On September 30, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported the topline results from the second part of the ongoing CORIST phase II trial studying Scandion’s lead compound SCO-101 as a combination treatment with FOLFIRI chemotherapy in patients with metastatic colorectal cancer (mCRC) (Press release, Scandion Oncology, SEP 30, 2022, View Source,c3639117 [SID1234621576]).

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The results confirm the safety and tolerability of SCO-101 in this indication and combination. Further, tumor reduction has been observed in some patients, however below the +30% threshold defined as the trial’s primary endpoint. Also, evidence of prolonged progression free survival and stable disease (secondary endpoints) were observed in this hard-to-treat refractory patient population.

Importantly, the data is obtained from the 25 patients enrolled in CORIST part 2, more of whom have only been evaluated after eight weeks of treatment. Patients are still participating in the study, which means that the topline results are not final and could change with longer treatment.

"While we do not achieve a clinical proof of concept for efficacy through these topline results, we are encouraged by the signals observed in the trial, confirming the rationale for combining SCO-101 and FOLFIRI in this indication. We look forward to continuing the development by progressing the CORIST trial further as planned," says Johnny Stilou, acting CEO of Scandion.

Scandion will continue the CORIST trial enrolling up to 36 patients to be treated according to an optimized dosing schedule as part 3 of the trial. Based on an improved understanding of the pharmacokinetics of SCO-101 in combination with FOLFIRI, increased doses of SCO-101 and chemotherapy will be explored aiming to exploit the full potential of SCO-101 in this indication and combination. The first patient is expected to be enrolled in CORIST part 3 shortly.

Depending on the dose escalation results, CORIST part 3 may be completed by Q3 2023, with an update on the timeline expected in Q1 2023. Scandion then expects to conduct part 4 of the trial, which will conclude the combined CORIST trial.

Webcast and conference call on October 4 at 10:00 am CET

On October 4 at 10:00 am, Scandion Oncology’s executive management will host a webcast and conference call about the topline results from the second part of CORIST.

The event can be accessed via www.scandiononcology.com or through dial in on below numbers:

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on September 30, 2022, at 10.30 CET.

On September 30, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company, reported the launch of Oncology FACETS: an educational platform for healthcare providers that will address clinically impactful topics in gynecologic oncology (Press release, Mersana Therapeutics, SEP 30, 2022, View Source [SID1234621575]). Oncology FACETS is driven by a Steering Committee of experts in gynecologic oncology and offers content developed in collaboration with Mersana.

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"Our goal is to create a destination where oncologists can find up-to-date, peer-reviewed educational content on emerging topics about ovarian, endometrial, cervical, and other gynecological cancers," said Dr. Thomas J. Herzog of the University of Cincinnati, who is serving as Steering Committee Chair. "We believe Oncology FACETS will provide a valuable resource for physicians seeking to keep pace with this field’s rapidly evolving science and data."

Each Oncology FACETS educational module is led by a Steering Committee member. The first module is "Current and Emerging Biomarkers in Gynecologic Cancer," led by Dr. Rebecca C. Arend, a leading gynecologic oncologist at the University of Alabama at Birmingham. The module is now available for download at OncologyFACETS.com.

Dr. Arend noted, "Precision medicine is now at the forefront of the oncology field. Biomarkers are central to this movement, and their use in gynecologic malignancies promises to shape the treatment paradigm in the near future. This module is intended to both educate and facilitate peer-to-peer dialogue about this important topic."

Oncology FACETS will release new modules on a regular basis. The next module, planned to be released in December 2022, will focus on antibody-drug conjugates (ADCs) in gynecologic malignancies.

"We are proud to collaborate with this esteemed group of gynecologic oncologists to advance knowledge and patient care," said Anna Protopapas, President and Chief Executive Officer of Mersana. "Oncology FACETS is a natural extension of our commitment to driving innovation aimed at improving outcomes for women with gynecologic cancers."

About Oncology FACETS
Oncology FACETS is the outcome of a collaboration between the Oncology FACETS Steering Committee and Mersana Therapeutics, Inc. Oncology FACETS disseminates educational resources to advance the learning of practicing healthcare professionals; it is not intended as medical advice and includes information on both approved medications and investigational agents not yet approved for use in any country. The committee of experts in gynecologic oncology was assembled to provide guidance and approval of the material contained within this website. Mersana provides financial, administrative, and writing support to the Steering Committee in developing these resources. Oncology FACETS is not an accredited provider of continuing medical education.

