On September 28, 2022 Pheon Therapeutics (Pheon), a leading Antibody-Drug Conjugate (ADC) specialist developing next generation ADCs for a wide range of hard-to-treat cancers, reported that launched following the closing of a $68 million Series A financing in March 2022 (Press release, Pheon Therapeutics, SEP 28, 2022, View Source [SID1234621482]). The investment will enable Pheon to advance its lead ADC program to clinical proof-of-concept and establish a pipeline of novel ADCs. The financing was led by Brandon Capital, Forbion and Atlas Venture, with participation from seed investor Research Corporation Technologies (RCT).

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Pheon’s lead program exploits a novel target that is highly expressed in a broad range of solid tumors. The lead compound is expected to reach IND within the next 18 months. Understanding there is no "one size fits all" in engineering ADCs, Pheon takes a methodical approach to ADC development. Using both novel and clinically validated mAbs and arming them either with warheads from its proprietary payload platform which boasts a novel mechanism of action or with off-the-shelf linker payload combinations, Pheon is finely attuned to balancing safety and efficacy for each target.

Chief Executive Officer Bertrand Damour heads the Company’s leadership team which includes industry veteran Leigh Zawel as Chief Scientific Officer. Pheon’s co-founders include Paul Jackson, Vice President R&D, and advisor Professor David Thurston. Professor Thurston was previously co-founder of Spirogen, whose payload technology is contained within ZynlontaTM, a recently approved ADC.

Bertrand Damour has over 20 years’ management experience in both the European and US biotech industries having been the CEO of several companies. He was previously CEO of NBE Therapeutics, the developer of NBE-002, an anti-ROR1 ADC which Boehringer Ingelheim acquired for $1.4 billion in 2020. Earlier in his career, he was CEO of GeneProt Inc., a US proteomics company; Mind NRG, a Swiss biotech in the field of CNS (which was acquired by Minerva Neurosciences); OncoEthix, a Swiss oncology company in the field of epigenetics, which was acquired by Merck & Co. for $375 million; and Synthena AG, a company developing oligonucleotide-based therapeutics for the treatment of genetic neuromuscular diseases. Bertrand has also held senior roles within the banking industry and has extensive expertise in corporate transactions including M&A, LBOs and IPOs, which he gained while working at JP Morgan, Rabobank International and Deutsche Bank in New York.

Bertrand Damour, Chief Executive Officer of Pheon Therapeutics, said: "Pheon is developing a first-in-class ADC and has built a highly differentiated proprietary payload platform which is gaining strong momentum. We are laser-focused on implementing our strategy to get our first program into clinical development as rapidly as possible and the preclinical data generated so far are very promising. The track record and expertise of the leadership team at Pheon is outstanding and I am proud to be working with them on this innovative approach to developing treatments for cancer patients."

Dr Leigh Zawel has over two decades of oncology drug discovery experience and was previously the CSO at NASDAQ-listed Cullinan Oncology where he oversaw the development of CLN-081, a best-in-class Exon20 EGFR TKI that was ultimately partnered with Taiho Pharmaceuticals and Zai Labs. Prior to Cullinan, Dr Zawel was Vice President and East Coast Site Head for Pfizer’s Centers for Therapeutic Innovation, a group that achieved four INDs in the four years under his remit. As an Oncology Site Head at Merck in the early 2010s he led the teams that brought the first ERK and P53/MDM2 inhibitors into the clinic. Dr Zawel also worked at the Novartis Institutes for Biomedical Research, where he brought one of the first IAP inhibitor compounds into early clinical development. Dr Zawel earned his PhD in the laboratory led by Professor of Biochemistry and Molecular Pharmacology at the New York University School of Medicine, Danny Reinberg, a biochemist whose contributions have impacted the fields of mammalian transcription, gene expression and epigenetics. Dr Zawel has published more than 35 scientific publications and is an author on 45 patents.

Dr Leigh Zawel, Chief Scientific Officer of Pheon Therapeutics, said: "ADC technology has reached an inflection point. At Pheon, I’m thrilled to be working with Bertrand and with the team that we have assembled which has deep technical expertise and the resources to develop the next generation of ADCs to positively impact the lives of patients with cancer."

On behalf of the Board, Chair Jonathan Tobin and Partner at Brandon Capital, said: "In the last few years ADC drugs have started to show unprecedented clinical efficacy through a better understanding of the properties that make an effective ADC, combined with next generation payloads and targets. We are excited by the potential of Pheon’s first-in-class antibody target coupled with its novel proprietary payload platform to make a significant contribution to the ADC field and cancer patients. Pheon has attracted a strong syndicate of investors with the likes of Brandon Capital, Forbion and Atlas, and a proven leadership team focused on rapidly bringing its first-in-class ADC to the clinic. We look forward to extending the benefit of these cutting-edge therapeutics to more patients through target and payload innovation at Pheon."

The Company’s Board includes Michael Gladstone, Partner at Atlas Venture; Jonathan Tobin, Chair, Partner at Brandon Capital; Rogier Rooswinkel, General Partner at Forbion; and Shaun Kirkpatrick, President Biotechnologies at Research Corporation Technologies (RCT) and Bertrand Damour, CEO of Pheon Therapeutics.

On September 27, 2022 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that the company will participate in the RBC Global CDMO Conference. Nick Green, president and chief executive officer, will be the featured speaker in a fireside chat at the conference, which will take place October 3-4, 2022 (Press release, Avid Bioservices, SEP 27, 2022, View Source [SID1234621515]).

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Details of the company’s participation are as follows:

RBC Global CDMO Conference

To listen to the webcast of the RBC fireside chat please visit: View Source

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."