On March 22, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported the publication of preclinical development data for SRK-181 in the peer-reviewed journal International Journal of Toxicology (Press release, Scholar Rock, MAR 22, 2021, View Source [SID1234576973]). SRK-181 is a product candidate that has been shown to be a potent and highly specific inhibitor of latent growth factor-beta 1 (TGFβ1) activation in preclinical studies. SRK-181 is being developed to overcome primary resistance to checkpoint inhibitor therapy and is currently being studied in the two-part DRAGON Phase 1 trial in patients with locally advanced or metastatic solid tumors exhibiting primary resistance to anti-PD-(L)1 therapy.

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"This publication provides a comprehensive preclinical assessment of the pharmacology, pharmacokinetics, and safety of SRK-181, which support its evaluation in the DRAGON Phase 1 trial," said Gregory Carven, Ph.D., Chief Scientific Officer of Scholar Rock. "The initial clinical response and safety data from the DRAGON trial, which we anticipate by end of year, will provide an early look into SRK-181’s safety and tolerability profile and the potential for a specific inhibitor of latent TGFβ1 to overcome the immune exclusion that we believe, for many patients, is responsible for primary resistance to checkpoint inhibitor therapies."

Targeting the TGFβ1 Pathway

Greater understanding of the role of TGFβ signaling in promoting cancer progression has led to heightened interest in the development of therapies that inhibit the TGFβ pathway. However, most of the approaches to date have been non-selective and target at least two of the three TGFβ isoforms, which may limit the therapeutic window and potentially result in a lack of efficacy, an unfavorable safety profile, or a combination of the two. Examples of dose-limiting toxicities observed nonclinically for nonselective anti-TGFβ therapies include cardiovascular abnormalities, skin lesions, epithelial oral hyperplasia, and gingival bleeding.

Scholar Rock’s approach to targeting the TGFβ pathway is fundamentally different. SRK-181 is a highly specific inhibitor of the latent TGFβ1 isoform with minimal or no binding to latent TGFβ2, latent TGFβ3, or any of the active TGFβ growth factors based on in vitro studies. Based on preclinical evaluations of SRK-181’s pharmacologic and safety profiles across multiple animal species, SRK-181 may offer an improved safety profile and a wider therapeutic window than non-selective TGFβ inhibitors.

About the Preclinical Data

The International Journal of Toxicology publication, "Nonclinical Development of SRK-181: An Anti-latent TGFβ1 Monoclonal Antibody for the Treatment of Locally Advanced or Metastatic Solid Tumors," provides a comprehensive preclinical assessment of the pharmacology, pharmacokinetics, and safety of SRK-181. (Welsh et al., Int J. Tox, March 19, 2021). Key findings include:

Selective inhibition of latent TGFβ1 activation by SRK-181 was shown to avoid dose-limiting toxicities associated with pan-TGFβ inhibitors in preclinical pharmacology studies.
In-vitro studies showed that SRK-181 had no effect on human platelet aggregation, activation, or binding and that SRK-181 does not trigger a proinflammatory cytokine response in peripheral blood mononuclear cells (PBMC).
Four-week toxicology study showed that weekly intravenous administration of SRK-181 achieved sustained serum exposure and was well-tolerated in rats and monkeys with no treatment-related adverse findings.
No observed adverse effect level (NOAEL) of 200 mg/kg and 300 mg/kg were achieved in rats and cynomolgus monkeys, respectively.
Preclinical pharmacologic and pharmacokinetics assessments provided support for the dose-selection strategy for the ongoing DRAGON Phase 1 trial in patients with solid tumors.
About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumors, particularly for those tumors where checkpoint therapies are currently approved. Based on profiling of human tumors that are resistant to anti-PD-(L)1 therapy, data suggests TGFβ1 is a key contributor to excluding immune cell entry into the tumor microenvironment, thereby preventing normal immune function. Scholar Rock believes SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy. By specifically targeting the latent TGFβ1 isoform, Scholar Rock hypothesizes that SRK-181 can increase the therapeutic window by potentially avoiding toxicities associated with non-selective TGFβ inhibition. A Phase 1 proof-of-concept clinical trial in patients with locally advanced or metastatic solid tumors is ongoing. The effectiveness and safety of SRK-181 have not been established and SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

On March 22, 2021 EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibody development, reported the closing of a $120 million Series C financing round (Press release, EpimAb Biotherapeutics, MAR 22, 2021, View Source [SID1234576974]). The round was co-led by China Merchants Bank International (CMBI) and Mirae Asset Financial Group (Mirae), and joined by Hony Capital, Cormorant Asset Management, Yanchuang Capital, Octagon Capital, renowned cultural entrepreneur and investor Adrian Cheng and ShangBay Capital, with strong participation from existing investors such as Decheng Capital, SDIC Fund, Sherpa Healthcare Partners, and Hidragon Capital. Proceeds from the financing will be used to fund the ongoing clinical development of EMB-01, EMB-02 and EMB-06, and to expand the company’s pipeline of novel bispecific antibodies and other biologics. Tony Rong, nominated by CMBI, and Sungwon Song, nominated by Mirae, will also join the EpimAb Board of Directors.