The Oncology FACETS Steering Committee members include Thomas J. Herzog, MD, University of Cincinnati (serving as Chair); Rebecca C. Arend, MD, MSPH, University of Alabama at Birmingham; John L. Hays, MD, PhD, Ohio State University; Bhavan Pothuri, MD, PhD, New York University; Leslie M. Randall, MD, MAS, Virginia Commonwealth University; and Ritu Salani, MD, MBA, University of California, Los Angeles. Committee members provide guidance on the development of all educational material. They represent diverse geographic regions across the United States.

Each educational module is led by a Steering Committee member. The first educational module is available for download at OncologyFACETS.com. A second module is in progress and will be released in December 2022. Associated content and updates can be followed @OncologyFACETS on Twitter.

On September 30, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results for the first six months of 2022 and provided an update on clinical and corporate progress (Press release, Vivoryon Therapeutics, SEP 30, 2022, View Source [SID1234621574]). The report is available on the Company’s website at View Source

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"The first half of 2022 was marked by decisive progress in the development of our lead candidate varoglutamstat in AD, which cumulated in several data presentations at the prestigious AAIC 2022 in San Diego in July and August," said Dr. Ulrich Dauer, CEO of Vivoryon. "Firstly, we have been able to further de-risk clinical development of varoglutamstat with extremely encouraging safety results from our VIVIAD Phase 2b study. At the same time, adding to the preclinical data package by characterizing the additive effect of varoglutamstat in combination with anti-Abeta antibodies, we continue to explore the full potential for its application in a variety of therapeutic settings. These data, which have sparked excitement within the medical community and beyond, substantiate our commitment to making a difference to all those affected by Alzheimer’s disease. Having secured a significant private placement will enable us to continue to follow our carefully crafted development strategy. We warmly welcome our new investor KKR Dawn Aggregator L.P. and are very grateful to them and to our longstanding investor Claus Christiansen for their support through the upcoming clinical milestones."

Portfolio Highlights (H1 2022 and post-period)

VIVIAD

VIVIAD (NCT04498650) is a state-of-the-art Phase 2b study conducted in Europe and designed to evaluate the safety, tolerability and efficacy of varoglutamstat in 250 subjects with mild cognitive impairment (MCI) and mild Alzheimer’s disease (AD).
On June 23, 2022, Vivoryon announced that it has completed the parallel group, dose-finding part of its VIVIAD study and that the independent Data Safety Monitoring Board (DSMB) has selected the highest dose investigated, 600 mg twice daily (BID), as the final dose to be administered in the second part of the study. The DSMB decision is based on safety data from 181 patients, 90 of which had completed the week 24 treatment visit at the May 17 cut-off date. All subjects randomized to the treatment arm will be treated at the selected dose of 600 mg BID moving forward and will continue treatment for up to 48-96 weeks dependent on study entry date.
Vivoryon presented detailed safety data from the VIVIAD study at the Alzheimer’s Association International Conference (AAIC) in San Diego (July 31 to August 4, 2022). The safety data showed that varoglutamstat was well tolerated with only 14% of overall reported adverse events (AEs) considered to be potentially related to study treatment. All of the AEs were gastrointestinal, general, or related to the nervous system or skin. Only four patients (2.2%) experienced serious AEs (SAEs) and only two patients (1.1%) discontinued the study. Both the total number of SAEs and the discontinuation rate were considerably lower than the respective numbers at the 800 mg BID varoglutamstat dose in Vivoryon’s completed Phase 2a SAPHIR study (NCT02389413; 15% SAEs, 33% discontinuation), while retaining a similar level of target inhibition.
VIVIAD is actively enrolling patients at 22 study centers in five European countries and will continue to evaluate its primary and secondary outcome measures, which include multiple cognitive, safety and biomarker endpoints. Vivoryon remains on track for final data readout for the study in the second half of 2023.
VIVA-MIND

