On December 15, 2021 Endomag reported that A novel procedure could now spare breast cancer patients an invasive surgical procedure on their lymphatic system (Press release, Endomag, DEC 15, 2021, View Source [SID1234597246]). At MD Anderson Cancer Center, doctors have pioneered the Targeted Axillary Dissection (TAD) technique, where a tiny magnetic seed is placed into patient lymph nodes known to contain cancer. Following a course of neoadjuvant chemotherapy aimed to shrink or even eradicate their cancer, prior to surgery, this novel technique allows surgeons to monitor the response of targeted lymph nodes to the chemotherapy without the need for upfront invasive surgery, such as a complete axillary dissection.

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The magnetic seed, known as a Magseed allows surgeons to accurately remove the node marked prior to chemotherapy and remove it with minimal damage to healthy lymph node tissue.

Lymph nodes are a vital part of the system which helps the body to fight infection but are also the first structures breast cancer can spread to. In 40 to 75% of women, a course of chemotherapy before surgery can clear the nodes of cancer.1,2,3 However, until now, there has been no way to confirm the chemotherapy has been effective without removing a large number of lymph nodes from the underarm.

"The standard surgical approach for patients with breast cancer that has spread to the lymph nodes has been axillary lymphadenectomy (ALND), which involves removing most of the lymph nodes in the axilla," explains Dr Abigail Caudle, MD, who first pioneered the TAD technique at MD Anderson. "Unfortunately, this approach is associated with significant complications which can impact a patient’s quality of life including swelling, pain, and decreased range of motion. Some patients have an excellent response to chemotherapy and may have no disease remaining in the lymph nodes. We suspect that these patients may not benefit from having all of their lymph nodes removed, although the studies looking at this question are not yet available.

The challenge has been how to identify these patients that might benefit from less aggressive surgery. By specifically removing the exact lymph nodes that had confirmed cancer at the time of diagnosis, as well as the lymph nodes most likely to contain disease, we can now accurately assess whether there is cancer remaining in the lymph nodes and consider no further surgery if there is no evidence of cancer."

It is widely reported that up to 70% of women who have multiple nodes removed in an ALND procedure will develop complications linked to their treatment, such as the life-altering condition of lymphedema.4,5,6 Lymphedema is a condition where damage to the lymphatic system results in a build-up of lymphatic fluid in the body as a result of lymphadenectomy, causing lifelong symptoms of severe swelling, altered sensation, pain and limitations in range of motion.3. There are currently more than 10m people in the United States living with lymphedema,7 and for many patients, lymphedema is incurable.8

"There is a sea-change afoot in the treatment of breast cancer as patients become increasingly educated about the options available to prevent side effects of treatment. Foremost on this list are procedures and technologies that can prevent lymphedema—an incurable, debilitating, progressive and disfiguring swelling that can occur when the lymphatic system is damaged during surgery, radiation or chemotherapy. Women who win their battle against breast cancer routinely state that lymphedema can be worse than their cancer. Their cancer was cured. Their lymphedema is forever. In this modern world, every woman deserves the full benefits of our knowledge to mitigate onset of the life-long disease of lymphedema," explains William Repicci, LE&RN President & CEO

The Magseed marker, used by surgeons at MD Anderson, is the world’s most studied non-radioactive seed, with the technology available in over 40 countries around the world. Results from a series of past and ongoing multi-national studies 9,10 have demonstrated the ease and accuracy of marking positive lymph nodes with a Magseed marker with 100% success in surgical retrieval, negating the need for unnecessary node removal.

"This pioneering surgery exemplifies the importance of new technologies such as Magseed in moving breast cancer treatment forward." said Eric Mayes, CEO of Endomag. "These technologies have already helped over 200,000 patients globally access a better standard of cancer care. We’re committed to continually learning from physicians around the world and providing access to cutting-edge clinical applications that will make a difference to these patients for years to come.

On December 15, 2021 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported that it has entered into a subscription agreement pursuant to which an affiliate of Social Capital Holdings Inc. ("Social Capital") will make a strategic C$43.4 million investment in the Company (Press release, Perimeter Medical Imaging AI, DEC 15, 2021, View Source [SID1234597242]).

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Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "We believe Social Capital’s investment marks a transformative, pivotal event for Perimeter that will help accelerate our growth. This strategic partnering comes at a time when we are ramping up our Perimeter S-Series market development activities and commercialization efforts across the U.S., while also supporting the ongoing clinical development of our next-gen AI technologies. This financing provides us with the backing to execute upon our long-term vision to transform cancer surgery."

