On November 1, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported it has entered into a worldwide research collaboration and license agreement with Merck, known as MSD outside the United States and Canada (Press release, Synthekine, NOV 1, 2021, View Source [SID1234594040]). The collaboration will leverage Synthekine’s proprietary surrogate cytokine agonist platform to discover, develop, and commercialize novel cytokine therapeutics.

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"At Synthekine, we are focused on advancing cytokine science through three protein engineering platforms to create optimized therapeutics in this important space. Our surrogate cytokine agonist platform produces a new class of cytokine therapeutics that are designed to deliver selective immunotherapies for the treatment of autoimmune diseases and cancer," said Debanjan Ray, chief executive officer of Synthekine. "We are thrilled to announce our first collaboration using this platform with an unequivocal leader in the field."

Under the terms of the agreement, Synthekine is responsible for initial research efforts in collaboration with Merck, and Merck will have exclusive rights to develop, manufacture and commercialize surrogate cytokine agonists for up to two cytokine targets. Initially, the collaboration will focus on a target that has the potential to treat autoimmune diseases. Merck will make an upfront payment and will make an additional one-time payment if it designates a second target. Synthekine will be eligible for up to $525 million in development, regulatory and commercialization milestones, as well as tiered royalties on net sales, for each target. Merck will provide research funding to Synthekine for programs under the collaboration.

"Emerging insights from immunology and oncology are providing new and different ways to think about treating diseases," said Dr. Dean Y. Li, president, Merck Research Laboratories. "We look forward to collaborating with Synthekine to evaluate new approaches to harness the therapeutic potential of cytokines."

Cytokines are small proteins that allow immune cells to communicate and are central to the body’s response to diseases and to the maintenance of immune homeostasis. Developing cytokines as therapeutics, however, is made challenging by the fact that cytokines are pleiotropic, meaning they can induce a range of responses across different cell types. Cytokine pleiotropy has historically led to the development of wild-type cytokines or mutein based therapies with narrow therapeutic windows, resulting in modest efficacy or dose limiting toxicities. Designed using a combinatorial engineering platform, Synthekine’s surrogate cytokine agonists dimerize or multimerize cytokine receptors in ways wild-type cytokines or mutein based approaches cannot, resulting in a wide range of selective and biased signaling possibilities.

On November 1, 2021 McKesson Corporation (NYSE: MCK) reported that it has entered into an agreement to sell its UK businesses to AURELIUS, a pan-European asset management group with offices in Munich, London, Stockholm, Madrid, Amsterdam, Milan and Luxembourg (Press release, McKesson, NOV 1, 2021, View Source [SID1234594056]). The transaction includes the sale of McKesson UK businesses LloydsPharmacy, LloydsDirect (previously Echo by LloydsPharmacy), AAH Pharmaceuticals, LloydsPharmacy Clinical Homecare, LloydsPharmacy Online Doctor, MASTA and John Bell & Croyden. The transaction is expected to close in fiscal 2022, subject to customary closing conditions, including receipt of required regulatory approvals.

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The agreement, which follows McKesson’s recently announced sale of certain European businesses, is another important step in advancing McKesson’s commitment to streamline the business and fully exit the European region.

"We are extremely proud of the role that our business has played to advance better healthcare in the UK, and especially the work during the pandemic to ensure that patients continue to have access to needed medicines and to assist the NHS with the distribution and administration of COVID-19 vaccines," said Brian Tyler, chief executive officer, McKesson. "As we explore strategic options to fully exit Europe, this transaction provides our UK operation with the best path forward to achieve its long-term growth potential, while allowing McKesson to focus future investments in strategic growth areas outside of Europe."

AURELIUS expects to support McKesson UK by further investing in and growing each of its business divisions. The pan-European multi-asset manager has a proven track record and focus on operational excellence and shares McKesson’s deep commitment to serving its customers.

On November 1, 2021, Theralink Technologies, Inc. (the "Company") reported that it entered into a Securities Purchase Agreement (the "SPA") with two investors (the "Investors") pursuant to which the Investors agreed to purchase convertible notes ("Notes") and accompanying warrants ("Warrants") for an aggregate investment amount of $1,000,000.00 (Filing, 8-K, Oncbiomune, NOV 1, 2021, View Source [SID1234594578]). The SPA contains customary representations, warranties, and covenants of the Company and Investors as detailed therein.