VIVA-MIND (NCT03919162) is a combined Phase 2a/b study for varoglutamstat conducted in the U.S. which seeks to enroll 180 patients with early AD into the Phase 2a adaptive dose finding part. If predefined criteria are fulfilled, the trial will pass a stage-gate into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for at least 72 weeks. Thus, taken together a total of 414 patients will be treated on stable doses of varoglutamstat for 18 months in the course of the study. The primary endpoint for this study is CDR-SB (clinical dementia rating scale – sum of boxes), an established approvable endpoint measuring a combination of cognitive abilities and activities of daily living. The study is coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), and supported by a USD15 million grant from the National Institute on Aging (NIA award number R01AG061146).
VIVA-MIND is actively enrolling patients, with currently 14 sites open and on track for an interim futility analysis planned for the first half of 2023.
Preclinical Programs

Also at AAIC 2022, Vivoryon presented preclinical data on the Company’s N3pE amyloid-targeting molecules. The results underscore the unique potential of Vivoryon’s N3pE amyloid-targeting therapeutic strategy in both mono- and combination therapy settings in AD. The data show, that a combination treatment of aducanumab and varoglutamstat achieves additive effect on Abeta pathology, indicating feasibility of dose reduction to improve safety of Abeta antibody-based AD treatments. This demonstrates the potential benefit of a combination therapy designed to simultaneously make use of two different and independent molecular N3pE-related mode of actions – small molecule based QPCT/L inhibition and anti-N3pE-immunotherapy. Additional data from murine analog of PBD-C06 highlight the differentiated safety profile vs. other anti-Abeta antibodies at N3pE amyloid-lowering concentrations.
Partnered Programs

On February 28, 2022, Vivoryon and its partner Simcere announced that China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has approved the Clinical Trial Application for varoglutamstat for the development in Greater China by Simcere. Simcere has communicated that the company is currently preparing for initiation of clinical studies in China.
Corporate Development Highlights (H1 2022 and post-period)

On September 30, 2022, the Company entered into a private placement of 2,054,796 registered shares at an offering price of EUR 7.30 per share. The new shares from the capital increase represent 9.3% of Vivoryon’s existing share capital and will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights. Consequently, the Company’s issued share capital will increase to EUR 24,105,278.00 on completion of the private placement. In addition, the investors will have the option to purchase, in aggregate, up to another 2,054,796 registered shares at a price of EUR 7.30 during a period ending twelve months after the date of the approval of a EU Recovery prospectus (in accordance with Section 14a Prospectus Regulation) or three months after the achievement date of a defined clinical milestone, whichever is later. The gross proceeds of the private placement amount to EUR 15.0 million, and up to an additional EUR 15.0 million will be raised if the option to purchase the additional shares is exercised in full. Vivoryon intends to use the net proceeds from the offering to support the ongoing clinical development of its lead candidate varoglutamstat, currently in Phase 2 in Europe and the United States for the treatment of patients with Alzheimer’s disease, as well as for general corporate purposes. The private placement was supported by Vivoryon’s longstanding investor Claus Christiansen and KKR Dawn Aggregator L.P. ("Dawn Biopharma"), a platform controlled by affiliates of Kohlberg Kravis Roberts & Co. L.P. ("KKR"), a leading global investment firm, as new investor to the Company. Completion of the private placement is expected to occur on October 6, 2022.
In an in-person and webcasted breakfast and networking event at AAIC 2022, held on August 2, 2022, Vivoryon met with researchers, clinicians and the investment community to discuss the future of AD treatments and provided updates on its VIVA-MIND and VIVIAD studies for varoglutamstat. The event also featured spotlight presentations by Prof. Howard Feldman, MD, Professor of Neurosciences and Director of the ADCS at UC San Diego and VIVA-MIND study director, Cynthia Lemere, PhD, Associate Professor of Neurology, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston and Dr. Frank Weber, CMO of Vivoryon.
On June 22, 2022, Vivoryon held its Annual General Meeting where all voting items were approved with a large majority. Voting items included the re-appointment of Charlotte Lohmann, Dr. Erich Platzer, Dr. Dinnies von der Osten and Dr. Jörg Neermann as members of the Company’s Non-Executive Board, as well as the appointment of Dr. Claudia Riedl and Samir Shah, MD, to its Non-Executive Board of Directors.
On April 1, 2022 Vivoryon announced the successful completion of a private placement, raising gross proceeds of EUR 21 million, with net proceeds from the offering intended to be used to support the ongoing clinical development of varoglutamstat, as well as for general corporate purposes. The capital raise was supported by a number of high-quality institutional investors from Europe and the U.S. as well as members of Vivoryon’s Executive and Non-Executive Boards.
Financial Results for the First Half Year 2022

The Company generated no license revenues or smaller revenue in half year 2022 or 2021.

