On August 26, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will participate at the Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 at 3:30 p.m. Eastern Time (Press release, Personalis, AUG 26, 2021, View Source [SID1234586943]).

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On August 26, 2021 TumorGen Inc., a biotechnology company, reported that it has received a $390,000 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to validate a revolutionary microfluidic platform used to develop anti-metastatic therapies (Press release, TumorGen, AUG 26, 2021, View Source [SID1234586942]).

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With this funding, the company will test the new technology in lung cancer patients, capturing metastatic cancer cell clusters (MCCCs) in their blood. Analyzing MCCCs will lead to new drugs that directly target metastasis, potentially saving many lives.

Cancer treatments, particularly immunotherapies, have made tremendous advances in recent years; however, despite these breakthroughs, metastasis remains deadly. Researchers and clinicians have largely focused on primary tumors, yet 90% of cancer patients die from metastasis.

"Metastasis is the real killer of any cancer," said Jeffrey K. Allen, Ph.D., TumorGen’s Founder, President and CEO. "It’s time we start focusing on metastasis and change the way cancer is treated."

TumorGen scientists believe targeting MCCCs is the key to halting metastasis. These clusters are the malignant messengers tumors release into the blood stream to attack other vital organs. Unfortunately, MCCCs are extremely rare and challenging to find.

"It’s beyond difficult to develop new drugs that directly target metastasis if we can’t find and study the cells that are causing the cancer to spread," said Darren Finlay, Ph.D., Director of Tumor Analysis at the Sanford Burnham Prebys Medical Discovery Institute, an NCI-Designated Cancer Center and Co-Investigator on the grant. Dr. Finlay also stated: "TumorGen’s MCCC capture platform combines biomimicry and antibody-based cancer cluster capture technology in a revolutionary microfluidic system. It leverages the same bio-molecules found in human blood vessels; the same bio-molecules cancer cells use to home in on new metastatic sites."

Using this advanced microfluidic platform, TumorGen scientists will isolate extremely rare MCCCs from patients’ whole blood. Analyzing the captured MCCCs can reveal previously unseen therapeutic targets directly linked to metastasis.

"By giving biopharmaceutical companies better insights to develop cluster-buster drugs that stop metastasis, we give them a critical new tool to develop life-saving medicines," said Dr. Allen. "This technology has the power to refocus research on metastasis, where it’s most needed."

On August 26, 2021 OntadaTM, McKesson’s oncology and insights business, reported a strategic agreement with Merck, known as MSD outside the United States and Canada, that will facilitate the development of real-world research excellence and innovation OntadaTM, McKesson’s oncology and insights business, reported a strategic agreement with Merck, known as MSD outside the United States and Canada, that will facilitate the development of real-world research excellence and innovation. This agreement enables the two healthcare leaders to harness the power of real-world evidence (RWE) towards the common goal of improving patient outcomes and the quality of cancer care. Ontada and Merck’s combined experience and expertise can help enable the confidence, acceptance, and ultimately impact of RWE on the quality of patient care.

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Susan Shiff, PhD, president of Ontada, shared, "Building on McKesson’s long history in community oncology, Ontada is uniquely positioned to advance cancer care by enabling collaboration between life sciences companies and oncology providers. With data insights from greater than two million records available for research and more than 2,000 oncology providers, Ontada helps life sciences companies like Merck leverage real-world data (RWD) and evidence-based insights at the point of care to accelerate innovation and improve cancer therapy."

As part of the agreement, Merck and Ontada can collaborate on RWD studies to explore new scientific evidence, advanced methods development, and assessment of efficiency in cancer care.

"Merck is focused on bringing excellence to RWE generation by advancing methods and applying rigorous methods to gain RWD based insights," said Ravinder Dhawan, PhD, Vice President and Head, Center for Observational and Real-World Evidence (CORE), Merck Research Laboratories. "We look forward to working with Ontada on our shared purpose of improving the lives of patients with cancer."

"The patients we serve depend on strong relationships between oncology insights leaders like Ontada, life science innovators like Merck, and oncology providers," said Dr. Michael Seiden, MD, PhD, president, The US Oncology Network. "RWD studies build on the body of evidence that oncology providers use in their treatment decision making, and innovation depends on all of us working together to achieve continued improvements in patient outcomes."

Ontada combines real-world data and research capabilities, targeted channels to connect life sciences and providers for education and engagement, and a leading suite of technologies for oncology clinicians – including the iKnowMed℠ electronic health record system and Clear Value Plus℠ regimen support tool – with the reach of The US Oncology Network, supported by McKesson.. This agreement enables the two healthcare leaders to harness the power of real-world evidence (RWE) towards the common goal of improving patient outcomes and the quality of cancer care. Ontada and Merck’s combined experience and expertise can help enable the confidence, acceptance, and ultimately impact of RWE on the quality of patient care.

