On July 28, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported an update on the investigator-initiated Phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC) (Press release, Onconova, JUN 28, 2021, View Source [SID1234584413]). The clinical data to date provide preliminary evidence of potential anti-cancer activity of rigosertib-nivolumab combination therapy in advanced metastatic KRAS+ non-small cell lung cancer and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not reached in the three cohorts of the trial’s dose-escalation phase. Patients enrolled in this trial have failed multiple lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations.

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The trial continues to recruit patients as part of the expansion phase at the highest dose of oral rigosertib defined in the current protocol. Based on the positive preliminary findings from the trial, a protocol amendment is being prepared that would allow for the evaluation of increased rigosertib doses in combination with the full dose of intravenous nivolumab, as recommended per its product label.

"The preliminary results from this Phase 1/2a trial are very encouraging and demonstrate the potential of rigosertib to address a critical unmet medical need by overcoming checkpoint inhibitor resistance in KRAS mutated lung adenocarcinoma," said Mark S. Gelder, M.D., Chief Medical Officer of Onconova. "The observation of preliminary evidence of efficacy in combination with acceptable safety of the doublet in this extremely challenging patient population provides a promising signal. This phase 1 study supports the preclinical observation in melanoma of the up regulation of crucial cell surface molecules by rigosertib which may synergize with immune checkpoint blockade, as recently published in Molecular Cancer, and strongly supports the continued clinical development of rigosertib-checkpoint inhibitor combination therapy. We look forward to the presentation of preliminary data at the upcoming 3rd Annual RAS Targeted Drug Development Summit taking place September 21-23, 2021, and at a future major medical meeting as the data mature."

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, "This Phase 1/2a trial is an important part of our investigator-initiated study program, which enables us to pursue opportunities to develop rigosertib in high-need KRAS mutated indications while maintaining our primary focus on our lead ON 123300 program. We are very pleased both with the safety and preliminary efficacy signal we have seen from the KRAS mutated NSCLC trial to date, considering the multiple lines of therapy many of these patients have previously failed, including checkpoint inhibitors in various combinations. We are supportive of the plan to expand dose-escalation of rigosertib to determine the optimal recommended Phase 2 dose of the combination; and are eagerly anticipating results of important correlative science that is part of the trial. We look forward to the trial’s continued progress and would like to thank the investigator and his team for conducting the trial, as well as the patients who are participating."

About the Investigator-initiated Phase 1/2a Trial
This Phase 1/2a trial is designed to evaluate the combination of rigosertib and nivolumab in advanced KRAS+ metastatic lung adenocarcinoma patients who have progressed on standard of care with anti-PD-1 monotherapy or anti-PD-1 in combination with chemotherapy. It includes a dose-escalating Phase 1 portion followed by a Phase 2a dose-expansion portion. Patients in the trial receive oral rigosertib twice daily on days 1-21, and intravenous nivolumab on days 1 and 15 of 28-day cycles. The primary endpoints of the trial are safety assessments and overall response rate. Secondary endpoints include progression free survival and overall survival. For more information on the trial, see ClinicalTrials.gov Identifier: NCT04263090.

On June 28, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that the first UK patient has been enrolled in the Phase I clinical trial of TG4050, Transgene’s innovative individualized cancer immunotherapy, currently being evaluated in HPV-negative head and neck cancer patients (Press release, Transgene, JUN 28, 2021, View Source [SID1234584412]). TG4050 is a therapeutic vaccine based on Transgene’s myvac technology platform, which leverages Transgene’s proprietary technologies and cutting-edge Artificial Intelligence (AI) capabilities to customize the treatment for each patient.

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The innovative approach behind TG4050 combines Transgene’s expertise in virus-based immunotherapies, NEC’s longstanding AI technologies and the commitment of prestigious cancer care centers in the United Kingdom, the European Union, and the United States.

THE FIRST UK PATIENT OF THE TRIAL EVALUATING THIS INDIVIDUALIZED CANCER IMMUNOTHERAPY HAS BEEN INCLUDED IN LIVERPOOL, UK, in a trial enrolling patients with squamous cell carcinoma of the head and neck.

