On September 27, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported its U.S. commercialization plan for APHEXDA (Motixafortide) in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients (Press release, BioLineRx, SEP 27, 2022, View Source [SID1234621514]). If approved, the Company intends to commercialize APHEXDA in the U.S. independently in order to accelerate its availability to patients and to maximize the value of this innovative therapeutic candidate. To lead its U.S. operations and drive commercial strategy, the Company has appointed commercial product veteran Holly May to the role of President, BioLineRx USA.

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In the U.S., autologous stem cell transplants for patients with multiple myeloma and other conditions are highly concentrated within academic and regional centers. To support a robust commercial launch, the Company will employ a small and targeted sales force to support outreach to this well-defined community.

"We are excited to announce our plan to commercialize Motixafortide, now known by its FDA approved trade name APHEXDA, independently in the U.S., assuming FDA approval next year," said Philip Serlin, Chief Executive Officer of BioLineRx. "Our approach ensures focused outreach to transplant centers and enhanced value for the Company over other potential commercialization approaches examined. Since the beginning of 2022, we have been advancing key pre-launch activities. Our progress, together with our recent financings, puts us in an ideal position to efficiently build the additional infrastructure and targeted sales team to ensure the rapid uptake of APHEXDA."

"Our independent market research suggests that the U.S. market for mobilization agents used in stem cell transplants is approximately $360 million annually and growing," said Holly May, President, BioLineRx USA. "Given the totality of clinical and pharmacoeconomic data that we have compiled to date, we believe APHEXDA, if approved, can quickly become part of a new standard of care, allowing us to capture a significant share of this opportunity. Our U.S. commercial team is actively engaged in launch preparedness and excited about the potential of bringing this important therapeutic candidate to patients."

The Company recently announced that it submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Motixafortide in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients.

The NDA submission is based on the overwhelmingly positive top-line results from BioLineRx’s GENESIS Phase 3 trial of Motixafortide on top of G-CSF (versus placebo on top of G-CSF) in stem cell mobilization for autologous bone marrow transplantation in multiple myeloma patients. The study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001). The combination was also found to be safe and well tolerated.

Investor and Key Opinion Leader Webinar
BioLineRx will provide more detail around its U.S. launch plans during an Investor and Key Opinion Leader Webinar that is occurring tomorrow, Wednesday, September 28, at 9:00 a.m. EDT.

The webinar will feature a presentation by Dr. John F. DiPersio, Chief of the Division of Oncology, Washington University School of Medicine, St. Louis, and lead investigator of BioLineRx’s GENESIS Phase 3 clinical study (the basis for the Company’s recently submitted New Drug Application), who will highlight the unmet need and current treatment landscape for the mobilization of stem cells (SCM) for multiple myeloma patients undergoing autologous stem cell transplantation.

Following Dr. DiPersio’s presentation, Lissa Gray, RN, who heads BioLineRx’s patient advocacy program, will moderate a panel discussion between an apheresis nurse, a multiple myeloma patient who underwent apheresis, and her caretaker, to provide a detailed assessment of the current treatment experience.

Holly May, President of BioLineRx USA, will then provide insight into the SCM market opportunity, as well as expand upon the Company’s plans to commercialize APHEXDA independently in the U.S., if approved.

Interested parties may register for the webinar here.

A replay of the webinar will be available on the Company’s Investor Relations page approximately two hours after the event’s completion. The webinar replay will be available until October 31, 2022.

About the GENESIS Trial
The GENESIS trial (NCT03246529) was initiated in December 2017. GENESIS was a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of Motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem-cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in only one apheresis session. In this regard, ~90% of patients in the GENESIS study went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide on top of G-CSF and in only one apheresis session, compared to less than 10% of those receiving G-CSF alone. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow with tumors. In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S. While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.

About Autologous Stem Cell Transplantation
Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In the U.S., nearly 15,000 ASCTs are performed each year with the majority in patients with multiple myeloma. The current standard of care includes the administration of 5-8 daily doses of granulocyte colony stimulating factor (G-CSF), with or without 1-4 doses of plerixafor, and the performance of 1-4 apheresis sessions. For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy is carried out, consisting of 1-4 additional doses of plerixafor on top of G-CSF, and the performance of an additional number of apheresis sessions as necessary. In light of this, an agent with superior mobilization activity may significantly reduce the mobilization and harvesting burden and associated risks of the ASCT process and lead to significant clinical and resource benefits.