Susan Shiff, PhD, president of Ontada, shared, "Building on McKesson’s long history in community oncology, Ontada is uniquely positioned to advance cancer care by enabling collaboration between life sciences companies and oncology providers. With data insights from greater than two million records available for research and more than 2,000 oncology providers, Ontada helps life sciences companies like Merck leverage real-world data (RWD) and evidence-based insights at the point of care to accelerate innovation and improve cancer therapy."

As part of the agreement, Merck and Ontada can collaborate on RWD studies to explore new scientific evidence, advanced methods development, and assessment of efficiency in cancer care.

"Merck is focused on bringing excellence to RWE generation by advancing methods and applying rigorous methods to gain RWD based insights," said Ravinder Dhawan, PhD, Vice President and Head, Center for Observational and Real-World Evidence (CORE), Merck Research Laboratories. "We look forward to working with Ontada on our shared purpose of improving the lives of patients with cancer."

"The patients we serve depend on strong relationships between oncology insights leaders like Ontada, life science innovators like Merck, and oncology providers," said Dr. Michael Seiden, MD, PhD, president, The US Oncology Network. "RWD studies build on the body of evidence that oncology providers use in their treatment decision making, and innovation depends on all of us working together to achieve continued improvements in patient outcomes."

Ontada combines real-world data and research capabilities, targeted channels to connect life sciences and providers for education and engagement, and a leading suite of technologies for oncology clinicians – including the iKnowMed℠ electronic health record system and Clear Value Plus℠ regimen support tool – with the reach of The US Oncology Network, supported by McKesson.

On August, 26, 2021 ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported it had entered into a royalty purchase agreement with HealthCare Royalty Partners (HealthCare Royalty) (Press release, ADC Therapeutics, AUG 26, 2021, View Source [SID1234586940]).

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Under the terms of the $325 million financing agreement, ADC Therapeutics will receive $225 million upon closing, and is eligible to receive an additional $75 million upon the first commercial sale of ZYNLONTATM (loncastuximab tesirine) in Europe and an additional $25 million upon the achievement of a near-term commercial milestone for ZYNLONTA. In exchange, HealthCare Royalty will receive a 7% royalty on worldwide net sales and licensing revenue from ZYNLONTA, with the exception of greater China, Singapore and South Korea, and a 7% royalty on worldwide net sales and licensing revenue from Cami (camidanlumab tesirine) (subject to limited carve-outs). Based on performance tests in 2026 and 2027, these royalty rates are subject to potential upward adjustment, up to a maximum of 10%. The total royalty payable by ADCT to HealthCare Royalty is capped in the range of 2.25x to 2.50x of the amount paid to ADCT, dependent upon the amount of royalties paid by 2029. Once the cap is hit, the agreement terminates. Upon closing of this transaction, and together with the Company’s current cash balance and anticipated business plan, ADC Therapeutics will have a substantial multi-year working capital runway.

"This transaction reflects the significant value of ZYNLONTA and Cami. We are delighted to partner with HealthCare Royalty, a leading healthcare investment firm, to continue the development and commercialization of ZYNLONTA in combination with other drugs, in earlier lines of therapy and in new histologies, as well as to continue our development and commercialization plans for Cami," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "With this transaction, we are well-positioned to continue executing on our plans and improving the lives of patients."

"We are pleased to partner with ADC Therapeutics to reach their vision of developing and commercializing potent and targeted ADCs for patients with hematological malignancies and solid tumors," said Clarke Futch, Chairman and Chief Executive Officer of HealthCare Royalty. "Our investment reflects our belief in both ZYNLONTA and Cami to deliver value, and underscores our mission to facilitate innovation by high growth biopharmaceutical companies globally."

The agreement includes customary provisions for a transaction of this nature, a repayment provision at the Company’s option, and change of control provisions. The Company expects to close the transaction in early September. The Company has concurrently filed a Form 6-K which includes further details.

Morgan Stanley & Co. LLC acted as Sole Structuring Agent and Ropes & Gray LLP and Davis Polk LLP acted as legal advisors to ADC Therapeutics on the transaction. Gibson Dunn LLP acted as legal advisors to HealthCare Royalty.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, evading DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/ triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

On August 26, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that Derek Maetzold, president and chief executive officer, and Frank Stokes, chief financial officer, are scheduled to present a company overview at the following upcoming investor conferences (Press release, Castle Biosciences, AUG 26, 2021, View Source [SID1234586939]):

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2021 Virtual Wells Fargo Healthcare Conference on Sept. 9, 2021, at 9:20 a.m. Eastern time.
Baird 2021 Global Healthcare Conference on Sept. 15, 2021, at 9:40 a.m. Eastern time.
Live audio webcasts of the company’s presentations will be available by visiting Castle Biosciences’ website at View Source Replays of the webcasts will be available for two weeks following the conclusion of the live broadcasts.

Castle will also be available on Sept. 14, 2021, for one-on-one investor meetings during the Lake Street Capital Markets 5th Annual Best Ideas Growth (BIG5) Conference. Meetings may be requested exclusively through Lake Street Capital Markets.