On 2 December 2021 Oncology One Pty Ltd, reported a partnership with WEHI (Walter and Eliza Hall Institute of Medical Research) to develop new drugs for the treatment of cancer, in collaboration with Curtin University (Press release, Oncology One, DEC 2, 2021, View Source [SID1234629324]).

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The collaboration centres on the development of novel small molecule drugs to treat solid tumours, initially focusing on breast cancer.

The project will seek to identify small molecule compounds that specifically inhibit a novel target in breast cancer that drives tumour growth. If successful, further work will need to be undertaken to refine these compounds towards candidate therapies, which could enter clinical trials in due course.

Chair of Oncology One’s Scientific Advisory Board, Dr Ian Street, said: "This project represents an important next step for Oncology One in building a pipeline of drug discovery programs that are highly differentiated and address unmet clinical needs. We have made great progress in early breast cancer detection, and this has had a dramatic effect on reducing mortality. However, if early disease is missed and the cancer metastasises, then unfortunately prognosis is poor. We are very much looking forward to a productive collaboration with David and Pieter, and the drug discovery and research teams at WEHI and Curtin".

This transcontinental project originated in the research labs of Professor David Komander at WEHI and Associate Professor Pieter Eichhorn at Curtin University. The objective is to develop a new therapeutic for treating metastatic ER+ breast cancers that have escaped current treatments. The new therapeutic also has the potential to address unmet clinical needs in other cancers such as colorectal and brain.

WEHI Ubiquitin Signalling Division Head, Professor David Komander, said: "The ubiquitin system offers many opportunities for innovative cancer treatments. We are delighted to work with Oncology One on this exciting project and to translate our research to benefit cancer patients. The project was initially born in a collaboration with Curtin University, and we are excited to draw upon our strengths and to work with industry to improve treatments for a disease that continues to impact so many lives."

Breast cancer is the most prevalent form of cancer in women and accounts for over 2 million cases and over 600,000 deaths per year worldwide according to the World Health Organisation (WHO). The emergence of resistance to existing therapies is a major challenge in the treatment of many people with breast cancer, and new treatment modalities are urgently required to improve patient outcomes.

Curtin University Associate, Professor Pieter Eichorn, said: "While breast cancer survival rates have improved, there are millions of patients who don’t respond to current treatments. Through this collaboration drawing on the expertise of WEHI in drug discovery and Oncology One in drug development, we can find the best way to bring our cancer treatment discoveries to patients, and make a real difference to them and to their loved ones and families."

On December 2, 2021 EOM Pharmaceuticals, Inc. ("EOM"), a privately held, clinical-stage pharmaceutical company, and ImmunoCellular Therapeutics, Ltd. (OTC: IMUC) ("ImmunoCellular") reported that the companies have entered into and closed on a merger agreement pursuant to which the shareholders of EOM are now the majority shareholders of the combined company (Press release, EOM Pharmaceuticals, DEC 2, 2021, View Source [SID1234618848]). The merger will create a public company that will continue EOM’s focus on advancing novel immunomodulatory and retinal disease drug agents to address a range of inflammatory, viral, retinal, and other diseases. ImmunoCellular will be renamed EOM Pharmaceuticals Holdings, Inc. Pending the assignment of a new ticker symbol, EOM Pharmaceuticals’ Common Stock will continue to be quoted on the OTC Markets under the ticker symbol "IMUC." EOM may consider in the future changing the principal listing of the Company Common Stock to a national exchange, assuming it will then meet the relevant listing requirements.

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The combined company’s two pipeline assets are EOM613 and EOM147.

• EOM613 is an investigational peptide-nucleic acid solution believed to have both antiinflammatory and pro-inflammatory broad-spectrum cytokine effects. Patients are currently enrolled in R 1 : RESCUE, a Phase 1/2a open-label clinical study in Brazil evaluating EOM613 treatment in severe hospitalized COVID-19 patients with "cytokine storm" immune responses. EOM expects to announce data from this trial in first quarter 2022. Further clinical development of EOM613 includes planning a Phase 2a multi-center trial for cancer cachexia in the U.S. and initiating exploratory trials for rheumatoid arthritis.

• EOM147 is an investigational, reformulated broad-spectrum aminosterol with a unique intracellular mechanism for the treatment of retinal diseases. EOM147 affects multiple angiogenic growth factors such as VEGF, PdGF, and bFGF. This mechanism of action is uniquely differentiated from other retinal therapies that are only anti-VEGF and administered as an intraocular injection. The novel formulation, administered as an eye drop, represents a potential breakthrough that does not require intraocular injection. Planning is underway for Phase 2 ophthalmic trials for macular edema in patients with diabetic retinopathy and wet age-related macular degeneration (wet-AMD).

EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger said, "EOM’s merger with ImmunoCellular provides the resources necessary to advance our lead program, EOM613, as a potential treatment for COVID-19, as well as support the development of both EOM613 and EOM147. We look 2 forward to advancing our pipeline assets and delivering value to all our stakeholders, including patients, the scientific and medical community, and our stockholders."

"COVID-19 continues to pose a grave threat to millions of people worldwide and to challenge the medical and scientific community as it seeks to understand and treat the underlying causes and symptoms of this devastating disease," said EOM Chief Executive Officer and Director Irach Taraporewala, Ph.D. "We are grateful to the investigators and patients in Brazil who are currently participating in our EOM613 clinical trial and look forward to reporting initial results in early 2022."

