Medtronic announces partnership with BioIntelliSense for exclusive U.S. distribution of multi-parameter wearable for continuous remote patient monitoring from in-hospital to home

On August 31, 2022 Medtronic plc (NYSE:MDT), a global leader in healthcare technology, reported it has entered into a strategic partnership with BioIntelliSense, a continuous health monitoring and clinical intelligence company, for the exclusive U.S. hospital and 30-day post-acute hospital to home distribution rights of the BioButton multi-parameter wearable for continuous, connected monitoring (Press release, Medtronic, AUG 31, 2022, View Source [SID1234618811]). The partnership enables the Medtronic Patient Monitoring business to offer access to a medical grade device that provides continuous vital sign measurements of general care patients in-hospital as well as post-discharge. This supports the simplification of care delivery through workflow automation, enabling proactive clinical intervention, and helping to address the implications of staffing shortages. Terms of the deal were not disclosed.

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The BioButton medical grade device, measuring up to 1,440 vital sign measurements per day, including skin temperature, respiratory rate at rest, and heart rate at rest, is the exclusive multi-parameter wearable for the Patient Monitoring business. This device, combined with advanced analytics, has the potential to help enable clinicians to better detect early signs of patient deterioration or, conversely, identify stable patients who may be candidates for earlier hospital discharge. The rechargeable BioButton device also has configurable acute and post-acute modes to continuously monitor patients as they transition from higher to lower acuity settings.

"Our vision is to empower clinicians and patients with actionable insights to personalize care — anytime, anywhere," said Frank Chan, Ph.D., president of the Patient Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic. "Today, our solutions touch more than 100 million patients annually in hospitals. Through our collaboration with BioIntelliSense, we will support continuous, connected care from in-hospital to home and expand our reach to help more patients in more places than ever before."

With staffing shortages projected to reach 3.2 million healthcare workers by 20261, the Patient Monitoring business intends to continue to expand its HealthCast portfolio to improve workflow automation so clinicians can focus on what matters most — their patients. The HealthCast connectivity gateway helps increase workflow efficiency by connecting unconnected devices to the electronic medical records (EMR) and saves valuable staff time by reducing the burden of manual charting. The HealthCast VitalSync remote patient monitoring system enables clinicians to receive near real-time trend and alert data on web-enabled devices so they can act on patient deterioration earlier. With the addition of the BioButton multi-parameter wearable to the HealthCast portfolio, Medtronic can help even more general care patients inside and outside of the hospital, furthering our commitment to patient safety.

"In partnership with Medtronic, we are poised to accelerate continuous connected care models that offer a new level of clinical surveillance and workflow efficiencies for hospitals that are challenged in today’s environment of growing workforce shortages and cost of care management," said James Mault, M.D., founder and CEO of BioIntelliSense. "This advanced remote physiologic monitoring simplifies care delivery to facilitate personalized patient care, clinical workflow automation and proactive clinical interventions."

ImmunoGen Provides Update on Pivotal CADENZA Study of Pivekimab Sunirine in Frontline Blastic Plasmacytoid Dendritic Cell Neoplasm

On August 31, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported an update on the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, ImmunoGen, AUG 31, 2022, View Source [SID1234618808]).

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The CADENZA study is enrolling frontline BPDCN patients, including patients with de novo disease and those with a prior or concomitant hematologic malignancy (PCHM). Although complete responses have been observed in BPDCN patients who present with PCHM, most will not achieve full hematologic recovery due to the impact of their prior or concomitant malignancy. For these patients, achieving a complete response with partial hematological recovery (CRh) is a potentially important measure of clinical benefit.

In data from the first ten patients in the pivotal CADENZA frontline cohort, the Company observed:

2 of 4 de novo patients achieved CR (complete response)/CRc (clinical complete response); and
4 of 6 PCHM patients achieved CR/CRc/CRh.
In addition, in three frontline patients (2 de novo, 1 PCHM) enrolled prior to the opening of the pivotal cohort, all three patients achieved CR/CRc.

In conjunction with a recent Type B meeting regarding these initial data from the CADENZA study, the Company has aligned with FDA that the efficacy analysis will be conducted in de novo BPDCN patients with CR/CRc as the primary endpoint and the key secondary endpoint of duration of CR/CRc. The Company will also continue to enroll PCHM patients in CADENZA to further explore the potential benefits of pivekimab in this population. Based upon this guidance from FDA, the Company will enroll up to 20 de novo patients for purposes of the efficacy analysis. To date, a total of 6 de novo BPDCN patients have enrolled in CADENZA. Given this is an ultra-rare disease, the Company now expects to report top-line data on the primary and key secondary endpoints in 2024.

