On November 16, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, President and CEO, will participate in an analyst-led fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 17 at 12:20 PM GMT / 7:20 AM ET (Press release, VBI Vaccines, NOV 16, 2021, View Source [SID1234595686]).

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Jefferies London Healthcare Conference

Discussion to be held with Kelechi Chikere, Ph.D.

Presenter: Jeff Baxter, President and CEO
Date: Wednesday, November 17, 2021
Time: 12:20-12:55 PM GMT / 7:20-7:55 AM ET
Webcast Link: View Source
Live webcasts of the presentations will also be available on the Investors page of VBI’s website at: View Source A replay of each webcast will be archived on the Company’s website following the presentation.

On November 16, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that BofA Securities and Morgan Stanley, as representatives of the several underwriters, notified Evotec of the underwriters’ exercise of their option to purchase up to 3,000,000 additional ADSs, representing 1,500,000 ordinary shares at the offering price of $ 21.75 per ADS (Press release, Evotec, NOV 16, 2021, View Source [SID1234595685]).

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An additional 2,995,000 American Depositary Shares ("ADSs"), representing 15% of the initial offering of 20,000,000 new ADS, have finally been registered in the commercial register on 15 November. Each ADS represents half of one ordinary share of Evotec. Upon exercise of the Greenshoe option, the free float amounts to approximately 68.4% of all outstanding Evotec shares.

In total, gross proceeds of the transaction amount to $ 500 million comprising the first offering of 20,000,000 ADSs ($ 435 million) and, the exercised option of 2,995,000 additional ADSs ($ 65 million), before deducting underwriting commissions and estimated offering expenses payable by Evotec. The proceeds from the issuance of the new shares are intended to be used to fund and in particular expand the ongoing business operations

Evotec’s ordinary shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or Jurisdiction.

This communication and the information contained herein is made solely for information purposes only and does not constitute or form part of a prospectus or any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities of Evotec, in any jurisdiction. Neither this communication, nor any part of it, nor the fact of its distribution, shall form the basis of, or be relied on in connection with, any contractual commitment or investment decision in relation to the securities of Evotec, in any jurisdiction, nor does it constitute a recommendation regarding any such securities.

The placement of the securities mentioned in this communication was directed only at persons in member states of the European Economic Area (the "EEA") who are "Qualified Investors" within the meaning of the Prospectus Regulation EU 2017/1129 ("Prospectus Regulation") ("Qualified Investors"). Any person in the EEA who acquires the securities in any offer (an "Investor") or to whom any offer of the securities is made will be deemed to have represented and agreed that it is a Qualified Investor.

In the United Kingdom, this communication is only directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 who are also (i) investment professionals falling within Article 19(5) of the UK Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any investment or investment activity to which this communication relates is available only to Relevant Persons in the United Kingdom and will only be engaged with such persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this communication or any of its contents.

On November 16, 2021 The Centers for Medicare & Medicaid Innovation (CMMI) reported that released results for the 8th Performance Period (PP8) of the Oncology Care Model (OCM), and practices in The US Oncology Network (The Network) participating in the program achieved high marks on quality metrics and provided significant cost savings to Medicare (Press release, US Oncology, NOV 16, 2021, View Source [SID1234595681]).

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All 14 of The Network participating practices improved patient care by achieving top quality measurement scores, resulting in a 100% Performance Multiplier for all 14 practices. Together, the practices saved Medicare approximately $54 million over the six-month performance period — for a total savings of $197 million since the OCM began in 2016.

The OCM is a pilot program designed by CMMI to provide higher quality, more coordinated cancer care at the same or lower cost to Medicare. It is an integral part of Medicare’s ongoing effort to transition healthcare to a more value-based approach.

"We are extremely proud of the exceptional performance of all 14 of the practices in The US Oncology Network participating in the OCM and the cost savings they delivered to Medicare," said Stuart Staggs, senior director of Strategic Programs for The Network. "Practices in The Network are bending the cost curve for oncology while providing enhanced care to patients, as demonstrated by their outstanding quality performance scores."

Since the program’s inception, The Network practices have improved steadily in OCM metrics, culminating in these impressive results for PP8. For example, patient emergency department use was the lowest since the start of the program, as practices cared for patients needing immediate attention through a variety of heightened services, such as nurse navigation, enhanced triage, telehealth or urgent care visits within the clinic. All practices also reported substantial gains on depression screening and pain management.

The 14 OCM practices in The Network represent approximately one-fourth of all providers participating in the program, demonstrating the leadership role The US Oncology Network is playing in the development of value-based oncology care. Since the program launched, more than 110,000 patients have been enrolled in the OCM across The Network, receiving high-quality, value-based care in their local communities.

"Much of the success The Network practices have achieved in the OCM is the result of strong support from The US Oncology Network," said Lalan Wilfong, MD, vice president of Payer Solutions and Practice Transformation for The Network. "The Network is dedicated to ensuring its member practices have access to the tools and expertise they need to thrive in the evolving healthcare landscape."