Chamath Palihapitiya, CEO of Social Capital, said, "Perimeter’s advanced imaging technology has the opportunity to materially improve cancer surgery outcomes. Today’s methods rely on contemporary imaging techniques, which often result in the need for additional surgery, increasing payer costs and potentially delaying subsequent treatment plans. This investment will support the commercial launch of Perimeter’s initial imaging device for breast cancer, but equally as important, we believe it can accelerate their path to become the standard of care for many other surgical applications in the future."

Social Capital has agreed to subscribe, on a non-brokered private placement basis (the "Private Placement"), for C$43.4 million in units of Perimeter at a price of C$3.00 per unit (each, a "Unit"), with each Unit consisting of one common share (each, a "Common Share") and a total of one warrant ("Warrant") to purchase an additional Common Share (a "Warrant Share"). 80% of the Warrants issued in the Private Placement will have a strike price of C$3.99 and 20% of the Warrants in the Private Placement will have a strike price of C$4.50. Half of the Warrants at each strike price will be subject to accelerated expiry if the 60-day volume weighted average trading price of Perimeter’s Common Shares is greater than the strike price during the applicable period. The other half of the Warrants will not be subject to accelerated expiry, and instead they may be exercised for cash or exercised using a cashless exercise feature at any time prior to expiry. Subject to the accelerated expiry clause described above, all Warrants will expire five years following the closing of the Private Placement.

Social Capital will also enter into an investor rights agreement with Perimeter at the closing of the Private Placement, which will provide Social Capital with the right to nominate one director to the board of Perimeter, with anti-dilution rights to participate in future financings, and with customary registration rights.

Perimeter may, but has not yet committed to, issue up to an additional C$7,000,000 million in Units on substantially the same economic terms as those issued to Social Capital.

The net proceeds of the Private Placement will be used for working capital, commercialization of Perimeter’s technology, clinical studies and the further development of Perimeter’s technology, and general corporate purposes.

About the Investment

Closing of the Private Placement is subject to the receipt of TSX Venture Exchange approval, the receipt of all necessary Perimeter shareholder approvals, and other customary closing conditions. The Private Placement will result in the creation of a new control person of Perimeter under Canadian securities laws as Social Capital will hold over 20% of the issued and outstanding shares of Perimeter, and accordingly, under TSX Venture Exchange policies, shareholder approval of the creation of the new control person will be required as a condition of closing, which will be sought by written consent. Roadmap Capital Inc., Perimeter’s largest shareholder, which owns or controls approximately 38% of the issued and outstanding Perimeter common shares, has signed a support agreement in favour of the Private Placement and has committed to sign a written consent resolution approving the Private Placement. Perimeter will provide further details on the shareholder approval in a subsequent news release. Social Capital is at arms length to Perimeter. The subscription agreement is also subject to a number of customary closing conditions, including the lack of any material adverse effect on Perimeter prior to Closing. The subscription agreement contains an outside date of January 31, 2021 for closing, which may be extended in limited circumstances. Social Capital’s board nomination and anti-dilution rights under the investor rights agreement will last so long as Social Capital holds at least 15% of the common shares of Perimeter on an undiluted basis, and Social Capital’s registration rights will last so long as Social Capital holds at least 10% of the common shares of Perimeter on an undiluted basis. A finder’s fee equal to 3% of the proceeds from the sale of Units to Social Capital is payable in respect of the Private Placement, which finders fee will be paid by issuing common shares of Perimeter ("Finder’s Shares") at $3.00 per share, subject to TSX-V approval.

The Common Shares comprising part of the Units, the Warrants and the Warrant Shares (if such Warrant Shares are issued before the date that is four months and one day following the applicable Closing Date) and the Finder’s Shares shall be subject to a hold period ending on the date that is four months and one day following the applicable Closing Date.

On December 15, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported that University of Louisville (UofL) Health, a leading academic health system based in Louisville, Kentucky, has deployed a full suite of Paige AI-enabled digital pathology software to improve diagnostic confidence, efficiency, and patient care during routine cancer diagnosis (Press release, Paige AI, DEC 15, 2021, View Source [SID1234597240]).

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UofL Health is one of the first health systems in the U.S. to implement Paige Prostate, the first and only AI-based pathology product to receive FDA approval for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies. UofL Health will also deploy Paige’s FullFocus as their digital pathology case management tool and digital pathology image viewer, and Paige Breast to elevate pathologists’ ability to diagnose cancer.