"We believe these initial frontline data from the CADENZA study further support the potential of pivekimab as an important treatment option for patients with BPDCN," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "With Breakthrough Therapy designation, we have had productive discussions with FDA. Based on the initial frontline data observed to date, we will continue to explore the benefit of pivekimab in both de novo and PCHM patients. We look forward to sharing additional details of pivekimab in frontline BPDCN at an upcoming medical meeting."

"With limited treatment options for this rare and aggressive cancer, I am encouraged by the data generated thus far for pivekimab in frontline BPDCN," said Kendra Sweet, MD, Associate Member in the Department of Malignant Hematology at Moffitt Cancer Center. "BPDCN patients with PCHM are increasingly recognized as having significant unmet need as there are no therapies specific for this population. BPDCN patients with PCHM are most likely to die of the aggressive BPDCN component, which requires urgent treatment, while the second malignancy is typically chronic and may not even require treatment. What has been observed is that patients with PCHM who’ve cleared their marrow of BPDCN with pivekimab may not fully recover counts, likely due to the underlying concurrent heme malignancy. Despite partial count recovery, complete clearance of BPDCN allows these patients to bridge to transplant, when eligible, the only curative option for BPDCN."

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT PIVEKIMAB SUNIRINE
Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies. Pivekimab is currently being evaluated as monotherapy for patients with BPDCN in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML. Pivekimab uses one of ImmunoGen’s novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020. Pivekimab also holds this designation in the U.S. In October 2020, the FDA granted pivekimab Breakthrough Therapy designation in relapsed/refractory BPDCN.

ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)
BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the approval of a CD123-targeting therapy, the unmet need remains high for patients, both in the frontline and in the relapsed/refractory setting.

Evogene Reports Second Quarter 2022 Financial Results

On August 31, 2022 Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, reported its financial results for the second quarter ended June 30, 2022 (Press release, Evogene, AUG 31, 2022, View Source [SID1234618807]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "We are very pleased with the two recent important developments that have taken place at the Evogene group: namely, the strategic collaboration and $10 million investment by ICL, a leading global specialty minerals company, into our subsidiary, Lavie Bio; as well as the launch of the Phase I first in human clinical trial, by our subsidiary, Biomica."

"The strategic collaboration between ICL and Lavie Bio and $10 million investment, combines Lavie Bio’s ag-biologicals expertise, built on Evogene’s Microboost AI tech engine, with ICL’s fertilizer experience, enabling the development of a pipeline of innovative bio-stimulant products for agriculture. Especially in a time of food scarcity, high prices, and macroeconomic uncertainty, Lavie Bio and ICL’s shared vision is to enhance global food quality, agricultural sustainability, and increased productivity. ICL will join Corteva, a major U.S. agricultural chemical and seed company, as well as Evogene, as a new shareholder of Lavie Bio and I am very proud that these two agricultural giants have a strong interest in what Evogene has built."

"From Evogene’s standpoint, this investment in our subsidiary Lavie Bio, is an additional key milestone that demonstrates the power of our business model, whereby we are leveraging the value of our tech engines through dedicated subsidiaries. It shows that our hard work in building, investing in and strengthening our subsidiaries, all of which are leveraging our underlying computational predictive biological tech engines, is the right strategy and bears fruit."

Continued Mr. Haviv, "The second important development was the launch by Biomica of its phase I clinical trial and the announcement that the first patient was dosed in its Phase I clinical trial for its microbiome-based immuno-oncology drug candidate, BMC128. The drug candidate is a consortium of microbes, which Biomica selected through a microbiome analysis via our MicroBoost AI tech engine."

"While Evogene has traditionally leveraged its platform and AI technology engines towards agriculture, Biomica is proof that we are uniquely positioned to play an important role in human health and is strong validation that our technology can be leveraged across multiple and massive industries."

"Finally, we continued to strengthen our management team, recently adding Eyal Ronen, as Executive Vice President of Business Development bringing us over 20 years of extensive business development experience with biotech companies. Eyal’s focus is to create and bring us additional value by building new partnerships or forming new subsidiaries, leveraging our technology engines and expanding our activities into new areas. I strongly believe that Evogene has significant untapped potential in its technology engines, and Eyal will focus on realizing some of that value."

Mr. Haviv added, "Evogene today is at a key inflection point, whereby we are meeting critical milestones and the inherent value of our subsidiaries is becoming increasingly obvious. Evogene’s goal in the near term, is to continue to bring high value-adding partners and investors at the subsidiary level, who understand and can value the potential from the products that our subsidiaries are developing. This we believe will demonstrate in a very public way, the significant untapped value contained within our activities."

"Our target is that each subsidiary will have its own financial resources to support its activities until its success, while we at Evogene, in addition to being a major shareholder, continue to play a major role in maintaining and building their competitive advantage through our tech-engines."

"In parallel, we are targeting and exploring the potential to establish new activities that can benefit from our technology. This is the main mission of our new EVP of Business Development, Eyal Ronen, and we are already starting to see some of his positive impact," concluded Mr. Haviv.