The trial is led by the coordinating investigator Professor Christian Ottensmeier, Consultant Medical Oncologist at The Clatterbridge Cancer Centre and Professor of Immuno-Oncology at the University of Liverpool. In the UK, the trial is being conducted in Liverpool and in Southampton (at the Clatterbridge Cancer Centre NHS Foundation Trust, at Liverpool University Hospitals and at the University Hospital Southampton NHS Foundation Trust / University of Southampton).

Professor Christian Ottensmeier, M.D., Ph.D., coordinating investigator of the study, added: "We are pioneering the personalized cancer vaccine field. If successful, this technique could be a potentially game-changing development in the treatment of advanced head and neck cancers. We have spent the last 15 years working on the science behind this immunotherapy so it is very gratifying to be beginning clinical trials with the first patient being enrolled in the UK. Head and neck cancers are particularly complex to treat if they spread and cannot then be completely removed surgically. Personalized cancer vaccines are an extremely exciting development and, if successful, the same technique could also be applied to treat other forms of cancer." P R E S S R E L E A S E Page 2/4

Dr. Maud Brandely, M.D., Ph.D., Chief Medical Officer of Transgene, added: "We are delighted to start the clinical trial with our individualized myvac immunotherapy in the UK. We have been collaborating for several years with Professor Ottensmeier on this novel therapy to better target tumor cells and we are excited to see that our world-leading innovations are now reaching patients in different countries in Europe and in the USA. We are convinced that, together with leading scientists and clinicians, we will be able to demonstrate the value of our individualized approach against head and neck cancer and leverage these future results to target other solid tumors."

TG4050 IS A CANCER VACCINE FULLY CUSTOMIZED FOR EACH PATIENT COMBINING BEST-IN-CLASS THERAPEUTIC VACCINE RESEARCH AND CUTTING-EDGE AI TECHNOLOGY

Transgene’s highly innovative technology platform, myvac, enables the generation of a virusbased immunotherapy, which encodes patient-specific cancer cell mutations (neoantigens) identified and selected by NEC’s Neoantigen Prediction System (NPS), an advanced AI technology approach. TG4050 has been designed to target up to 30 patient-specific neoantigens.

With more than 20 years of AI expertise, NEC’s NPS has been trained using both proprietary and public immune databases. Preclinical work with the myvac technology platform has demonstrated that NEC’s AI-based tumor mutanome profiling tool accurately selects and prioritizes the most immunogenic neoantigens from each unique tumor1.

Transgene is using its expertise in viral genome engineering to incorporate the selected neoantigens into the DNA of the myvac-MVA viral vector.

The company has also set up a unique in-house Good Manufacturing Practices (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 that are needed for the ongoing Phase I clinical studies with this novel therapeutic vaccine.

FIRST DATA FROM TWO ONGOING CLINICAL TRIALS EXPECTED IN 4Q 2021
In a first Phase I trial, TG4050 is being administered to patients with HPV-negative head and neck cancer (NCT04183166). A personalized treatment is created for each patient after they complete surgery and while they receive an adjuvant therapy. Half of the participants receive their vaccine immediately after they complete their adjuvant treatment. The other half will be given TG4050 as an additional treatment at the time of recurrence of the disease. This randomized study is evaluating the treatment benefits of TG4050 in patients who have a high risk of relapse. Up to 30 patients will receive TG4050 in France, in the UK and in the USA.