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The Notes have an aggregate face value of $1,000,000 and each Note bears interest at a rate of 8% per annum (which shall increase to 10% per year upon the occurrence of an "Event of Default" (as defined in the Notes)) and shall mature on November 1, 2026 (the "Maturity Date"). The Notes will be funded in two tranches on November 1, 2021 and December 1, 2021. The Notes are convertible into shares of the Company’s common stock at a conversion price equal to $0.00366 per share for any amount of principal and accrued interest remaining outstanding (subject to adjustment as provided therein). The Company may prepay the Notes at any time in an amount equal to 110% of outstanding principal balance and accrued interest.

In connection with each Note, the Investors were issued Warrants to purchase an amount of common stock equal to 20% of the shares of common stock issuable upon conversion of the Notes at an exercise price of $0.00366 per share (subject to adjustment as provided therein) until November 1, 2026. The Warrants are exercisable for cash at any time.

On November 1, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, reported that preclinical data for a conditionally activated interferon alpha-2b (IFN-a2b) will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (SITC 2021) taking place November 12-14, 2021, at the Walter E. Washington Convention Center in Washington, D.C (Press release, CytomX Therapeutics, NOV 1, 2021, View Source [SID1234593985]).

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"Cytokines are powerful immune modulators with much potential for the treatment of cancer. We are excited to showcase the preclinical safety and anti-cancer activity of our conditionally activated interferon, highlighting the versatility and robust therapeutic potential of CytomX Probody-based biologics," stated Marcia P. Belvin, Ph.D., senior vice president and head of research of CytomX Therapeutics.

Details on CytomX’s poster presentation at SITC (Free SITC Whitepaper) 2021 are as follows:
Presentation Title: Conditional Cytokine Therapeutics for Tumor-Selective Biological Activity: Preclinical characterization of a dual-masked IFN-a2b
Abstract: 706

On November 1, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported financial results for the third quarter ended September 30, 2021 (Press release, Lantern Pharma, NOV 1, 2021, View Source [SID1234594007]).

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"Lantern has continued to advance our portfolio, both clinically and in new preclinical indications, as well as rapidly expand our RADR A.I. platform this past quarter," stated Panna Sharma, President & CEO of Lantern Pharma Inc. "Our A.I. driven approach to oncology drug development will be pivotal in discovering additional indications for our existing compounds, as well as the identification of entirely new drug candidates. Our strong balance sheet with over $73.8 million of cash, cash equivalents and marketable securities as of September 30, 2021 provides us with a solid foundation as we execute on our clinical programs and expand our proprietary RADR A.I. platform."

Third Quarter 2021 and Subsequent Highlights:

Achieved over 10 billion data points from highly curated oncology datasets focused on increasing the performance and scale of our A.I. platform, RADR, for oncology drug development
LP-184 granted Orphan Drug Designation for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas by the U.S. Food and Drug Administration (FDA)
Announced positive preclinical data in glioblastoma with LP-184 and expanded GBM research collaboration with Johns Hopkins University
LP-184 granted Orphan Drug Designation for the treatment of pancreatic cancer by the FDA
Submitted poster presentation on the effectiveness of LP-184 in pancreatic cancers, which was accepted for presentation at the AACR (Free AACR Whitepaper) Virtual Special Conference: Pancreatic Cancer
Presented positive preclinical data for LP-184 in pancreatic cancers that have either high levels of PTGR1 expression or deficiencies/mutations in DNA damage repair genes
Confirmed LP-184 efficacy in the nanomolar range in the ultra-rare brain cancer, Atypical Teratoid Rhabdoid Tumor (ATRT), using animal models
Advanced two new undisclosed programs focused on rare cancers which are expected to advance into preclinical indications during 2022
Entered strategic collaboration with Deep Lens to accelerate patient enrollment for Lantern’s planned Phase 2 clinical trial for never-smokers with non-small cell lung cancer (NSCLC), utilizing LP-300 in combination with chemotherapy
Entered into a strategic collaboration with Code Ocean to facilitate the accelerated development of RADR both internally and with external collaborators while reducing development complexity and cost and increasing security and reproducibility
"We continue to advance our pipeline of drug candidates and made significant progress across multiple areas of our business during the third quarter," commented Panna Sharma, President and CEO of Lantern Pharma. "Specifically, we reported positive preclinical data for LP-184 in pancreatic cancer and GBM. LP-184 demonstrated remarkable efficacy, in both in vivo and ex vivo models, validating the in-silico predictions generated by our RADR A.I. platform. Based upon our highly encouraging preclinical data, the FDA granted LP-184 Orphan Drug Designations for the treatment of pancreatic cancer and glioblastoma multiforme and other malignant gliomas. Our plan is to develop LP-184 for a number of targeted oncology indications where we can exploit the important mechanistic insights we have obtained about the compound."

