your personal access information (phone number, passcode, personal PIN). Please don’t distribute your dial-in details which will be personalized. Please dial in at least 10 minutes before start time.

On August 3, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that the Company’s second quarter 2022 financial results will be released after market close on Tuesday, August 9, 2022 (Press release, ChemoCentryx, AUG 3, 2022, View Source [SID1234617400]). ChemoCentryx executive management will host a conference call and webcast beginning at 5:00 p.m. Eastern Time on August 9, 2022 to discuss these results and to answer questions.

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To participate by telephone, please dial (800) 715-9871 (Domestic) or (646) 307-1963 (International). The conference ID number is 9726781. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.

On August 3, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported financial results for the second quarter ended June 30, 2022 and provided a review of recent business and clinical highlights (Press release, Xencor, AUG 3, 2022, View Source [SID1234617397]).

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"Xencor is applying our leading protein engineering tools and proprietary XmAb technologies to create a broad portfolio of novel bispecific antibodies and cytokines, and we are using our resources on multiple clinical programs where the data to date indicate we have the greatest potential for success," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "We are expanding and maturing our clinical portfolio of XmAb drug candidates, recently dosing the first patient in a Phase 1 study of XmAb819, our ENPP3 x CD3 bispecific antibody for renal cell carcinoma, which is engineered with our multivalent 2+1 antibody format, as well as the first patient in our second Phase 2 study of vudalimab, our PD-1 x CTLA-4 bispecific antibody, in certain gynecologic tumors and clinically defined high-risk mCRPC."

"Later this year, we plan to present additional clinical data from our vudalimab and plamotamab programs and initial data from our IL2-Fc autoimmune program, XmAb564, in healthy volunteers. Near year-end we also expect to dose the first patient in the Phase 1 study of XmAb808, our B7-H3 x CD28 bispecific antibody, placing Xencor at the forefront of efforts to engage CD28 to selectively activate T cells."

Recent Portfolio Highlights

Vudalimab (PD-1 x CTLA-4): The first patient was dosed in a Phase 2 study evaluating vudalimab monotherapy in patients with clinically-defined high-risk metastatic castration-resistant prostate cancer (mCRPC) and certain gynecologic malignancies. A separate, ongoing Phase 2 study, in which vudalimab is being evaluated in combination with chemotherapy or a PARP inhibitor depending on the tumor’s molecular subtype, is enrolling patients, and the Company plans to present early data from the study later this year.
XmAb104 (PD-1 x ICOS): Initial dose-escalation data from the Phase 1 study in patients with advanced solid tumors were presented in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022. XmAb104 was well tolerated and exhibited a distinct safety profile compared to other clinical-stage ICOS programs. Anti-tumor activity and biomarker activity consistent with T-cell engagement were observed. The expansion portion of the study is exploring XmAb104 in combination with ipilimumab in parallel cohorts of patients with several advanced solid tumor types.
XmAb819 (ENPP3 x CD3): The first patient was dosed in a Phase 1 study in patients with advanced renal cell carcinoma. XmAb819 uses the XmAb 2+1 bispecific antibody format for greater selectivity for ENPP3-expressing tumor cells compared to normal cells, which express lower levels of ENPP3.
XmAb808 (B7-H3 x CD28): The company is initiating a Phase 1 study in combination with pembrolizumab. CD28 is a key immune co-stimulatory receptor on T cells; however, the ligands that activate T cells through CD28 are usually not expressed on tumor cells. Targeted CD28 bispecific antibodies are a new class of bispecific, engineered to provide conditional co-stimulation of T cells when the molecule is also bound to tumor cells, which may enhance the activity CD3 bispecifics and checkpoint inhibitors. XmAb808 targets the broadly expressed tumor antigen B7-H3.
Progress Across Partnerships