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"The completion of our Series C financing will enable us to accelerate the development of our three clinical assets EMB-01, EMB-02 and EMB-06, and to advance our rich pipeline of preclinical programs into the clinic as we continue to build on our portfolio of novel bispecific antibodies generated based on our proprietary FIT-Ig technology," said Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. "With three candidates currently progressing through clinical trials and several ongoing high-value development projects in the pipeline poised to move towards the clinic, we are confident in our development strategy and our potential for long-term value generation. We greatly appreciate the support from our new and current investors as we move into this next phase of our company’s development and remain committed to bringing innovative bispecific antibody therapeutics to patients worldwide."

EpimAb is creating a pipeline of novel proprietary bispecific antibody therapeutics with a focus on oncology and other areas of high value to patients. EMB-01, EpimAb’s lead candidate designed to simultaneously target EGFR and cMET on tumor cells, is currently progressing through a Phase I/II clinical study in both China and the U.S. EMB-02, EpimAb’s second clinical candidate, which simultaneously targets two checkpoint proteins, PD-1 and LAG-3, and has shown strong anti-tumor activities in preclinical models resistant to standard anti-PD-1 monotherapies, recently received FDA clearance to progress into the clinic in the U.S. EMB-06, a T cell engaging bispecific designed to simultaneously target CD3 and BCMA with differentiated properties, has been cleared to initiate clinical trials in Australia.

"EpimAb is among the premier innovative biopharmaceutical companies in China, revolutionizing the bispecific antibody space with a proprietary technology that has global potential," said Tony Rong. "As we continue to expand our global life sciences portfolio, CMBI is committed to support EpimAb’s mission of bringing novel bispecific therapeutics to patients."

"Each of EpimAb’s assets impressed us with enormous potential and a unique approach to treating areas of high unmet medical need. EpimAb’s dedicated pipeline of bispecific antibodies with best-in-class mechanisms makes it one of the driving forces behind Chinese biopharma innovations," said Sungwon Song. "Mirae is excited to be a part of the company’s rapid evolution to become a global leader in its space."

On March 22, 2021 Nuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, reported that Oxilio Ltd ("Oxilio") has exercised its option to acquire a licence for NXP001 (a proprietary new form of aprepitant) for oncology indications (Press release, Nuformix, MAR 22, 2021, View Source [SID1234621610]).

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· On 23 September 2020, Nuformix granted an exclusive option to Oxilio, a private pharmaceutical development company, to license NXP001 globally for oncology indications. This triggered the first upfront payment and the option period ran until 23 March 2021
· Nuformix and Oxilio will now work together to finalise a global licensing agreement for NXP001. Once this has been agreed, this will trigger a second undisclosed upfront payment, payable to Nuformix. Under this agreement, Nuformix will license its patent estate and know-how on NXP001 in return for development milestone payments and a royalty on any future net sales, capped at £2m per annum

Dr Anne Brindley, CEO of Nuformix, said: "We are very pleased that Oxilio has exercised its option for NXP001, allowing them to continue the development of NXP001 in oncology. We will now look to finalise the licensing agreement with Oxilio that will provide Nuformix with near term revenue and an opportunity to benefit from the upside of the significant global oncology market. This successful outcome endorses the Nuformix strategy of identifying new improved forms of existing drugs for repurposing into new indications with early-stage licensing during the pre-clinical or Phase 1 stages of development."

Dr Simon Yaxley, Co-Founder and Director of Oxilio said: "Exercising our option gives us the opportunity to continue to develop NXP001 in line with our approach to optimise the delivery of our drug for the effective treatment of certain cancers. We look forward to continuing our collaboration with Nuformix to realise the huge potential of this approach."

About NXP001
NXP001 is a proprietary new form of the drug aprepitant that is currently marketed as a product in the oncology supportive care setting (chemotherapy induced nausea and vomiting). A disadvantage of aprepitant is that its suboptimal properties necessitate a complex formulation. Nuformix discovered new forms of aprepitant (NXP001) with improved properties and it has granted patents on its new forms.

About NXP001 and Oxilio
Oxilio will develop and seek to exploit NXP001 globally for the treatment of cancer. Cancer is one of the world’s primary causes of death. The total worldwide annual economic cost of cancer is substantially in excess of US$1 trillion. Traditional cancer treatments such as surgery, chemotherapy and radiotherapy are expensive and often have debilitating consequences for the patient. Costs of cancer drug treatments are also increasing, in large part due to the expense of taking new drugs through clinical trials where historically there is a very low rate of success. Therefore, there is an urgent need to develop safe, effective, and readily available anticancer agents.