Consolidated Financial Results Summary

Cash position: Evogene continues to maintain a solid financial position for its activities with approximately $35.3 million in consolidated cash, cash related accounts and marketable securities as of June 30, 2022. Approximately $3.6 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio. The Company does not have bank debt. It is noted that these amounts do not include the recent $10 million investment of ICL in Lavie Bio, which was fully received in August 2022 and will be reflected in the financial statements of the Company for the third quarter.

During the second quarter of 2022, the consolidated cash usage was approximately $9.3 million, or approximately $6.4 million, excluding Lavie Bio. Out of the $9.3 million, $1.7 million is a non-cash charge related to foreign exchange expenses due to US Dollar and New Israeli Shekel exchange rate differences and a decrease in the market value of marketable securities on Evogene’s balance sheet.

As previously stated, Evogene’s full year net cash burn rate, excluding exchange rate impacts in 2022, is expected to be in the range of $26-28 million including Lavie Bio and $18-20 million excluding Lavie Bio, which manages its own cash position.

Revenues: Revenues for the second quarter were $312 thousand, in comparison to $135 thousand in the same period the previous year. Revenues were primarily due to the initial sales of Lavie Bio’s Thrivus product (previously branded as Result) and sales of Canonic products in the Israeli market.

R&D expenses for the quarter, which are reported net of non-refundable grants received, were $5.4 million, in comparison to $5.0 million in the same period the previous year. The increase in R&D expenses were primarily due to:

Biomica’s ongoing phase I trial of its first-in-human proof-of-concept study in its immuno-oncology program; and
Lavie Bio’s activities supporting the production and commercialization of its inoculant product;
Business Development expenses were approximately $1.0 million for the second quarter of 2022, in comparison to $0.7 million in the same period the previous year. The increase in the Business Development expenses was primarily due to recruitment of business development personnel supporting the commercialization activities of Evogene’s subsidiaries.

General and Administrative expenses remained stable, and for the second quarter of 2022 were $1.7 million, in comparison to $1.8 million in the same period in the previous year.

Operating loss: Operating loss for the second quarter of 2022 was $8.0 million in comparison to $7.4 million in the same period in the previous year.

Financing expenses for the second quarter of 2022 were $1.7 million in comparison to financing income of $0.6 million in the same period in the previous year. The increase in financing expenses was mainly due to the US Dollar and New Israeli Shekel exchange rate differences between periods and a decrease in marketable securities value as mentioned above.

Net loss: The net loss for the second quarter of 2022 was $9.8 million in comparison to a net loss of $6.9 million in the same period in the previous year. The increase in net loss was mainly due to the financing expenses as described above.

The Company’s investor presentation can be viewed at the above link, which is in the investor relations section of the company website.

Replay Information: A replay of the conference call will be available approximately two hours following the completion of the call.

To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible following the call for three days. An archive of the webcast will be available on the Company’s website

Enveric Biosciences to Participate in the H.C. Wainwright 24th Annual Global Investment Conference on September 12-14, 2022

On August 31, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that Avani Kanubaddi, President & COO of Enveric, will participate in the H.C. Wainwright 24th Annual Global Investment Conference to be held at the Lotte New York Palace Hotel in New York City on September 12-14, 2022 (Press release, Enveric Biosciences, AUG 31, 2022, https://www.enveric.com/news/enveric-biosciences-to-participate-in-the-h-c-wainwright-24th-annual-global-investment-conference-on-september-12-14-2022/ [SID1234618806]).

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Mr. Kanubaddi will present on Wednesday, September 14th at 2:00 p.m. ET. To attend, please register here.

For more information about the conference, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate H.C. Wainwright representative, or send an email to KCSA Strategic Communications at [email protected].

Decibel Therapeutics to Participate in Upcoming Investor Conferences

On August 31, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer, will be participating in the following upcoming investor conferences in September (Press release, Decibel Therapeutics, AUG 31, 2022, View Source [SID1234618805]).

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Citi 17th Annual BioPharma Conference:

Rare disease panel on Wednesday, September 7, 2022 at 11:20 a.m. ET in Boston, MA.
H.C. Wainwright 24th Annual Global Investment Conference:

Virtual presentation available for on demand viewing starting on Monday, September 12, 2022 at 7:00 a.m. ET
Baird 2022 Global Healthcare Conference:

Fireside chat on Tuesday, September 13, 2022 at 3:10 p.m. ET in New York, NY.
Cantor Cell & Genetic Medicines Conference:

Panel titled, "Ring Ring: Is That Large-Cap Pharma Calling? Importance of Established Partnerships in Place," on Thursday, September 15, 2022 at 8:00 a.m. ET in New York, NY.
Webcasts of the Citi, H.C. Wainwright and Baird events may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcasts will be available on the Company’s website for approximately 90 days following these events.