The principal investigator of the trial is Prof. Christian Ottensmeier, M.D., Ph.D., Consultant Medical Oncologist at the Clatterbridge Cancer Centre and Professor of Immuno-Oncology at the University of Liverpool. In France, the clinical trial is being conducted at the IUCT-Oncopole, Toulouse, by Prof. Jean-Pierre Delord,M.D., Ph.D. and at Institut Curie, Paris, by Prof. Christophe Le Tourneau, M.D., Ph.D., Head of the Department of Drug Development and Innovation (D3i). In the USA, the trial is being led by Dr. Yujie Zhao, M.D., Ph.D., at the Mayo Clinic. 1 Mallone et al., "Performance of neoantigen prediction for the design of TG4050, a patient specific neoantigen cancer vaccine", AACR (Free AACR Whitepaper), June 2020 Page 3/4

In parallel, a second Phase I clinical trial of TG4050 is enrolling patients with ovarian cancer (NCT03839524). This second trial is including patients after surgery and first-line chemotherapy. Dr. Matthew Block, M.D., Ph.D., Consultant Medical Oncology, Consultant Immunology and Associate Professor of Oncology at the Mayo Clinic (USA) is the principal investigator of the trial; in France, the trial is being conducted by Prof. Christophe Le Tourneau at Institut Curie and by Dr. Alexandra Martinez, M.D., Associate Head of Surgical Department, at Toulouse-Oncopole. The first data from the two trials evaluating TG4050 are expected in 4Q 2021.

About TG4050
TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences. TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient. This best-in-class candidate is being evaluated in two Phase I clinical trials for patients with ovarian cancers (NCT03839524) and HPV-negative head and neck cancers (NCT04183166).

About myvac
myvac is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future" funding from Bpifrance for the development of its platform myvac. TG4050 is the first myvac-derived product being evaluated in clinical trials. Click here to watch a short video on myvac.

On June 28, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported key clinical and regulatory updates across its pipeline (Press release, Zentalis Pharmaceuticals, JUN 28, 2021, View Source [SID1234584411]).

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"We continue to build substantial value in Zentalis’ portfolio, driving toward approval of our differentiated cancer therapeutics to help patients worldwide," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Based on our clinical results reported to date, the emerging clinical profiles of our candidates support the potential for best-in-class positioning for a range of tumor types addressing large patient populations, is use as a monotherapy or in combinations. In particular, we are excited about the compelling profile of ZN-c3, our WEE1 inhibitor, as it demonstrated additional, deepening and durable tumor responses as a monotherapy in heavily pretreated solid tumors. These promising data set the stage for the many upcoming planned trials – two of which have the potential to be registrational monotherapy studies in indications with significant unmet medical needs. We look forward to a productive second half of 2021, as we focus on delivering on our milestones across our entire pipeline."

ZN-c3: Oral WEE1 Inhibitor for Solid Tumors

Updates from our ongoing trials of ZN-c3 continue to support the potential for our WEE1 inhibitor, ZN-c3, to be both first-in-class and best-in-class. Since our last update at AACR (Free AACR Whitepaper) in April 2021, and as of the data cut-off date of May 15, 2021:

The 2 unconfirmed Partial Responses (PRs) reported at AACR (Free AACR Whitepaper) were confirmed, bringing the total number of confirmed PRs from our monotherapy trial from 3 to 5. Since AACR (Free AACR Whitepaper), an additional unconfirmed PR was reported in a patient with uterine serous carcinoma (USC), resulting in 3 out of 7 USC patients enrolled having responded to treatment. Overall, the objective response rate (ORR) in the USC population increased from 40% to 43% based on RECIST criteria.
Additionally, within the exceptional responder population in the Phase 1 monotherapy trial, we have observed a patient with an ongoing treatment duration of more than 8 months, with a deepening response of 65% to 69% tumor size decrease based on RECIST criteria.
Lower overall severe hematological adverse event rates – severe neutropenia adverse event rates decreased from 2.9% to 2.2% with an additional 11 patients enrolled since AACR (Free AACR Whitepaper) 2021.
Following an End-of-Phase 1 meeting, the U.S. Food and Drug Administration (FDA) concurred in principle with the proposal that ZN-c3 has the potential for an accelerated approval pathway based on the proposed global study design of a Phase 2 monotherapy trial in women with recurrent or persistent USC. The trial has initiated with multiple sites open.
Zentalis is planning to launch a biomarker-driven Phase 2 study pending FDA feedback. The tumor-agnostic trial will investigate ZN-c3 in patients with solid tumors that express the identified predictive biomarker, and is expected to initiate by year-end.
ZN-c3 has received orphan drug designation, and rare pediatric disease designation from the FDA for pediatric osteosarcoma. The Phase 1/2 trial of ZN-c3 in combination with chemotherapy in pediatric patients with osteosarcoma is expected to initiate in 3Q 2021. If ZN-c3 were to obtain approval for the designated indication, it could be eligible for a rare pediatric disease priority voucher upon approval.
Zentalis will also support two planned additional investigator-initiated trials: a trial with the Ivy Brain Center in glioblastoma multiforme (GBM) and a trial with immunotherapy with Dana Farber in triple negative breast cancer.
Zentalis’ China JV Zentera is advancing corresponding clinical trials in China with ZN-c3.
ZN-c5: Oral SERD for ER+/HER2- Advanced or Metastatic Breast Cancer