Vir Biotechnology, Inc.: In the second quarter of 2022, Xencor recognized $22.1 million in royalty revenue under the Company’s agreement with Vir. Sotrovimab, an antibody that targets the SARS-CoV-2 virus and incorporates Xencor’s Xtend Fc domain for longer duration of action, has been made available by Vir and its partner Glaxo Wellcome UK Limited and GlaxoSmithKline Biologicals S.A. Sotrovimab’s authorization was previously ended in all U.S. regions.
Alexion Pharmaceuticals, Inc.: In July 2022, Ultomiris (ravulizumab-cwvz), which incorporates an Xtend Fc domain, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe for patients with generalized myasthenia gravis. In the second quarter of 2022, Xencor earned $6.7 million from Alexion on net sales of Ultomiris. Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.
Caris Life Sciences: In August 2022, the Company announced a new target discovery option and license agreement to create XmAb bispecific or multi-specific antibodies with Caris’ unique human tissue bank and bioinformatics approach to find addressable tumor markers.
Financial Results for the Second Quarter Ended June 30, 2022

Cash, cash equivalents, receivables and marketable debt securities totaled $679.7 million as of June 30, 2022, compared to $664.1 million on December 31, 2021. During the first half of 2022, the Company received royalty and milestone payments from partners of $113.7 million, which offset net spending on operations of $105.0 million and resulted in an increase in cash balance amounts at June 30 relative to the 2021 year-end amount.

Total revenue for the second quarter ended June 30, 2022 was $30.2 million, compared to $67.4 million for the same period in 2021. Revenues earned in the second quarter of 2022 were primarily royalties from the Alexion and Vir agreements, compared to the same period in 2021, which were primarily from the Janssen and Novartis collaborations, and royalty revenue from Alexion. Revenues for the six months ended June 30, 2022 were $115.7 million, compared to $101.4 million for the same period in 2021. Revenues for the six-month period in 2022 were primarily from milestone revenue from Astellas and royalty revenue from Alexion and Vir, compared to the same period in 2021, which were earned primarily from the collaborations with Janssen and Novartis, milestone revenue from MorphoSys and the royalties from Alexion and Vir.

Research and development (R&D) expenses for the second quarter ended June 30, 2022 were $47.1 million, compared to $49.5 million for the same period in 2021. Decreased R&D spending for second quarter of 2022 compared to 2021 reflects decreased spending on plamotamab and XmAb819 (ENPP3 x CD3) programs, partially offset by increased spending on our new development programs, XmAb808 (B7-H3 x CD28) and XmAb662 (IL12-Fc). R&D expenses for the six months ended June 30, 2022 were $94.8 million, compared to $90.9 million for the same period in 2021. Increased R&D spending for the first six months of 2022 compared to 2021 is primarily due to an increase in stock-based compensation charges.

General and administrative (G&A) expenses for the second quarter ended June 30, 2022 were $11.1 million, compared to $8.9 million for the same period in 2021. G&A expenses for the six months ended June 30, 2022 were $22.4 million, compared to $17.1 million for the same period of 2021. Increased G&A spending for the second quarter and first six months of 2022 compared to amounts for the same periods in 2021 reflects increased spending on professional services and additional facility costs.

Other expenses for the second quarter ended June 30, 2022 were $6.0 million, compared to other income of $43.2 million in the same period in 2021. Other expenses for the six months ended June 30, 2022 were $8.8 million, compared to other income of $56.3 million in the same period in 2021. Other expenses for the second quarter and first six months of 2022 include unrealized losses on the Company’s marketable equity investments while other income for the second quarter and first six months of 2021 includes realized gains on the sale of an investment equity security and an increase in unrealized gains on the Company’s marketable equity investments.

Non-cash, stock-based compensation expense for the six months ended June 30, 2022 was $23.4 million, compared to $17.6 million for the same period in 2021.