Research and development expenses increased in 2022 by EUR 1.6 million compared to the six months ended June 30, 2021. This increase is primarily attributable to EUR 1.7 million higher expenses related to our clinical trial VIVIAD, which has advanced significantly compared to the six months ended June 30, 2021.

General and administrative expenses for the six months ended June 30, 2022 are about the same level as for the six months ended June 30, 2021. Higher expenses for share based payments with EUR 0.3 million were compensated by EUR 0.3 million lower expenses for legal and consulting services.

Net loss for the six months ended June 30, 2022 was EUR 12.6 million, compared to EUR 11.7 million for the six months ended June 30, 2021. The Company held EUR 24.4 million in cash and cash equivalents as of June 30, 2022, compared to EUR 14.7 million as of December 31, 2021.

Cash flows provided from financing activities were EUR 19.6 million for the six months ended June 30, 2022 compared to cash used in financing activities of EUR 0.5 million in the six months ended June 30, 2021. The change mainly relates to a private placement on April 1, 2022 by way of accelerated book building, placing 2,000,000 registered shares at an offering price of EUR 10.50 per share. The Company’s issued share capital has increased to EUR 22,050,482. The gross proceeds of the offering amounted to EUR 21.0 million.

Financial Guidance

Including the proceeds from the private placement entered into on September 30, 2022, according to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well the general and administrative expenses and cash flows from investing and financing activities at least through December 2023. This does not include the exercise of the option to acquire up to an additional 2.054.796 shares for a period ending the later of twelve months after the date of the approval of a EU Recovery prospectus (in accordance with Section 14a Prospectus Regulation) or the achievement date of a defined clinical milestone.

Vivoryon Therapeutics N.V. Financial Statements

Condensed Statements of Profit or Loss and Other Comprehensive Income for the six months ended June 30, 2022 and 2021

The accompanying notes are an integral part of these condensed interim financial statements.

The accompanying notes are an integral part of these condensed interim financial statements.

The accompanying notes are an integral part of these condensed interim financial statements.

Half Year Financial Report 2022

The condensed interim financial statements of Vivoryon have been prepared in accordance with IAS 34 Interim Financial Reporting and International Financial Reporting Standards (IFRS) of the International Accounting Standards Board, as adopted by the European Union (EU-IFRS). The half-year financial statements were not audited or reviewed. The reports are available on the Company’s website www.vivoryon.com.

Conference Call and Webcast

Vivoryon will host a conference call and webcast today, September 30, 2022, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the full year results.

Please dial in ten minutes prior to commencement.

A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/

Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/

On September 29, 2022 HanX Biopharmaceuticals reported Puyouheng (generic name: Putalimab Injection, also known as HX008) received marketing approval from the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic melanoma after failure of previous systemic therapy (Press release, HanX Biopharmaceuticals, SEP 29, 2022, View Source [SID1234655944]). This is another new indication for Puyouheng (Putalimab Injection), following its approval for MSI-H/dMMR solid tumors in July of this year, and will provide a new immunotherapy option for melanoma patients in China.

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Putalimab was developed by Hans Biopharma and conducted early clinical trials in 2018 in collaboration with Lepu Biopharma. Lepu Biopharma submitted two NDAs to the NMPA in June and October 2021, for the treatment of melanoma and MSI-H/dMMR solid tumors, respectively. Both NDAs have been approved. Dr. Zhang Faming, Chairman of Hans Biopharma, stated, "The market potential for melanoma and MSI-H/dMMR solid tumors in China is enormous. This approval by the NMPA of another NDA for this product will provide new treatment options for domestic patients. I am pleased with the effective collaboration between Hans Biopharma and Lepu Biopharma over the past few years and the approval of Putalimab for both indications."

On September 29, 2022 LEPU BIOPHARMA reported that its first innovative biological drug, anti-PD-1 antibody – Puyouheng (generic name: pucotenlimab injection) has been approved for marketing by the National Medical Products Administration (NMPA) for the indication of unresectable or metastatic melanomas after the failure of previous systemic therapy (Press release, Lepu Biopharma, SEP 29, 2022, View Source [SID1234633515]). It is another approved indication for Puyouheng (pucotenlimab injection) following the approval of the indication of MSI-H/dMMR solid tumor in July this year and will bring a new immunotherapy treatment option for patients with melanoma in China. The Company is also pleased to announce that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC) has granted MRG003 breakthrough therapy designation for the treatment of recurrent or metastatic nasopharyngeal cancer (R/M NPC).