Based on the interim results from multiple ongoing trials, ZN-c5 has demonstrated the potential to support best-in-class tolerability in both monotherapy and combination settings, with strong clinical results observed. As of May 11, 2021, the following data were collected:

Monotherapy Trials (Expansion and Dose Escalation)

In total, 56 patients with 2 median prior lines of treatment were evaluated for safety and efficacy. Across all doses from 50 mg QD to 300 mg QD, the observed CBR was 33% and the ORR was 5%. ZN-c5 generated 2 PRs at the 150 mg and 300 mg doses. Adverse events (AEs) were found in less than 10% of the patients and there were no observed cases of bradycardia, visual disturbances, QTC or dizziness. Of note, treatment related diarrhea adverse event rate was 3.6%, with only grade 1 or 2 events observed. The Phase 2 monotherapy trial has been initiated and Zentalis may take multiple doses into this study.

An oral dose of 50 mg QD (n=16) demonstrated a CBR of 40%, with many patients in this dose cohort remaining on study drug and in the trial. Final determination of the monotherapy RP2D will occur following completion of this 50 mg QD dose cohort.
Combination Dose Escalation Trials with Pfizer’s CDK4/6 Palbociclib and Lilly’s CDK4 and 6 Abemaciclib

Tolerability data for ZN-c5 suggests it could be best-in-class in oral SERDS, making this candidate ideal for further evaluation in combination. The two separate trials will continue to enroll patients and the Company expects to report interim results in 1H 2022 from one or more of these trials.
Window of Opportunity Trial

The Window of Opportunity trial (n=35) demonstrated ER degradation across all doses tested.
ZN-d5: Highly Selective Oral BCL-2 Inhibitor for Hematologic Tumors

The Phase 1 monotherapy dose-escalation trial, initiated in 4Q 2020, has enrolled 14 patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) thus far in the fifth dose cohort. Additionally, no dose-limiting toxicities have been identified. Patients with acute myeloid leukemia will begin enrollment in 3Q 2021. Interim results from this Phase 1 trial are expected in 1H 2022.
ZN-e4: 3rd Generation Oral EGFR Inhibitor for Non-Small-Cell Lung Carcinoma

The Phase 1/2 dose-escalation trial in patients with advanced non-small cell lung cancer is ongoing with 26 patients (both osimertinib-naïve and experienced) enrolled to date. ZN-e4 has been well-tolerated at all doses as of the March 25, 2021 data cut-off, and clinical activity was identified at doses greater than 80 mg QD. Interim results from the Phase 1/2 trial are expected in 4Q 2021.
Webcast Event:
Zentalis will host a webcast event today, June 28, 2021 at 8:30 a.m. EDT. To register and access the event, the webcast link is available on the Investors & Media section of the Zentalis website at www.zentalis.com.

On June 28, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the Company has joined the broad-market Russell 3000 and Microcap Indexes as part of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens today, Monday, June 28, 2021 (Press release, Vincerx Pharma, JUN 28, 2021, View Source [SID1234584409]).