With cancer cases on the rise globally, AI technologies have the potential to help pathologists work more confidently and efficiently. AI can act as a second pair of eyes for pathologists, helping them to quickly spot very small, almost imperceptible regions of cancer in a tissue sample that may be challenging to recognize with the naked eye. This can translate into better accuracy in cancer diagnosis and ultimately better clinical management for patients.

"We are proud to be one of the first health systems in the U.S. to adopt an AI-enabled digital pathology software platform which offers an enhanced look at tissues and acts as a built-in second opinion in our routine diagnostic processes," said Dibson Dibe Gondim, M.D., Director of Pathology Informatics, Assistant Professor of Pathology and Laboratory Medicine, Associate Residency Program Director of Anatomic Pathology, and Director of Genitourinary Pathology at the University of Louisville School of Medicine. "Leveraging the Paige Platform and AI tools, such as Paige Prostate, will help us increase efficiency and diagnostic confidence for our patients and improve our pathology workflows."

Additionally, UofL Health will leverage Paige’s Software Development Kit, an open platform that enables institutions to deploy customized laboratory developed tests for digital pathology, to deploy AI algorithms to assist in operational efficiencies and image analysis that were developed in-house.

"Completing our deployment at University of Louisville Health is an exciting milestone for Paige as we help hospital systems adopt digital, AI-based technologies to make their existing workflows more accurate and efficient," said Andy Moye, Ph.D., Chief Commercial Officer at Paige. "We are proud to offer a robust portfolio of AI-enabled digital pathology technologies backed by the FDA. We are also excited to see how the University of Louisville is utilizing the Paige Software Development Kit to achieve near-term clinical impact, and we hope this will be the first of many research applications adopting our open technology to improve patient care."

Outside of the U.S., Paige Prostate is CE-marked for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK. FullFocus is FDA cleared and CE-marked. The products are otherwise available for research use only in other territories.

About Paige

On December 15, 2021 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported an overview of its cis-targeting platform and growing pipeline of highly differentiated precision immunotherapies (Press release, Asher Biotherapeutics, DEC 15, 2021, View Source [SID1234597237]). The update follows presentations by Asher Bio on its cis-targeting technology at PEGS Europe: Protein & Antibody Engineering Summit, held November 2-4, 2021 in Barcelona, and the Antibody Engineering & Therapeutics (AET) Conference, held December 12-16, 2021 in San Diego .

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"We were delighted to present additional details on our cis-targeting technology at recent scientific conferences," said Andy Yeung, Ph.D., Chief Technology Officer and Founder of Asher Bio. "Our platform enables us to build a broad pipeline of potentially best-in-class precision immunotherapies, each of which engages both an immunomodulatory receptor and a specific target on the same cell. By focusing our potent immunomodulators selectively on only the desired immune cell type, we believe we can deliver improved clinical outcomes, offering patients more efficacious medicines that carry a reduced risk of off-target toxicities. Importantly, our approach can be applied systematically to target multiple classes of immunomodulators to a diverse set of immune cell types, creating numerous opportunities to generate new immunotherapies for a range of cancers, autoimmune and infectious diseases."

As outlined in Asher Bio’s presentations at PEGS Europe and AET, the company’s proprietary cis-targeting platform yields immunotherapies that selectively activate specific immune cell subsets, in order to avoid the pleiotropic effects that characterize the systemic delivery of existing cytokines and immunotherapies. Asher Bio is applying its modular toolkit, which includes a library of targeting arms and engineered cytokines that can be readily recombined to generate new molecules, to rapidly build and de-risk a portfolio of drug candidates for treatments in multiple disease areas.

"Since our founding, we progressed our three most advanced programs – all of which leverage our discoveries in IL-2 and other cis-targeted cytokines for the treatment of oncology – through preclinical proof-of-concept, demonstrating the reproducibility of our approach and providing the foundation for us to build a portfolio of potentially best-in-class immunotherapies," said Ivana Djuretic, Ph.D., Chief Scientific Officer and Founder of Asher Bio. "We look forward to building on this momentum as we advance our existing programs toward the clinic and apply our proprietary cis-targeting technology to discover, develop and, ultimately, deliver novel molecules with the potential to restore hope, health and happiness to many more patients."