On September 27, 2022, Nascent Biotech Inc. (the "Company") reported that entered into an agreement with YA II PN, Ltd. ("YA II"), an unrelated third party. YA II has already loaned the Company $1,000,000 (Filing, 8-K, Nascent Biotech, SEP 27, 2022, View Source [SID1234621510]). The third tranche of $500,000.00 will be paid at Closing of this transaction. In connection with the loan, the Company is issuing YA II its third Convertible Debenture (the "Third Debenture"). The Third Debenture is for $500,000.00, has a maturity date of one year and is due on September 27, 2023. The interest rate is six percent (6%) per annum. The Debenture may be converted at the lesser of $0.30 per share or eighty percent (80%) of the lowest VWAP of the Company’s common stock for ten consecutive trading days immediately prior to the conversion date. The Debenture may be prepaid in accordance with the terms set forth in the Debenture. The Debenture also contains certain representations, warranties, covenants, and events of default including, among other things, if the Company becomes delinquent in its periodic report filings with the Securities and Exchange Commission (the "SEC"). If an event of default occurs, the amount of the principal and interest rate due under the Debentures increases.

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YA II will not affect any conversion which will result in its holding more than 9.99% of our common stock. The Debenture provides for certain penalties for failure to timely deliver stock and contains other protective provisions for YA II. As required, the Company filed its Registration Statement on Form S-1 which was declared effective on September 26, 2022. As required under the terms of this financing, to date, $1,500,000 of the total proposed loan amount of $1,500,000 principal amount of the Debenture has been received.

On September 27, 2022 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecological cancers, reported updated cash guidance to extend its runway into Q1 2024 (Press release, Context Therapeutics, SEP 27, 2022, View Source [SID1234621503]).

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The company plans to defer noncritical R&D activities, reduce future overhead and infrastructure expenditures, and prioritize its onapristone extended release (ONA-XR) ELONA Phase 1b/2 clinical trial and Claudin 6 (CLDN6) program.

"Context has been fortunate to collaborate with two tremendous organizations – The Menarini Group and Integral Molecular. We believe these collaborations have broadened the therapeutic potential for ONA-XR through the ELONA trial and accelerated the development of a new treatment modality to address CLDN6 positive tumors," said Martin Lehr, CEO of Context Therapeutics. "In light of the challenging current investment climate for biotechnology, we are streamlining the organization’s resources with the intent to take the Company through the execution of the Phase 1b portion of the ELONA trial and the advancement of our CLDN6xCD3 bispecific antibody program to an Investigational New Drug Application (IND)."

The ELONA Phase 1b/2 clinical trial is evaluating ONA-XR, an oral progesterone receptor (PR) antagonist, in combination with Menarini’s elacestrant in estrogen receptor positive (ER+), PR+, HER2- metastatic breast cancer (mBCa) patients who have previously been treated with a CDK4/6 inhibitor. An IND amendment filed specifically for this trial was submitted to the U.S. Food and Drug Administration in September 2022. The Company remains on track to initiate the ELONA clinical trial in Q4 2022 and to report Phase 1b data in Q4 2023. Context retains worldwide rights for ONA-XR, other than the rights it out-licensed for Greater China.

Context anticipates the nomination of a CLDN6xCD3 bispecific monoclonal antibody (BsMAb) development candidate from the organization’s research collaboration with Integral Molecular in Q4 2022. An IND submission is planned in Q1 2024. Context retains worldwide rights to certain CLDN6 antibody patents in the field of bispecific antibodies.

In addition, Context will continue to provide access to ONA-XR through the Company’s ongoing Investigator-Sponsored Trials (ISTs) and anticipates sharing preliminary data from its Phase 2 clinical trials in granulosa cell tumors and endometrial cancer in November 2022, and from its Phase 2 clinical trial in breast cancer in December 2022.

"We’re fortunate to have ISTs that can continue to explore the potential of ONA-XR while we focus on derisking and moving our near-term priority programs forward," said Lehr. "We’re thinking long-term; Context is committed to improving the lives of women with cancer and we believe that these thoughtful and future-focused changes best position us to be nimble during the current market challenges. We continue to concentrate on fully realizing the value of our collaborations and pipeline."

On September 27, 2022 Optellum, an Oxford-based medtech company that provides a breakthrough AI platform to diagnose and treat early-stage lung cancer, reported that has raised $14 million in a Series A funding round (Press release, Optellum, SEP 27, 2022, View Source [SID1234621495]). The investment will enable Optellum to scale its base, operations, and commercial launches in the UK and USA; accelerate research and development; and expand its platform into personalized therapy decisions by integrating imaging data with molecular data, robotics, and liquid biopsies.

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Optellum is a commercial-stage lung health company providing artificial intelligence decision-support software that assists physicians in early diagnosis and optimal treatment for their patients. The company was founded so that every lung disease patient is diagnosed and treated at the earliest possible stage, when the probability of better health outcomes is highest.
Optellum is a commercial-stage lung health company providing artificial intelligence decision-support software that assists physicians in early diagnosis and optimal treatment for their patients. The company was founded so that every lung disease patient is diagnosed and treated at the earliest possible stage, when the probability of better health outcomes is highest.
This funding round was led by Mercia, with additional investors Intuitive Ventures (Sunnyvale, CA, USA) and Black Opal Ventures (New York, NY, USA). Existing investors, including St John’s College in the University of Oxford, IQ Capital, and the family office of Sir Martin & Lady Audrey Wood, also participated in this round.