Net loss for the second quarter ended June 30, 2022 was $34.0 million, or $(0.57) on a fully diluted per share basis, compared to net income of $52.2 million, or $0.87 on a fully diluted per share basis, for the same period in 2021. For the six months ended June 30, 2021, net loss was $10.4 million, or $(0.17) on a fully diluted per share basis, compared to net income of $49.8 million, or $0.82 on a fully diluted per share basis, for the same period in 2021. Net loss reported for the second quarter ended June 30, 2022 and first six months of 2022, compared to the net income reported for the same periods in 2021, were primarily due to realized gain on an equity investment and an increase in unrealized gains on marketable equity securities during the second quarter and six months ended June 30, 2021.

The total shares outstanding were 59,684,420 as of June 30, 2022, compared to 58,315,485 as of June 30, 2021.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations through the end of 2025. The Company expects to end 2022 with between $550 million and $575 million in cash, cash equivalents, receivables and marketable debt securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the second quarter 2022 financial results and provide a corporate update. To participate in the conference call,

The live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website at investors.xencor.com and will be archived for at least 30 days. Conference call participants may register through the following link: register.vevent.com/register/BI8b3886bf9772414c8dd5900d3aa4457b.

On August 3, 2022 TransCode Therapeutics, Inc. (Nasdaq: RNAZ) ("TransCode" or the "Company"), the RNA oncology company, and The University of Texas MD Anderson Cancer Center ("MD Anderson"), reported a strategic alliance to advance TransCode’s pipeline of RNA-targeted oncology therapeutic and diagnostic candidates (Press release, TransCode Therapeutics, AUG 3, 2022, View Source [SID1234617396]).

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Through the alliance, TransCode and MD Anderson scientists will collaborate on preclinical studies to further validate TransCode’s therapeutic and diagnostic candidates and to expand the reach of TransCode’s discovery engine. The results of these studies will inform future clinical trials with these agents, including trials to be led at MD Anderson.

"RNA-based therapeutics offer exciting possibilities to treat cancer. We can now examine how regulatory RNAs affect signaling, both spatially and temporally, at the single-cell level in tumor cells, immune cells and stem cells — all critical for tumor progression, relapse and immune evasion," said principal investigator Sendurai Mani, Ph.D., Professor of Translational Molecular Pathology. "Our goals in collaborating with TransCode are to gain a deeper understanding of RNA-targeted therapies and to bring innovative new treatment options to our patients."

The collaboration has the potential to inform multiple clinical programs in TransCode’s pipeline, starting with its lead therapeutic candidate, TTX-MC138, designed to treat multiple metastatic cancers. Future clinical trials will be designed and led by Vivek Subbiah, M.D., Associate Professor of Investigational Cancer Therapeutics at MD Anderson.

"This strategic alliance offers the opportunity to further unlock the potential of our therapeutic pipeline by combining the promise of our image capable delivery platform and discovery engine with the unique talent and resources found at MD Anderson," said Zdravka Medarova, PhD, Co-Founder and CTO of TransCode.

Prior to a Phase I clinical trial, TTX-MC138 is scheduled to enter a first-in-human Phase 0 clinical trial designed to demonstrate delivery of the therapeutic candidate to metastatic lesions in patients with advanced solid tumors.

"We are acutely aware of the expectations that come with a therapeutic approach that has the potential to induce durable regressions of metastatic disease. We are committed to taking every opportunity to fulfill the promise of RNA in cancer," said Michael Dudley, Co-Founder and CEO of TransCode.

On August 3, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and business highlights for the second quarter of 2022 as well as upcoming anticipated corporate milestones (Press release, Surface Oncology, AUG 3, 2022, View Source [SID1234617395]).

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"In the second quarter, we presented encouraging new SRF388 clinical data in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting," said Rob Ross, M.D., chief executive officer. "SRF388, our first-in-class anti-IL27 antibody, demonstrated activity as both a monotherapy and in combination with other IO agents, bolstering our belief that this agent holds the potential to treat a broad range of tumor types. With cash runway into 2024, we believe we are well positioned to deliver a series of meaningful clinical data updates across our pipeline beginning later this year and through the first half of 2023."