The presentations at PEGS Europe and AET provide additional detail on Asher Bio’s cis-targeting technology and support the company’s emerging pipeline of cis-targeted immunotherapies:

Asher Bio’s lead program, AB248, is a fusion protein that selectively activates the interleukein-2 (IL-2) receptor pathway on CD8+ T cells. In preclinical studies, AB248 has demonstrated highly compelling anti-tumor activity across multiple mouse tumor models, showing superior efficacy and tolerability compared to wild-type IL-2 and other not-α IL-2 therapies currently in clinical development. Asher Bio expects to file an investigational new drug application with the U.S. Food and Drug Administration in the third quarter of 2022.
Beyond AB248, Asher Bio is advancing two additional programs for the treatment of cancer, both of which have achieved preclinical proof of concept:
A cis-targeted cytokine that selectively activates STAT3 signaling in CD8+ T cells, promoting cytotoxicity, memory cell differentiation and survival, all of which are signals potentially complementary to the proliferation signal provided by IL-2 and STAT5 activation.
A CAR-T cis-targeted IL-2 that selectively expands CAR-Ts post-adoptive transfer, supporting better engraftment, peak expansion and persistence, all of which have been correlated with improved clinical efficacy and outcomes.
The scientific overview presented at PEGS Europe and AET is now available in the "Presentations and Posters" section of Asher Bio’s website: View Source

On December 15, 2021 Mythic Therapeutics reported its launch to develop smarter and safer antibody-drug conjugates (ADCs) with an oversubscribed Series B financing round of $103 million (Press release, Mythic Therapeutics, DEC 15, 2021, View Source [SID1234597235]). Viking Global Investors led the round, along with new investors including Venrock Healthcare Capital Partners, Foresite Capital, Perceptive Advisors, and Highside Capital. Existing Mythic investors participating in the round include Venrock, First Round Capital, OMX Ventures, Lifeforce Capital, and Refactor Capital. The proceeds from Mythic’s Series B will finance the lead program through first-in-human clinical studies in lung cancer and fund pipeline development.

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"We are thrilled to partner with this distinguished group of investors," said Alex Nichols, PhD, co-founder, President, and CEO of Mythic Therapeutics. "This financing validates the FateControl approach and supports our efforts to achieve expanded use of Mythic’s ADCs within and across indications, translating to improved outcomes for patients with unmet medical needs."

Although the development history of ADCs spans more than four decades, the clinical benefit of ADCs has so far remained limited to a subset of diseases and targets with optimal biological characteristics, such as high levels of target expression. Mythic has developed a breakthrough approach to expand the role of ADCs in precision medicine by dramatically improving ADC therapeutic index against a broad set of molecular targets and patient profiles.

"To date, approaches to improve the performance of ADCs have focused primarily on innovation in one of three dimensions: linker and payload chemistries, conjugation technology, and new target biology," said Brian Fiske, PhD, co-founder and Chief Scientific Officer of Mythic Therapeutics. "Mythic seeks to improve the clinical performance of ADCs by introducing a new dimension of ADC technology focused on manipulating the fate of ADCs within the cell."

ADCs are designed to specifically deliver a therapeutic payload to a target tissue or disease site. However, studies have demonstrated that the vast majority of payload is ultimately released non-specifically throughout the body, causing systemic toxicity and reducing efficacy. Mythic’s FateControl technology increases the amount of ADC that is internalized by the target tissue while reducing payload release in non-targeted tissues, thereby improving therapeutic index independent of the linker and payload. Mythic’s lead program in lung cancer has the potential to drive a multi-fold expansion of the number of lung cancer patients eligible for treatment using ADCs; the company plans on developing a pipeline of products incorporating its platform technology.

"Venrock was attracted by Mythic’s innovative strategy to overcome one of the most historically challenging obstacles to realizing the full potential of ADCs for patients," said Bryan Roberts of Venrock, a member of Mythic’s Board of Directors. "The progress this team has made in a short time reinforces our deep conviction in Mythic’s ability to develop a pipeline of safer and more effective ADCs, beginning with their lead program. We are delighted to be part of the Mythic story."

Leadership

Alex Nichols, PhD, Co-Founder, President, CEO, and Director
Brian Fiske, PhD, Co-Founder, Chief Scientific Officer, and Director
Sandra Poole, MASc, PEng, Chief Operating Officer
In addition to Alex and Brian, the Mythic Therapeutics Board of Directors is comprised of:

Bryan Roberts, PhD, Partner, Venrock
Josh Kopelman, Partner, First Round Capital
Peter Hecht, PhD, Co-Founder and CEO, Cyclerion; Co-Founder and former CEO, Ironwood Pharmaceuticals
Scientific Advisory Board

Douglas E. Williams, PhD, President and CEO, Codiak Biosciences
John Lambert, PhD, former EVP and CSO, ImmunoGen
Michael Vasconcelles, MD, Chief Medical Officer, Flatiron Health
Richard Gregory, PhD, former CSO, ImmunoGen and former head of R&D, Sanofi
Scott J. Dylla, PhD, Co-Founder and Former CSO, Stemcentrx