Comprehensive, proven resources are available, including industry-leading technologies from Ontada that support decision-making at the point of care and advanced analytics for optimal data management and reporting. The Network, supported by McKesson, also gives practices access to thought leaders and key staff who have deep expertise in value-based care. This includes a Value-Based Care Transformation Lead, an expert assigned to each practice to guide them in not only program requirements, but also performance improvement.

"It is reassuring to see how well The Network practices are performing, as the OCM is a bridge to the future and an important first step in creating patient-centered cancer care that focuses on both quality and value," said Judi Payne, director of Value-Based Care Transformation for The Network. "Building on our successes in the OCM, The US Oncology Network will continue working to advance value-based cancer care by finding new and innovative ways to elevate and enhance patient care while controlling costs."

On November 16, 2021 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, reported that it successfully closed a $40 million Series A3 financing round led by Perceptive Xontogeny Ventures Fund II (PXV Fund) (Press release, Sermonix Pharmaceuticals, NOV 16, 2021, View Source [SID1234595680]). Existing investors also participated in the financing.

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As part of the agreement, Fred Callori and Ben Askew, Ph.D., partners in the PXV Fund, were appointed to the Sermonix Board of Directors.

"We are excited to welcome investors who share our passion as we work to leverage a precision medicine approach to address a significant unmet need in the metastatic breast cancer setting," said David Portman, M.D., Sermonix founder and chief executive officer. "This is a pivotal moment for Sermonix. With a strengthened balance sheet and both our ELAINE Phase 2 studies fully enrolled and progressing, we have set the stage for a catalyst-rich 2022, with initial data from each trial expected in the first half."

The PXV Fund team brings significant scientific, business, operational and investment expertise to the Sermonix team, with a singular goal of shepherding lasofoxifene through compelling and rigorously designed clinical proof-of-concept studies.

"We are pleased to announce our support for Sermonix Pharmaceuticals in their endeavors to develop an effective treatment for the approximately 40% of breast cancer patients who develop ESR1 mutations and progress following endocrine therapy," said Mr. Callori. "We believe lasofoxifene, if approved, may become a treatment of choice for oncologists and many of their patients with this challenging disease. The accomplished team at Sermonix recognizes the acute medical need and will be executing effectively on these strategies."

Sermonix recently announced significant progress in the advancement of its ELAINE (Evaluation of Lasofoxifene in ESR1 Mutations) Phase 2 clinical program for lasofoxifene:

In August, Sermonix announced completion of enrollment in its Phase 2 ELAINE 1 trial (NCT03781063), which is evaluating lasofoxifene versus the current standard of care, fulvestrant, for the treatment of ER+/HER2- breast cancer in patients with an ESR1 mutation. Sermonix expects topline data from the trial, which enrolled a total of 100 patients, in the first half of 2022.
In June, Sermonix announced completion of enrollment in its Phase 2 Elaine 2 trial (NCT04432454), which is evaluating lasofoxifene in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib. Initial data from the trial is expected in the first half of 2022.
LifeSci Capital acted as placement agent for Sermonix on this transaction.

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On November 16, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported an update on ongoing OT-101/IL-2 combination trial (the "Trial"), which has now successfully completed the safety evaluation of its safety cohort, allowing for further expansion of its clinical program into phase 2 clinical trials and higher doses (Press release, Mateon Therapeutics, NOV 16, 2021, View Source [SID1234595679]).

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The Trial, Multi-center, Open label, Phase Ib clinical study to evaluate the safety, tolerance, and efficacy of TASO-001 ("OT-101"), a TGF-β targeting anti-sense oligonucleotide, in combination with recombinant interleukin-2 (Aldesleukin, "IL-2"), in patients with advanced or metastatic solid tumor cancer. ClinicalTrials.gov Identifier: NCT04862767.

OT-101 is a first-in-class anti-TGF-β ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19.

In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. The 140 mg/m2 dose was shown to be the optimal dose for OT-101 in the prior trial targeting pancreatic cancer, melanoma, and colorectal cancer ("P001"). In the P001 trial, the maximum tolerated dose was not reached even at 330 mg/m2. Therefore, the Company believes that increasing the dose above 140 mg/m2 should further enhance the clinical activity of OT-101.

"We are excited to see this clear demonstration of safety for the OT-101/IL-2 combination," noted Dr. Vuong Trieu, CEO of Oncotelic. "Unlike other common treatments, such as chemotherapy, IL-2 has the potential to bring about long-lasting responses and even cures in about one in 10 patients with metastatic kidney cancer and metastatic melanoma. Our analysis to date suggests that the OT-101/IL-2 combination could further improve the cure rate of these cancers. We look forward to updating shareholders as we gain further insights with additional data."

The Trial is being conducted by Autotelic BIO, a partner of Oncotelic on the OT-101/IL-2 combination, and Clinigen Group, a UK-based global pharmaceutical company.

About OT-101

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 could further demonstrate its utility as adjunct to other immunotherapies. IL-2, immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma. OT-101 has also received orphan drug designation for glioblastoma, melanoma, and pancreatic cancers. Furthermore, the Food and Drug Administration recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is being evaluated for effectiveness against coronaviruses, including COVID-19, and has been deployed against the COVID-19 epidemic in the Company’s C001 trial.

OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).