Second Quarter and Subsequent Corporate Highlights

In June, Surface announced the publication of a new study highlighting the role of the IL-27 pathway in hepatocellular carcinoma (HCC). Surface collaborated with Cedars-Sinai Medical Center and Fox Chase Cancer Center to conduct the study which evaluated the role of the IL-27 pathway in the development of HCC. The study was published in the online edition of Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

In June, Surface presented new SRF388 Phase 1/1b clinical data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. SRF388 demonstrated clinical activity in multiple solid tumor types with three partial responses across non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC) and HCC. Surface also announced plans to conduct a new expansion study of SRF388 in combination with pembrolizumab in up to 40 patients with relapsed/refractory NSCLC.

In June, Surface announced the appointment of Carsten Brunn, Ph.D., to the board of directors. Dr. Brunn brings more than 25 years of senior leadership experience within multiple biotech and pharmaceutical companies worldwide.

In April, Surface announced the initiation of two Phase 2 clinical studies evaluating SRF388 in multiple tumor types, including a randomized Phase 2 clinical study evaluating SRF388 in combination with atezolizumab and bevacizumab in patients with treatment-naïve HCC and a Phase 2 monotherapy study in patients with previously-treated NSCLC. In addition, the company announced an expansion of the open-label lead-in of the SRF388 randomized Phase 2 study in first-line HCC. The 30-patient lead-in is expected to inform the start of the randomized stage and could elucidate important biomarkers to support enriched patient selection.

At the AACR (Free AACR Whitepaper) Annual Meeting 2022 in April, Surface presented preclinical and translational data supporting the SRF388 recommended Phase 2 monotherapy dose of 10 mg/kg administered intravenously every four weeks.

In April, the company announced that it was recognized by the Boston Business Journal as one of the Best Places to Work for the second year in a row

In Q2, Surface received the anticipated $30 million milestone payment from GlaxoSmithKline for the initiation of the first Phase 1 study for GSK4381562. As part of the licensing agreement, Surface is eligible to receive up to $700 million in potential milestone payments, as well as tiered royalties on global net sales.

The company granted non-qualified stock options to one new employee to purchase 80,000 shares of the company’s common stock with a per share exercise price of $1.64, the closing price on August 1, 2022. The option grant was made under Surface’s 2021 Inducement Plan (the Plan) as an inducement material to the employee entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4) and was granted pursuant to the terms of the Plan.
Selected Anticipated Near-term Corporate Milestones

The company expects to provide a clinical data update on SRF617, a fully human antibody designed to inhibit CD39, in the fourth quarter of 2022.

Surface remains on track to file an Investigational New Drug (IND) application for SRF114, a fully human IgG1 anti-CCR8 antibody, before the end of the year.

Surface anticipates providing multiple SRF388 clinical updates in the first half of 2023, including initial safety and efficacy data from the expanded 30 patient lead-in to the Phase 2 study in first-line HCC.
Financial Results
As of June 30, 2022, cash, cash equivalents and marketable securities were $156.6 million, compared to $154.1 million on December 31, 2021.

General and administrative (G&A) expenses were $6.4 million for both the second quarter ended June 30, 2022, and for the same period in 2021. Decreases in legal and professional fees were partially offset by increased personnel related costs and increased insurance premiums. G&A expenses included $1.3 million in stock-based compensation expense for the second quarter ended June 30, 2022.

Research and development (R&D) expenses were $18.2 million for the second quarter ended June 30, 2022, compared to $12.7 million for the same period in 2021. This increase was primarily driven by progress on our SRF617 and SRF388 Phase 1 and Phase 2 clinical trials. R&D expenses included $0.8 million in stock-based compensation expense for the second quarter ended June 30, 2022.

For the second quarter ended June 30, 2022, net loss was $25.2 million, or basic and diluted net loss per share of $0.46. Net loss was $19.0 million for the same period in 2021, or basic and diluted net loss per share of $0.44.

Surface Oncology continues to project that current cash and cash equivalents are sufficient to fund the company into 2024.