"Earlier today, we announced that our proprietary A.I. platform, RADR, has now surpassed 10 billion datapoints powered by a growing library of algorithms designed specifically to help solve challenging data and correlation problems in cancer drug development. This directly advances our stated goal of building the world’s largest A.I. platform for precision oncology drug development. Our RADR platform will be pivotal in uncovering potential new therapeutic opportunities for Lantern and developing insights into the creation of combination-therapy programs, both internally and through third-party collaborations to drive long-term shareholder value. Our goal is to expand RADR to over 20+ billion datapoints during 2022. This will not only open more opportunities for collaborations with additional biopharma partners, but will also dramatically accelerate development timelines, derisk key decisions and reveal new opportunities that may have gone undeveloped — ultimately leading to additional therapeutic opportunities for patients and additional sources of value for our investors. By advancing our clinical pipeline, cultivating new discoveries, and growing our RADR platform, we believe we have laid the groundwork for numerous upcoming catalysts in the quarters and years ahead. "

Anticipated Upcoming Milestones:

Lantern Pharma to host virtual Key Opinion Leader (KOL) event on LP-184 for the treatment of pancreatic cancer with Dr. Igor Astsaturov, an established, NCI -funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center and Dr. Kishor G. Bhatia, Chief Scientific Officer of Lantern Pharma on November 18th, 2021, World Pancreatic Cancer Day
Planned launch of 90 patient Phase 2 clinical trial in the US for LP-300 in NSCLC focused on never-smokers that are chemo naïve and failed/relapsed on TKI therapy
Share detailed scientific results from LP-184 collaborative research program in GBM after presentation at Society of Neuro Oncology conference November 18-21 in Boston, MA
Share results from other studies and preclinical work with LP-184 in pancreatic, bladder, GBM, ATRT and other tumors over the next several months
Launch Phase 1 clinical trial for LP-184 in solid tumors
Launch Phase 1/2 clinical trial for LP-184 in GBM
Progress LP-184 in ATRT towards Phase 1/2 clinical trial
Launch IND enabling studies for ADC program
Explore potential combinations for LP-184 and LP-300 with other existing approved drugs for additional targeted cancer indications
Strategically grow RADR A.I. platform to 20 billion datapoints, including continued expansion in blood cancers and additional rare cancers under review by our development team
Explore biopharma licensing and partnership opportunities
Third Quarter 2021 Financial Highlights:

Balance Sheet: Cash, cash equivalents, and marketable securities were $73.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020.
R&D Expenses: Research and development expenses were $2.96 million for the three months ended September 30, 2021, compared to $0.6 million for the three months ended September 30, 2020. The increase was primarily attributable to increased manufacturing related expenses and expenditures to advance and expand the Company’s product portfolio.
G&A Expenses: General and administrative expenses were $1.2 million for the three months ended September 30, 2021, compared to $1.1 million for the three months ended September 30, 2020. The nominal increase was primarily attributable to increased business and corporate development expenses, legal and patent related fees, and general and administrative related stock option expenses.
Net Loss: Net loss was $4.1 million for the three months ended September 30, 2021, compared to a net loss of $1.7 million for the three months ended September 30, 2020.
A copy of the Company’s quarterly report on Form 10-Q for the third quarter ended September 30, 2021 has been filed with the Securities and Exchange Commission and posted on the Company’s website at View Source

Conference Call & Webcast:
Monday, November 1, 2021 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time

To register for the live webcast, please sign up here: View Source
To access the conference by phone: One-tap dial-in: +19292056099,,99145071949#
A replay of the conference call will be available on the investor relations section of the Company’s website: ir.lanternpharma.com