Oxilio is focused on alleviating the current dilemma of a shortage of effective drug candidates that have potential as new cancer therapies, by adopting a drug repurposing strategy (identifying new uses for approved or investigational drugs that are outside the scope of the original medical indication). The major advantage of this approach is that the pharmacokinetics, pharmacodynamics and toxicity profiles of these drugs are already reasonably well established. Thus, drug repurposing is a less risky development route with substantially lower associated development costs. The agreement with Nuformix allows Oxilio to focus on developing rapidly a unique formulation and dosage form with NXP001 and progressing into the clinic.

Oxilio is a privately held pharmaceutical development company focused on repurposing known drugs for the treatment of cancer through a programme of corporate alliances coupled with rapid proof of concept clinical development.

On March 22, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa" or the "Company"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co. under which the underwriter has agreed to purchase on a firm commitment basis 1,904,762 shares of common stock of the Company at a public offering price of $5.25 per share, less underwriting discounts and commissions (Press release, Anixa Biosciences, MAR 22, 2021, View Source [SID1234576955]). The Company also has granted the underwriter a 30-day option to purchase up to an additional 285,714 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about March 25, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $10 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by the Company and excluding the exercise of the underwriter’s option to purchase additional shares. The Company intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to its technologies, and licensing activities related to current and future product candidates and working capital.

The shares of common stock are being offered pursuant to an effective registration statement on Form S-3 (File No. 333-232067) that was filed with the U.S. Securities and Exchange Commission ("SEC") on June 11, 2019 and declared effective on June 21, 2019. The shares of common stock may be offered only by means of a prospectus supplement forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when filed, may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (212) 856-5711.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 22, 2021 EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibody development, reported the closing of a $120 million Series C financing round (Press release, EpimAb Biotherapeutics, MAR 22, 2021, View Source [SID1234576974]). The round was co-led by China Merchants Bank International (CMBI) and Mirae Asset Financial Group (Mirae), and joined by Hony Capital, Cormorant Asset Management, Yanchuang Capital, Octagon Capital, renowned cultural entrepreneur and investor Adrian Cheng and ShangBay Capital, with strong participation from existing investors such as Decheng Capital, SDIC Fund, Sherpa Healthcare Partners, and Hidragon Capital. Proceeds from the financing will be used to fund the ongoing clinical development of EMB-01, EMB-02 and EMB-06, and to expand the company’s pipeline of novel bispecific antibodies and other biologics. Tony Rong, nominated by CMBI, and Sungwon Song, nominated by Mirae, will also join the EpimAb Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The completion of our Series C financing will enable us to accelerate the development of our three clinical assets EMB-01, EMB-02 and EMB-06, and to advance our rich pipeline of preclinical programs into the clinic as we continue to build on our portfolio of novel bispecific antibodies generated based on our proprietary FIT-Ig technology," said Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. "With three candidates currently progressing through clinical trials and several ongoing high-value development projects in the pipeline poised to move towards the clinic, we are confident in our development strategy and our potential for long-term value generation. We greatly appreciate the support from our new and current investors as we move into this next phase of our company’s development and remain committed to bringing innovative bispecific antibody therapeutics to patients worldwide."

EpimAb is creating a pipeline of novel proprietary bispecific antibody therapeutics with a focus on oncology and other areas of high value to patients. EMB-01, EpimAb’s lead candidate designed to simultaneously target EGFR and cMET on tumor cells, is currently progressing through a Phase I/II clinical study in both China and the U.S. EMB-02, EpimAb’s second clinical candidate, which simultaneously targets two checkpoint proteins, PD-1 and LAG-3, and has shown strong anti-tumor activities in preclinical models resistant to standard anti-PD-1 monotherapies, recently received FDA clearance to progress into the clinic in the U.S. EMB-06, a T cell engaging bispecific designed to simultaneously target CD3 and BCMA with differentiated properties, has been cleared to initiate clinical trials in Australia.

"EpimAb is among the premier innovative biopharmaceutical companies in China, revolutionizing the bispecific antibody space with a proprietary technology that has global potential," said Tony Rong. "As we continue to expand our global life sciences portfolio, CMBI is committed to support EpimAb’s mission of bringing novel bispecific therapeutics to patients."

"Each of EpimAb’s assets impressed us with enormous potential and a unique approach to treating areas of high unmet medical need. EpimAb’s dedicated pipeline of bispecific antibodies with best-in-class mechanisms makes it one of the driving forces behind Chinese biopharma innovations," said Sungwon Song. "Mirae is excited to be a part of the company’s rapid evolution to become a global leader in its space."