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"Vincerx is pleased to be included in the Russell 3000 and Microcap Indexes, a milestone that highlights our growth since becoming a public company late last year and will broaden our visibility within the investment community," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Our inclusion in these indexes demonstrates our continued commitment to creating value for our shareholders, and we look forward to continuing our mission of developing innovative targeted oncology therapeutics to transform treatment paradigms for hematological malignancies and solid tumors."

Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of May 7, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell 3000 Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

About FTSE Russell:
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group.

On June 28, 2021 SHINE Medical Technologies LLC reported that it has closed a $150-million Series C-5 financing (Press release, Shine Medical Technologies, JUN 28, 2021, View Source;pk_kwd=shine-medical-technologies-closes-150-million-series-c-5-financing [SID1234584407]). Koch Disruptive Technologies (KDT) led the round, which also included participation by Fidelity Management & Research Company, Baillie Gifford and other new and current investors . The financing will support SHINE’s commercialization of its diagnostic and therapeutic medical isotope technologies and position the company for future growth as it works toward developing new fusion-based technology applications.

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"KDT is an incredible strategic partner for SHINE as we commercialize both diagnostic and therapeutic medical isotopes, and work towards fusion-based nuclear waste recycling and clean energy production," said Greg Piefer, Chairman and CEO of SHINE. "Koch knows how to scale a company, with more than 120,000 employees around the world, and we look forward to tapping that knowledge as we continue to grow. SHINE’s mission is to usher in a new era of nuclear fusion technology and Koch, which is among the biggest players in energy, is a great long-term, strategic match for us as we pursue our ultimate goal: fusion-based clean energy. We are grateful for their confidence and investment in SHINE."

"SHINE’s innovative medical isotope technologies, which play a crucial role in identifying and treating patients with debilitating diseases, are astounding," said Chase Koch, President of KDT. "We believe SHINE has the potential to change not only the production and supply of medical isotopes, but to transform industrial segments globally by leveraging the company’s nuclear-fusion based technology for industrial inspection and imaging, nuclear waste recycling and energy production. Koch’s global knowledge networks and capabilities are uniquely suited to help SHINE’s impressive team implement its vision to advance fusion technology. We look forward to a productive partnership."

An existing SHINE facility produces the therapeutic medical isotope lutetitum-177 (Lu-177). Radiotherapeutics are one of the fastest growing areas of oncology and has significant potential for the treatment of several cancers because of their ability to directly irradiate cancer including at the late stages. SHINE’s manufacturing process can produce high-specific-activity Lu-177, the form of the isotope most in demand by today’s clinical trial sponsors. Last December, SHINE also broke ground for a large-scale therapeutic isotope plant, which is expected to be operational in mid-2022 and will produce Lu-177.

SHINE is also constructing a U.S. fusion-based medical isotope production facility in Janesville, Wisconsin, to produce molybdenum-99 (Mo-99), which more than 40 million patient procedures rely on each year. There has been little production of Mo-99 in the United States for decades – contributing to chronic shortages of the isotope – and this production facility will be capable of supplying more than one-third of the global demand for Mo-99. SHINE announced in May a location for its new European medical isotope production facility, which when combined with the capacity of SHINE’s U.S. plant will give the company the ability to produce 70 percent of the global patient need for Mo-99. The production facility will be driven by nuclear fusion technology that does not require a reactor and is cleaner, safer and more sustainable than a nuclear research reactor.

"SHINE is grateful for the confidence of our world-class investor syndicate and the ongoing support of our early-stage investors," said Todd Asmuth, SHINE’s President and Chief Strategy Officer. "The support of our institutional and individual investors and local, state and federal partners ensures that SHINE can fully execute its medical isotope plans by building multiple facilities and improving the lives of people around the world. As we bring these production facilities online, we will move into nuclear waste recycling and clean energy production, the next two phases of our plan. By doing so, we will continue to build long-term value for our stakeholders, including our customers, physicians and their patients, our employees and our shareholders."