Lung cancer is the most common type of cancer and the leading cause of cancer deaths in the world. Approximately 150,000 people in the United States and 1.8 million people worldwide die from lung cancer each year. The current worldwide five-year survival rate is 20 percent, primarily because most patients are diagnosed after symptoms have appeared and the disease has progressed to an advanced stage (Stage III or IV). In contrast, the survival rate for small tumors treated at Stage 1A is up to 90 percent. This disparity highlights a critical need for diagnosis and treatment at the earliest stage possible.

Optellum is the leader in AI-enabled lung cancer diagnosis, and the first and only medtech company to attain FDA clearance, CE-MDR in the EU, and UKCA in the UK for its software platform Virtual Nodule Clinic. This first-of-a-kind platform can help physicians identify and track at-risk patients, and optimally diagnose the signs of lung cancer early, so treatment can be started sooner for patients with tumors, and invasive procedures such as biopsies on benign lesions can be minimized.

Jason Pesterfield, CEO at Optellum, said: "With this strong support and commitment of highly specialized investors, we are positioned to accelerate commercial deployment in both the UK and the United States to expand our installed base. Following years of research and clinical trials that have shown the impact of our software on the diagnosis of at-risk lung nodules, we’re focused on expanding patient access to this crucial technology and identifying deadly lung cancer faster in more at-risk people. The funding will also boost our research and development with world-leading institutions and partners to progress further innovation."

Lead investor Mercia brings expertise in software technologies having a significant impact on global health issues and an existing portfolio that includes AI and machine-learning technology.

Investment Director at Mercia, Stephen Johnson, said: "Optellum is the latest in a series of companies to channel research from the UK’s world-leading universities into commercially viable products that can make a difference to the provision of medical care. Having observed Optellum achieve great milestones over the years, we are now excited to become part of their success and apply our experience with scaling up software and deep-tech companies to help accelerate Optellum’s impact on patient lives across the world."

Intuitive Ventures, the independent venture-capital arm of Intuitive (NASDAQ: ISRG), a world leader in medical robotics, including lung cancer care, was founded in 2020 to accelerate the future of minimally invasive care. The investment team supports Optellum’s ambitions to think and move beyond earlier diagnosis into decision support across the treatment pathway, integrating liquid biopsies, molecular tests, and drug therapies.

"Lung cancer is an urgent public health crisis and Optellum’s groundbreaking approach utilizing AI to accelerate early detection and intervention may fundamentally alter the healthcare community’s approach to combating this disease," said Oliver Keown, MD, managing director of Intuitive Ventures. "Optellum is uniquely positioned to align and provide considerable value to patients, providers, and payers alike. Intuitive Ventures is thrilled to provide our full arsenal of financial and strategic support to Optellum as we work towards a world of better outcomes for cancer patients."

Physician-led, female-founded fund Black Opal Ventures has a mission to build better businesses and a better future at the intersection of healthcare and technology. Its expertise in reimbursement and health economics will assist Optellum, which recently announced a New Technology Ambulatory Payment Classification for Medicare patients in the USA.

Founder Tara Bishop, MD, commented: "We value solutions that make medicine more accurate and accessible. The strong validation data that underpins the Optellum solution has demonstrated its ability to make a difference to patients. We share Optellum’s vision of making this available to every doctor in every hospital – and transform the diagnosis and treatment path for lung cancer."

Optellum’s platform was developed and clinically validated in partnership with leading universities and healthcare systems around the world. Optellum also has strategic collaborations with GE Healthcare and the Lung Cancer Initiative at Johnson & Johnson to accelerate clinical deployments and continue the advancement of the platform. In the UK, Optellum’s solution is being used to predict at-risk lung nodules in a multi-center study with NHS Trusts as part of a major investment in AI for healthcare.

On September 27, 2022 The Cancer Research Institute (CRI), a nonprofit organization dedicated to harnessing the immune system’s power to control and potentially cure all types of cancer, reported that it will confer its prestigious 2022 William B (Press release, Cancer Research Institute, SEP 27, 2022, View Source [SID1234621488]). Coley Award for Distinguished Research in Basic and Tumor Immunology on four scientists for their collective work that revealed the role of the pore-forming gasdermins in pyroptosis and promotion of anti-tumor immunity, setting the stage for targeting gasdermins in cancer therapeutics.