"After an extensive review of strategic options for ImmunoCellular, we are pleased to announce the merger with EOM," said Gary S. Titus, ImmunoCellular’s Chairman of the Board. "We believe EOM’s focus on advancing novel immunomodulatory and retinal disease agents addressing unmet medical needs, as well as its experienced management team and board of directors, represent a potentially meaningful opportunity for stockholders in the newly combined company to realize long-term value."

About the Merger Pursuant to the merger agreement, EOM shareholders have exchanged all of their EOM common stock for newly issued shares of ImmunoCellular common and Series C convertible preferred stock. Postmerger, ImmunoCellular’s then-current equity holders will own approximately 3.5% and the former EOM equity holders will own approximately 96.5% percent of ImmunoCellular’s common stock, calculated on a fully diluted basis. Effective with the merger, all existing officers and directors of EOM have assumed their same positions in the new company and all existing officers and directors of ImmunoCellular have resigned. The transaction has been unanimously approved by the board of directors of both companies. EOM Pharmaceuticals Holdings, Inc. will be headquartered in Montvale, NJ. Bridgeway Capital Partners and its affiliates served as exclusive financial advisor to EOM on the transaction.

Management and Organization

The new senior leadership team at EOM Pharmaceuticals Holdings, Inc. includes Chief Executive Officer Irach Taraporewala, Ph.D.; EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger; EOM Co-founder, Chief Scientific Officer and Medical Director Shalom Z. Hirschman, M.D; Wayne I. Danson, Chief Financial Officer and Treasurer; and Scientific Advisor and Chair of the Scientific Advisory Board, Frank L. Douglas, Ph.D., M.D.

On December 2, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that the company will be presenting interim clinical data in a virtual poster on BDC-1001, starting on December 6, 2021 in conjunction with the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021 taking place on December 8 – 11, 2021 (Press release, Bolt Biotherapeutics, DEC 2, 2021, View Source [SID1234618692]). BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated to a TLR7/8 agonist with a non-cleavable linker.

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"The data we will be presenting at ESMO (Free ESMO Whitepaper) I-O includes more than 50 patients at increasing exposures and builds upon the data presented at ASCO (Free ASCO Whitepaper) 2021. We will be presenting additional insights into BDC-1001’s safety and tolerability profile, pharmacokinetics, tumor and serum biomarkers, and early signs of clinical activity. These interim results support continued investigation towards an optimal dosing regimen, as well as the initiation of a combination dose-escalation study with Opdivo by year-end," said Edith A. Perez, M.D, Chief Medical Officer of Bolt Biotherapeutics.

The poster will be available in the e-Posters section of the conference virtual platform as of December 6 at 12 p.m. CET:

Abstract Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors
Presenter: Manish R. Sharma, M.D., Associate Director of Clinical Research, START Midwest
Presentation Number: 164P
Timing: On-Demand Access

Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study at 8:00 a.m. ET/5 a.m. PT on Monday, December 6, 2021.

A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.

Opdivo is a trademark of Bristol-Myers Squibb Company.

On December 2, 2021 HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, reported it had licensed exclusive worldwide ex-China rights to the KRAS inhibitor, JMKX1899, from Shanghai Jemincare Pharmaceutical Co., Ltd. Jemincare will retain the relevant rights in the greater China area (Press release, HUYA Bioscience, DEC 2, 2021, View Source [SID1234596454]).

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Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, "We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program outlicensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs."

KRAS is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of KRAS in the switch-II region, which has made KRAS druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare filed the IND with the NMPA in October 2021. The parties will work closely to file the IND with the US FDA in 2021 to move towards clinical development.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "We are excited to have added the clinical stage KRAS inhibitor to our oncology pipeline especially to test in combination with our SHP2 inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide."

On December 2, 2021 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported that is has secured €280m of funding to significantly expand and advance its clinical pipeline, including its lead asset SOT101, an IL-15 superagonist, and three new clinical programs until end of 2023 (Press release, SOTIO, DEC 2, 2021, View Source [SID1234596442]).

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The funding will be used to advance SOT101 through two multi-indication phase 2 clinical trials: The phase 2 AURELIO-03 study tests SOT101 as monotherapy in patients with melanoma, squamous skin carcinoma and kidney cancer, and a planned phase 2 AURELIO-04 study will evaluate the combination of SOT101 with a checkpoint inhibitor.

This funding will also be used to advance three novel programs through phase 1: BOXR1030 is the company’s lead CAR-T program for the treatment of various solid tumors expressing GPC3. It’s based on the proprietary BOXR platform that aims to enhance the fitness of T cells in the hostile tumor microenvironment. The study is scheduled to start early 2022. SOT102 is a novel ADC with a best-in-class potential for Claudin 18.2 targeting therapies. A phase 1 dose escalation in patients with gastric and pancreatic cancer shall start in March 2022. Finally, SOTIO plans to initiate a phase 1 study with our first IL-15 based immunocytokine using a PD-1 inhibitor as the targeting arm by the end of 2022.

"We are very excited and grateful for the continued strong support we’ve received from PPF Group today and since our inception," said Radek Spisek, Ph.D., CEO of SOTIO. "This very significant funding will allow us to advance a broad pipeline of unique clinical stage programs to key value inflection points."

"Over the last several years SOTIO has created an attractive pipeline of programs based on multiple differentiated modalities," said Ladislav Bartonicek, CEO and shareholder of PPF Group. "We appreciate the successful track record of execution by the Company to this point and are confident that this funding will further enable SOTIO to continue building a unique, privately financed oncology company with a mature and diversified pipeline. It will be an important step to achieve our long-term goal of building a fully integrated oncology business."

The funding is contingent on the achievement of certain development and regulatory milestones.