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Bringing a new option to tumor immunotherapy for patients.

This approval was mainly based on a single-arm, open-label, pivotal phase II clinical study with a primary endpoint of the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to the RECIST 1.1. A total of 119 patients were enrolled in this trial. As of July 30, 2021, the ORR assessed by the IRC was 20.2% (95% CI: 13.4-28.5, 1 case of complete response, 23 cases of partial response). The results of the study show that Puyouheng brings significant benefits to patients in the treatment of unresectable or metastatic melanomas after the failure of previous systemic therapy, and meets the preset primary endpoint with excellent safety. The results of the clinical study were first published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Melanoma is a malignant tumor of melanocytes. Although melanoma only accounts for less than 5% of skin cancers, it is the deadliest form which takes up more than 75% of all deaths caused by skin cancers. Surgical treatment is the main option for malignant melanomas in the early stage with a better prognosis, while the treatment of advanced melanomas is limited with a poor prognosis. As an innovative anti-PD-1 humanized monoclonal antibody drug, Puyouheng innovatively prolongs its half-life through triple mutations and can bind to PD- 1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2.

With a strong affinity to PD-1 and outstanding binding stability, Puyouheng has demonstrated excellent anti-tumor efficacy in both in vitro and clinical trials.

Actively conducting studies on the combination therapy within our pipelines under the support of a clinical layout covering multiple solid tumors.

Puyouheng has been approved for marketing with indications of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors and advanced melanomas. In addition to the two approved indications, focusing on Puyouheng, LEPU BIOPHARMA is accelerating its development in the treatment of multiple solid tumors and actively investigating combined tumor immune immunotherapies, including the treatment of gastric cancer, liver cancer, lung cancer, and other cancer types with high incidence. In terms of international development, LEPU BIOPHARMA is also speeding up its efforts to expand the international market, promoting joint development, cooperation and authorization of new drugs globally. In January 2022, it obtained IND approval from the US FDA for pucotenlimab in the treatment of advanced solid tumors.

Breakthrough therapy designation granted by the CDE to MRG003 for the treatment of R/M NPC Breakthrough therapy designation is for innovative or modified new drugs that treat a condition that is seriously life-threatening or has serious quality-of- life impairment, and such condition has no effective therapies or compared with current available therapies, sufficient evidence demonstrates an obvious advantage in clinic treatment of the new drugs.

Previously, MRG003 has been granted the Orphan-drug Designation by the Food and Drug Administration of the United States (the "FDA") for the treatment of R/M NPC. MRG003 is the most advanced EGFR-targeted ADC in clinical-stage development in China and has the potential to seize market opportunities. The breakthrough therapy designation, which helps to expedite the development and review of the drug by the CDE, represent an encouraging signal to the promotion of MRG003 as well as the strategy of developing market-differentiating pipeline of the Company.

About Puyouheng (pucotenlimab injection)
Puyouheng (pucotenlimab injection) is a humanized IgG4 monoclonal antibody against human PD-1 independently developed in China. It can bind to PD-1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2. Puyouheng (pucotenlimab injection) adopts an innovative molecular design to prolong its half-life, showing strong clinical anti-tumor activity and good safety. The innovative use of antibody engineering technology to introduce triple mutations in the Fc region improves the binding affinity of FcRn, thereby prolonging the drug’s half-life significantly, showing its promising clinical efficacy and drug compliance in patients. Compared with all rival anti-PD-1 antibodies that have been marketed or entered phase III clinical trials, the mean half-life of Puyouheng (pucotenlimab injection) is 21.8 days (single dosing) and 38.2 days (steady-state). In addition, the prolonged half-life does not cause additional adverse events, indicating the excellent clinical efficacy of the drug.

About MRG003
MRG003 is an ADC comprised of an EGFR-targeted monoclonal antibody ("mAb") conjugated with the potent microtublin inhibiting payload monomethyl auristatin E ("MMAE") via a valinecitrulline linker. It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment. In China, the Company is conducting exploring research of MRG003 in several indications and amongst others, patient enrollment was completed in March 2022 for exploratory Phase II clinical study of MRG003 in advanced NPC. It has entered the follow-up period and clinical data is outstanding.