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Judy Lieberman, M.D., Ph.D., and Hao Wu, Ph.D., of Boston Children’s Hospital and Harvard Medical School, Feng Shao, Ph.D., of the National Institute of Biological Sciences, Beijing, and Vishva Dixit, M.D., of Genentech will receive their Coley Awards during an evening ceremony taking place Tuesday, September 27, at The New York Hilton Midtown, where CRI with its partners the European Network for Cancer Immunotherapy (ENCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) will host their four-day International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper).

Gasdermins (GSDMs) are a family of proteins originally identified and named from their expression in the gastrointestinal tract and the skin. In 2015, Dixit and Shao’s groups discovered that gasdermin D (GSDMD) is a substrate of inflammatory caspases, which are activated downstream of the immune system’s inflammasomes when they sense pathogen- or damage-associated molecules. GSDMD is the key executioner of inflammasome-induced inflammatory cell death called pyroptosis in immune sentinel cells and is responsible for the secretion of IL-1 family cytokines. Pyroptosis is a highly immunogenic form of cell death, and pyroptosis in cancer in theory could result in the release of danger-associated molecules and neoantigens to alert the immune system and promote antitumor immunity.

In 2016, Lieberman and Wu, and Shao, went on to demonstrate the mechanisms by which gasdermins effect cell death. Specifically, they discovered that upon processing by inflammatory caspases, the GSDMD N-terminal domain (GSDMD-NT) binds acidic lipids and forms cell membrane pores that are responsible for cell death. These pores also release mature IL-1 family cytokines and other danger signals, including chemokines, which recruit and activate immune cells to the site of danger. The requirement for binding to acidic lipids for GSDMD pore formation and the enrichment of these lipids in the inner leaflet of the cytoplasmic membrane suggested that GSDMD kills from within the cell but does not harm bystander mammalian cells. Lieberman and Wu further showed that GSDMD kills bacteria upon activation by binding to an acidic lipid called cardiolipin on bacterial membranes. Shao developed a crystal structure of a GSDM family member, mouse GSDMA3, showing that GSDMD-NT is autoinhibited by the GSDMD C-terminal region in full-length GSDMD. Dixit and other groups subsequently published their identification of the pore-forming activity of GSDMD.

"Discovery of the pore-forming activity of GSDM proteins changed the definition of pyroptosis from a ‘fiery death’ induced by inflammasome activation to GSDM-mediated lytic cell death, opening the search for other proteolytic pathways for activating GSDMD and other GSDMs," says Frederick W. Alt, Ph.D., a Howard Hughes Medical Institute Investigator and director of the Program in Cellular and Molecular Medicine at Boston Children’s Hospital and a member of the CRI Scientific Advisory Council.

The direct relationship to cancer of another gasdermin, GSDME, became clear in a series of papers authored by Lieberman and Wu, and Shao. They showed that the expression of GSDME is often repressed or mutated to lose its function in cancers while expression of GSDME converts noninflammatory apoptosis to inflammatory pyroptosis, effectively altering immunogenically "cold" tumors that do not ignite an anticancer immune response into "hot" tumors that attract killer cytotoxic T lymphocytes and natural killer cells. Shao showed that delivery of gasdermins via cancer-targeting nanoparticles can result in cancer cell pyroptosis in mice, resulting in the suppression of entire tumor grafts, not only the targeted tumor tissue because the treatment activated an effective adaptive immune response to the tumor.

"The groundbreaking molecular and mechanistic studies carried out by Lieberman and Wu, Shao, and Dixit along with the preclinical development of effective therapeutics that can convert immunologically cold tumors to hot have made possible therapeutic interventions that specifically activate GSDMs in cancer cells to promote antitumor immunity and responsiveness to checkpoint blockade immunotherapy," said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute.

In addition to presenting the 2022 William B. Coley Award, the ceremony will also feature the presentation of the 2022 Frederick W. Alt Award for New Discoveries in Immunology to David Masopust, Ph.D., the McKnight University Professor and a Howard Hughes Medical Institute Faculty Scholar in the Department of Microbiology and Immunology at the University of Minnesota, for his body of research focused on T cell development and biology, primarily memory T cell development and behavior. The Alt Award is given to a former CRI postdoctoral fellow whose work has made a significant impact on the fields of immunology or tumor immunology. Masopust received CRI funding while carrying out postdoctoral research in the laboratory of renowned immunologist and virologist Rafi Ahmed, Ph.D., at Emory University, from 2002-2005.

About the William B. Coley Award for Distinguished Research in Basic and Tumor Immunology
The Cancer Research Institute established this award in 1975 in honor of Dr. William B. Coley, now regarded as the Father of Cancer Immunotherapy, whose daughter Helen Coley Nauts (1907-2001) founded the Cancer Research Institute. Considered CRI’s highest scientific accolade as well as a predictor of more widely recognized scientific honors including the Lasker Award and Nobel Prize, the Coley Award has been given to 119 immunologists and tumor immunologists including the 2022 recipients.